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The Chena Cervical Peek Spacer System is an anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level or two contiguous levels from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Chena Cervical Peek Spacer interior should be packed with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and implanted via an anterior approach. The Chena Cervical Peek Spacer is intended to be used with supplemental fixation.

The Axis Chena Cervical PEEK Spacer System consists of a variety of footprints and heights of PEEK cervical interbody spacer implants to assist in interbody fusion.

The Axis Chena Cervical PEEK Spacer System implant components are fabricated from medical implant grade Polyetheretherketone and tantalum described by such standards as ASTM F2026-17 and ASTM F560-17. Axis Orthopaedics Corporation expressly warrants that these devices are fabricated from one of the foregoing material specifications.

Do not use any of the Axis Chena Cervical PEEK Spacer System implant components with components from any other system or manufacturer. As with all orthopaedic and neurosurgical implants, none of the Axis Chena Cervical PEEK Spacer System components should ever be reused under any circumstances.

The provided document is a 510(k) summary for the Axis Chena Cervical PEEK Spacer System and focuses on demonstrating substantial equivalence to predicate devices, primarily through performance testing rather than clinical studies or reader studies. Therefore, many of the requested categories related to human-in-the-loop performance, expert ground truth, and clinical efficacy will not be directly applicable or available in this specific document.

However, I can extract and infer information relevant to its acceptance criteria and the engineering performance testing showing it meets those criteria.

Here's the breakdown based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are largely based on demonstrating equivalence to predicate devices through mechanical performance testing according to established ASTM standards. The reported performance is that the device met these standards.

Study Details (as inferable from the document)

Because this is a 510(k) submission primarily relying on mechanical testing for substantial equivalence, clinical study details (like MRMC, human-in-the-loop, etc.) are not part of this submission and are therefore not available in the provided text.

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

   • Sample Size: Not explicitly stated for each test, but standard engineering protocols for ASTM testing would involve a sufficient number of samples (e.g., typically N=5-6 per test condition).
   • Data Provenance: The testing was performed by the manufacturer, Axis Orthopaedics, or a contracted lab. The document does not specify the country of origin for the testing or whether it was retrospective or prospective in a clinical sense. It's prospective in the sense that the tests were conducted specifically to support this 510(k) submission.

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

   • Not Applicable. For mechanical performance testing of an implant, "ground truth" is established by the well-defined parameters and methods outlined in the ASTM standards. There are no human experts "establishing ground truth" in the way clinical studies would. The device's performance is objectively measured against the standard's specifications.

3. Adjudication Method for the Test Set:

   • Not Applicable. Adjudication methods like 2+1 or 3+1 are used for clinical trials involving human interpretation of data. For mechanical testing, the results are quantitative and objective measurements against established criteria.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

   • No. An MRMC study is a type of clinical study involving human readers evaluating images or data. This 510(k) is based on mechanical testing, not a clinical MRMC study.

5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Not Applicable. This device is a passive mechanical implant, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

6. The Type of Ground Truth Used:

   • Mechanical Test Standards and Predicate Performance: The "ground truth" for this submission is adherence to recognized industry standards (ASTM F2077-14 and F2267-11) for intervertebral body fusion devices, and demonstrating that the device performs equivalently to its legally marketed predicate devices under these conditions.

7. The Sample Size for the Training Set:

   • Not Applicable. The concept of a "training set" applies to machine learning algorithms. This device is a mechanical implant; therefore, no training set was used.

8. How the Ground Truth for the Training Set was Established:

   • Not Applicable. See point 7.

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