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The GS Medical AnyPlus® PEEK Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. GS Medical AnyPlus® PEEK Cage System are used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. GS Medical AnyPlus® PEEK Cage System are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage.

The GS Medical AnyPlus® PEEK Cage System device is designed for restoring the height of the intervertebral space after resection of the disc. AnyPlus® PEEK Cage System device consists of implants available in various heights and lordotic configurations with an open architecture to accept packing of bone graft material. The intervertebral body fusion devices are made of poly-ether-ether- ketone (PEEK Optima LT1) body with the X-ray (radio-opaque) markers made of Tantalum. The AnyPlus® PEEK Cage System devices are radiolucent allowing X-ray visualization to verify device placement. AnyPlus® PEEK Cage System device is supplied sterile and non-sterile and is intended for single use only. AnyPlus® PEEK Cage System is designed for interbody stabilization of the cervical spine.

The provided text describes a medical device, the GS Medical AnyPlus® PEEK Cage System, for which FDA 510(k) clearance was sought. It details the device's intended use, technological characteristics, and non-clinical testing.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and the Reported Device Performance

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

The document mentions non-clinical testing according to ASTM standards. It does not provide specific sample sizes for these tests, nor does it detail the provenance of any data beyond indicating "worst-case" models for pyrogen testing. There is no human patient data or a "test set" in the traditional sense for evaluating diagnostic or predictive performance.

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

This information is not applicable (N/A) as the device is a spinal fusion cage and underwent non-clinical performance testing, not a study requiring expert-established ground truth for diagnostic accuracy.

4. Adjudication method for the test set

This information is not applicable (N/A) for the same reason as point 3.

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. The document explicitly states: "No clinical testing was performed." The device did not involve human readers or AI assistance.

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

No, this device is a physical medical implant (spinal cage), not an algorithm or AI system. Therefore, standalone algorithm performance testing is not applicable (N/A).

7. The type of ground truth used

The "ground truth" for this device's performance was established through engineering and material science standards (ASTM 2077-11 and ASTM F2267-04). These standards define the acceptable mechanical and material properties for intervertebral body fusion devices.

8. The sample size for the training set

This information is not applicable (N/A). This product is a physical medical device, not an AI/ML algorithm that requires a training set.

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

This information is not applicable (N/A) for the same reason as point 8.

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