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The Carmen plate and bone screw components are intended for anterior interbody screw fixation from C2-T1. The plate and bone screw components are indicated for use in the temporary stabilization of the anterior spine during the development of spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (including fractures), 3) tumors, 4) deformity (defined as kyphosis, or scoliosis), 5) pseudoarthrosis, and/or 6) failed previous fusions.

Carmen anterior cervical cage component is intended to be used for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy with herniated disc and/or osteophyste formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. This cage is to be used in patients who have had six weeks of non-operative treatment. The Carmen™ cage must be used with supplemental fixation. The Carmen™ cage is also required to be used with autogenous bone graft comprised of cancellous and/or corticocancellous bone graft and is to be implanted via an open, anterior approach.

When used together, the Carmen components can be used only to treat cervical disc disease.

Shanghai Sanyou Carmen™ Cervical Fusion System includes cervical plates and screws and interbody cages to stabilize and promote bone fusion during the normal healing process following surgical correction of disorders of the cervical spine. The interbody device is available in 2 widths (12 mm and 14 mm) and 4 heights (4, 5, 6 and 7 mm) and is composed of PEEK. The interbody device is offered with only one lordosis angle; each size is available with 7° lordosis. The plate is available in small or large with an integrated locking screw. The self-tapping screw is available in 3.5 or 4.0 mm diameter screws either 13 mm, 15 mm or 17 mm in length.

This document is a 510(k) Premarket Notification from the FDA regarding the Shanghai Sanyou CARMEN Cervical Fusion System. It primarily focuses on the regulatory clearance process and equivalency to predicate devices, rather than detailed acceptance criteria and a study proving device performance in a statistical sense for an AI/algorithm.

Therefore, many of the requested sections (2-9) cannot be answered from the provided text as they pertain to studies typically performed for AI/algorithmic devices, which is not the nature of this submission. The "Performance Testing" section describes mechanical testing for a spinal implant, not an AI model.

Here's an analysis based on the provided text, focusing on what can be extracted:

Acceptance Criteria and Device Performance

The concept of "acceptance criteria" in this context refers to demonstrating that the CARMEN Cervical Fusion System performs as intended and is substantially equivalent to legally marketed predicate devices. The study proving this comes in the form of performance testing as required for spinal implants.

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

• Similar sizes, materials, and geometry of system components.
• Same indications for use.
• Mechanical testing results. |

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. For mechanical testing of physical devices, "sample size" would refer to the number of devices tested, and "data provenance" might relate to where the testing occurred, but these details are not present.

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 is not applicable as this document describes a physical medical device (spinal fusion system) and its mechanical testing, not an AI/algorithmic device requiring expert ground truth for image interpretation or diagnosis.

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 for a physical medical device, not an AI-assisted diagnostic tool.

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

Not applicable. This is a physical medical device, not an algorithm.

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

For the mechanical performance testing, the "ground truth" would be the engineering specifications and performance standards established by organizations like ASTM, determined by the mechanical properties and failure points observed in testing. For substantial equivalence, the predicates' established safety and effectiveness are the reference.

8. The sample size for the training set

Not applicable. This is about mechanical testing of a physical device, not an AI/algorithm with a training set.

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

Not applicable. There is no training set for a physical device in this context.

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