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The Patriot SI Implant System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The Patriot SI Implant System is a minimally invasive sacroiliac joint fusion implant that pierces the cortical bone of the ilium and sacrum and is intended for the purpose of stabilizing and fusing the sacroiliac joint with intrinsic fixation features. It is available in one size and may be implanted using the designated surgical instruments into the SI joint space. Bone graft materials may be used with the Patriot SI Implant System. The Patriot SI Implant System device is made from additively manufactured titanium alloy, Ti-6Al-4V-ELI per ASTM F3001 and is offered with or without a hydroxyapatite (HA) coating per ASTM F1185. The Patriot SI Implant System device is provided sterile and individually packed.

The provided FDA 510(k) clearance letter for the Patriot SI Implant System does not contain any information regarding acceptance criteria or the study that proves the device meets those criteria for the purposes of an AI/software device.

The document is for a physical medical implant device (sacroiliac joint fusion implant). The information it provides is:

• Device Type: Patriot SI Implant System (a physical implantable device)
• Intended Use: Sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
• Materials: Additively manufactured titanium alloy, Ti-6Al-4V-ELI, with or without hydroxyapatite (HA) coating.
• Testing Information: "Non-clinical cadaveric biomechanical testing was performed to support substantial equivalence of the Patriot SI Implant system." This type of testing is relevant for mechanical implants, not AI/software.
• Predicate Device: Patriot-SI Posterior Implant System (K232259).

Therefore, I cannot provide details on acceptance criteria and study design for an AI/software device based on this document. The questions posed in your request (sample size, expert qualifications, MRMC studies, standalone performance, ground truth types) are universally applicable to AI/software performance studies, but the source document is entirely about a physical hardware device.

If you have a document describing an AI/software medical device, I would be happy to analyze it according to your criteria.

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The Patriot-SI Posterior Implant System is intended for sacroiliac joint fusion including sacroiliac joint disruptions and degenerative sacroiliitis. When the Patriot Implant System (i.e., an "in-line" or "in-line" or "intraarticular" device) is implanted, it must be used with a Spinal Simplicity Liberty-SI Lateral System device (i.e., a "transfixing" device) implanted across the same sacroiliac joint to create a hybrid SI joint fusion construct.

The Patriot-Sl Posterior Implant System is a minimally invasive sacrolliac joint fusion implant that is intended for implantation on a trajectory in line with the joint space (i.e., the device is an in-line or intra-articular implant). The Patriot Implant System device is required to be implanted with the Spinal Simplicity Liberty-Sl Lateral System device implanted across the same sacroiliac joint to create a hybrid SI joint fusion construct for the purpose of stabilizing and fusing the sacroiliac joint. It is available in one size and may be implanted using the designated surgical instruments through a posterior approach into the Sl joint space, fixating on both the sacrum and ilium via external threads. Bone graft materials may be used with the Patriot-Sl Posterior Implant System. The Patriot-SI Posterior Implant System device is manufactured titanium alloy, Ti-6AI-4V-ELI per ASTM F3001 and is offered with or without a hydroxyapatite (HA) coating per ASTM F1185. The Patriot-SI Posterior Implant System device is provided sterile and individually packed.

This document describes a spinal implant device, not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, ground truth, and AI-specific metrics (like MRMC studies or standalone AI performance) is not applicable.

The document is a 510(k) premarket notification for the "Patriot-SI Posterior Implant System," which is a physical medical device for sacroiliac joint fusion. The FDA letter confirms that the device is substantially equivalent to a legally marketed predicate device (NADIA® SI Fusion System, K190580) based on non-clinical mechanical tests and cadaver testing.

Here's a breakdown of the provided information, emphasizing why the AI/ML-specific questions are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a physical implant, "acceptance criteria" and "reported device performance" are based on mechanical properties and safety/effectiveness relative to its predicate, rather than AI model metrics like sensitivity, specificity, or AUC. The document lists the types of non-clinical mechanical tests performed to support substantial equivalence:

The conclusion states that "performance testing provided in this 510(k) application demonstrates that the Patriot SJ Posterior Implant System is capable of performing as intended and is as safe and effective as the legally marketed predicate device." Specific numerical acceptance criteria or performance values are not included in this summary document.

2. Sample Size for Test Set and Data Provenance:

Not applicable, as this is a physical device. Mechanical tests involve test specimens, and cadaver testing involves human cadavers, but these are not "datasets" in the AI/ML sense. Data provenance regarding country of origin or retrospective/prospective is not relevant here.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. Ground truth for mechanical testing is derived from engineering principles and standards, and for cadaver testing, it pertains to the anatomical and biomechanical performance, typically evaluated by biomechanical engineers and potentially surgeons. There isn't a "ground truth" established by a panel of medical experts in the way it would be for an AI diagnostic algorithm.

4. Adjudication Method:

Not applicable. This concept pertains to resolving discrepancies in expert labeling or diagnoses for AI training/testing, which is not relevant for a physical implant's mechanical and cadaver testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This type of study assesses the impact of AI on human reader performance for diagnostic tasks. The Patriot-SI system is a surgical implant, not a diagnostic AI.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:

Not applicable. There is no algorithm to evaluate in a standalone manner.

7. Type of Ground Truth Used:

For the mechanical tests, the "ground truth" is defined by the requirements of the ASTM standards (F3574 and F2077) and the performance characteristics of the predicate device. For cadaver testing, it relates to the successful implantation and biomechanical stability observed. This is distinct from pathology, expert consensus, or outcomes data used for AI models.

8. Sample Size for the Training Set:

Not applicable. There is no AI model, and therefore no training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As there's no training set, there's no ground truth to establish for one.

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PATRIOT® Spacers (including CONSTITUTION®, SIGNATURE®, CONTINENTAL®, TransContinental®, and TransContinental® M) are interbody fusion devices indicated at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and had at least six (6) months of non-operative treatment. PATRIOT® Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, and anterior screw and rod systems). Hyperlordotic interbody devices (>20° lordosis) must be used with at least anterior supplemental fixation. All PATRIOT® TPS coated spacers are indicated for the same use as non-coated PEEK versions.

When used as thoracolumbar intervertebral body fusion devices, SUSTAIN® Spacers (including SUSTAIN® R. SUSTAIN®-IR, and SUSTAIN®-RT) are indicated at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc hemiation (with myelopathy), soondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. SUSTAIN® Spacers are to be used with autograft and/or allogenic bone graft comprised of cancellous, and/or corticocancellous bone graft. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). All SUSTAIN® TPS coated spacers are indicated for the same use as non-coated PEEK versions.

PATRIOT® (including CONSTITUTION®. SIGNATURE®. Spacers TransContinental®, CONTINENTAL®, TransContinental® and M) are thoracolumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. Each of the PATRIOT® spacers provides a different shape to accommodate various surgical approaches to the spine. CONSTITUTION® PLIF Spacers are inserted using a posterior or transforaminal approach. SIGNATURE® TLIF Spacers are inserted using a transforaminal or lateral approach. CONTINENTAL® ALIF Spacers are inserted using an anterior, anterolateral, or lateral approach. TransContinental® and TransContinental® M Spacers are inserted using an anterior, anterolateral, or lateral approach. All approaches may be used in the lumbar spine; only anterior, anterolateral, or lateral approaches may be used in the thoracic spine. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. Each spacer has an axial hole to allow grafting material to be packed inside the spacer.

SUSTAIN® Spacers (including SUSTAIN® R, SUSTAIN®-IR, and SUSTAIN®-RT) are devices that can be used as intervertebral fusion devices or as vertebral body replacement devices. When used as interbody fusion devices, each of the spacers provides a different shape to accommodate various surgical approaches to the spine. SUSTAIN Small, SUSTAIN-R, and SUSTAIN-RT Spacers are inserted using a posterior or transforaminal approach. SUSTAIN Arch Spacers are inserted using a transforaminal or lateral approach. SUSTAIN Large Spacers are inserted using an anterior, anterolateral, or lateral approach. SUSTAIN Oblique and SUSTAIN G Spacers are inserted using a posterior, transforaminal, or lateral approach. These spacers are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. Each spacer has an axial hole to allow grafting material to be packed inside the spacer.

These spacers are used to provide structural stability in skeletally mature individuals following discectomy, corpectomy, or vertebrectomy (including partial). All approaches may be used in the lumbar spine; only the anterior, anterolateral, or lateral approach may be used in the thoracic spine.

This document describes the premarket notification (510(k)) for two medical devices: PATRIOT® Lumbar Spacers and SUSTAIN® Spacers. It seeks clearance for additional implants and indications for these devices.

Based on the provided text, the acceptance criteria and the study that proves the device meets the acceptance criteria primarily revolve around demonstrating substantial equivalence to already legally marketed predicate devices, rather than a de novo clinical trial with specific performance metrics for the AI component. This is typical for 510(k) submissions for Class II medical devices like intervertebral body fusion devices, where the focus is on a comparison to existing cleared products.

Therefore, the table for "acceptance criteria and reported device performance" will be framed differently than for a typical AI/ML medical device, as the "performance" here is primarily about mechanical and physical characteristics matching predicates, and clinical support comes from literature rather than a new study with specific metrics.

Here's a breakdown of the information requested, as extractable from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

• Dynamic Compression
• Static Compression
• Compression-Shear
• Subsidence resistance
• Expulsion resistance | Mechanical testing conducted in accordance with:
• "Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Intervertebral Fusion Device," June 12, 2007
• ASTM F2077 (Dynamic and Static Compression and Compression-Shear)
• ASTM F2267 (Subsidence)
• Expulsion testing
  Result: Demonstrated substantial equivalence to the predicate spacers. |
  | Technological Characteristics Equivalence:
• Design
• Intended Use
• Material Composition
• Range of Sizes | Subject implants have the same technological characteristics as the predicate devices. |
  | Clinical Equivalence for Additional Indications:
• Safety and effectiveness for treating disc herniation, spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, or failed previous fusion (pseudarthrosis). | Published clinical data for interbody fusion devices provided.
  Result: The clinical data demonstrates that the use of interbody fusion devices for these conditions does not pose new risks to patients. |

2. Sample Size Used for the Test Set and Data Provenance

This document describes a 510(k) submission based on substantial equivalence and mechanical testing, not a clinical study with a "test set" of patients in the typical sense for AI/ML device validation.

• Sample Size for Test Set: Not applicable in the context of a prospective clinical trial. The "testing" referred to is mechanical testing of the devices themselves, on samples of the physical product. The number of samples for these mechanical tests is not specified in the document but would follow the requirements of the ASTM standards.
• Data Provenance: The mechanical testing is performed in a lab setting. The clinical support data is "published clinical data" for interbody fusion devices, implying retrospective analysis of existing medical literature. The specific country of origin for this literature is not stated but would typically encompass international studies.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Not applicable. For this type of 510(k) submission, ground truth isn't established by expert consensus on a test set of patient cases in the way it is for diagnostic AI. The "ground truth" for mechanical testing is derived from adherence to engineering standards. The rationale for clinical safety and effectiveness for new indications relies on a review of existing clinical literature by the manufacturer and the FDA.
• Qualifications of Experts: Not applicable in this context. The FDA's review committee would consist of qualified experts in orthopedic devices.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This wasn't a clinical test set requiring adjudication of patient cases.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This submission does not involve an AI component that assists human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done

• Standalone Study: Not applicable. This device is an intervertebral body fusion device, not a software algorithm.

7. The Type of Ground Truth Used

• Ground Truth:
  • For Mechanical Performance: Engineering standards (e.g., ASTM F2077, ASTM F2267) define the "ground truth" for mechanical properties and performance.
  • For Clinical Efficacy/Safety: Published clinical literature and established medical understanding of interbody fusion devices (for the new indications) serve as the "ground truth" for safety and effectiveness.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This is not an AI/ML device that requires a training set. The "training" in the context of device development would involve engineering design, prototyping, and iterative mechanical testing, not data-driven machine learning.

9. How the Ground Truth for the Training Set was Established

• Ground Truth for Training Set: Not applicable. As there is no AI/ML component, there's no "training set" or establishment of ground truth for such a set in the machine learning sense.

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PATRIOT® COLONIAL® ACDF Spacers are interbody fusion devices indicated at one or more levels of the cervical spine C2-T1 in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as intractable radioulopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. All PATRIOT® TPS coated spacers are indicated for the same use as non-coated versions.

PATRIOT® Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone. These devices are intended to be used with supplemental fixation, such as the ASSURE® or PROVIDENCE® Anterior Cervical Plate Systems.

When used as cervical intervertebral body fusion devices, SUSTAIN® SUSTAIN® R are intended for one or more levels of the cervical spine C2-T1 in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as intractable radior myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. These patients should be skeletally mature and have had at least six (0) weeks of non-operative treatment. All SUSTAIN® TPS coated spacers are indicated for the same use as non-coated versions.

SUSTAIN® Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone. These devices are intended to be used with supplemental fixation, such as the ASSURE®, PROVIDENCE®, or XTEND® Anterior Cervical Plate Systems.

PATRIOT® COLONIAL® ACDF Spacers are cervical interbody fusion devices used to provide structural stability in skeletally mature individuals following discectorny. PATRIOT® Spacers are inserted through an anterior cervical approach, and are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.

SUSTAIN® Spacers, including SUSTAIN® R, are devices that may be used as cervical intervertebral fusion devices. These spacers are available in different shapes and heights to accommodate various surgical approaches and anatomical needs. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.

The provided text is a 510(k) premarket notification for an intervertebral body fusion device. While it describes the device, its indications for use, and a basis for substantial equivalence, it does not include the detailed information required to answer your specific questions about acceptance criteria and a study proving device performance against those criteria.

Specifically, the document mentions:

• Mechanical testing (static compression-shear and torsion) in accordance with ASTM F2077 to demonstrate substantial equivalence to predicate spacers.
• Bacterial endotoxin testing (BET) in accordance with ANSI/AAMI ST72:2011.
• Clinical literature being provided in the submission to support additional indications.

However, it does not provide:

1. A table of acceptance criteria and reported device performance. It only states that testing was conducted "to demonstrate substantial equivalence."
2. Sample size used for the test set or data provenance for any clinical study.
3. Number of experts or their qualifications for establishing ground truth.
4. Adjudication method.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or effect sizes.
6. Details of a standalone (algorithm-only) performance study. The device is a physical implant, not an AI algorithm.
7. The type of ground truth used (e.g., pathology, outcomes data), as no specific clinical study is described in detail.
8. Sample size for the training set. There's no mention of a "training set" as this is not an AI/machine learning device.
9. How ground truth for the training set was established. (Not applicable for this type of device).

The document is a regulatory submission for a physical medical device (intervertebral body fusion spacers), not an AI/software device that would typically involve acceptance criteria related to accuracy, sensitivity, specificity, or reader studies with ground truth established by experts.

Therefore, I cannot provide the requested information based on the given input.

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The Patriot Spinal Fixation System, when used in the non-cervical posterior spine (TI to S1), is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudoarthrosis, and failed previous fusion.
In addition, when used placed between L5 and S1, the Patriot Spinal Fixation System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) in skeletally mature patients receiving fusion with autologous bone graft.

The Patriot Spinal Fixation System is a posterior, non-cervical, spinal fixation system consisting of a variety of shapes and sizes of rods, screws, and crosslinks, to provide temporary internal fixation and stabilization during bone graft healing as an adjunct to fusion of the thoracic, lumbar and sacral spine.

I am sorry but this document does not contain the information you are looking for. This document is a 510(k) premarket notification for a medical device called the "Patriot Spinal Fixation System." It primarily focuses on demonstrating the device's substantial equivalence to previously marketed predicate devices based on its design, materials, manufacturing, indications for use, and mechanical testing results.

The document does not contain information about:

• Acceptance criteria and reported device performance in the context of an AI/algorithm-based medical device.
• Sample sizes used for test sets or data provenance for such studies.
• Number of experts or their qualifications for establishing ground truth for AI model testing.
• Adjudication methods for test sets.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or effect sizes of human reader improvement with AI assistance.
• Standalone (algorithm only) performance studies.
• Types of ground truth used in AI model development (e.g., expert consensus, pathology, outcomes data).
• Sample sizes for training sets for AI models.
• How ground truth for training sets was established for AI models.

The "testing performed" mentioned in the document refers to mechanical integrity testing of the spinal fixation system components (static and dynamic compression, static torsion per ASTM F1717), not performance validation of an AI algorithm.

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FORTIFY® and FORTIFY® Integrated Corpectomy Spacers are vertebral body replacement devices intended for use in the thoracolumbar spine (T1-L5). FORTIFY® Spacers (titanium) are also intended for use in the cervical spine (C2-T1). All FORTIFY® TPS coated spacers are indicated for the same use as non-coated PEEK versions.

When used in the cervical spine (C2-T1), FORTIFY® devices (titanium) are intended for use in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor fracture or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal tissues in cervical degenerative disorders. These spacers are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

When used in the thoracolumbar spine (T1-L5), FORTIFY® Integrated devices are intended for use to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). These spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

The interior of the spacers can be packed with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft as an adjunct to fusion.

These devices are intended to be used with FDA-cleared supplemental spinal fixation systems that have been labeled for use in the cervical, thoracic, and/or lumbar spine (i.e., posterior screw and rod systems, anterior plate systems, and anterior screw and rod systems). When used at more than two levels, supplemental fixation should include posterior fixation.

XPand® Corpectomy Spacers (including XPand®-R) are vertebral body replacement devices intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, or unstable vertebral body due to tumor or trauma (i.e., fracture). XPand® Corpectorny Spacers are intended to be used with supplemental spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate system, and anterior screw and rod systems). The interior of the spacer can be packed with bone grafting material. XPand® Corpectomy Spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. All XPand® TPS coated spacers are indicated for the same use as non-coated PEEK versions.

NIKO® Corpectomy Spacers are vertebral body replacement devices intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). NIKO® Corpectomy Spacers are intended to be used with supplemental spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, and anterior screw and rod systems). The interior of the spacers can be packed with bone grafting material. NIKO® Corpectomy Spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. All NIKO® TPS coated spacers are indicated for the same use as non-coated PEEK versions.

When used as lumbar intervertebral body fusion devices, SUSTAIN® Spacers (including SUSTAIN® R, and SUSTAIN®-IR) are intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of nonoperative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis at the involved level(s). SUSTAIN®, SUSTAIN® R and SUSTAIN®-IR Spacers are to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion. SUSTAIN® TPS Spacers are to be used with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the CREO®, REVERE®, REVOLVE®, or BEACON® Stabilization Systems.

When used as cervical intervertebral body fusion devices, SUSTAIN® Spacers (including SUSTAIN® R) are intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) at one level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and at least six (6) weeks of non-operative treatment. SUSTAIN® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the ASSURE®, PROVIDENCE®, or XTEND® Anterior Cervical Plate Systems. All SUSTAIN® TPS coated spacers are indicated for the same use as non-coated PEEK versions.

When used as vertebral body replacement devices, SUSTAIN® Spacers (including SUSTAIN® R TPS) are intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, or unstable vertebral body due to tumor or trauma (i.e., fracture). The spacers are intended to be used with supplemental spinal frave been labeled for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacers can be packed with bone grafting material. SUSTAIN® Spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. All SUSTAIN® TPS coated spacers are indicated for the same use as non-coated PEEK versions.

COALITION® Spacers are interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) for one or two contiguous levels, depending on the system. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone, depending on the system.

The COALITION® Spacer is a stand-alone interbody fusion device intended for use at one or two levels of the cervical spine (C2-T1) and is to be used with two titanium alloy screws which accompany the implant. The spacer is to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.

The COALITION MIS™ Spacer is an interbody fusion device and is to be used with two titanium alloy screws or anchors which accompany the implants. When used with screws, COALITION MIS™ Spacers are stand-alone interbody fusion devices intended for use at one or two levels of the cervical spine (C2-T1). When used with anchors, COALITION MIS™ Spacers are intended for use at one level of the cervical spine (C2-T1) with additional supplemental fixation such as posterior cervical screw fixation. The spacer is to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.

The COALITION AGX™ Spacer is intended to be used with supplemental fixation, such as anterior cervical plates or posterior cervical screw fixation. When used with the COALITION AGX™ Plate, the plate-spacer assembly takes on the indications for use of the COALITION AGX™ Spacer, with the COALITION AGX™ Plate acting as the supplemental fixation. The COALITION AGX™ Plate and Spacer assembly is a stand-alone device intended for use at one level of the cervical spine (C2-T1) and is to be used with two titanium alloy screws which accompany the implant. The spacer is to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.

The COALITION AGX™ Plate is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), turnors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.

COALITION® TPS Spacers are stand-alone interbody fusion devices intended for use at one level of the cervical spine (C2-T1) and are to be used with two titanium alloy screws which accompany the implants. The spacers are to be filled with autogenous bone graft.

PATRIOT® Spacers (including Constitution®, Signature®, TransContinental®, and TransContinental® M) are interbody fusion devices intents with degenerative disc disease (DDD) at one or two continuous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis at the involved level(s). PATRIOT® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine (e.g. posterior pedicle screw and rod systems, anterior plate systems, and rod systems). Hyperlordotic interbody devices (>20° lordosis) must be used with at least anterior supplemental fixation. All PATRIOT® TPS coated spacers are indicated for the same use as non-coated PEEK versions.

PATRIOT® Spacers (including COLONIAL®) are interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) at one level. DDD is defined as discogenic pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. All PATRIOT® TPS coated spacers are indicated for the same use as non-coated PEEK versions.

PATRIOT® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the ASSURE® or PROVIDENCE® Anterior Cervical Plate Systems.

The ALTERA™ Spacer is an interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

The ALTERA™ Spacer is to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation.

The RISE® Spacer is a lumbar interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

The RISE® Spacer is to be filled with autogenous bone graft material. This device is intended to be used with supplemental fixation, such as the REVERE® or REVOLVE® Stabilization Systems.

CALIBER® Spacers are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). All CALIBER® TPS coated spacers are indicated for the same use as non-coated PEEK versions.

CALIBER® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the CREO®, REVERE® or REVOLVE® Stabilization Systems.

The ELSA™ Spacer is an interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The ELSA™ Spacer is to be filled with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone, may be used with two bone screws, and is to be used with supplemental fixation. Hyperlordotic (≥20°) implants must be used with the two bone screws and supplemental fixation in addition to the bone screws.

LATIS® Spacers are interbody for intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

LATIS® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation.

The MONUMENT™ Spacer is an interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The MONUMENT™ Spacer is to be filled with autogenous bone graft material, and is to be used with four titanium alloy screws that accompany the implant. The device is intended to be used with supplemental fixation (i.e. pedicle screws, facet fixation).

InterContinental® Plate-Spacers are lateral lumbar interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be sketally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). InterContinental® Plate-Spacers are to be filled with autogenous bone graff material, and are to be used with two titanium alloy screws which accompany the implant. These devices are intended to be used with supplemental fixation (e.g. pedicle or facet screw systems) in addition to the integrated screws. All InterContinental® TPS coated spacers are indicated for the same use as noncoated PEEK versions.

The MAGNIFY™ Spacer is an interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of nonoperative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The MAGNIFY™ Spacer is to be filled with autogenous bone graft material, and is to be used with supplemental fixation, such as the CREO®, REVERE® or REVOLVE® Stabilization Systems.

The MAGNIFY™-S Spacer is a stand-alone interbody fusion device in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of nonoperative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The MAGNIFY™-S Spacer is to be filled with autogenous bone graft material, and is to be used with three titanium alloy screws that accompany each implant.

INDEPENDENCE® (including INDEPENDENCE MIS™, and INDEPENDENCE MIS AGX™ Spacers) are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1), DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of nonoperative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis at the involved level(s). INDEPENDENCE® Spacers are to be filled with autograft bone graft composed of cancellous and/ or corticocancellous bone. All INDEPENDENCE® TPS coated spacers are indicated for the same use as non-coated PEEK versions.

INDEPENDENCE® are stand-alone interbody fusion devices intended to be used with three titanium alloy screws which accompany the implants.

INDEPENDENCE MIS™ are interbody fusion devices intended to be used with three titanium alloy screws or anchors which accompany the implants. When used with screws, these devices are stand-alone interbody fusion devices. When used with anchors, these devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation), Hyperlordotic implants (≥25° lordosis) are intended for use with supplemental fixation (e.g. facet screws or posterior fixation).

INDEPENDENCE MIS AGX™ Integrated Spacer and INDEPENDENCE MIS AGX™ Integrated Ti Spacer are interbody fusion devices that may be used with three titanium alloy screws or anchors which accompany the implants. When used with screws, these devices are stand-alone interbody fusion devices. When used with anchors, these devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). Hyperlordotic implants (≥25° lordosis) are intended for use with supplemental fixation (e.g. facet screws or posterior fixation).

INDEPENDENCE MIS AGX™ Spacers are C-shaped, non-integrated PEEK spacers that are intended to be used with supplemental fixation (e.g. facet screws or posterior fixation). When used in conjunction with the INDEPENDENCE MIS AGX™ Integrated Ti Spacer, these devices become the INDEPENDENCE MIS AGX™ Integrated Spacer.

Globus Medical's interbody fusion and vertebral body replacement devices are cervical, thoracic or lumbar devices used to provide structural stability in skeletally mature individuals following discectomy, corpectomy or vertebrectomy and may be inserted using an anterior, posterior, lateral or transforaminal approach. The devices are available in various heights and geometric options to accommodate surgical approaches and patient anatomy. Ridges on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. These devices are to be used in conjunction with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to be packed inside the device.

These devices are made from radiolucent PEEK polymer with titanium alloy or tantalum markers or titanium alloy, commercially pure titanium, titanium alloy, and cobalt chromium molybdenum al. Implants are also available with hydroxyapatite (HA) coating.

The provided document is a 510(k) Premarket Notification from Globus Medical Inc. to the FDA, focusing on updating the labeling for MRI compatibility of various intervertebral fusion and vertebral body replacement devices. It is not a study proving the performance of a device against specific acceptance criteria for a diagnostic AI/ML algorithm.

Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details cannot be extracted from this document, as it pertains to the MRI compatibility of physical implants, not a software algorithm.

However, I can extract the following relevant, albeit limited, information:

Area of Acceptance Criteria and Performance (related to MRI Compatibility):

The document states that MRI testing was performed per specific ASTM standards. While the specific numerical acceptance criteria (e.g., maximum displacement, temperature rise, artifact size) are not explicitly detailed in the provided text, the successful completion of these tests implies that the devices met the relevant acceptance criteria defined by these standards for MRI compatibility.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is the MRI testing conducted according to the following ASTM standards:

• ASTM F2052:2006: Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
• ASTM F2119:2007: Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
• ASTM F2182:11a: Standard Test Method of Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging
• ASTM F2213:2006: Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment

The document explicitly states: "No further device performance testing was required for this submission. The performance testing remains the same for the subject and predicate devices." This implies that the results of these ASTM standard tests were deemed acceptable by the FDA for the purpose of updating the MRI compatibility labeling.

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is not:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria: Not explicitly stated in numerical terms within the document for each specific test. The acceptance criteria are implicitly those defined by the referenced ASTM standards for MRI safety parameters (magnetic field interaction, heating, artifact size).
   • Reported Device Performance: The document only states that "MRI testing was performed on the subject devices per the following ASTM Standards" and that "No further device performance testing was required." This indicates that the performance met the requirements for MRI compatibility, but specific quantitative results (e.g., measured displacement in Gauss/cm, specific heating in degrees Celsius, or artifact dimensions) are not provided.

   Therefore, a full table with specific numerical criteria and performance cannot be created from this text.

2. Sample sized used for the test set and the data provenance:

   • Sample Size: Not specified. The testing was done on the "subject devices," referring to the various types of implants listed (FORTIFY®, XPand®, NIKO®, SUSTAIN®, etc.). The number of individual implants tested for each type is not mentioned.
   • Data Provenance: Not explicitly stated. This type of testing (MRI compatibility) is typically performed in a laboratory setting on the physical devices, not clinical data from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. This is not a study involving human experts establishing ground truth from clinical images. The "ground truth" for MRI compatibility is determined by physical measurements and adherence to engineering standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable. There's no adjudication process for this type of physical device testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not applicable. This document is about the MRI compatibility of physical implants, not an AI/ML diagnostic device requiring an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This is not an AI/ML algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • The "ground truth" for MRI compatibility is established by the specifications and measurement techniques outlined in the referenced ASTM standards. This involves physical measurements of magnetic field interaction, temperature changes, and image artifacts, not clinical ground truth derived from patients or expert consensus.

8. The sample size for the training set:

   • Not applicable. This is not a machine learning model, so there is no training set.

9. How the ground truth for the training set was established:

   • Not applicable. There is no training set.

In summary, this document is a regulatory submission for physical medical devices and their MRI compatibility labeling, not for a software-based diagnostic device. Therefore, most of the questions pertaining to AI/ML device study design parameters are not addressed and are not relevant to the provided text.

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The Patriot 1 Family of Lasers, 400, 600 and 1000 micron sterile, disposable, single use fibers are indicated for incision, excision, resection, ablation, vaporization and coagulation of soft tissue encountered in urology, gastroenterology, thoracic and pulmonary, gynecology, ENT, dermatology and plastic surgery general surgery and arthroscopy.

General Description- Thulium Laser/ Patriot 1 family of lasers. The U. S. Laser Worx Family of lasers are surgical instrument for use in general and plastic surgery and in dermatology (GEX). The Patriot 1 Family of lasers are installed with a single Tm:Fiber Laser Source with CW emission at 1.94 microns with adjustable power from 5 W to the maximum output power (as given below). The laser radiation is delivered to the tissue to be treated through fiber optics. The Patriot 1 Family (that includes 120, 150, 180 and the 200) and its accessories are intended for use in surqical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coaqulation and hemostasis of soft tissue in use in medical specialties including: Urology, Gastroenterology, Thoracic and Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery, General Surgery and Arthroscopy.

The provided document is a 510(k) summary for the U.S. Laser Worx Patriot 1 Family of Lasers. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study results to meet specific performance acceptance criteria. Therefore, the document primarily details the device's specifications and how it compares to predicate devices, but does not contain the acceptance criteria or a study proving the device meets them in the format usually associated with clinical performance studies for AI/software devices.

However, based on the information provided, here's what can be extracted and inferred regarding the closest equivalents to "acceptance criteria" and "study":

The "acceptance criteria" in this context are implicitly that the U.S. Laser Worx Patriot 1 Family of Lasers is substantially equivalent to the predicate devices in terms of its intended use, design, performance, and safety. There are no explicit quantitative performance metrics or thresholds stated as acceptance criteria that a study would directly "prove" the device meets.

The "study" that proves the device meets this "acceptance criteria" is the Substantial Equivalence Summary and the Non-Clinical Performance Data presented. This is not a human-in-the-loop, standalone, or MRMC study in the context of AI/software for diagnostic tasks. Instead, it's a comparative analysis against predicate devices and adherence to safety standards.

Here's the breakdown of the information requested, based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

• Similar laser medium (Tm:Fiber)
• Similar wavelength
• Similar power to tissue range
• Similar operating modes (at least Continuous)
• Similar beam delivery options (fiber sizes)
• Similar aiming beam functionality
• Adherence to electrical supply requirements
• Similar cooling mechanism
• Comparable dimensions and weight (within reasonable manufacturing variations)
• Same intended uses/indications for use | Device is Substantially Equivalent:
• Laser Medium: Tm:Fiber (Matches predicates)
• Wavelength: 1.94 microns (Similar to 2.01 microns of predicates)
• Power to Tissue: 5 to 120, 150, 180, and 200 Watts (Comparable to and encompasses predicate ranges)
• Operating Modes: Continuous (One predicate offers only continuous; others offer continuous and pulsed, but the applicant's device is noted to be "CW" for pulsed mode - which implies continuous wave, suggesting pulsed capabilities weren't deemed necessary for equivalence or were handled differently)
• Beam Delivery: 400, 600, 1000 micron fibers, specialty fibers (Comparable to predicates, with some minor differences in specific fiber sizes offered)
• Aiming Beam: 450 nm Blue Diode, adjustable (Different wavelength/color than predicates' 635 nm Red Diode, but performs the same function)
• Electrical Supply: 230 VAC, 30 Amps, 50/60 Hz (Comparable to predicates)
• Cooling: Closed cycle, internal (Matches predicates)
• Dimensions: H: 35.3", W: 19.8", L: 29.3" (Comparable to predicates)
• Weight: TBD Pounds (Not yet finalized, but assumed to be within comparable range)
• Indications for Use: Matches the broad range of soft tissue procedures across multiple specialties of the predicate devices. |
  | Safety Standards Adherence:
• Compliance with relevant IEC safety standards. | Safety Standards Met:
• IEC 60601-1 ED 3.1(2012)
• IEC 60601-1-2:2014 4th Ed
• IEC 60601-2-22 Ed 3.1(2012)
• IEC 60601-1:2005
• IEC 60601-1 ED3 (2007) AMENDMENT 1(2013)
• IEC 60601-14(2014) —CANADA
• IEC 60825-1 2007 |
  | Performance Verification:
• Verification of power, measurements, software accuracy, and energy transmission. | Numerous Bench Tests Conducted:
• Power verifications
• Measurements
• Accuracy of software
• Energy transmission |

2. Sample Size for the Test Set and Data Provenance

• Sample Size: Not applicable in the context of this 510(k). The "test set" here refers to the comparisons made against predicate devices' specifications on paper, along with non-clinical bench testing. There is no patient-based or image-based test set as would be seen in an AI performance study.
• Data Provenance: Not applicable. The document describes the device's technical specifications and compares them to predicate devices, along with listing safety standards adhered to. There is no "data" in the sense of patient records, images, or clinical outcomes.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not applicable. This is a laser surgical instrument, and the submission focuses on engineering specifications and intended use comparison, not diagnostic performance requiring expert interpretation of data.

4. Adjudication Method for the Test Set

• Not applicable. There is no "test set" that would require adjudication in this context.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No, an MRMC comparative effectiveness study was not done. This device is a surgical laser, not an AI diagnostic tool involving human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is a physical surgical laser, not a standalone algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this 510(k) submission is the established specifications, intended uses, and safety standards of the predicate devices, as well as internationally recognized electrical and laser safety standards. There isn't a "ground truth" derived from expert consensus, pathology, or outcomes data in the typical sense of a clinical trial for an AI/diagnostic device.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the Ground Truth for the Training Set was Established

• Not applicable. This is not an AI/machine learning device.

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SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, COALITION® Spacers, COALITION® Spacers, COALITION AGX™ Spacers, INDEPENDE® Spacers, FORTIFY@-R Corpectomy Spacers, FORTIFY® I-R Corpectomy Spacers, XPand®-R Corpectorny Spacers, NIKO® Corpectony Spacers, MONUMENT™ Spacers, MAGNIFY™ Spacers, InterContinental® Plate-Spaces

SUSTAIN® R Spacers:
When used as lumbar intervertebral body fusion devices, SUSTAIN® Radiolucent (SUSTAIN® R) Spacers are intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of nonoperative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis at the involved level(s). The SUSTAIN® and SUSTAIN® R Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the REVERE®, REVOLVE® or BEACON® Stabilization Systems.
When used as cervical intervertebral body fusion devices, the SUSTAIN® R Spacers are intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) at one level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The SUSTAIN® and SUSTAIN® R Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the ASSURE®, PROVIDENCE® or XTEND® Anterior Cervical Plate Systems.
When used as vertebral body replacement devices, SUSTAIN® R Spacers are intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The spacers are intended to be used with supplemental spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems and anterior screw and rod systems). The interior of the spacer can be packed with bone grafting material. SUSTAIN® R Spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

PATRIOT® Spacers:
Lumbar Spacers: PATRIOT® Spacers (including Constitution®, Constitution® TPS, Signature® TPS, Continental®, Continental® TPS, TransContinental®, TransContinental® TPS, TransContinental® M and TransContinental® M TPS) are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and at least six (0) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis at the involved level(s). PATRIOT® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine (e.g. posterior pedicle screw and rod systems, anterior plate systems, and rod systems). Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation.
Cervical Spacers: PATRIOT® Spacers (COLONIAL® ACDF) are interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-T1) at one level. DDD is defined as discogence pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of nonoperative treatment. PATRIOT® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the ASSURE® or PROVIDENCE® Anterior Cervical Plate System.

CALIBER® Spacers:
CALIBER® Spacers are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of nonoperative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). CALIBER® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the REVERE® or REVOLVE® Stabilization Systems.

RISE® Spacers:
The RISE® Spacer is a lumbar interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of nonoperative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The RISE® Spacer is to be filled with autogenous bone graft material. This device is intended to be used with supplemental fixation, such as the REVERE® or REVOLVE® Stabilization Systems.

COALITION® and COALITION AGX™ Spacers:
The COALITION® and COALITION AGX™ Spacers are interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) at one level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and at least six (6) weeks of non-operative treatment. These devices are to be filled with autogenous bone graft material. The COALITION® Spacer is a stand-alone interbody fusion device. The COALITION AGX™ Spacer is intended to be used with supplemental fixation such as the COALITION AGX™ Plate, ASSURE®, PROVIDENCE™, VIP®, XTEND®, or UNIFY™ Anterior Cervical Plate Systems. When used with the COALITION AGX™ Plate, the assembly takes on the indications for use of the COALITION AGX™ Spacer, with the COALITION AGX™ Plate acting as the supplemental fixation. The COALITION AGX™ Plate is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.

INDEPENDENCE® Spacers:
INDEPENDENCE® (including INDEPENDE® MIS, INDEPENDENCE® TPS, and INDEPENDENCE® MIS TPS) Spacers are interbody fusion devices intents with degenerative disc disc disc discase (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis at the involved level(s). INDEPENDENCE® Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. The INDEPENDENCE® Spacer is a stand-alone interbody fusion device intended to be used with three titanium alloy screws which accompany the implant. The INDEPENDENCE® MIS Spacer is an interbody fusion device to be used with three titanium alloy screws or anchors which accompany the implants. When used with screws. the INDEPENDENCE® MIS Spacer is a stand-alone interbody fusion device. When used with anchors, the INDEPENDENCE® MIS Spacer is intended for use with supplemental fixation (e.g. facet screws or posterior fixation). Hyperlordotic implants (≥25° lordosis) are intended for use with supplemental fixation (e.g. facet screws or posterior fixation).

FORTIFY®-R and FORTIFY® I-R Corpectomy Spacers:
FORTIFY® (FORTIFY® and FORTIFY®-R) and FORTIFY® Integrated (FORTIFY® I and FORTIFY® I-R) Corpectomy Spacers are vertebral body replacement devices intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). These devices are intended to be used with supplemental spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, and anterior screw and rod systems). The interior of the spacers can be packed with autogenous bone graft or allograft. These spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

XPand®-R Corpectomy Spacers:
The XPand® and XPand® Radiolucent Corpectomy Spacers are vertebral body replacement devices intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The XPand® and XPand® Radiolucent Corpectomy Spacers are intended to be used with supplemental spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and rod systems). The interior of the spacer can be packed with bone grafting material. The XPand® and XPand® Radiolucent Corpectomy Spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

NIKO® Corpectomy Spacers:
The NIKO® Corpectomy Spacer is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-LS) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The NIKO® Corpectomy Spacer is intended to be used with supplemental spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, and anterior screw and rod systems). The interior of the spacer can be packed with bone grafting material. The NIKO® Corpectomy Spacer is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

MONUMENT™ Spacers:
The MONUMENT™ Spacer is an interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of nonoperative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The MONUMENT™ Spacer is to be filled with autogenous bone graft material, and is to be used with four titanium alloy screws that accompany the implant. The device is intended to be used with supplemental fixation (i.e. pedicle screws, facet fixation).

ALTERA™ Spacers:
The ALTERA™ Spacer is an interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of nonoperative treatment. In addition, these patients may have up to Grade 1spondylolisthesis or retrolisthesis at the involved level(s). The ALTERA™ Spacer is to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation.

MAGNIFY™ Spacers:
The MAGNIFY™ Spacer is an interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of nonoperative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The MAGNIFY™ Spacer is to be filled with autogenous bone graft material, and is to be used with supplemental fixation, such as the CREO®, REVERE® or REVOLVE® Stabilization Systems. The MAGNIFY™-S Spacer is a stand-alone interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The MAGNIFY™-S Spacer is to be filled with autogenous bone graft material, and is to be used with three titanium alloy screws that accompany each implant.

InterContinental® Plate-Spacers:
InterContinental® Plate-Spacers (including InterContinental® TPS) are lateral lumbar interbody fusion devices intended for use in patients with degenerative disc disease (DOD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DOD is defined as discogenic back pain with degeneration of the disc confirmed by history and radios. These patients should be skeletally mature and at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). InterContinental® PlateSpacers are to be filled with autogenous bone graft material, and are to be used with two titanium alloy screws which accompany the implant. These devices are intended to be used with supplemental fixation (e.g. pedicle or facet screw systems) in addition to the integrated screws.

SUSTAIN® and SUSTAIN® Radiolucent (SUSTAIN® R) Spacers are devices that can be used as intervertebral fusion devices or as vertebral body replacement devices. These spacers are available in different shapes and heights to accommodate various surgical approaches and anatomical needs. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. Each spacer has an axial hole to allow grafting material to be packed inside the spacer. These spacers are used to provide structural stability in skeletally mature individuals following discectomy, corpectomy, or vertebrectomy (including partial). Lumbar spacers may be inserted using a posterior, transforaminal, anterior, anterolateral, or lateral lumbar approach. Cervical spacers are inserted using an anterior cervical approach. The SUSTAIN® Spacers are made from commercially pure titanium or titanium alloy as specified in ASTM F67, F136, and F1295.The SUSTAIN® R Spacers are made from radiolucent PEEK polymer with titanium alloy or tantalum markers as specified in ASTM F136, F560, F1295, and F2026.

PATRIOT® Cervical Spacers (COLONIAL® ACDF) are cervical interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. COLONIAL® ACDF Spacers are inserted through an anterior cervical approach, and are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. These spacers are to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. PATRIOT® Spacers are made from radiolucent polymer, with titanium allov or tantalum markers, as specified in F2026, F136, F1295, and F560.

PATRIOT® Lumbar Spacers (including Constitution®, Constitution® TPS, Signature®, Signature® TPS, Continental®, Continental® TPS, TransContinental®, TransContinental® TPS, TransContinental® M and TransContinental® M TPS) are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. Each of the PATRIOT® spacers provides a different shape to accommodate various surgical approaches to the lumbar spine. Constitution® PLIF Spacers are inserted using a posterior approach. Signature® TLIF Spacers are inserted using a transforaminal approach. Continental® ALIF Spacers are inserted using an anterior approach. Transcontinental® and TransContinental® M Spacers are inserted using an anterior or lateral approach. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. These spacers are to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. PATRIOT® Spacers are made from PEEK radiolucent polymer (ASTM F2026) with titanium alloy or tantalum markers (ASTM F560). Signature® R Spacers also include an internal titanium alloy or commercially pure titanium (ASTM F67) component, and TransContinental® M Spacers also include an integrated titanium alloy nut. The Signature® Ti Spacer is made from titanium alloy or commercially pure titanium. The titanium alloy is TAV (ASTM F136) or TAN (ASTM F1295). PATRIOT® TPS Spacers also have a commercially pure titanium plasma spray coating, as specified in ASTM F67 and F1580.

InterContinental® Plate-Spacers (including InterContinental® TPS) are lateral lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. InterContinental® Plate-Spacers are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces grip the endplates of the adjacent vertebrae to aid in expulsion resistance. InterContinental® Plate-Spacers are to be filled with autogenous bone graft material, and are to be used with titanium alloy bone screws, with or without hydroxyapatite coating. Bone screws are used to attach to the lateral portion of the adjacent vertebral bodies for bony fixation. The spacers in the InterContinental® Plate-Spacers are manufactured from radiolucent polymer, with titanium alloy or tantalum markers, as specified in ASTM F136, F560, F1295, and F2026. The plates in the InterContinental® Plate-Spacers are manufactured from titanium alloy, as specified in ASTM F136 and F1295. The screws in the InterContinental® Plate-Spacers are manufactured from titanium alloy, as specified in ASTM F136 and F1295, and are available with or without hydroxyapatite (HA) coating, as specified in ASTM F1185. InterContinental® TPS Plate-Spacers also have a commercially pure titanium plasma spray coatinq, as specified in ASTM F67 and F1580.

CALIBER® Spacers are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. CALIBER® Spacers provide different shapes to accommodate various surgical approaches to the lumbar spine (posterior, transforaminal [posterolateral] or lateral). The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. These spacers are to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. CALIBER® Spacers are manufactured from radiolucent PEEK polymer and titanium alloy per ASTM F2026, F136 and F1295; non-expandable CALIBER® Spacers are manufactured from PEEK only. CALIBER® Spacers contain radiopaque titanium alloy or tantalum markers as specified in ASTM F136, F1295 and F560.

The COALITION® and COALITION AGX™ Spacers are a cervical interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. These spacers are inserted through an anterior cervical approach, and are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to aid in expulsion resistance. The spacer is to be filled with autogenous bone graft material. The COALITION AGX™ Plate is an anterior cervical fixation device that is available in various lengths and widths to fit the anatomical needs of a wide variety of patients. The COALITION® Spacer and the COALITION AGX™ Spacer used with a COALITION AGX™ Plate are stand-alone cervical interbody fusion devices. Screws are inserted through the anterior titanium portion of the implant into adjacent vertebral bodies for bony fixation. The COALITION® and COALITION AGX™ Spacers are manufactured radiolucent PEEK polymer, with titanium alloy or tantalum markers, as specified in ASTM F2026 F136, F1295 and F560. The plates are made from titanium alloy, as specified in ASTM, F136, F1295, and F1472. The screws are manufactured from titanium alloy, as specified in ASTM F136 and F1295.

INDEPENDENCE® (including INDEPENDENCE® MIS, INDEPENDENCE® TPS, and INDEPENDENCE® MIS TPS) Spacers are anterior lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The spacers are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to aid in expulsion resistance. Screws are inserted through the anterior titanium portion of the implant into adjacent vertebral bodies for bony fixation. The INDEPENDENCE® MIS Spacer may also be used with anchors inserted through the anterior titanium portion of the implants into adjacent vertebral bodies for bony fixation. INDEPENDENCE® and INDEPENDENCE® MIS Spacers are made from titanium alloy and radiolucent polymer with titanium alloy or tantalum markers, as specified in ASTM F136, F560, F1295, and F2026. INDEPENDENCE® MIS Spacers are additionally available in an all titanium alloy version. All PEEK implants are additionally available with a commercially pure titanium plasma spray coating (TPS), as specified in ASTM F1580 and F67. The screws and anchors are manufactured from titanium alloy, as specified in ASTM F136 and F1295, and the screws and anchors are available with or without hydroxyapatite (HA) coating, as specified in ASTM F1185.

The MONUMENT™ Spacer is an anterior lumbar interbody fusion device used to provide structural stability in skeletally mature individuals following discectomy. The MONUMENT™ Spacer is intended to aid in reduction of a Grade 1 spondylolisthesis. The spacers are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to aid in expulsion resistance. Screws are inserted through the anterior titanium portion of the implant into adjacent vertebral bodies for bony fixation. The spacer is to be filled with autogenous bone graft material. The MONUMENT™ Spacer is made from PEEK radiolucent polymer and titanium alloy, as specified in ASTM F136, F1295, and F2026. The mating screws are manufactured from titanium alloy, as specified in ASTM F136 and F1295, and are available with hydroxyapatite (HA) coating, as specified in ASTM F1185.

The XPand® and XPand® Radiolucent Corpectomy Spacer devices are vertebral body replacement devices used to provide structural stability in skeletally mature individuals following corpectomy or vertebrectomy. The system is comprised of spacers of various heights and footprints to fit the anatomical needs of a wide variety of patients. Each spacer has an axial hole to allow grafting material to be packed inside of the spacer. Protrusions on the superior and inferior surfaces of each device will grip the endplates of the adjacent vertebrae to resist expulsion. The XPand® devices are made from titanium alloy as specified in F136 and F1295. The XPand® Radiolucent Corpectomy Spacer devices are made from radiolucent polymer and titanium alloy as specified in ASTM F2026, F136 and F1295, and include markers made from titanium alloy or tantalum as specified in ASTM F136, F1295 and F560.

FORTIFY® and FORTIFY® Integrated Corpectomy Spacers are vertebral body replacement devices used to provide structural stability in skeletally mature individuals following corpectomy or vertebrectomy. The components include a central core and endplates, which are available in a range of sizes and options to accommodate the anatomical needs of a wide variety of patients. The core and endplates can be preoperatively or intraoperatively assembled to best fit individual requirements. Each spacer has an axial hole to allow autogenous bone graft or allograft to be packed inside of the spacer. Protrusions (teeth) on the superior and inferior surfaces grip the endplates of the adjacent vertebrae to resist expulsion. Additional spikes are available on some implants. FORTIFY® Integrated endplates have an integrated plate to accommodate screws for additional fixation and are assembled to the core. FORTIFY® and FORTIFY® I Corpectomy Spacers are manufactured from titanium allov per ASTM F136 and F1295. FORTIFY®-R and FORTIFY® I-R Corpectomy Spacers are manufactured from radiolucent PEEK OPTIMA LT1, with titanium alloy and tantalum components, per ASTM F2026, F136, F1295, and F560. Screws are manufactured from titanium alloy per ASTM F136 and F1295, with or without hydroxyapatite coating per ASTM F1185.

The NIKO® Corpectomy Spacer device is a vertebral body replacement device used to provide structural stability in skeletally mature individuals following corpectomy or vertebrectomy. The system is comprised of spacers of various fixed heights to fit the anatomical needs of a variety of patients. Each spacer has an axial hole to allow grafting material to be packed inside of the spacer. Protrusions on the superior and inferior surfaces of each device will grip the endplates of the adjacent vertebrae to resist expulsion. The NIKO® Corpectomy Spacer device is made from radiolucent polymer and titanium alloy or tantalum as specified in ASTM F2026, F136, F1295, and F560.

RISE® Spacers are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. RISE® Spacers are provided in different shapes to accommodate various surgical approaches to the lumbar spine (posterior, transforaminal [posterolateral] or lateral) and can expand to the desired height. The implants are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. This device is to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. RISE® Spacers are manufactured from titanium alloy, as specified in ASTM F136 and F1295. An internal component is manufactured from radiolucent PEEK polymer, as specified in ASTM F2026.

The ALTERA™ Spacer is an expandable lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The ALTERA™ Spacer accommodates various surgical approaches to the lumbar spine (posterior or transforaminal [posterolateral]) and allows articulation upon insertion. The devices are available in various height ranges, allowing continuous expansion within the range, to fit the anatomical needs of a wide variety of patients. This device is to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. The ALTERA™ Spacer is made from titanium alloy, as specified in ASTM F136, F1295. and F1472. Internal components are made from radiolucent PEEK polymer and cobalt chromium molybdenum alloy, as specified in ASTM F2026 and F1537, respectively.

MAGNIFY™ Spacers are expandable anterior lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The devices are available in various height expansion ranges and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to aid in expulsion resistance. These devices are to be filled with autogenous bone graft material. The MAGNIFY™ Spacer is to be used with supplemental fixation. The MAGNIFY™-S Spacer is to be used with three titanium alloy screws that accompany the implant. MAGNIFY™ Spacers are manufactured from titanium alloy, as specified in ASTM F136, and include an internal component manufactured from radiolucent PEEK polymer, as specified in ASTM F2026. The screws used with MAGNIFY™-S are manufactured from titanium allov, as specified in ASTM F136 and F1295, and are available with hydroxyapatite (HA) coating, as specified in ASTM F1185.

The provided document is a 510(k) Pre-market Notification from the FDA regarding a range of intervertebral body fusion devices and vertebral body replacement devices manufactured by Globus Medical, Inc. This document does not contain a study that proves the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy of an AI/ML device.

Instead, this document focuses on demonstrating substantial equivalence to existing predicate devices based on technical characteristics, performance, and intended use, primarily through mechanical performance testing as outlined below.

Therefore, many of the requested elements for an AI/ML device's acceptance criteria and study proving its efficacy cannot be found in this document.

Here's an analysis based on the information available:

Acceptance Criteria and Reported Device Performance

The document does not specify quantified acceptance criteria in terms of clinical outcomes or AI/ML performance metrics (e.g., sensitivity, specificity, AUC). Instead, the acceptance criterion for regulatory clearance is "substantial equivalence" to predicate devices. The reported "performance" is that the devices meet or exceed the mechanical performance standards of the predicate devices.

Device Type and Missing Information

It is crucial to understand that the devices described are physical medical implants (spinal spacers/fusion devices), not AI/ML-driven diagnostic or prognostic tools. Therefore, the questions related to AI/ML specific studies, such as sample size for test/training sets, experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types, are not applicable to this type of medical device submission.

Specific Information from the Document:

1. A table of acceptance criteria and the reported device performance

   • See table above. The primary acceptance criterion is substantial equivalence based on mechanical, material, and design similarity to existing devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Not applicable in the context of an AI/ML device. For these physical devices, unspecified "performance testing" was conducted per ASTM F2077. The document does not provide details on the number of samples or specimens tested, nor the provenance of any data beyond indicating it's mechanical testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Not applicable to this device type. There is no diagnostic ground truth established by experts mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not applicable to this device type.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

   • Not applicable to this device type. This is an implantable medical device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   • Not applicable to this device type.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   • Not applicable in the AI/ML sense. For the mechanical performance, the "ground truth" would be established by the ASTM F2077 standards and the measured physical properties of the materials and devices.

8. The sample size for the training set

   • Not applicable to this device type.

9. How the ground truth for the training set was established

   • Not applicable to this device type.

In summary: The provided FDA 510(k) document is for a range of spinal implants. The "study" mentioned refers to mechanical performance testing against an ASTM standard to demonstrate substantial equivalence to previously cleared predicate devices. It does not contain information relevant to the assessment of an AI/ML powered medical device.

Ask a specific question about this device

SUSTAIN® Spacers: When used as lumbar intervertebral body fusion devices, SUSTAIN® SUSTAIN® R and SUSTAIN® R TPS) are intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of nonoperative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis at the involved level(s). SUSTAIN® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the CREO®, REVERE®, REVOLVE®, or BEACON® Stabilization Systems. When used as cervical intervertebral body fusion devices, SUSTAIN® Spacers are intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) at one level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be sketally mature and have had at least six (6) weeks of non-operative treatment. SUSTAIN® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the ASSURE®. PROVIDENCE®, or XTEND® Anterior Cervical Plate Systems. When used as vertebral body replacement devices, SUSTAIN® Spacers are intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The spacers are intended to be used with supplemental spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, and anterior screw and rod systems). The interior of the spacers can be packed with bone grafting material. SUSTAIN® Spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

PATRIOT® Lumbar Spacers: PATRIOT® Spacers (including Constitution®, Constitution® TPS, Signature®, Signature® TPS, Continental®, Continental® TPS, TransContinental® TPS, TransContinental® M, and TransContinental® M TPS) are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (0) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis at the involved level(s). PATRIOT® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation.

PATRIOT® Cervical Spacers: PATRIOT® Spacers (including COLONIAL® and COLONIAL® TPS) are interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) at one level. DDD is defined as discogenic pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. PATRIOT® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the ASSURE® or PROVIDENCE® Anterior Cervical Plate Systems.

CALIBER® Spacers: CALIBER® Spacers (including CALIBER® TPS) are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). CALIBER® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the CREO®, REVERE® or REVOLVE® Stabilization Systems.

COALITION® Spacers: COALITION® Spacers (including COALITION® TPS) are stand-alone interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) at one level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. COALITION® Spacers are to be filled with autogenous bone graft material, and are to be used with two titanium alloy screws which accompany the implants.

INDEPENDENCE® Spacers: INDEPENDENCE® Spacers (including INDEPENDENCE® TPS) are stand-alone interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radios. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis at the involved level(s). INDEPENDENCE® Spacers are to be filled with autogenous bone graft material, and are to be used with three titanium alloy screws, which accompany the implants.

FORTIFY® Corpectomy Spacers: FORTIFY® (including FORTIFY®-R TPS) and FORTIFY®-R TPS) and FORTIFY® Integrated (including FORTIFY® I-R and FORTIFY® I-R TPS) Corpectomy Spacers are vertebral body replacement devices intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, or unstable vertebral body due to tumor or trauma (i.e., fracture). These devices are intended to be used with supplemental spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior screw and rod systems). The interior of the spacers can be packed with autogenous bone graft or allografi. These spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

XPand® Corpectomy Spacers: XPand® Corpectomy Spacers (including XPand®-R and XPand®-R TPS) are vertebral body replacement devices intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, or unstable vertebral body due to tumor or trauma (i.e., fracture). XPand® Corpectomy Spacers are intended to be used with supplemental spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate system, and anterior screw and rod systems). The interior of the spacer can be packed with bone grafting material. XPand® Corpectomy Spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

NIKO® Corpectomy Spacers: NIKO® Corpectomy Spacers (including NIKO® TPS) are vertebral body replacement devices intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). NIKO® Corpectomy Spacers are intended to be used with supplemental spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, and anterior screw and rod systems). The interior of the spacers can be packed with bone grafting material. NIKO® Corpectomy Spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

SUSTAIN® Spacers (including SUSTAIN® R and SUSTAIN® R TPS) are devices that can be used as intervertebral fusion devices or as vertebral body replacement devices. These spacers are available in different shapes and heights to accommodate various surqical approaches and anatomical needs. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. Each spacer has an axial hole to allow grafting material to be packed inside the spacer. These spacers are used to provide structural stability in skeletally mature individuals following discectomy, corpectomy, or vertebrectomy (including partial). Lumbar spacers may be inserted using a posterior, transforaminal, anterior, anterolateral, or lateral lumbar approach. Cervical spacers are inserted using an anterior cervical approach. The SUSTAIN® Spacers are made from commercially pure titanium or titanium alloy as specified in ASTM F67, F136, and F1295. SUSTAIN® Radiolucent (SUSTAIN® R) and SUSTAIN® R TPS Spacers are made from radiolucent PEEK polymer with titanium alloy or tantalum markers as specified in ASTM F136, F560, F1295, and F2026. SUSTAIN® R TPS Spacers also have a commercially pure titanium plasma spray coating, as specified in ASTM F67 and F1580.

PATRIOT® Lumbar Spacers (including Constitution®, Constitution® TPS, Signature®, TransContinental® TPS, TransContinental® M and TransContinental® M TPS) are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. Each of the PATRIOT® spacers provides a different shape to accommodate various surgical approaches to the lumbar spine. Constitution® PLIF Spacers are inserted using a posterior approach. Signature® TLIF Spacers are inserted using a transforaminal approach. Continental® ALIF Spacers are inserted using an anterior approach. Transcontinental® and TransContinental® M Spacers are inserted using an anterior or lateral approach. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. These spacers are to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. PATRIOT® Spacers are made from PEEK radiolucent polymer (ASTM F2026) with titanium alloy or tantalum markers (ASTM F560). Signature® R Spacers also include an internal titanium alloy or commercially pure titanium (ASTM F67) component, and TransContinental® M Spacers also include an integrated titanium alloy nut. The Signature® Ti Spacer is made from titanium alloy or commercially pure titanium alloy is TAV (ASTM F136) or TAN (ASTM F1295). PATRIOT® TPS Spacers also have a commercially pure titanium plasma spray coating, as specified in ASTM F67 and F1580.

PATRIOT® Cervical Spacers (including COLONIAL® and COLONIAL® TPS) are cervical interbody fusion devices used to provide structural stability in skeletally mature individuals following discectorny. COLONIAL® ACDF Spacers are inserted through an anterior cervical approach, and are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. These spacers are to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. PATRIOT® Spacers are made from radiolucent polymer, with titanium alloy or tantalum markers, as specified in F2026, F136, F1295, and F560. PATRIOT® TPS Spacers also have a commercially pure titanium plasma spray coating, as specified in ASTM F67 and F1580.

CALIBER® Spacers (including CALIBER® TPS) are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. CALIBER® Spacers provide different shapes to accommodate various surgical approaches to the lumbar spine (posterior, transforaminal [posterolateral] or lateral). The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. These spacers are to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. CALIBER® Spacers are manufactured from radiolucent PEEK polymer and titanium alloy per ASTM F2026, F136 and F1295; non-expandable CALIBER® Spacers are manufactured from PEEK only. CALIBER® Spacers contain radiopaque titanium alloy or tantalum markers as specified in ASTM F136, F1295 and F560. CALIBER® TPS Spacers also have a commercially pure titanium plasma spray coating, as specified in ASTM F67 and F1580.

COALITION®Spacers (including COALITION®TPS) are stand-alone cervical interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. COALITION® Spacers are inserted through an anterior cervical approach, and are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to aid in expulsion resistance. Screws are inserted through the anterior titanium portion of the implant into adjacent vertebral bodies for bony fixation. The spacers are to be filled with autogenous bone graft material. COALITION® Spacers are made from radiolucent polymer, with titanium alloy or tantalum markers, as specified in ASTM F2026, F136, F1295, and F560. The anterior portion of the implant and the mating screws are manufactured from titanium allov, as specified in ASTM F136 and F1295. COALITION® TPS Spacers also have a commercially pure titanium plasma spray coating, as specified in ASTM F67 and F1580.

INDEPENDENCE® Spacers (including INDEPENDENCE® TPS) are stand-alone anterior lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The spacers are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to aid in expulsion resistance. Screws are inserted through the anterior titanium portion of the implant into adjacent vertebral bodies for bony fixation. The spacers are to be filled with autogenous bone graft material. INDEPENDENCE® Spacers are made from radiolucent polymer, with titanium allov or tantalum markers, as specified in ASTM F2026. F136. F1295, and F560. The anterior portion of the implant and the mating screws are manufactured from titanium alloy, as specified in ASTM F136 and F1295. The screws are available with or without hydroxyapatite (HA) coating, as specified in ASTM F1185. INDEPENDENCE® TPS Spacers also have a commercially pure titanium plasma spray coating, as specified in ASTM F67 and F1580.

FORTIFY® (including FORTIFY®-R and FORTIFY®-R TPS) and FORTIFY® Integrated (including FORTIFY® I-R and FORTIFY® I-R TPS) Corpectomy Spacers are vertebral body replacement devices used to provide structural stability in skeletally mature individuals following corpectomy or vertebrectomy. The components include a central core and endplates, which are available in a range of sizes and options to accommodate the anatomical needs of a wide variety of patients. The core and endplates can be preoperatively or intraoperatively assembled to best fit individual requirements. Each spacer has an axial hole to allow autogenous bone graft or allograft to be packed inside the spacer. Protrusions (teeth) on the superior and inferior surfaces grip the endplates of the adjacent vertebrae to resist expulsion. Additional spikes are available on some implants. FORTIFY® Integrated endplates have an integrated plate to accommodate screws for additional fixation and are assembled to the core. FORTIFY® and FORTIFY® I-R Corpectomy Spacers are manufactured from titanium alloy per ASTM F136 and F1295. FORTIFY®-R, FORTIFY®-R TPS, FORTIFY® I-R, and FORTIFY® I-R TPS Corpectomy Spacers are manufactured from radiolucent PEEK polymer, with titanium alloy and tantalum components, per ASTM F2026, F136, F1295, and F560. Screws are manufactured from titanium alloy per ASTM F136 and F1295, with or without hydroxyapatite coating per ASTM F1185. FORTIFY® R TPS and FORTIFY® I-R TPS Corpectomy Spacers also have a commercially pure titanium plasma spray coating, as specified in ASTM F67 and F1580.

XPand® Corpectomy Spacers (including XPand®-R and XPand®-R TPS) are vertebral body replacement devices used to provide structural stability in skeletally mature individuals following corpectomy or vertebrectomy. The system is comprised of spacers of various heights and footprints to fit the anatomical needs of a wide variety of patients. Each spacer has an axial hole to allow grafting material to be packed inside the spacer. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. The XPand® devices are made from titanium alloy as specified in F136 and F1295. The XPand®-R and XPand®R TPS Corpectomy Spacers are made from radiolucent polymer and titanium alloy as specified in ASTM F2026, F136 and F1295, and include markers made from titanium allov or tantalum as specified in ASTM F136, F1295 and F560. XPand®-R TPS Corpectomy Spacers also have a commercially pure titanium plasma spray coating, as specified in ASTM F67 and F1580.

NIKO® Corpectomy Spacers (including NIKO® TPS) are vertebral body replacement devices used to provide structural stability in skeletally mature individuals following corpectomy or vertebrectomy. The system is comprised of spacers of various fixed heights to fit the anatomical needs of a variety of patients. Each spacer has an axial hole to allow grafting material to be packed inside the spacer. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. NIKO® Corpectomy Spacers are made from radiolucent polymer and titanium alloy or tantalum as specified in ASTM F2026, F136, F1295, and F560. NIKO® TPS Corpectomy Spacers also have a commercially pure titanium plasma spray coating, as specified in ASTM F67 and F1580.

This document refers to an FDA 510(k) premarket notification for several intervertebral body fusion and corpectomy spacers, all with Titanium Plasma Spray (TPS) coatings. The primary purpose of this submission is to demonstrate substantial equivalence to previously cleared devices.

Based on the provided text, the following information can be extracted regarding acceptance criteria and performance studies:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table with specific numerical acceptance criteria. Instead, it states that performance was evaluated in accordance with recognized standards and guidance documents. The reported performance is a general statement of compliance.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not specify the sample size used for the mechanical or coating tests. These are typically in-vitro (laboratory) tests performed on a representative number of device samples. The data provenance is laboratory testing, not human subject data, so country of origin, retrospective/prospective, etc., are not applicable in the way they would be for clinical studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is a submission for a medical device (surgical implant), not an AI/diagnostic device that relies on expert interpretation of data. Therefore, the concept of "ground truth established by experts" in this context is not applicable. The "ground truth" for these tests would be the accepted parameters and methods defined by the referenced ASTM standards and FDA guidance documents.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This is not applicable as the studies described are in-vitro mechanical and material characterization tests, not clinical studies requiring adjudication of outcomes or interpretations.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was done. This document pertains to physical orthopedic implants, not AI-powered diagnostic or assistive technologies.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This is not applicable as the device is a physical implant, not an algorithm or software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance data presented is based on established engineering and material science standards (ASTM F2077, F1044, F1147, F1160, F1854, F1978) and FDA guidance documents for mechanical testing and coating characterization of orthopedic implants. It is not derived from biological pathology or clinical outcomes in the same way a diagnostic device would.

8. The sample size for the training set

This is not applicable as this is a physical medical device, not an AI model requiring a training set.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for a physical implant.

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PATRIOT® Spacers (Constitution® PLIF, Signature® TLIF, Continental® ALIF, TransContinental® and TransContinental® M Spacers) are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

PATRIOT® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation.

PATRIOT® Spacers (Constitution® PLIF, Signature® TLIF, Continental® ALIF, and TransContinental® and TransContinental® M Spacers) are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. Each of the PATRIOT® spacers provides a different shape to accommodate various surgical approaches to the lumbar spine. The Constitution® PLIF Spacer is inserted using a posterior approach. The Signature® TLIF Spacer is inserted using a transforaminal approach. The Continental® ALIF Spacer is inserted using an anterior approach. The Transcontinental® and Transcontinental® M Spacers are inserted using an anterior or lateral approach. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. These spacers are to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.

PATRIOT® Spacers are made from PEEK radiolucent polymer (ASTM F2026) with titanium alloy or tantalum markers (ASTM F560). The Signature® R Spacer also includes an internal titanium alloy or commercially pure titanium (ASTM F67) component, and the TransContinental® M Spacer also includes an integrated titanium alloy nut. The Signature® Ti Spacer is made from titanium alloy or commercially pure titanium. The titanium alloy is TAV (ASTM F136) or TAN (ASTM F1295).

The provided text describes a 510(k) submission for PATRIOT® Spacers, which are intervertebral body fusion devices. The submission aims to gain clearance for additional spacers and sterile lumbar PATRIOT® spacers. The study presented is a confirmatory static compression testing.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states, "Confirmatory static compression testing was conducted in accordance with ASTM F2077-03 with the subject device meeting all acceptable criteria." This indicates that the acceptance criteria were defined by the ASTM F2077-03 standard, and the device successfully met those criteria.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. The text only mentions "confirmatory static compression testing" without specifying the number of samples or whether the data was retrospective or prospective, or its country of origin.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not applicable to this type of study. The study involves mechanical testing (static compression testing), not clinical or diagnostic evaluation requiring expert review of medical data. The "ground truth" here is the performance metrics defined by the ASTM standard.

4. Adjudication Method for the Test Set

This information is not applicable as there is no human interpretation or adjudication involved in static compression testing.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, an MRMC comparative effectiveness study was not done. This study is a mechanical test for substantial equivalence, not a clinical study involving human readers and AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, this is not an algorithm-based device. PATRIOT® Spacers are physical medical devices (intervertebral body fusion devices), and the testing described is mechanical performance testing, not software or AI algorithm testing.

7. The Type of Ground Truth Used

The ground truth used for this study is the performance specifications and criteria outlined in the ASTM F2077-03 standard for static compression testing of intervertebral body fusion devices.

8. The Sample Size for the Training Set

This information is not applicable as this is a mechanical performance study, not a machine learning study that would have a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no training set for this type of mechanical testing.

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