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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 ANATOMIC PEEK 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 ANATOMIC PEEK device is to be used with supplemental fixation. The ANATOMIC PEEK device is also required to be used with autograft and is to be implanted via an open, anterior approach.

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 autograft.

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 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. 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 autograft 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 CAPSTONE CONTROLTM 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. 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 CLYDESDALE® 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 CLYDESDALE® Spinal System is used for patients diagnosed with degenerative disc disease (DDD) at one or two contiguous levels from L2 to SI. 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 nonoperative treatment. These implants may be implanted via a minimally invasive lateral approach.

The CRESCENT® 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. 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 SOVEREIGN® Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a laparoscopic or an open anterior approach. The SOVEREIGN® interbody system may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the SOVEREIGN® interbody device is intended to be used with the three titanium alloy fixed or variable angle screws. The accompanying cover plate MUST be used anytime the device is used with any number of variable angle screws. If the physician chooses to use less than three or none of the provided screws, then additional supplemental fixation for use in the lumbar spine must be used to augment stability.

The TELAMON® PEEK Spinal System is indicated for interbody fusion with autogenous bone graft in 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 nonoperative treatment. 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 ANATOMIC PEEK Cervical Fusion Implants 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. These implants are manufactured from implant grade polyetheretherketone (PEEK). The hollow geometry of the implants allows them to be packed with autogenous bone graft in cervical interbody fusion procedures. The ANATOMIC PEEK devices are intended to be implant via an open anterior approach and used with supplemental fixation and autogenous bone graft.

The CORNERSTONE® PSR Cervical Fusion Implants consist 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. These implants are manufactured from implant grade PEEK. The hollow geometry of the implants allows them to be packed with autogenous 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 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 2 screw midline configuration. This device is intended to be radiolucent and the interior space of the product is to be used with autograft. The PEEK PREVAIL™ Cervical Interbody device implant is manufactured from PEEK and contains tantalum radiopaque markers and a Nitinol screw locking mechanism. The screws used with this device (ZEPHIR® Anterior Cervical Screws) are manufactured from Titanium Alloy.

The CAPSTONE CONTROL™ Spinal System Implants consist of PEEK cages of various widths and heights which include Tantalum markers. These implants can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft. The CAPSTONE CONTROL™ Spinal System Implants are to be used with supplemental instrumentation and are to be implanted via an open or minimally invasive, posterior or transforaminal approach.

The CLYDESDALE® Spinal System Implants consist of PEEK cages of various widths and heights, which include Tantalum markers. These devices can be inserted via a lateral approach between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft. The CLYDESDALE® Spinal System Implants are to be used with supplemental instrumentation.

The CRESCENT® Spinal System (PEEK) Implants consist of PEEK cages of various widths and heights which include Tantalum markers. These implants can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft. The implants may be implanted via a posterior, transforaminal or lateral approach and the procedure may be open or minimally invasive. The CRESCENT® Spinal System Implants are to be used with supplemental instrumentation.

The SOVEREIGN® Spinal System Implants are an intervertebral body fusion devices 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 lens-shaped with three holes for placement of titanium screws. The SOVEREIGN® Spinal System contains both a fixed and a variable angle screw option. The fixed angle screw option provides an interference fit with the PEEK interbody implant. The variable angle screw option provides a slight clearance between the PEEK interbody implant and the screw which allows for a small amount of variable screw angulation. This system is intended to be radiolucent and the interior space of the product is to be used with autogenous bone graft. The accompanying cover plate is designed to resist screw backout and must be used when the variable angle screws are implanted. The SOVEREIGN® Spinal System interbody device is manufactured from PEEK and contains tantalum radiopaque markers. The screws used with this device are manufactured from titanium alloy.

The TELAMON® PEEK Spinal System Implants consist 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. The hollow geometry of the implants allows them to be packed with autogenous bone graft. These implants may be implanted via an open or a minimally invasive posterior approach. The TELAMON® PEEK Spinal System Implants are to be used with supplemental instrumentation.

The provided document is a 510(k) summary for Medtronic Sofamor Danek MRI Update for PEEK Interbody Fusion Devices. The purpose of this submission is to provide appropriate MRI safety labeling for the devices and information on how to perform an MRI scan on patients with these implants. The submission determines that the devices are "MR Conditional" as per ASTM F2503.

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

• Sample Size: The document states that "testing has been completed on the worst case implants." It does not specify a numerical sample size for the test set (number of individual implants tested).
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It describes non-clinical testing performed in accordance with ASTM guidance. This implies laboratory testing rather than human subject data.

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

This information is not applicable to this submission. The "ground truth" here is established by the specified ASTM standards for MRI safety of implants, not by expert interpretation of data generated by the device. The testing involved physical measurements and evaluations according to these standards.

4. Adjudication Method for the Test Set

This information is not applicable. As the testing is non-clinical and based on physical measurements and adherence to ASTM standards, there is no need for adjudication by multiple readers or a consensus process.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This submission focuses on the MRI safety of the implanted devices themselves, not on an AI system assisting human readers in interpreting medical images.

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

No, a standalone algorithm performance study was not done. This submission is for physical medical devices—interbody fusion implants—and their safety in an MRI environment, not for an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this assessment is defined by the ASTM International Standards for evaluating the safety and compatibility of passive implants in the Magnetic Resonance (MR) Environment:

• ASTM F2052
• ASTM F2213
• ASTM F2119
• ASTM F2182
• ASTM F2503

These standards outline the methodologies and acceptable limits for magnetic displacement, torque, RF heating, and image artifacts.

8. The Sample Size for the Training Set

This information is not applicable. This submission is not about an AI/ML algorithm that requires training data. It is about the physical properties of medical implants.

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

This information is not applicable for the same reason as point 8.

Ask a specific question about this device

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 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. 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 autograft 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 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 2 screw midline configuration. This device is intended to be radiolucent and the interior space of the product is to be used with autograft.

The PEEK PREVAIL® Cervical Interbody device implant is manufactured from PEEK Optima LT1® and contains tantalum radiopaque markers and a Nitinol screw locking mechanism. The screws used with this device (ZEPHIR® Anterior Cervical Screws) are manufactured from Titanium Alloy.

The provided text is a 510(k) premarket notification for a medical device, the PEEK PREVAIL® Cervical Interbody Device. It describes the device, its intended use, and states that it is substantially equivalent to a previously cleared device (K094042).

However, this document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria. It is a regulatory submission for premarket clearance based on substantial equivalence, not a clinical study report or a performance validation document.

Therefore, I cannot provide the requested information, particularly items 1-9, as this type of detail is not present in the provided text. The document states:

• Substantial Equivalence: "Documentation was provided which demonstrated the subject intervertebral devices to be substantially equivalent to PEEK PREVAIL® Cervical Interbody Device components previously cleared in K094042 (S.E. 06/30/2010)."
• Non-Clinical Testing: "The subject and predicate PEEK PREVAIL® Cervical Interbody Device are identical in terms of indications for use, intended use, performance specifications, and technological characteristics. Cleaning and sterilization assessments have been performed to provide the appropriate instructions for the use of the PEEK PREVAIL device."
• Conclusions: "The information above demonstrates equivalence and supports a determination of substantial equivalence between the subject and predicate PEEK PREVAIL® Cervical Interbody Device."

This regulatory pathway (510(k)) often relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than requiring new, extensive clinical trials to establish de novo acceptance criteria and prove performance against them. The "non-clinical testing" mentioned here likely refers to bench testing to confirm material properties, mechanical strength, and sterility, consistent with the predicate device, rather than a study against a specific set of clinical performance acceptance criteria.

Ask a specific question about this device

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 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. 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 autograft 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 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 2 screw midline configuration. This device is intended to be radiolucent and the interior space of the product is to be used with bone graft.
The key difference between the predicate PEEK PREVAIL™ Cervical Interbody Device and the subject PEEK PREVAIL™ Cervical Interbody Device is the reduction of the device footprint by 2mm in the anterior/posterior dimension (i.e., adding a smaller footprint cage).
This product will be manufactured from PEEK Optima and will have tantalum radiopaque markers and a nitinol screw locking mechanism. The screw designed to be used with this device will be manufactured from titanium alloy.

Here's an analysis of the provided text regarding the PEEK PREVAIL™ Cervical Interbody Device, addressing your requested information:

This submission (K094042) is a 510(k) summary for a medical device, which typically focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical studies to establish new safety and effectiveness. Therefore, many of your requested points regarding clinical study design, ground truth, and expert evaluation will not be directly relevant or available in this type of document.

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is described as "Non-Clinical Testing" and specifically mentions the mechanical tests performed.

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

• Sample Size for Test Set: Not specified. For mechanical testing of medical devices, sample sizes are typically determined by the relevant ASTM standard (ASTM F2077-03 in this case), often involving a small number of devices (e.g., 5-10) per test condition.
• Data Provenance: Not applicable in the context of this 510(k) submission, as it relies on non-clinical, in-vitro mechanical testing rather than patient data.

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

• This is not applicable. The "ground truth" for mechanical testing is defined by the objective pass/fail criteria set forth in the ASTM standard, not by expert consensus on clinical findings.

4. Adjudication method for the test set

• This is not applicable. Adjudication methods are relevant for subjective evaluations, typically in clinical studies or image interpretation. Mechanical testing results are objectively measured against predefined criteria.

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

• No MRMC comparative effectiveness study was done. This device is a physical implant (interbody fusion device), not an AI diagnostic tool. Therefore, MRMC studies and AI assistance are irrelevant to this submission.

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

• Not applicable. This device is a physical implant, not an algorithm, so standalone AI performance is not relevant.

7. The type of ground truth used

• The "ground truth" for this device's evaluation is defined by the objective, quantitative results of mechanical tests performed according to the specified ASTM standard (F2077-03). The standard itself outlines the methods and criteria for evaluating the mechanical properties of intervertebral body fusion devices.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device. No "training set" in that sense was used. The design and manufacturing processes are based on engineering principles and material science, validated through benchtop testing.

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

• Not applicable. As no training set for an AI/ML model was used, there's no ground truth to establish for it. The design of the device is informed by engineering knowledge, material properties, and surgeon feedback (as mentioned, to accommodate variations in patient anatomies by providing a smaller footprint).

Ask a specific question about this device

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 and/or myelopathy with hemiated 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 autograft 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 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 is "I-Beam" shaped with a 2 screw midline configuration. This device is intended to be radiolucent and the interior space of the product is to be used with autograft. The PEEK PREVAIL™ Cervical Interbody device implant is manufactured from PEEK Optima and contains tantalum radiopaque markers and a Nitinol screw locking mechanism. The screws used with this device (ZEPHIR® Anterior Cervical Screws) are manufactured from Titanium Alloy.

The provided text is a 510(k) premarket notification for a medical device, the PEEK PREVAIL™ Cervical Interbody Device. It primarily focuses on demonstrating substantial equivalence to previously approved devices, rather than presenting a study with specific acceptance criteria and detailed performance metrics. As such, much of the requested information regarding acceptance criteria, study design, and performance statistics is not available in the provided document.

Here's an analysis of what information can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. 510(k) submissions for devices like interbody fusion devices often rely on demonstrating substantial equivalence to predicate devices through material properties, design features, and possibly biomechanical testing, rather than clinical trials with explicit acceptance criteria for diagnostic accuracy or clinical outcomes in the same way an AI/software device would. The document does not specify any performance metrics or acceptance criteria for the PEEK PREVAIL™ device itself.

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

This information is not applicable/not provided in the context of this 510(k) submission. This document describes a physical medical device (an intervertebral body fusion device) and not a software algorithm that would typically have a "test set" in the sense of AI/ML evaluation. The submission relies on establishing substantial equivalence to existing devices through design, materials, and intended use, rather than a clinical study requiring test sets of patient data.

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

This information is not applicable/not provided. Ground truth establishment by experts is a concept relevant to evaluating diagnostic devices or AI algorithms. For this physical interbody fusion device, "ground truth" in the AI sense is not relevant.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. Adjudication methods are used in studies involving expert review, typically for diagnostic accuracy or outcome assessment in clinical trials or AI performance evaluations, which are not detailed here.

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

This information is not applicable/not provided. MRMC studies are typically used for evaluating the effectiveness of diagnostic imaging devices or AI tools, often comparing human reader performance with and without AI assistance. This document does not describe such a study.

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

This information is not applicable/not provided. This document pertains to a physical medical implant, not a standalone algorithm.

7. The Type of Ground Truth Used

This information is not applicable/not provided. For a physical implant, "ground truth" as it relates to expert consensus, pathology, or outcomes data in the context of device performance claims isn't specified in this substantial equivalence document. Clinical outcomes for such devices are typically established through post-market surveillance or larger clinical trials that are beyond the scope of a 510(k) summary.

8. The Sample Size for the Training Set

This information is not applicable/not provided. Training sets are relevant for machine learning algorithms. The PEEK PREVAIL™ Cervical Interbody Device is a physical implant.

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

This information is not applicable/not provided. As above, this concept applies to AI/ML development, not the submission for a physical interbody fusion device.

Summary of Device and 510(k) Submission:

The provided document (K073285) is a 510(k) premarket notification for the PEEK PREVAIL™ Cervical Interbody Device.

• Device Description: An intervertebral body fusion device with internal screw fixation, "I-Beam" shaped, made from PEEK Optima with tantalum radiopaque markers and a Nitinol screw locking mechanism. It's intended to be radiolucent and used with autograft.
• Indications for Use: Anterior cervical interbody fusion in skeletally mature patients with cervical disc disease at one level (C2-C3 to C7-T1), defined by intractable radiculopathy/myelopathy with herniated disc/osteophyte formation causing nerve root/spinal cord compression. Must be used with ZEPHIR® Anterior Cervical Screws and autograft, implanted via an open, anterior approach, after six weeks of non-operative treatment.
• Substantial Equivalence: The submission demonstrates substantial equivalence to previously approved devices, including the AFFINITY® Anterior Cervical Cage, BAK/C® Cervical Interbody Fusion System, VERTE-STACK® Spinal System, and VENTURE™ Anterior Cervical Plate System. This is the primary method of approval for this device, emphasizing similarity in materials, design, and intended use to already cleared predicate devices.

Conclusion:

The provided 510(k) submission document for the PEEK PREVAIL™ Cervical Interbody Device focuses on demonstrating substantial equivalence to already approved predicate devices. It does not contain information about acceptance criteria, specific performance metrics, or study designs involving test sets, ground truth establishment, or human reader performance comparisons, as typically requested for AI/ML or diagnostic imaging device evaluations.

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