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The SCARLET®AC-T is intended to be used as an intervertebral body fusion cage as a standalone system used with the two bone screws provided and requires no additional supplementary fixation systems. It is inserted between the vertebral bodies into the disc space from levels C2 to T1 for the treatment of cervical degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The device system is designed for use with autograft bone to facilitate fusion. SCARLET@AC-T is intended to be used at one level. The cervical cage is to be used in a skeletally mature patient who has had six weeks of non-operative treatment prior to implantation of the cage

The SCARLET®AC-T Spinal System is a Cervical Intervertebral Body Fusion device with integrated fixation. It consists of an interbody cage intended to be used with the bone screws provided as a stand-alone system and requires no additional supplementary fixation system. SCARLET®AC-T is a box-shaped spacer with two cancellous bone screws that pass through screw holes within its body. It is intended to be used as a stand-alone interbody fusion device with a central cavity that can be filled with bone graft (autograft) to facilitate fusion. SCARLET®AC-T intervertebral body fusion spacer comes in various sizes and footprints in order to accommodate different patient anatomies. It receives two cancellous bone screws that come in various diameters and lengths so as to better fulfill surgeon's needs and to accommodate anatomical variations.

The provided document is a 510(k) premarket notification for a medical device called the SCARLET® AC-T Secured Anterior Cervical Cage. This document describes the device, its intended use, and provides a summary of non-clinical testing performed to demonstrate substantial equivalence to predicate devices. It does not present acceptance criteria or the results of a study designed to prove the device meets specific acceptance criteria in the way one might find for a diagnostic or AI-driven device.

Instead, the document focuses on demonstrating that the SCARLET® AC-T device is substantially equivalent to other legally marketed predicate devices, primarily through mechanical performance testing. The "acceptance criteria" here are implicitly tied to demonstrating comparable mechanical properties to these predicate devices.

Therefore, many of the requested elements for describing acceptance criteria and a study proving device performance (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance) are not applicable or available in this type of submission. This document is for a physical implantable device, not a diagnostic or AI-based system.

However, I can extract information related to the device and the mechanical tests performed:

1. Table of "Acceptance Criteria" (Implicitly, comparability to predicates) and Reported Device Performance:

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

• Sample Size: Not applicable. These were non-clinical, in-vitro mechanical tests, not clinical studies with patient data. No "test set" in the sense of patient data was used. The document does not specify the number of devices or test repetitions for each mechanical test.
• Data Provenance: Not applicable. These are laboratory-based mechanical test results, not originating from a country or being retrospective/prospective clinical data.

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

• Not applicable. There is no "ground truth" established by experts for mechanical performance testing of a physical device in this context. The "truth" is determined by the physical properties and performance measured against engineering standards and a comparison to known predicate devices.

4. Adjudication method for the test set:

• Not applicable. There was no "test set" requiring adjudication in the context of clinical outcomes or expert review.

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 not an AI-driven or diagnostic device. No human reader studies or MRMC studies were performed.

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

• Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used:

• For mechanical testing, the "ground truth" (or reference for evaluation) is established by adherence to recognized ASTM and ISO standards for spinal implants and by comparing measured mechanical properties against those of legally marketed predicate devices.

8. The sample size for the training set:

• Not applicable. This is not an AI-driven device, so there is no "training set."

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

• Not applicable. There is no training set or ground truth in the context of machine learning.

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