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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

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 F3D Lateral Lumbar Interbody System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). F3D Lateral Lumbar implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Hyperlordotic interbody devices (≥20° lordosis) must be used in conjunction with the Oro Lateral plate for fixation. If using the 1-hole CoreLink Oro Lateral Plate System, additional supplemental fixation is required (e.g. posterior fixation).

The CL5 Lumbar Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). CL5 Lumbar implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The CoreLink Oro Lateral Plate System (LPS), in two and four-hole configurations, is intended for use as a laterally placed supplemental fixation device via the lateral or anterolateral surgical approach above the bifurcation of the great vessel or via the anterior surgical approach, below the bifurcation of the great vessels. The CoreLink Oro Lateral Plate System is designed to provide temporary stability until fusion is achieved. It is intended for lateral or anterolateral lumbar (L1-S1) fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudarthrosis, and failed previous fusion.

Alternatively, the CoreLink Oro Lateral Plate System may remain attached to CoreLink Lateral lumbar interbody devices after implantation. In this configuration the CoreLink Oro LPS must only be used to treat patients with degenerative disk disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels.

The CoreLink Oro LPS, one-hole configuration is intended for use in conjunction with traditional supplemental fixation to maintain the relative position of interbody spacers during spinal fusion. The one-hole plate is not intended for use in load-bearing applications.

Hyperlordotic interbody devices (≥20° lordosis) must be used in conjunction with the CoreLink Oro Lateral Plate System (LPS) for fixation.

The F3D Lateral Lumbar Interbody System, additively manufactured Ti-6A1-4V ELI per ASTM F3001 implants, and the CL5 Lateral Lumbar Interbody System, PEEK implants per ASTM F2026 with Tantalum per ASTM F560, are lumbar interbody spacers designed to provide mechanical support to the lumbar spine while arthrodesis occurs. The lateral lumbar spacers with hollow footprints for placement of graft material feature a wide variety of footprint, height, and lordosis options to accommodate patient anatomical needs. The F3D spacers are designed with a porous surface to optimize bone in-growth. The CL5 spacers are designed with ridges on the superior and inferior surfaces to improve grip against the end-plates and prevent expulsion. The Oro Lateral Plate System consists of plates and screws intended for use as a laterally placed supplemental fixation device via the lateral or anterior lateral surgical approach above the great vessels or via the anterior surgical approach below the bifurcation of the great vessels. The Oro Plate System implants are manufactured from Ti-6AI-4V ELI per ASTM F136 with Nitinol springs per ASTM F2063 in the plate's screw anti-backout plates. The plates are offered in 1-Screw, or 4-Screw configurations and in multiple lengths for single level fixation. The 1-Screw plate configuration is designed to maintain the relative position of interbody spacers during spinal fusion and is non-load bearing. The 2-Screw and 4-Screw plate configurations are designed as supplemental fixation for lumbar fusion. The plate screws are available in a variety of size options.

All Oro plates may be permanently attached to the F3D or CL5 spacers and assume the indications for use of the spacers.

The spacer and plate systems have been previously cleared (K183239, K150847, and K190016). This 510(K) submission offers additional implants to the previously cleared sets.

The provided text describes medical devices (spinal implants) and their indications for use, characteristics, and comparison to predicate devices for FDA clearance. However, it does not include information about acceptance criteria, a specific study proving the device meets those criteria, or details regarding sample sizes for test/training sets, expert involvement, or MRMC studies.

The document is a 510(k) summary for premarket notification, which focuses on demonstrating substantial equivalence to already legally marketed devices, rather than presenting a detailed clinical study with performance metrics against pre-defined acceptance criteria for diagnostic AI/software.

Therefore, I cannot provide the requested information about acceptance criteria and the study proving the device meets them because this type of information is not present in the provided text. The document primarily discusses mechanical testing results to demonstrate that the strength of the devices is "sufficient for their intended use and are substantially equivalent to legally marketed predicate devices."

The requested information points cannot be extracted from the given text as it pertains to AI/software performance validation, while the document describes physical medical devices and their mechanical testing.

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The ATEC Lateral Plate System is intended for use via the lateral surgical approach above the bifurcation of the great vessels in the treatment of thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbosacral (L1- S1) spine instability as a result of fracture (including dislocation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, spondylolisthesis, scoliosis, lordotic deformities of the spinal stenosis, or a failed previous spine surgery.

The ATEC Lateral Plate System is implanted through a lateral or anterolateral surgical approach to the thoracolumbar spine to provide temporary stabilization until fusion has occurred. The system will be comprised of both implants manufactured from titanium alloy (Ti-6A1-4V ELI) per ASTM F136 for fixation and the required instruments to place them. ATEC Lateral Plate System implants will be provided in a range of sizes and lengths used to create a construct to immobilize the spinal segments.

This document is a 510(k) summary for the ATEC Lateral Plate System. It describes the device, its indications for use, and a comparison to predicate devices, focusing on demonstrating substantial equivalence. It explicitly states that clinical data was "Not applicable" for the determination of substantial equivalence. Therefore, there is no study described in this document that proves the device meets specific acceptance criteria based on clinical performance.

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

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

No acceptance criteria for performance (e.g., sensitivity, specificity, accuracy, etc.) are stated as this is not a diagnostic or AI/ML device requiring such metrics. The "device performance" in this context refers to nonclinical mechanical testing.

2. Sample size used for the test set and the data provenance

Not applicable. There was no clinical test set used for performance evaluation that involved human data. The testing mentioned is nonclinical (mechanical) and typically uses a set number of manufactured devices.

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

Not applicable. There was no clinical test set requiring expert-established ground truth.

4. Adjudication method for the test set

Not applicable. There was no clinical test set requiring an adjudication method.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No. An MRMC study was not done. The document explicitly states "Clinical Information: Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data."

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

Not applicable. This device is a medical implant (plate system for spinal fixation), not an algorithm or AI/ML product.

7. The type of ground truth used

Not applicable. Clinical ground truth (e.g., expert consensus, pathology, outcomes data) was not used as no clinical performance study was conducted. The "ground truth" for the nonclinical testing would be the physical properties and mechanical behavior of the tested devices against established ASTM standards and predicate device data.

8. The sample size for the training set

Not applicable. This device is a medical implant, not an AI/ML product that would require a training set.

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

Not applicable. See response to #8.

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When used as an interbody fusion device, the TruLift® Lateral Expandable Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. Patients with previous non-fusion spinal surgery at involved level(s) may be treated with the device is intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the TruLift® Lateral Expandable Spacer can also be connected to the Lateral Plate System by a set screw.

The Lateral Plate System is intended to be used as a non-pedicle lateral fixation system in skeletally mature patients and is intended to provide immobilization of spinal segments, as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic and lumbar spine. It may be used from levels T1-L5 with the following indications:

• Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)

• -Spondylolisthesis

• -Spinal stenosis

• -Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis)

• -Tumor

• -Pseudoarthrosis

• -Failed previous fusion

• -Trauma (i.e., fracture or dislocation)

The Lateral Plate System, 1-hole buttress configuration is intended for use in conjunction with traditional supplemental fixation to maintain the relative position of interbody spacers during spinal fusion. The 1-hole plate is not intended for use in load-bearing applications. The Lateral Plate System can also be connected to the TruLift® Lateral Spacer System by a set screw.

The TruLift® Lateral Expandable Spacer System is available in a range of sizes and footprints and can expand to the desired height (8mm) to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136. The implant allows packing of autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral bodies to prevent rotation and/or migration.

All implants are provided sterile and intended for SINGLE USE ONLY and should not be reused under any circumstances. Do not use any of the TruLift® Lateral Expandable Spacer System components with components from any other system or manufacturer. The TruLift® Lateral Expandable Spacer System components should never be reused under any circumstances.

The Lateral Plate System consists of a variety of plates and screws to suit the individual pathology and anatomical conditions of the patient. All components are fabricated and manufactured from titanium alloy 6AL-4V-ELI per ASTM F-136.The plates are manufactured in a variety of configurations with options including different lengths and curvature. The screws are manufactured in variable and fixed configurations with diameters and lengths. Fixation is provided by bone screws inserted through the plates and into the vertebral body of the Lumbar spine using an anterior approach. The responsible surgeon will determine the correct size of the implant in accordance with the size of the individual patient.

The Lateral Plate System also utilizes a variety of standard orthopedic instruments to assist in the placement of the devices.

Do not use any of the Lateral Plate System components from any other system or manufacturer. The Lateral Plate System components should never be reused under any circumstances.

This document is an FDA 510(k) summary for a medical device (TruLift® Lateral Expandable Spacer System & Lateral Plate System). It describes the device, its intended use, and its equivalence to predicate devices, focusing on design, materials, and mechanical performance. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria related to AI/software performance.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, ground truth establishment, or AI-specific study details (such as MRMC studies or standalone algorithm performance), as these types of studies are not relevant to the content provided in this 510(k) summary. This document is focused on demonstrating the physical and mechanical equivalence of the spinal implant system to existing predicate devices, not on the performance of a software or AI component.

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The Meridian Anterior Plate System is indicated as additional support during fusion via an anterior or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, spinal stenosis, or a failed previous spine surgery.

The SeaSpine Regatta Lateral Plate System is indicated as additional support during fusion via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracolumbar (T) -L5) spine instability or via a lateral or anterolateral surgical approach below the bifurcation of the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery.

The Meridian Anterior Plate and Regatta Lateral Plate Systems each consist of varying sizes of plates and fixation options that accommodate either anterior or lateral surgical approaches in the thoracic, lumbar, and sacral spine (T1-S1). Each plate is manufactured from titanium alloy per ASTM F136 and is designed to provide additional support during spinal fusion procedures.

The provided text is an FDA 510(k) clearance letter and summary for a spinal plate system. It details the device's indications for use, its classification, and a comparison to predicate devices, including the non-clinical testing performed.

However, the document does not describe an AI medical device or a study proving an AI device meets acceptance criteria. It lacks any information regarding:

• Acceptance criteria for an AI device.
• Performance metrics (e.g., sensitivity, specificity, AUC) for an AI device.
• Sample sizes for test sets or training sets for an AI model.
• Data provenance for AI model development.
• Expert involvement in establishing ground truth for AI.
• Adjudication methods.
• Multi-reader multi-case (MRMC) studies or human-in-the-loop performance.
• Standalone AI performance.
• Ground truth types (pathology, outcomes data, etc.) for AI.

Therefore, I cannot extract the requested information as it is not present in the provided text.

The document explicitly states the testing performed:

• Static Compression Bending (ASTM F1717)
• Static Torsion (ASTM F1717)
• Dynamic Compression Bending (ASTM F1717)

These are mechanical and physical performance tests for an orthopedic implant, not an AI diagnostic or assistance device. The conclusion states "Minor differences in non-clinical test results do not impact device performance when compared to the legally marketed predicate devices," which further confirms the focus on mechanical equivalence.

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The CoreLink Lateral Plate System (LPS) is intended for use as a laterally placed supplemental fixation device via the lateral or anterolateral surgical approach above the bifurcation of the great vessel or via the anterior surgical approach, below the bifurcation of the great vessels. The CoreLink LPS is designed to provide temporary stability until fusion is achieved. It is intended for lateral or anterolateral lumbar (L1-S1) fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

Alternatively, the CoreLink LPS may remain attached to CoreLink Lateral lumbar interbody devices after implantation. In this configuration the CoreLink LPS must only be used to treat patients with degenerative disk disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels.

The CoreLink Lateral Plate System (LPS) is comprised of a lumbar plate and screws. The lumbar plate has a sliding, spring loaded lock tab for each screw position to prevent back-out of the screw. The plate is available in a 2-screw or 4-screw version and in multiple lengths for single level fixation. The screws are available in various lengths and 2 diameters.

This document is a 510(k) premarket notification for a medical device, specifically a Spinal Intervertebral Body Fixation Orthosis. As such, it primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of its performance against a set of acceptance criteria for diagnostic or AI-driven systems.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these relate to AI/diagnostic device validation, are not applicable or extractable from this document.

The document discusses mechanical performance testing to demonstrate that the device is sufficient for its intended use and substantially equivalent to legally marketed predicate devices. However, this is not the type of performance data typically associated with the "device performance" and "acceptance criteria" structure you are asking about for AI/diagnostic devices.

Here's an attempt to fill in relevant sections based on the provided text, while explicitly noting where the requested information is not applicable due to the nature of the device (a spinal fixation system, not a diagnostic AI):

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

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

This information is not applicable as the document describes mechanical testing of a physical implant rather than a study involving human or animal subjects that generate data in the context of AI/diagnostic device validation. The "tests" refer to laboratory mechanical assessments of the device components.

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 information is not applicable. Ground truth, in the context of diagnostic or AI systems, is not relevant for the mechanical testing of a spinal fixation device.

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

This information is not applicable. Adjudication methods are typically used for expert review and consensus in diagnostic or AI studies and are not relevant for mechanical 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

There was no MRMC comparative effectiveness study done. This device is a passive spinal implant, not an AI-assisted diagnostic or treatment system involving human readers.

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

There was no standalone algorithm performance study done. This device is a passive spinal implant, not an algorithm.

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

This information is not applicable. "Ground truth" in the diagnostic/AI sense is not established for the mechanical properties of a spinal implant. The "truth" for this device lies in its adherence to established ASTM standards for mechanical strength and material composition.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this device is a physical implant, not an AI model requiring machine learning.

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

This information is not applicable. As there is no training set for an AI model, there is no ground truth to establish for it.

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The AccuFit Lateral Plate System is indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery. The device is intended as a temporary fixation device until fusion is achieved.

The AccuFit Lateral Plate System consists of non-sterile, single use, titanium alloy (Ti6Al4V ELI per ASTM F136) rigid plates and bones screws of varying sizes and lengths. The plate attaches by means of screws to the lateral portion of the vertebral body of the thoracolumbar spine (T1-L5). The system includes instrumentation which assists in the surgical implantation of the devices. The Lateral Plate System implants and instruments are provided non-sterile. Thev require sterilization prior to use.

This document is a 510(k) premarket notification decision letter from the FDA for the AccuFit™ Lateral Plate System. It confirms that the device is substantially equivalent to legally marketed predicate devices.

Based on the provided text, here's an analysis of the acceptance criteria and study information:

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

The document does not explicitly state "acceptance criteria" in a numerical or categorical format for specific performance metrics. Instead, it indicates that the device has undergone performance testing according to recognized ASTM standards and the results lead to a conclusion of substantial equivalence to predicate devices. This implies that the performance met the standards expected for such devices, which is to perform comparably to existing, legally marketed devices.

The performance testing mentioned are:

The overarching acceptance criterion is achieving substantial equivalence to the predicate devices based on these mechanical tests.

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

The document mentions "Performance Testing Summary" which includes mechanical tests (Static Axial Compression, Static Torsion, Dynamic Axial Compression). These are typically benchtop mechanical tests performed on physical device samples, not human or patient data. The document does not specify the sample size (number of devices tested) for these mechanical tests. It also does not provide information about the country of origin or whether "data provenance" (as in, patient data) is relevant for these types of tests, as they are not 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 question is not applicable to the information provided. The "test set" here refers to the physical devices undergoing mechanical stress tests, not clinical data requiring expert human interpretation or ground truth establishment in a medical context.

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies for resolving discrepancies in expert interpretations of medical data. The tests described are mechanical engineering tests, not clinical evaluations.

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. The device is a spinal plate system, a physical implant, not an AI-assisted diagnostic or imaging device.

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

No, a standalone (algorithm only) performance study was not done. The device is a physical spinal implant.

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

The "ground truth" for the mechanical performance tests would be the established scientific and engineering principles and the performance benchmarks set by the ASTM F1717 standard for spinal implants, as well as the performance characteristics of the predicate devices. There is no mention of "expert consensus, pathology, or outcomes data" being used as ground truth for these specific performance tests.

8. The sample size for the training set

This question is not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The "training" for a mechanical device would involve engineering design, material selection, and manufacturing processes, not numerical data sets.

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

This question is not applicable for the reasons mentioned in point 8.

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The SKYHAWK Lateral Plate System is intended to be used as a non-pedicle lateral or anterolateral fixation system in skeletally mature patients and is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic and lumbar spine. It may be used from levels T1 to L5 with the following indications:

• Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies);
• Spondylolisthesis;
• Spinal stenosis;
• Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis);
• Tumor;
• Pseudoarthrosis;
• Failed previous fusion; and
• Trauma (i.e., fracture or dislocation).

The SKYHAWK Lateral Plate System consists of an assortment of non-sterile, single use, titanium alloy (Ti6Al4V ELI per ASTM F136) rigid plates, bone screws, and set screws. The.plates attach by means of screws to the anterolateral or lateral portion of the vertebral body of the thoracolumbar spine (T1-L5). The system includes instrumentation which assists in the surgical implantation of the devices. The SKYHAWK Lateral Plate System implants and instruments are provided non-sterile. They require sterilization prior to use.

The SKYHAWK Lateral Plate System is a medical device for spinal fixation. The provided document details its mechanical testing results but lacks information on performance metrics typically associated with AI/ML-driven devices (like sensitivity, specificity, etc.) or specific acceptance criteria beyond meeting performance benchmarks of predicate devices. Therefore, some sections of your request cannot be fully addressed.

Here's an analysis based on the provided text, focusing on what is available:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document describes non-clinical mechanical testing of the device itself, not a test set of data reflecting patient outcomes or imaging. Therefore, concepts like "sample size for the test set" and "data provenance (e.g., country of origin of the data, retrospective or prospective)" as they relate to AI/ML studies are not applicable here. The "sample" in this context refers to the physical devices subjected to mechanical stress tests. The number of devices tested is not specified, but it would align with the requirements of ASTM F1717-13.

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

This is not applicable as the study involves mechanical testing of a physical device, not an AI/ML diagnostic or prognostic system requiring expert review of data for ground truth establishment. The "ground truth" here is the physical performance of the device under specific, standardized mechanical loads, as measured by testing equipment.

4. Adjudication Method for the Test Set

Not applicable. The "test set" is the physical device and its components, and performance is determined by mechanical measurements against established ASTM standards and predicate device performance, not by expert adjudication.

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 is a 510(k) submission for a physical medical device (spinal plate system) based on mechanical equivalency, not an AI/ML device involving human readers or comparative effectiveness studies of human performance.

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

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

7. The Type of Ground Truth Used

The "ground truth" for this study is the physical performance of the SKYHAWK Lateral Plate System as measured through standardized mechanical testing (static and dynamic axial compression bending, and static torsion testing), compared against the established performance of legally marketed predicate devices and the requirements of ASTM F1717-13.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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The NuVasive Decade Lateral Plate System is indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery.

The NuVasive Decade Lateral Plate System is an anterior/anterolateral plate system that may be used in the thoracic, lumbar, and sacral spine (T1-S1). The Decade Lateral Plate System includes plates, large bolts, threaded small bolts, and impactable small bolts manufactured from titanium alloy (Ti-6A1-4V ELI) conforming to ASTM F136 or ISO 5832-3, as well as associated manual general surgical instruments. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The subject of this 510(k) premarket notification is for the addition of the impactable small bolt.

The provided text describes a medical device, the NuVasive® Decade Lateral Plate System, which is a spinal implant. The document is a 510(k) summary from NuVasive, Inc. to the FDA, demonstrating substantial equivalence to predicate devices.

This document describes a spinal implant (hardware) device, not an AI/Software as a Medical Device (SaMD). Therefore, the requested information pertaining to AI/SaMD (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth for training set, etc.) is not applicable and not available in this filing.

The "Performance Data" section (G) in the document outlines non-clinical testing performed to demonstrate substantial equivalence to predicate devices.

Here's the relevant information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of numerical acceptance criteria with corresponding performance values for the NuVasive Decade Lateral Plate System. Instead, it states that "The results demonstrate that the subject Decade Lateral Plate System presents no new worst-case for performance testing, and the subject device was therefore found to be substantially equivalent to the predicate devices."

The acceptance criteria are implicitly defined by the standards and the performance of the predicate devices. The "reported device performance" is the successful demonstration of equivalence through the listed non-clinical tests.

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

Not applicable. This is not an AI/SaMD study, but rather non-clinical physical testing of a medical implant. The "test set" would refer to the number of physical samples of the device components (plates, bolts, etc.) subjected to mechanical testing. This detail is not provided in the summary.

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

Not applicable. Ground truth for AI/SaMD is not relevant for this physical device testing.

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

Not applicable. Adjudication methods are typically for expert consensus in clinical or image-based studies, not for 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 is not an AI-assisted diagnostic or imaging device.

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

Not applicable. This is a physical spinal implant, not an algorithm.

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

Not applicable. The "ground truth" for this device's performance is based on the established safety and effectiveness of its predicate devices and its ability to meet the relevant ASTM F1717 physical testing standards.

8. The sample size for the training set:

Not applicable. This is a physical device, not an AI/Machine Learning model that requires a training set.

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

Not applicable. No training set is used for this physical device.

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The NuVasive Sage Lateral Plate System is indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery.

The NuVasive Sage Lateral Plate System is an anterior/anterolateral plate system that may be used in the thoracic, lumbar, and sacral spine (T1-S1). The Sage Lateral Plate System includes plates, screws, and spikes manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 or ISO 5832-3, as well as associated manual general surgical instruments. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.

The NuVasive Sage Lateral Plate System is a medical device. The provided text describes the 510(k) summary for this device, which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific clinical acceptance criteria or through a standalone clinical study.

Here's an analysis based on your request, highlighting what information is and is not available in the provided text:

Based on the provided 510(k) summary, the device is a spinal implant system and the "study" conducted is a nonclinical performance testing to demonstrate substantial equivalence to predicate devices. There is no information about a clinical study with human subjects, acceptance criteria related to a specific performance metric (like accuracy, sensitivity, specificity, etc.), or expert ground truthing as would be typical for an AI/algorithm-based device.

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

Note: The acceptance criteria here are focused on mechanical performance and equivalence, not clinical performance metrics for an AI/software device.

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

• Sample Size: Not applicable in the context of a "test set" for an AI/algorithm. The "testing" refers to mechanical and material tests of the physical implants. The number of samples/units tested is not specified, but it would involve a certain number of implant components (plates, screws, spikes) to conduct the ASTM F1717 tests.
• Data Provenance: Not applicable. The "data" comes from engineering and material testing in a lab setting, not from patient data or 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 not applicable as the ground truth here is based on engineering and material standards (ASTM F1717) and mechanical testing results, not expert interpretation of clinical data.

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

• This is not applicable as there is no human interpretation or adjudication involved in establishing ground truth for mechanical 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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/software devices that aid in interpretation or diagnosis, which is not the function of a spinal implant system.

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

• No, a standalone study was not done. The device is a physical implant, not an algorithm.

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

• The "ground truth" for this device, in the context of a 510(k) submission for a physical implant, is based on established engineering standards and mechanical test results (e.g., strength, durability, fatigue resistance as defined by ASTM F1717). The comparison is against predicate devices that have already been cleared, implying their safety and effectiveness have been established through a similar process or prior clinical use.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not applicable. There is no "training set" for this physical implant device.

In summary: The provided document is a 510(k) summary for a physical medical implant (spinal plate system). It demonstrates substantial equivalence to predicate devices through nonclinical mechanical testing. The concepts of "acceptance criteria," "test set," "ground truth," "experts," "adjudication," and "training set" as you typically define them for AI/software devices are not relevant or described in this context. The study outlined is a set of engineering performance tests to ensure the new device is as safe and effective as similar, already-approved devices.

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