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The InterForm Cervical Interbody Cage System is intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should have had at least six weeks of non-operative treatment. The device is intended to be implanted via an open, anterior approach and used with autogenous bone graft to facilitate fusion. Additionally, the InterForm Cervical Interbody Cage System is intended for use with supplemental spinal fixation systems cleared for use in the cervical spine. Patients with previous non-fusion spinal surgery at the involved level may be treated with the device.

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I am sorry, but the provided text from the FDA 510(k) K161608 document does not contain information about the acceptance criteria or a study that proves the device meets those criteria. The document is primarily an FDA clearance letter and an "Indications for Use" statement for the InterForm Cervical Interbody Cage System.

It states that the device is substantially equivalent to legally marketed predicate devices, which is the basis for its clearance, rather than a detailed report of a new study to establish acceptance criteria for the device's performance.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance
2. Sample size and data provenance for a test set
3. Number and qualifications of experts for ground truth establishment
4. Adjudication method
5. MRMC comparative effectiveness study details
6. Standalone algorithm performance
7. Type of ground truth used
8. Sample size for the training set
9. Ground truth establishment for the training set

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