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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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