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The ANATOMIC PEEK CERVICAL FUSION SYSTEM 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 CERVICAL FUSION SYSTEM is also required to be used with autogenous bone graft and is to be implanted via an open, anterior approach.

The ANATOMIC PEEK™ CERVICAL FUSION SYSTEM is designed for use as a cervical interbody fusion device. The device is manufactured from PEEK™ OPTIMA™ and is to be used with autogenous bone graft. The ANATOMIC PEEK™ CERVICAL FUSION SYSTEM consists hemicylindrical of cages of various widths, heights and depths. The hollow geometry of the implants allows them to be inserted between two cervical vertebral bodies packed with autogenous bone graft in cervical fusion procedures. The ANATOMIC PEEK™ device is to be used with cleared cervical supplemental fixation.

The provided text describes a 510(k) premarket notification for the "ANATOMIC PEEK™ CERVICAL FUSION SYSTEM" and does not contain information about a study proving the device meets acceptance criteria in the context of a software or AI-based medical device. Instead, it details non-clinical testing performed on the physical device to demonstrate substantial equivalence to predicate devices.

Therefore, many of the requested categories in your prompt are not applicable to the provided document. I will fill in the information that is present and indicate where information is not available or not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria were based on established ASTM standards: ASTM F2077-03, ASTM F2267-04, and ASTM F-04.25.02.02 (Draft Static Push-out Test Method). The specific numerical thresholds for acceptance are not detailed in this document but are implied to be part of these standards.

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

This information is not applicable as the document describes non-clinical physical device testing (mechanical characteristics) rather than testing related to AI/software performance or human subject data.

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

This information is not applicable. The "ground truth" for the physical device performance was established by the technical specifications outlined in the ASTM standards for mechanical testing.

4. Adjudication Method for the Test Set

This information is not applicable. The mechanical tests would have objective pass/fail criteria based on measured physical properties, rather than expert adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

This information is not applicable. No MRMC study was conducted or is relevant for this type of physical device submission.

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

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

7. The Type of Ground Truth Used

The ground truth was based on pre-defined mechanical performance specifications as outlined by the standards ASTM F2077-03, ASTM F2267-04, and ASTM F-04.25.02.02. This is a form of engineering or objective performance metrics, not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

This information is not applicable. This is a physical device, and there is no "training set" in the context of 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 a physical device, no ground truth was established for it.

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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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