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The CORNERSTONE® PSR device is indicated for cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. This device is to be used in patients who have had six weeks of non-operative treatment. The CORNERSTONE® PSR device is to be used with supplemental fixation. The CORNERSTONE® PSR device is also required to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and is to be implanted via an open, anterior approach.

The PERIMETER® C Spinal System is intended to be used for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc who have had six weeks of nonoperative treatment. Cervical discase is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. Additionally, the PERIMETER® C Spinal System implants are to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation and implanted via an open, anterior approach.

The PEEK PREVAIL® Cervical Interbody Device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. 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. The PEEK PREVAIL® Cervical Interbody Device must be used with internal screw fixation provided by ZEPHIR® Anterior Cervical Screws. The PEEK PREVAIL® Cervical Interbody Device implants are to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and implanted via an open, anterior approach. This cervical device is to be used in patients who have had six weeks of non-operative treatment.

The CORNERSTONE® PSR Cervical Fusion System consists of cages of various widths and heights, which can be inserted between two cervical vertebral bodies to give support and correction during cervical interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft in cervical fusion procedures. The CORNERSTONE® PSR device is to be used with supplemental instrumentation, and is to be implanted via an open, anterior approach. The CORNERSTONE® PSR devices are manufactured from medical grade polyetheretherketone (PEEK) material with tantalum or titanium alloy (Ti-6Al-4V) pin markers.

The PERIMETER® C Spinal System consists of spacers of various widths and heights which can be inserted between two cervical vertebral bodies to give support and correction during cervical interbody fusion procedures. Additionally, this implant has six degrees of lordosis and the superior and inferior surfaces of the implant are designed with teeth which interact with the surface of the vertebral endplates to aid in resisting expulsion. The hollow geometry of the implants allows them to be packed with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and is to be used with supplemental fixation in all procedures. PERIMETER® C Spinal System is used with instrumentation that enables the surgeon to implant the devices via an open, anterior approach. The subject PERIMETER® C devices are manufactured from medical grade titanium alloy (Ti-6Al-4V) or polyetheretherketone (PEEK) material with tantalum pin markers.

The PEEK PREVAIL® Cervical Interbody Device is an intervertebral body fusion device with internal screw fixation. The screws protrude through the interbody portion of the device and stabilize the vertebral body while preventing expulsion of the implant. The implant is "I-Beam" shaped with a two screw midline configuration. This device is intended to be radiolucent and the interior space of the product is to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The subject PEEK PREVAIL® Cervical Interbody device implant is manufactured from medical grade polyetheretherketone (PEEK) material and contains tantalum radiopaque markers. The subject device also contains a Nitinol screw locking mechanism and uses bone screws made of grade titanium alloy (Ti-6Al-4V).

The provided text is a 510(k) Summary for a medical device submission, focusing on establishing substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study proving performance against those criteria. In the context of a 510(k) submission, the "acceptance criteria" are typically related to demonstrating that the new device is as safe and effective as a legally marketed predicate device. The "study" here primarily refers to the justification of this substantial equivalence.

Here's an analysis of the provided information, framed by your request.

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

The document does not specify quantitative acceptance criteria in the way one might see for a diagnostic device (e.g., sensitivity, specificity thresholds). Instead, the "acceptance" for a 510(k) device like this fusion system is achieving substantial equivalence to a predicate device.

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

The document mentions "Published retrospective clinical data for the cervical interbody fusion devices were provided in support of this application."

• Sample size: Not explicitly stated. The document refers to "clinical data" in general, not a specific sample size for a new study.
• Data provenance: "Published retrospective clinical data". The country of origin is not specified.

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 type of information (number and qualifications of experts for ground truth) is typically relevant for diagnostic AI/ML devices where expert consensus labels are critical. For a device like an intervertebral body fusion system, ground truth would be established through clinical outcomes, pathology, or successful fusion rates in a clinical study. The document refers to "clinical data" but does not detail how specific ground truth was established by experts in the context of a new test set for this 510(k). The "ground truth" for proving safety and effectiveness of the expanded indication would implicitly be successful clinical outcomes (e.g., fusion, lack of complications) from the retrospective data using allogenic bone graft.

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

Not applicable in the context of this 510(k) submission. Adjudication methods like 2+1 or 3+1 are common in studies for diagnostic devices where multiple readers interpret images, and a tie-breaking mechanism is needed to establish a "ground truth" label. This document refers to retrospective clinical data rather than a new reader study.

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 is no indication that an MRMC comparative effectiveness study was done, nor is there any mention of human readers or AI assistance. This device is a physical implant, not a diagnostic imaging or AI-assisted system.

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

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

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

For the retrospective clinical data that supports the expanded indication, the implicit ground truth would be outcomes data (e.g., successful fusion, absence of adverse events, patient recovery) from patients who received allogenic bone graft in cervical interbody fusion procedures. The document states the data "demonstrated that the use of allogenic bone graft... poses no new risks to patients."

8. The sample size for the training set

Not applicable. This 510(k) submission does not describe the development of an AI/ML algorithm that would typically involve a training set. The "study" mentioned refers to retrospective clinical data used to support the safety and effectiveness of using an allogenic bone graft, not to train a model.

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

Not applicable for the same reasons as point 8.

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The PERIMETER® C Spinal System is intended to be used for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc who have had six weeks of non-operative treatment. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. Additionally, the PERIMETER® C Spinal System implants are to be used with autogenous bone graft and supplemental fixation and implanted via an open, anterior approach.

The CAPSTONE® Spinal System is indicated for interbody fusion with autogenous bone graft in patients with Degenerative Disc Disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. 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 six months of non-operative treatment. Additionally, the CAPSTONE® Spinal System is indicated in the setting of spinal deformity as a supplement to pedicle screw fixation in patients diagnosed with degenerative scoliosis. These implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via an anterior and/or transforaminal approach. These implants are to be used with autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.

The CAPSTONE® L Spinal System is designed to be used with autogenous bone graft to facilitate interbody fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The CAPSTONE® L Spinal System is used for patients diagnosed with degenerative disc 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. 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 six months of non-operative treatment. These implants may be implanted via a minimally invasive lateral approach.

The PERIMETER® Interbody Fusion Device is indicated for interbody fusion with autogenous bone graft in patients with degenerative disc 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. 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 six months of non-operative treatment. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior, lateral and oblique. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.

The PERIMETER® C Spinal System consists of PEEK spacers with tantalum markers of various widths and heights, which can be inserted between two cervical vertebral bodies to give support and correction during cervical interbody fusion procedures. Additionally, the superior and inferior surfaces of the implant are designed with teeth which interact with the surface of the vertebral endplates to aid in resisting expulsion. The hollow geometry of the implants allows them to be packed with autogenous bone graft and is to be used with supplemental fixation in all procedures.

The CAPSTONE® PEEK Spinal System consists of PEEK cages with tantalum markers of various widths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. Additionally, the superior and inferior surfaces of the implant are designed with teeth which interact with the surface of the vertebral endplates to aid in resisting expulsion. The hollow geometry of the implants allows them to be packed with autogenous bone graft.

The CAPSTONE® L Spinal System consists of PEEK cages of various widths and heights, which include Tantalum markers. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. Additionally, the superior and inferior surfaces of the implant are designed with teeth which interact with the surface of the vertebral endplates to aid in resisting expulsion. The hollow geometry of the implants allows them to be packed with autogenous bone graft.

The PERIMETER® Interbody Fusion Device consists of PEEK cages with tantalum markers of various widths and heights which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. Additionally, the superior and inferior surfaces of the implant are designed with teeth which interact with the surface of the vertebral endplates to aid in resisting expulsion. The hollow geometry of the implants allows them to be packed with autogenous bone graft. The PERIMETER® Interbody Device is to be used with supplemental fixation instrumentation.

The provided document is a 510(k) premarket notification for Medtronic Sofamor Danek MRI Update for PEEK Interbody Fusion Devices. The primary purpose of this submission is to obtain MRI safety labeling for these devices and provide instructions on how to perform MRI scans on them. It asserts that the devices are "MR Conditional" according to ASTM F2503.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document repeatedly mentions "worst case implants" were used for testing. However, it does not specify the exact number of implants constitutive of this "worst case" test set for any of the ASTM standards.
• Data Provenance: The document does not specify the country of origin of the data. The testing was non-clinical and conducted in accordance with FDA Guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment." It's reasonable to infer the testing was conducted in a laboratory setting, likely in the USA where Medtronic Sofamor Danek is based. The data would be prospective for the purpose of this 510(k) submission, as it was specifically generated to demonstrate MRI safety for these devices.

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

• This information is not provided in the document. The testing described focuses on non-clinical, objective measurements defined by ASTM standards. These standards themselves establish the "ground truth" for MR safety parameters through their methodologies. There is no mention of human experts establishing a ground truth for the test set data in the context of MRI safety.

4. Adjudication Method for the Test Set:

• None specified. The testing involves physical measurements adhering to established ASTM standards, not subjective evaluation requiring adjudication by multiple experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No, an MRMC comparative effectiveness study was not done. This submission is for MRI safety labeling of interbody fusion devices, which are passive implants. An MRMC study would be relevant for diagnostic imaging interpretation or active devices with AI assistance, neither of which applies here.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• Not applicable. This device is a passive implant (interbody fusion device), not an algorithm or an AI-powered diagnostic tool. The performance evaluated is the physical interaction of the implant with MRI fields, not an algorithm's output.

7. The Type of Ground Truth Used:

• The ground truth relies on objective physical measurements and adherence to established industry standards (ASTM F2052, F2213, F2119, F2182, F2503) for assessing MRI safety of passive metallic medical implants. These standards provide the methodology and criteria for evaluating displacement force, torque, image artifacts, and RF-induced heating.

8. The Sample Size for the Training Set:

• Not applicable. This is a non-clinical evaluation of a physical device's interaction with an MRI environment, not a machine learning model. Therefore, there is no "training set."

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

• Not applicable. As there is no training set, this question is not relevant.

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The PERIMETER® C Spinal System is intended to be used for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc who have had six weeks of nonoperative treatment. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. Additionally, the PERIMETER® C Spinal System implants are to be used with autogenous bone graft and supplemental fixation and implanted via an open, anterior approach.

The PERIMETER® C Spinal System consists of spacers/cages of various widths and heights, which can be inserted between two cervical bodies to give support and correction during cervical interbody fusion procedures. Additionally, this implant has six degrees of lordosis and the superior and inferior surfaces of the implant are designed with teeth which interact with the surface of the vertebral endplates to aid in resisting expulsion. The hollow geometry of the implants allows them to be packed with autogenous bone graft and is to be used with supplemental fixation in all procedures.

The purpose of this submission is to include additional interbody cages manufactured from medical grade titanium alloy (Ti-6A1-4V ELI) and designed with lateral windows. The lateral windows allow for visibility of bone graft placement. The subject device is offered in a non-sterile form.

The Medtronic PERIMETER® C Spinal System is a medical device for anterior cervical interbody fusion procedures. The study demonstrates substantial equivalence to existing predicate devices based on non-clinical mechanical testing and Finite Element Analysis (FEA), following FDA guidance document, "Class II Special Controls Guidance Document: Intervertebral Body Fusion Devices".

1. Acceptance Criteria and Device Performance:

The study concludes that "Based on the results the subject intervertebral devices demonstrated that they are as safe and effective as the predicate device(s)."

2. Sample Size and Data Provenance for Test Set:

No specific sample sizes for mechanical testing are provided in the document. The testing was non-clinical (laboratory-based) and not based on patient data, so "data provenance" in terms of country of origin or retrospective/prospective is not applicable.

3. Number of Experts and Qualifications for Ground Truth (Test Set):

Not applicable. This was a non-clinical, mechanical engineering study, not involving human expert assessment for ground truth.

4. Adjudication Method for Test Set:

Not applicable. As this was a non-clinical mechanical test, there was no adjudication method involving human interpretation of results.

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

No MRMC comparative effectiveness study was done, as this was a non-clinical mechanical engineering study and did not involve human readers or AI assistance.

6. Standalone Performance Study:

Yes, a standalone performance study was done for the device in the sense of mechanical testing of the device itself (algorithm only without human-in-the-loop performance). The tests listed above are all standalone tests of the device's mechanical properties.

7. Type of Ground Truth Used:

The "ground truth" for the non-clinical tests was based on the performance requirements specified in the FDA guidance document "Class II Special Controls Guidance Document: Intervertebral Body Fusion Devices" and the applicable ASTM standards (ASTM F2077, ASTM F2267, and DRAFT ASTM F-04.25.02.02). The device's performance was compared against these established engineering standards and implicitly, against the performance of predicate devices.

8. Sample Size for Training Set:

Not applicable, as this was a non-clinical mechanical engineering study, not involving machine learning or a "training set" of data in the conventional sense.

9. How Ground Truth for Training Set Was Established:

Not applicable, as there was no training set in the context of this non-clinical mechanical study.

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The PERIMETER® C Spinal System is intended to be used for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc who have had six weeks of non-operative treatment. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. Additionally, the PERIMETER® C Spinal System implants are to be used with autogenous bone graft and supplemental fixation and implanted via an open, anterior approach.

The PERIMETER® C Spinal System consists of spacers of various widths and heights, which can be inserted between two cervical vertebral bodies to give support and correction during cervical interbody fusion procedures. Additionally, this implant has six degrees of lordosis and the superior and inferior surfaces of the implant are designed with teeth which interact with the surface of the vertebral endplates to aid in resisting expulsion. The hollow geometry of the implants allows them to be packed with autogenous bone graft and is to be used with supplemental fixation in all procedures. This device is offered in PEEK-OPTIMA® (i.e., POLYETHERETHERKETONE) with tantalum markers. Medical grade titanium implants and medical grade PEEK implants may be used together. Never use titanium or titanium alloy implants with stainless steel in the same construct.

Here's a breakdown of the acceptance criteria and the study information for the PERIMETER® C Spinal System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided 510(k) summary focuses on non-clinical mechanical testing for the PERIMETER® C Spinal System. Therefore, there is no "test set" in the context of patient data (e.g., medical images, clinical outcomes).

• Sample Size for Test Set: Not applicable, as this refers to mechanical test specimens, not patient data. The document does not specify the number of individual test articles (implants) used for each mechanical test.
• Data Provenance: Not applicable. The data comes from in-vitro mechanical testing, not a country of origin for patient data. This is a retrospective analysis of device performance against established ASTM standards.

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

Not applicable. For mechanical testing, the "ground truth" is defined by the established ASTM standards and engineering principles. The results are compared against these predetermined criteria, not against expert human interpretations of patient data.

4. Adjudication Method for the Test Set

Not applicable. Mechanical test results are measured and directly compared to quantitative acceptance criteria defined by the ASTM standards. There is no need for adjudication as you would have for subjective interpretations of clinical findings.

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 submission is for a medical implant (spinal system), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human reader performance with and without AI is not relevant.

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

Not applicable. This is not an algorithm-based device.

7. The Type of Ground Truth Used

The ground truth used for demonstrating the device's performance against its acceptance criteria is:

• Standardized Mechanical Test Criteria: Specifically, the requirements outlined in ASTM F2077-03 (Standard Test Methods for Intervertebral Body Fusion Devices) and ASTM F2267-04 (Standard Test Method for Evaluating the Subsidence of an Intervertebral Body Fusion Device Under Static Axial Compression).
• Engineering Rationale: Complementary engineering analysis to support the mechanical test results.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not a machine learning or AI-driven device requiring data for model training.

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

Not applicable. As there is no training set, there is no ground truth to be established for it.

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