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The INTESS™ Cervical Cage is intended for anterior interbody spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one disc level (C2-T1). Cervical degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. This device is intended for use with supplemental internal fixation systems and autogenous bone graft implanted via an open, anterior approach. Patients should have at least six weeks of non-operative treatment prior to treatment with intervertebral cage.

The INTESS™ Cervical Cage was developed as implants for the stabilization of the cervical column. The INTESS™ implants have graft windows which help facilitate bony integration. The INTESS™ implants have ridges on both their inferior and superior surfaces. X-ray markers are integrated for visualization of the implants during and after surgery.

Materials:
Zeniva ZA500 PEEK conforming to ASTM F2026. Unalloyed tantalum conforming to ASTM F560.

Function:
Maintain adequate disc space until fusion occurs.

The provided document is a 510(k) Summary for the INTESS™ Cervical Cage. This type of document is a premarket notification to the FDA to demonstrate that the device to be marketed is substantially equivalent to a legally marketed predicate device.

It's important to understand that a 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with defined performance metrics like a typical AI/software device. For a traditional medical device like the INTESS™ Cervical Cage, "acceptance criteria" are usually met by demonstrating that the device's functional and safety characteristics are comparable (substantially equivalent) to already approved devices.

Therefore, the prompt's request for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/software device (with details like sample sizes, expert ground truth, MRMC studies, etc.) does not directly apply to this 510(k) submission for a physical implant.

However, I can extract the information relevant to the equivalence demonstration for the INTESS™ Cervical Cage:

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

Since this is a 510(k) to demonstrate substantial equivalence, "acceptance criteria" are implied by the performance of the predicate devices. The "reported device performance" is a demonstration that the INTESS™ Cervical Cage performs comparably to these predicates in non-clinical tests.

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

• Sample Size for Test Set: Not applicable in the context of human data. For mechanical testing, the "sample size" refers to the number of physical devices tested. This information is typically detailed in the test reports referenced by the ASTM standards, but not usually in the 510(k) summary itself. The document states "The following tests were conducted," implying a sufficient number of devices were tested to meet the ASTM standards.
• Data Provenance: Not applicable for a non-clinical mechanical test summary.

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. Ground truth from human experts is not used for mechanical testing of a physical implant. The "ground truth" for mechanical performance is established through adherence to recognized ASTM standards and the associated testing methodologies.

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

Not applicable. This device's evaluation did not involve human adjudication of test results in the way an AI/software device would. The mechanical tests have pass/fail criteria based on engineering specifications.

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 a physical implant, not an AI/software device. No MRMC study was performed.

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

No. This is a physical implant.

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

The "ground truth" for the non-clinical tests is based on established engineering and materials standards (ASTM F2077, ASTM F2267, ASTM F2026, ASTM F560) and the performance characteristics of the legally marketed predicate devices.

8. The sample size for the training set:

Not applicable. There is no training set for a physical implant.

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

Not applicable. There is no training set for a physical implant.

Summary of the Study (Equivalence Demonstration):

The study conducted to support the INTESS™ Cervical Cage was a series of non-clinical bench tests designed to demonstrate the device's mechanical integrity and material properties.

• Tests Performed:
  • Static and dynamic compression per ASTM F2077
  • Static and dynamic torsion per ASTM F2077
  • Subsidence per ASTM F2267
• Materials Conformance: Zeniva ZA500 PEEK conforming to ASTM F2026 and Unalloyed tantalum conforming to ASTM F560.
• Conclusion: The results of this testing indicated that the INTESS™ Cervical Cage is substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety, and performances.
• Clinical Studies: No clinical studies were performed.

In essence, for this device, "acceptance criteria" are met by demonstrating that its physical and mechanical properties, as measured by standard engineering tests, are comparable to those of already approved predicate devices.

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