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The InterPlate™ Interbody Fusion Device (IFD) is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space.

The InterPlate™ C, CGC and PEEK OPTIMA® Cervical Systems are intended for usc at onc level in the cervical spine, from C3 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment.

The InterPlate™ L and LGC Systems are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had six months of non-operative treatment.

The InterPlate™ IFD System consists of plates, bone screws and screw covers. Various plate sizes are available to accommodate individual patient anatomy and graft material size. Screw covers are individually matched to the plate size.

This submission (K08/1994) is for the InterPlate™ Interbody Fusion Device, a spinal implant. The document states that "Documentation was provided which demonstrated the InterPlate™ to be substantially equivalent to previously cleared devices. The substantial equivalence is based upon equivalence in intended use, indications, anatomic sites, performance and material of manufacture." This indicates that the device's acceptance criteria are met through a showing of substantial equivalence to predicate devices, rather than through a direct study outlining specific performance metrics for this particular device.

Therefore, the requested information elements cannot be fully generated as they pertain to a direct study proving specific performance metrics, which is not what is presented in the provided text. The submission relies on demonstrating similarity to already approved devices.

However, based on the provided text, here's what can be extracted and inferred:

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

Since this is a substantial equivalence submission, there are no explicit acceptance criteria for this specific device's performance defined in terms of efficacy or diagnostic accuracy. The criteria are based on its similarity to legally marketed predicate devices.

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

Not applicable. There is no specific "test set" or clinical trial data presented to assess the performance of this specific device in the provided document. The submission relies on comparison to predicate devices, which would have had their own studies.

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

Not applicable. Ground truth for a test set is not discussed in the context of this substantial equivalence claim.

4. Adjudication method for the test set

Not applicable. Adjudication methods for a test set are not discussed.

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. This device is a spinal implant, not an AI or imaging diagnostic device.

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

Not applicable. This device is a spinal implant, not an algorithm.

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

Not applicable. Ground truth data for performance evaluation of this specific device is not discussed.

8. The sample size for the training set

Not applicable. This device is a spinal implant, not an AI or machine learning model.

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

Not applicable. This device is a spinal implant, not an AI or machine learning model.

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