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TRYPTIK2C-Plate® Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions

The TRYPTIK2C-Plate Anterior Cervical Plate System consists of a range of anterior cervical plates and polyaxial (variable angle) bone screws. The plate attaches to the anterior portion of the vertebral body of the cervical spine (C2-C7) and functions as an adjunct to fusion to provide immobilization and stabilization of cervical segments of the spine.

This is a 510(k) premarket notification for a medical device called the "TRYPTIK2C-Plate Anterior Cervical Plate System". The document describes the device, its intended use, and provides a summary of testing conducted to demonstrate its substantial equivalence to legally marketed predicate devices.

Here's the breakdown of the requested information based on the provided text:

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

The document does not explicitly state "acceptance criteria" in the format of pass/fail thresholds against specific performance metrics for the TRYPTIK2C-Plate, but rather implies comparison to predicate devices. The "reported device performance" is described in terms of mechanical testing.

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

The document does not specify the sample size for the mechanical testing (e.g., number of plates or screws tested). It also does not provide information on the data provenance, such as the country of origin or whether the study was retrospective or prospective. The testing described is non-clinical/bench testing, not human or animal 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)

This information is not applicable. The study is a non-clinical/bench testing study of a medical implant's mechanical properties, not a diagnostic or prediction algorithm requiring expert review for ground truth.

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

This information is not applicable, as it's a non-clinical mechanical testing study.

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, an MRMC comparative effectiveness study was not done. This device is a physical implant (anterior cervical plate system), not an AI diagnostic or assistive device.

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

This information is not applicable. The device is a physical implant, not an algorithm.

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

The "ground truth" for this type of study is the established mechanical testing standards (ASTM F1717-15) and the mechanical properties of the legally marketed predicate devices. The performance of the new device is compared against these benchmarks to establish substantial equivalence.

8. The sample size for the training set

This information is not applicable. This is a mechanical testing study for a physical implant, not an AI/machine learning model that requires a training set.

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

This information is not applicable, as there is no training set for a physical implant's mechanical testing.

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