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TRYPTIK®ca cages are 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. TRYPTIK®ca are used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. TRYPTIK®ca are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage

TRYPTIK ca of cervical interbody fusion devices made of PEEK OPTIMA conforming ASTM F2026. Markers made of titanium conforming ASTM F136 are used to visualize the position of the implant in the disc space. TRYPTIK ca devices are designed for an anterior approach. All devices are supplied sterile.

The provided text is a 510(k) summary for the TRYPTIK ca intervertebral body fusion device. It does not describe an AI/ML powered medical device, but rather a physical implant. Therefore, most of the questions relating to acceptance criteria of an AI/ML model, such as sample sizes for test and training sets, expert consensus, adjudication methods, MRMC studies, or standalone performance, are not applicable.

Here's a breakdown of the relevant information from the document:

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

The document states that the TRYPTIK ca cervical interbody fusion devices conform to the Class II Special Controls Guidance Document: Intervertebral Body Fusion Device - Document issued on: June 12, 2007. This guidance document would contain the specific acceptance criteria for devices of this type. However, the provided text does not explicitly list these criteria or report the device's performance against them in a table format. It only states its conformance to the guidance document.

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

Not applicable. This is a physical medical device, not an AI/ML algorithm that uses a "test set" of data in the same way. The evaluation for this device would involve mechanical testing, biocompatibility testing, and a literature review of predicate devices, not data-driven performance metrics against a test set.

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. This concept applies to AI/ML models where human experts label data to establish ground truth. For a physical medical device, "ground truth" is established through engineering and biological testing standards.

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

Not applicable for a physical medical device.

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

Not applicable for a physical medical device.

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

Not applicable for a physical medical device. The device is a "human-in-the-loop" device in the sense that a surgeon implants it. Its performance is inherent to its design and material properties.

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

Not applicable in the context of an AI/ML model's "ground truth." For this device, "ground truth" for its safety and effectiveness would be established through:

• Conformance to ASTM F2026 (for PEEK OPTIMA material).
• Conformance to ASTM F136 (for titanium markers).
• Mechanical testing (e.g., fatigue, static compression, subsidence, expulsion) as required by the Class II Special Controls Guidance Document.
• Biocompatibility testing.
• Comparison to legally marketed predicate devices in terms of intended use, material, design, mechanical properties, and function.

8. The sample size for the training set

Not applicable for a physical medical device.

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

Not applicable for a physical medical device.

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