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The IN:C2 Spinal Fixation System is indicated 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 and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. IN:C2 is a stand-alone device intended to be used with an anterior cover plate and a minimum two provided bone screws angled both cephalad and caudal with a minimum of one screw into each vertebral body. The implants are to be used with autogenous bone graft and implanted via an open, anterior approach. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral cage.

The IN:C2 System consists of a 'U' shaped PEEK block in multiple footprint configurations and heights. The PEEK implants contain a titanium marker intended to verify position radiologically. The IN:C2 is a stand-alone system, intended for use with its cover plate assembly and two titanium bone screws provided. The IN:C2 implant is intended to be implanted via an open anterior approach.

The anterior cover plate assembly attaches to the anterior most portion of the device, and includes housing features for placement of two bone screws angled cephalad and caudal. The cover plate assembly and integrated screws are supplemental fixation.

The provided document is a 510(k) Premarket Notification from the FDA regarding the SpineSmith IN:C2 Spinal Fixation System. It focuses on demonstrating substantial equivalence to a predicate device rather than on the performance of an AI/ML powered device.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and study details for an AI/ML medical device. Specifically:

• Table of acceptance criteria and reported device performance: Not present, as this is for a physical medical device (spinal fixation system) and not an AI/ML device.
• Sample size and data provenance for test set: Not present.
• Number of experts and their qualifications for ground truth: Not present.
• Adjudication method: Not present.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable and not present.
• Standalone (algorithm only) performance: Not applicable and not present.
• Type of ground truth used: Not applicable and not present.
• Sample size for training set: Not applicable and not present.
• How ground truth for training set was established: Not applicable and not present.

The document describes mechanical testing performed on the IN:C2 Spinal Fixation System to demonstrate its safety and effectiveness, conforming to ASTM standards for intervertebral body fusion devices. This mechanical testing served as the 'study' to prove the device met the criteria for substantial equivalence to its predicate.

The acceptance criteria for this physical device were its ability to perform comparably to the predicate device under specific mechanical stress tests, as outlined by the mentioned ASTM standards (e.g., F2077-11, F2267-04, F1877-05, and pull-off force testing). The reported device performance was that these tests demonstrated that "any minor differences, modification of the snap interface, do not impact device performance as compared to the predicates and demonstrate that the IN:C2 System is substantially equivalent to the predicate device."

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