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The Biolign® Roto-Loc Anterior Cervical Plating System is indicated for use in the temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following: 1. Degenerative disc disease (as defined by neck pain of discogenic origin confirmed by patient history and radiographic studies) 2. Trauma (including fractures) 3. Tumor 4. Spondylolisthesis 5. Spinal stenosis 6. Deformity (i.e., scoliosis, kyphosis, lordosis) 7. Pseudarthrosis 8. Failed previous fusions

The Biolign® Roto-Loc Cervical Plate system consists of cervical plates, locking caps, bone screws and all necessary instrumentation to implant the plate system. The system is manufactured from Titanium 6Al 4V (ISO 5832-3). A screw locking system is incorporated in the plate, allowing the surgeon to insert the screws, and afterwards locking the screws into place with the Biolign® Roto-Loc locking mechanism. This blocks the screw from backing out of the plate. The plates feature lordotic curvature and a transverse plane curvature for an anatomical fit to match patient pathology.

This document is a 510(k) summary for the Biolign® Roto-Loc Cervical Plate System. It describes a medical device, not an AI/ML algorithm or software. Therefore, the questions related to AI/ML device performance, ground truth, sample sizes for training/test sets, expert adjudication, and multi-reader multi-case studies are not applicable.

Here's the relevant information from the document:

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

The document does not state specific acceptance criteria in quantitative terms for the mechanical testing results. Instead, it broadly states that "Substantial equivalence is supported by the results of mechanical testing including static and dynamic compression bending, and static torsion per ASTM F1717." This implies that the device's performance in these tests met the standards set by ASTM F1717, making it comparable to the predicate device.

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

This information is not provided in the document. The document refers to "mechanical testing" but does not detail the specific sample sizes of components tested or the provenance of any data beyond the manufacturer's location (South Africa).

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 is a physical medical device, not an AI/ML system requiring expert-established ground truth for performance evaluation.

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

Not applicable for a physical medical device's mechanical testing.

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 is a physical medical device, not an AI/ML system.

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

Not applicable. This is a physical medical device.

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

Not explicitly stated in the context of "ground truth" as it applies to software. For a physical device, the "ground truth" for mechanical testing would be the physical properties and behavior of the device under stress, measured against engineering standards (like ASTM F1717).

8. The sample size for the training set

Not applicable. This is a physical medical device and does not involve AI/ML training sets.

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

Not applicable. This is a physical medical device and does not involve AI/ML training sets.

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