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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.

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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).

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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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