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The Phenix Cervical Interbody Device (Phenix CID) is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. Phenix CID implants are used to facilitate fusion in the cervical spine and are placed via an anterior approach at the C-3 to C-7 disc levels using autograft bone. Patients should have received 6 weeks of non-operative treatment prior to treatment with the devices. The device should be used with supplemental fixation.

The Phenix ® Cervical Interbody Device is a cervical interbody fusion device made from PEEK Optima. It is implanted from the anterior approach. The device is provided in various geometries and is designed to fit within the outer cortex of cervical spine vertebrae. It is to be packed with autogenous bone graft to facilitate fusion. The device is intended to provide mechanical support to the implanted level until biologic fusion is achieved.

The provided text is a 510(k) summary for the Phenix® Cervical Interbody Device (Phenix® CID). It describes the device, its indications for use, and identifies predicate devices. However, it does not contain details about specific acceptance criteria for device performance or a study demonstrating that the device meets those criteria by comparing it to an AI system or human reader performance.

The "Performance Testing" section states: "The pre-clinical testing performed indicated that the Phenix CID is substantially equivalent to the predicate devices and is adequate for the intended use." This suggests that the device's performance was evaluated against the predicate devices for achieving substantial equivalence, which is a regulatory standard for medical devices. However, it does not provide quantitative acceptance criteria or detailed study results in the context of an AI device and reader performance.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is a summary of what can be inferred or directly stated, with the understanding that detailed performance metrics are not included for AI or reader studies:

1. A table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not provided. The summary mentions "pre-clinical testing" but does not detail sample sizes, data provenance, or whether the study involved human subjects (which would be the case for a test set in the context of AI/reader studies).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not applicable/Not provided. This device is a physical implant, not an AI diagnostic tool that requires ground truth established by experts for performance evaluation in the way a diagnostic AI would. The "pre-clinical testing" would likely refer to mechanical and material tests rather than expert-adjudicated diagnostic performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable/Not provided. Similar to point 3, this is not relevant for the type of device described.

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. This is not an AI device, and therefore, an MRMC study comparing human readers with and without AI assistance was not conducted.

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

• Not applicable. This is a physical medical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Not applicable/Not provided in the context of AI/reader studies. For this device, "ground truth" for "pre-clinical testing" would refer to established engineering standards for mechanical and material properties (e.g., strength, durability, biocompatibility).

8. The sample size for the training set:

• Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

• Not applicable. This is a physical medical device, not an AI model.

In summary, the provided document is a 510(k) summary for a cervical interbody fusion device, focusing on its physical properties and intended use, and demonstrating substantial equivalence to predicate devices. It does not contain information related to AI performance, reader studies, or the types of "test sets" and "training sets" that would be relevant for an AI-powered diagnostic device.

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