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SPICCA Cervical Fusion Cages are cervical interbody fusion devices intended for spinal fusion procedures at one or two levels from the C2/C3 disc space to the C7/T1 disc space in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients must have undergone a regimen of at least six (6) weeks non-operative treatment prior to being treated with these devices. The implant is intended to be used in combination with an anterior cervical plating system.

The SPICCA Cervical Fusion Cages system is an intervertebral spinal fusion system comprised of cervical interbody spacers which are designed to provide mechanical support to the cervical spine while arthrodesis occurs. The implant includes a variety of footprints, heights, and lordosis options to optimize patient fit. All implants are manufactured from PEEK per ASTM F560 with tantalum (ASTM F2026) markers. All the implants are offered with a titanium powder coating per ASTM F1580 and some of the implants are also offered without the coating.

The provided document describes a 510(k) premarket notification for the "SPICCA Cervical Fusion Cages," a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a full clinical study with specific acceptance criteria related to diagnostic performance or efficacy for AI/ML devices. Therefore, much of the requested information regarding acceptance criteria, study details, expert involvement, and ground truth for an AI-powered device is not applicable to this submission.

However, I can extract information related to the device's physical performance testing as described:

Report on SPICCA Cervical Fusion Cages Performance (K230607)

The SPICCA Cervical Fusion Cages are intervertebral spinal fusion systems intended for cervical spine procedures. The device's performance was evaluated through non-clinical mechanical testing to demonstrate its safety and substantial equivalence to predicate devices. The document does not specify quantitative acceptance criteria or reported values for these tests, only that the device's strength was found sufficient and substantially equivalent to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide specific numerical acceptance criteria or reported values for the mechanical tests. It only states that the device's strength was "sufficient for its intended use" and "substantially equivalent to legally marketed predicate devices."

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

• Sample Size: Not explicitly stated for the mechanical tests. Mechanical testing typically involves a set number of samples for each test mode (e.g., 3-6 samples per test).
• Data Provenance: The data is from non-clinical laboratory testing performed by the manufacturer or a certified testing facility, as part of the 510(k) submission process. It is not clinical data from patients.

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

• Not Applicable. This is a non-clinical mechanical performance study of a physical device, not an AI/ML diagnostic device requiring expert interpretation or ground truth establishment in a clinical context. The "ground truth" for mechanical testing is derived from the physical properties and performance metrics measured during the tests.

4. Adjudication method for the test set

• Not Applicable. As a non-clinical mechanical study, there is no expert adjudication method like those used for clinical assessments or AI model evaluations. The results are based on objective physical measurements against established ASTM standards and benchmarks (predicate devices).

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 diagnostic or assistive technology. Therefore, an MRMC study related to human reader performance with or without AI assistance was not conducted.

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

• Not Applicable. This is a physical medical device. There is no algorithm for standalone performance testing in the context of diagnostic or assistive AI.

7. The type of ground truth used

• For mechanical tests, the "ground truth" is typically defined by the physical test parameters, load applications, displacement measurements, and ultimate failure points, compared against specified ASTM standards (e.g., ASTM F2077, ASTM F2267) and the performance of an equivalently intended predicate device.

8. The sample size for the training set

• Not Applicable. This is a physical medical device. There is no "training set" in the context of AI/ML model development.

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

• Not Applicable. As there is no training set for an AI/ML model, there is no ground truth establishment method for it.

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