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The QUARTEX® Occipito-Cervico-Thoracic Spinal System implants are intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (CI-C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radior myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. These implants are also 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. In order to achieve additional levels of fixation, rods may be connected to occipital cervical thoracic or thoracolumbar stabilization systems ranging in diameter from 3.2mm to 6.5mm, using corresponding connectors.

The ExcelsiusGPS® is intended for use as an aid for precisely locating anatomical structures and for spatial positioning and orientation of an instrument holder or guide to be used by surgeons for navigating compatible surgical instruments in open or percutaneous provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws and interbody spacers.

The ExcelsiusHub™ is intended for use as an aid for precisely locating anatomical structures to be used by surgeons for navigating compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws and interbody fusion devices.

QUARTEX® additional implants include monoaxial, polyaxial, and dual lead polyaxial screws manufactured from titanium alloy; MIS rods manufactured from titanium alloy, stainless steel, and/or cobalt chromium molybdenum; and, associated manual and navigated surgical instruments.

ExcelsiusGPS® Instruments are nonsterile, reusable instruments that can be used with ExcelsiusGPS® or ExcelsiusHub® and may be used for a navigated surgical procedure. No changes were made to the ExcelsiusGPS® or ExcelsiusHub® systems with the addition of the subject ExcelsiusGPS® instruments.

The provided text is a US FDA 510(k) K231850 clearance letter for the QUARTEX® Occipito-Cervico-Thoracic Spinal System and ExcelsiusGPS® Instruments. This document primarily focuses on regulatory approval based on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed study proving performance against acceptance criteria in the context of an AI/medical device standalone or comparative effectiveness study.

Therefore, the requested information regarding acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) is not available within the provided text.

The document mentions "Verification and validation testing were conducted to confirm implant placement accuracy with ExcelsiusGPS®" under the "Performance Data" section. However, it does not provide any specifics about these tests, methodologies, acceptance criteria, or the results of these tests.

In summary, the provided document does not contain the information needed to fill out the requested table or answer the detailed questions about the study proving the device meets acceptance criteria.

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ADIRATM Lateral Plate System

The ADIRA™ 2-Hole and 4-Hole Plates, when used with screws only, are intended for use in the treatment of thoracolumbar (T1-L5) spinal instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (DDD, defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or failed previous spinal surgery.

The ADIRA™ 1-Hole Plate is intended to stabilize allograft at one level (T1-L5), aiding in spinal fusion and to provide temporary stabilization and augment of a spinal fusion. It may be used alone or with other anterior, lateral, anterolateral, or posterior spinal systems. The device is not intended for load bearing applications.

ADIRA™ Plate-Spacer Assemblies

ADIRA™ Plates may be assembled to a lateral lumbar interbody fusion device (HEDRON® L, TransContinental®, RISE®-L, Modulus® XLIF, CoRoent®, or Cohere® XLIF Spacers) to create a plate-spacer assembly. When assembled to HEDRON® L, TransContinental®, or RISE®-L Spacers, the plate-spacer assembly is indicated for use at one or more levels of the lumbosacral spine (L1-L5), 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 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. When ADIRA™ Plates are assembled to Modulus® XLIF, CoRoent®, or Cohere® XLIF Spacers, the plate-spacer assembly takes on the indications of the interbody device.

ADIRA™ Plate-Spacers are intended to be used with screws and/or anchors which accompany the implants. These devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). In addition, the 2-Hole or 4-Hole Plate-Spacers are intended for stand-alone use in patients with DDD at one or two levels only when <20° lordotic implants are used with two or four screws, respectively.

ADIRA™ Plate-Spacers are to be filled with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone.

The ADIRA™ Lateral Plate System consists of 4-, 2- and 1-hole thoracolumbar plates of various sizes to accommodate varying patient anatomy and surgical needs. The ADIRA™ plates are used with bone screws to attach to the anterolateral or lateral portion of the vertebral body of the thoracolumbar spine. ADIRA™ plates may also be attached to certain lateral lumbar interbody fusion devices (HEDRON L™, TransContinental™, RISE-L™, Modulus® XLIF, Cohere® XLIF, or CoRoent®) with an alignment screw. The plate-spacer assembly is used with bone screws and/or lateral anchors.

The provided text describes a medical device called the ADIRA™ Lateral Plate System and its clearance by the FDA based on substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria and a study proving the device meets those criteria, as typically seen for AI/ML-based devices with performance metrics like accuracy, sensitivity, specificity, etc.

Instead, the document focuses on regulatory approval for a physical medical implant (thoracolumbar plate system) based on material, design, and mechanical performance. The "Performance Data" section in the document refers to mechanical testing for physical device characteristics, not clinical performance or diagnostic accuracy.

Therefore, many of the requested fields regarding AI/ML device performance metrics, study design, expert adjudication, and ground truth establishment cannot be populated from the provided text.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Cannot be provided in the requested format. The document describes mechanical testing (static and dynamic compression bending, static torsion, expulsion testing) against ASTM standards and FDA guidance for spinal systems. It states: "Performance data demonstrate substantial equivalence to the predicate devices." It does not list specific numerical acceptance criteria (e.g., "accuracy > 90%") or reported performance values (e.g., "accuracy = 92%") for AI/ML-related performance.

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/Not mentioned. This information is typically for clinical or AI/ML performance studies. The testing mentioned is mechanical testing of physical implants, not data-driven 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)

• Not applicable/Not mentioned. This is for AI/ML performance studies.

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

• Not applicable/Not mentioned. This is for AI/ML performance studies.

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 study was not done as this is not an AI-assisted device.

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

• No. Not an AI algorithm.

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

• Not applicable/Not mentioned. The "ground truth" for mechanical testing would be the physical properties and structural integrity measured against engineering standards.

8. The sample size for the training set

• Not applicable/Not mentioned. Not an AI/ML device requiring a training set.

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

• Not applicable/Not mentioned. Not an AI/ML device.

Summary regarding the acceptance criteria and study as requested for AI/ML devices:

The provided FDA 510(k) clearance letter for the ADIRA™ Lateral Plate System does not contain information typically found for AI/ML-based medical devices regarding acceptance criteria, study design for performance evaluation (e.g., accuracy, sensitivity, specificity), sample sizes for test/training sets, expert adjudication, or ground truth establishment.

The device is a physical thoracolumbar plate system, and the "Performance Data" section solely refers to mechanical testing against engineering standards (ASTM F1717) and FDA guidance documents for spinal implant systems, demonstrating "substantial equivalence to the predicate devices."

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The STRETTO™ Cable System is indicated for use in: general orthopedic trauma surgery (e.g., fractures of the olecranon, patella, femur - including periprosthetic, pelvis, acetabulum, humerus and ankle, and acromioclavicular dislocations); prophylactic banding during total joint procedures; and, temporary reduction techniques for ORIF (Open Reduction Internal Fixation) procedures.

STRETTO™ Screw Anchors are indicated for fractures that may not be securely held by either a screw or a cerclage device alone, and where cerclage is used in combination with bone screws and/or plates to provide internal fixation of fractured bone.

STRETTO™ Press-In Anchors are indicated for use with a cerclage cable and plate to augment long bone fracture fixation, particularly when the use of screws would be inhibited, as in the presence of intramedullary implants.

The STRETTO™ Cable System implants are comprised of cables, crimps and anchors. Anchors include a thru hole for the cables to pass through, and are available in multiple styles. Press-in anchors mate with ANTHEM fracture plates and screw anchors mate with the hex recess of ANTHEM screws. The cable is secured with the crimp and may be used with the anchors. STRETTO™ Implants are manufactured from titanium alloy, commercially pure titanium, cobalt chromium alloy, cobalt chromium molybdenum alloy, or stainless steel.

The provided text is a 510(k) summary for the STRETTO™ Cable System to the FDA. It details the device, its indications for use, and a brief summary of performance data to establish substantial equivalence to predicate devices. However, it does not contain the specific information requested about acceptance criteria, detailed study results, sample sizes, ground truth establishment, or multi-reader multi-case studies.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance
2. Sample sizes used for the test set and data provenance
3. Number of experts used to establish ground truth
4. Adjudication method
5. MRMC comparative effectiveness study details (effect size, improvement)
6. Standalone performance details
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

The document states:

• Performance Data: "Mechanical testing (static and dynamic tension) was conducted using ASTM E8 as a guide. Performance data demonstrate substantial equivalence to the predicate devices. An engineering analysis was conducted for the anchors to demonstrate substantial equivalence to the predicate devices. Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST72:2011."

This indicates that mechanical and endotoxin testing were performed, and the results demonstrated substantial equivalence. However, the specific acceptance criteria, detailed test results, actual performance metrics, sample sizes, or methods for establishing ground truth (which would be relevant for clinical or diagnostic AI/ML devices but not typically for mechanical implants) are not provided in this summary.

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CALIBER® Spacers are interbody fusion devices intended for use 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 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. All CALIBER® TPS coated spacers are indicated for the same use as non-coated PEEK spacers.

CALIBER® 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).

The RISE® Spacer is an interbody fusion device intended for use 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 confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment.

The RISE® Spacer is to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. This device is 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).

LATIS® Spacers are interbody fusion devices intended for use 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 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.

LATIS® 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).

The ALTERA® Spacer is an interbody fusion device intended for use 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 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.

The ALTERA® Spacer is 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, anterior plate systems, and anterior screw and rod systems).

The MAGNIFY® Spacer is an interbody fusion device intended for use 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 disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kvphosis), 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.

The MAGNIFY® Spacer is to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone, and is 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).

SABLE® Expandable Spacer is an interbody fusion device intended for use 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 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 at least six (6) months of non-operative treatment. The spacer is to be filled with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone and is 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).

The MONUMENT® Spacer is an interbody fusion device indicated for use at one or more levels of the 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), deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). In addition, these patients may have up to Grade 2 spondylolisthesis or retrolisthesis at the involved level(s). 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. All MONUMENT® TPS coated spacers are indicated for the same use as noncoated spacers.

The MONUMENT® Spacer is to be used with four screws that accompany the implant. These devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). The MONUMENT® Spacer is to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.

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. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.

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. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.

LATIS® Spacers are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. LATIS® Spacers are provided in a shape that accommodates a posterior, transforaminal, or lateral approach to the lumbar spine; after insertion the implant can be transformed to the desired footprint. 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.

The ALTERA® Spacer is an expandable lumbar interbody fusion device 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. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adiacent vertebrae to resist expulsion.

MAGNIFY® Spacers are expandable anterior lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectorny. 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.

SABLE® Spacers are expandable lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The devices are available in various heights and geometric options to fit the anatomical needs of a wide varietv of patients.

The MONUMENT® Spacer is an anterior lumbar interbody fusion device used to provide structural stability in skeletally mature individuals following discectorny. 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 provided text describes different types of interbody fusion devices (CALIBER®, RISE®, LATIS®, ALTERA®, MAGNIFY®, SABLE®, and MONUMENT® Spacers) and their indications for use, but it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in terms of AI/algorithm performance.

The document is a 510(k) premarket notification for expanded indications and additional sterile implants for these devices. The "Performance Data" section mentions "Confirmatory mechanical testing was conducted on CALIBER® and RISE® spacers in accordance with ASTM F2077" and "Cadaveric testing was conducted on MONUMENT® spacers to support Grade 2 spondylolisthesis or retrolisthesis indications." It also states that "The sterilization and biocompatibility testing are unchanged for the subject and predicate devices" and "A biocompatibility risk assessment was conducted to assess the new sterile devices. No further sterilization or biocompatibility testing was required for this submission."

This information pertains to the physical performance of the interbody fusion devices and their biological compatibility, which are mechanical and material science tests. It does not describe any AI or algorithm-driven components, nor does it provide details about any clinical studies (like MRMC or standalone studies) with human readers, ground truth establishment, or sample sizes related to AI performance.

Therefore, for the specific questions related to acceptance criteria and studies proving AI device performance, the provided text does not contain the requested information.

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The HILINE™ Fixation System consists of temporary implants for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:

· Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques;

· Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, and spondylolisthesis;

· Spinal degenerative surgery, as an adjunct to spinal fusions;

· Use with a posterior spinal instrumentation construct when ligament augmentation is needed.

The HILINE™ Fixation System may also be used in conjunction with other medical implants made of similar metals whenever "wiring" may help secure the attachment of other implants.

The HILINE™ Fixation System is a sublaminar fixation system consisting of bands and clamps to mate with 3.5-6.5mm diameter rods, and associated manual surgical instruments. The bands have a titanium anchor attachment on one end that is detached after insertion and is not intended to be implanted. HILINE™ implants are manufactured from polyethylene terephthalate (PET), titanium alloy, commercially pure titanium, stainless steel, or cobalt chromium molybdenum alloy.

The provided text is a 510(k) summary for the HILINE™ Fixation System, which is a medical device. It focuses on demonstrating substantial equivalence to predicate devices based on mechanical testing and material characteristics. The summary explicitly states:

"Performance data demonstrate substantial equivalence to the predicate devices."

However, the provided text does not contain the detailed information required to fill out the table regarding acceptance criteria, specific device performance metrics, or study design details for clinical or AI-related performance evaluations. The "Performance Data" section solely mentions mechanical testing in accordance with ASTM F1798. There is no indication of a study involving human readers, ground truth establishment by experts, or any AI component.

Therefore, several sections of your request cannot be fulfilled based on the given information.

Here's what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

The document states that mechanical testing (static and dynamic tension, band pull-through, rod push-through, and static component torsion) was conducted in accordance with ASTM F1798, and that the performance data demonstrated substantial equivalence to the predicate devices. However, it does not specify the numerical acceptance criteria or the specific numerical results of these tests.

2. Sample size used for the test set and the data provenance: Not applicable. No clinical or human-involved test set is described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment by experts for a test set is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set requiring expert adjudication is described.

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 study was not done. The device description and performance data section do not mention any AI component or human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, a standalone algorithm study was not done. The device description and performance data section do not mention any AI component.

7. The type of ground truth used: Not applicable. No ground truth for an AI algorithm or diagnostic performance study is mentioned. The "ground truth" relevant here pertains to the physical properties and performance of the device under mechanical stress, which are assessed through standardized mechanical testing (ASTM F1798).

8. The sample size for the training set: Not applicable. No training set for an AI algorithm is mentioned.

9. How the ground truth for the training set was established: Not applicable. No training set for an AI algorithm is mentioned.

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MARVEL™ Growing Rods are indicated in patients under 10 years of age with potential for additional spine growth who require surgical treatment to obtain and maintain correction of severe, progressive, life threatening, early onset spinal deformities associated with thoracic insufficiency, including early onset scoliosis, as part of a growing rod construct.

MARVEL™ Growing Rods are posterior stabilization rods that can be surgically lengthened by manual mechanical actuation on a periodic basis as the patient grows. These rods are used as part of a growing rod construct consisting of MARVEL™ rods and screws, and are limited to a posterior approach. The rods include a tapered distal tip for a minimally invasive surgical approach. MARVEL ™ Growing Rods are manufactured from titanium alloy and PEEK.

The provided text describes a medical device submission (K213196) for MARVEL™ Growing Rods. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results in the format you requested for an AI/algorithm-based device.

Therefore, the information required to answer your specific questions about acceptance criteria, study data, ground truth, and expert involvement for an AI medical device cannot be found in this document.

This document describes a physical medical device (growing rods for spinal deformities) and primarily relies on mechanical performance testing and material biocompatibility to demonstrate substantial equivalence, not the performance of an AI algorithm.

To explicitly answer your points:

1. A table of acceptance criteria and the reported device performance: Not applicable. The document describes mechanical performance tests (static and dynamic compression bending, static component torsion) in accordance with ASTM F1717 and ASTM F543, and bacterial endotoxin testing (BET) per ANSI/AAMI ST-72:2011. It states "Performance data demonstrate substantial equivalence to the predicate devices" but does not provide specific numerical acceptance criteria or reported performance values for these tests.
2. Sample size used for the test set and the data provenance: Not applicable. This refers to mechanical testing of physical rods, not a test set for an algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth and expert review are not relevant for the mechanical testing of a physical device.
4. Adjudication method: Not applicable.
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 device is not an AI diagnostic or assistance tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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HEDRON C® Spacers and HEDRON IC® Spacers are interbody fusion devices indicated at one or more levels of the cervical spine (C2-T1) in patients with cervical 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 radiculopathy 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.

HEDRON C® Spacers and HEDRON IC® Spacers are intended to be used with supplemental fixation, such as an anterior cervical plate or posterior cervical fixation. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone.

When the HEDRON IC® Spacer is used with the COALITION AGX® Plate, the plate-spacer assembly (HEDRON IC® Plate-Spacer) is a stand-alone device intended for use at one or two levels of the cervical spine (C2-TI) 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. These devices are to be used with two titanium alloy screws which accompany the implants (≥20°) must be used with supplemental fixation in addition to the two screws.

HEDRON® Lumbar Spacers (HEDRON A™, HEDRON P®, HEDRON T™, and HEDRON RT™) are lumbar interbody fusion devices indicated at one or more levels of the thoracic spine (T -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 or kyphosis), 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 sketally mature and have had at least six (6) months of non-operative treatment. HEDRON® Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous 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, anterior plate systems, and rod systems). Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation.

HEDRON IA® Integrated Lumbar Spacers are integrated lumbar interbody fusion devices indicated for use at one or more levels of the lumbosacral spine (L1-S1), as an adjunct to fusion in patients with the following indications: degenerative disc disease (DD), disc herniation (with myelopathy), spondylolisthesis, 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. These devices are intended to be used with or without three screws and or anchors which accompany the implants. These devices are with supplemental fixation (e.g. facet screws or posterior fixation). In addition, these devices are intended for stand-alone use in patients with DDD at one or two levels only when <259 lordotic implants are used with three screws per implant. HEDRON IA® Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.

SABLE® Expandable Spacer is an interbody fusion device intended for use 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 disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, 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. The spacer is to be filled with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone and is 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).

The ExcelsiusGPS® is intended for use as an aid for precisely locating anatomical structures and for spationing and orientation of an instrument holder or guide tube to be used by surgeons for navigating compatible surgical instruments in open or percutaneous provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws and interbody spacers.

HEDRON® Cervical Spacers (HEDRON C® and HEDRON IC®) are anterior cervical interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. HEDRONIC® Spacer may be assembled to the COALITION AGX® Plate to create the HEDRON IC® Plate-Spacer, a standalone cervical interbody fusion device. HEDRON® Spacers are additively manufactured from titanium allov. as specified in ASTM F3001.

HEDRON® Lumbar Spacers are lumbar interbody fusion devices used to provide structural stability following discectomy. Each HEDRON® spacer has a different shape to accommodate various surgical approaches to the spine, including anterior, anterolateral, lateral, posterior or transforaminal approaches. All approaches are used in the lumbar spine; only anterolateral, or lateral approaches are used in the thoracic spine.

HEDRON® Integrated Lumbar Spacers are integrated anterior lumbar interbody fusion devices used to provide structural stability following discectomy. They are used with or without screws and/or anchors.

All HEDRON® Lumbar Spacers are additively manufactured from titanium powder. The mating screws and anchors are manufactured from titanium alloy and/or cobalt chrome alloy. Titanium screws and anchors are available with or without hydroxyapatite (HA) coating.

The SABLE® Expandable Spacer is an expandable lumbar interbody fusion device used to provide structural stability in skeletally mature individuals following discectomy. The device is available in various heights and geometric options to fit the anatomical needs of a wide variety of patients.

SABLE® Spacers are manufactured from titanium alloy. The endplates are additively manufactured from titanium alloy powder and an internal component is manufactured from radiolucent PEEK polymer. The drive screw is manufactured from cobalt chromium alloy.

ExcelsiusGPS® Instruments are nonsterile, reusable instruments that can be operated with ExcelsiusGPS® and may be used for a freehand navigated surgical procedure.

The provided text describes a 510(k) premarket notification for several spinal implant devices (HEDRON® Cervical Spacers, HEDRON® Lumbar Spacers, SABLE® Expandable Spacer, and ExcelsiusGPS® Instruments). However, it does not contain information about an AI/ML-based device.

Therefore, I cannot provide the detailed information requested regarding machine learning acceptance criteria, study design, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The document focuses on the substantial equivalence of the new devices to existing predicate devices based on:

• Mechanical testing: Dynamic compression-shear testing was conducted in accordance with "Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Intervertebral Fusion Device," June 12, 2007, and ASTM F2077.
• Technological Characteristics: The subject implants are stated to have the same technological characteristics as the predicate devices, including design, intended use, material composition, and range of sizes.
• Basis of Substantial Equivalence: The information provided within the premarket notification supports substantial equivalence of the subject spacers to the predicate devices with respect to technical characteristics, performance, and intended use.

In summary, the document addresses the regulatory requirements for hardware medical devices and does not involve AI/ML components or related performance studies.

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The ONVOY™ Acetabular System is intended for use in reconstruction of the articulating surface of the acetabular portion of the hip that is severely disabled and/or very painful resulting from:

1. Non-inflammatory degenerative joint disease including osteoarthritis, and avascular necrosis,
2. Rheumatoid arthritis.
3. Correction of functional deformity.
4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
5. Revision of previously failed total hip arthroplasty.
   The ONVOY™ Acetabular System is used in conjunction with Globus/Stelkast hip systems. The acetabular components of this system are intended for cementless fixation.

The ONVOY™ Acetabular System consists of shells, liners, and bone screws that are used as part of a complete total hip system in conjunction with a femoral head and femoral stem in total hip arthroplasty. Implants are available in various configurations and sizes to fit a wide variety of patient anatomy. Shells are available in a cluster hole design, liners are available in hooded and non-hooded designs used in conjunction with the shells, and bone screws provide additional fixation when inserted through the shell.
ONVOY™ acetabular shells are manufactured from titanium alloy, with a commercially pure titanium vacuum sintered coating. The liners are manufactured from ultra-high molecular weight polyethylene (UHMWPE) with Vitamin E. Bone screws are manufactured from titanium alloy.

This document is a 510(k) premarket notification from the FDA for a medical device called the ONVOY™ Acetabular System. A 510(k) submission is for demonstrating that a medical device is substantially equivalent to a legally marketed predicate device, not for proving that a device meets specific performance criteria beyond substantial equivalence. Therefore, the information typically requested in your prompt regarding acceptance criteria, specific studies to prove criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training data is not part of this type of regulatory submission.

This document confirms substantial equivalence through:

• Indications for Use: The ONVOY™ Acetabular System has the same intended use as its predicate devices, which is for reconstructing the articulating surface of the acetabular portion of the hip in cases of non-inflammatory degenerative joint disease, rheumatoid arthritis, functional deformity, certain fractures, and revision of failed hip arthroplasty. It is used with Globus/StelKast hip systems and intended for cementless fixation.
• Technological Characteristics: The subject implants possess the same technological characteristics as the predicate devices, including design, material composition (titanium alloy shells with commercially pure titanium vacuum sintered coating, UHMWPE liners with Vitamin E, and titanium alloy bone screws), and range of sizes.
• Performance Data (Mechanical Testing): Mechanical testing was conducted in accordance with several ASTM and ISO standards (F1820, F2582, ISO 7206-12, F543, F3090, ISO 21535). These tests cover aspects like push-out, torque-out disassembly, impingement, deformation, screw testing, shell fatigue, and range of motion. The results of these tests "demonstrate substantial equivalence to the predicate devices."
• Bacterial Endotoxin Testing (BET): BET was conducted in accordance with ANSI/AAMI ST-72:2011.

Therefore, it's not possible to provide the specific details you requested because a 510(k) summary focuses on demonstrating substantial equivalence to existing devices, rather than establishing and meeting novel acceptance criteria through independent performance studies. The document indicates that the performance data shows substantial equivalence, which is the "acceptance criteria" for a 510(k) submission itself.

Here's a breakdown based on the information provided and what is not provided in a 510(k) summary:

In summary, this document is a regulatory approval notice based on demonstrating substantial equivalence to existing predicate devices through comprehensive mechanical and material testing, rather than presenting a study against novel, pre-defined acceptance criteria for a new type of performance claim (like an AI model's accuracy).

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AUTOBAHN® EVO Femoral Nails are indicated for long bone fracture fixation in skeletally mature patients, specifically femoral fracture fixation, which may include the following: open and closed femoral fractures, pseudoarthrosis and correction osteotomy, pathologic fractures, impending pathologic fractures, tumor resections, supracondylar fractures, including those with intra-articular extension, ipsilateral hip/shaft fractures, ipsilateral femur/tibia fractures, fractures proximal to a total knee arthroplasty, fractures distal to hip joint, nonunions and malunions, poly trauma patients, fractures in the morbidly obese, fractures involving osteopenic and osteoporotic bone, compound and simple shaft fractures, proximal, metaphyseal, and distal shaft fractures, segmental fractures, closed supracondylar fractures, fractures involving femoral condyles, comminuted fractures with bone loss, and periprosthetic fractures. In addition, the AUTOBAHN® EVO Antearade Nails are intended for use in adolescents (12-21 years) in which the growth plates have fused.

The AUTOBAHN® Nailing System is a family of intramedullary nails, screws and washers designed to be used for internal bone fixation. The AUTOBAHN® EVO implants include femoral nails (antegrade and retrograde) and locking screws available in various lengths and diameters to accommodate a wide range of patient anatomy; the nails are secured with locking screws. Washers and nuts are also available. Devices are manufactured from titanium allov, cobalt chrome allov, and stainless steel.

The provided document describes a 510(k) premarket notification for the AUTOBAHN® EVO Femoral Nails and does not contain information about acceptance criteria or a study proving that an AI/device meets such criteria.

The document is a regulatory submission for a medical device (intramedullary fixation rod) and focuses on demonstrating substantial equivalence to previously cleared predicate devices through mechanical testing and comparison of technological characteristics. It does not involve AI, image analysis, or performance metrics typically associated with AI/ML device evaluations. Therefore, I am unable to extract the requested information based on the provided text.

The information sought in your request, such as a table of acceptance criteria, sample size for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, and training set details, are all relevant to the evaluation of AI/ML-based medical devices, which this document does not concern.

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The InstaFill™ Graft Delivery System is intended to be used for the delivery of allograft, autograft, or synthetic bone graft material to an orthopedic surgical site.

The InstaFill™ Graft Delivery System consists of a delivery device with an actuating handle, loading plunger, conical tip, and empty and pre-filled cartridges, designed to deliver graft material to an orthopedic surqical site. Cartidges are pre-filled with DBM or SIGNIFY® Gel. The delivery device and associated instruments are reusable, and the cartridges are provided sterile for single use. InstaFill™ components are manufactured from stainless steel, aluminum and PEEK, with polypropylene cartridges.

The InstaFill™ Graft Delivery System is intended for the delivery of allograft, autograft, or synthetic bone graft material to an orthopedic surgical site.

Here's an analysis of the acceptance criteria and the study performed:

1. Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

The document does not explicitly state the sample sizes for the specific tests (e.g., number of cadavers for usability, number of devices for axial pull-off, axial force, and burst testing).
The data provenance is not specified. However, the testing was conducted in-house by the manufacturer (Globus Medical Inc.) to confirm the device's performance.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This device is a delivery system for bone graft material and the testing described is primarily mechanical and functional verification, not an AI or diagnostic device that requires expert-established ground truth on medical images or patient outcomes.

4. Adjudication Method for the Test Set

Not applicable. The testing described focuses on mechanical and functional performance, not diagnostic classification requiring adjudication.

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

Not applicable. This is not an AI or diagnostic device that would typically undergo an MRMC study.

6. Standalone (Algorithm Only) Performance

Not applicable. This is a physical medical device, not a software algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is based on engineering specifications, material standards, and functional requirements inherent in its design and intended use. For example:

• Usability: Successful delivery of graft material in a cadaveric setting.
• Axial Pull-Off, Axial Force, Burst: Measurement against predefined mechanical thresholds.
• BET: Compliance with the ANSI/AAMI ST-72:2011 standard for endotoxin levels.
• Biocompatibility: Conformance to established standards for medical device materials or prior FDA clearance of the materials.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning model.

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

Not applicable.

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