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The Zero Profile Anterior Cervical Plating (ACP) System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:

• Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
• Trauma (including fractures)
• Tumors
• Deformities or curvatures (including kyphosis, lordosis, or scoliosis)
• Pseudarthrosis
• Failed previous fusion
• Decompression of the spinal cord following total or partial cervical vertebrectomy
• Spondylolisthesis
• Spinal stenosis

WARNING: This device is not approved or intended for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

The Zero Profile ACP System includes anterior cervical plates in one-level and two-level configurations, and in lengths from 12mm to 42mm, depending on the configuration. The subject plates are intended for use with the predicate Reflex HybridTM ACP bone screws. The components of the Zero Profile ACP system are manufactured from Ti6Al4V alloy per ASTM F-136 and will be provided non-sterile. The intended use and materials of the subject anterior cervical plates are identical to those of the predicate anterior cervical plates. The new plates feature a lower profile design than the predicate Reflex HybridTM Anterior Cervical Plates, but are used with the predicate Reflex Hybrid™ ACP System screw.

The provided text describes a medical device, the "Zero Profile Anterior Cervical Plate System," and its submission for a 510(k) premarket notification. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical studies to prove effectiveness or meeting specific performance acceptance criteria from a study.

Therefore, many of the requested categories related to clinical study design, acceptance criteria, sample sizes, expert ground truth, and AI performance do not apply to this specific document or the type of regulatory submission it represents.

Here's a breakdown of the information as it relates to your request, noting where information is not present or not applicable:

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

• Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for a study. The acceptance criterion for this 510(k) submission is to demonstrate "substantial equivalence" to predicate devices.
• Reported Device Performance: The document states, "Engineering analysis and performance testing verify that the subject device system is substantially equivalent in terms of performance characteristics to the predicate device systems." Specific quantitative performance results from these tests are not provided in this summary. Instead, the assertion of substantial equivalence is the "performance reported."

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

• Not Applicable: This 510(k) summary does not describe a clinical study with a "test set" in the context of evaluating a diagnostic or AI device. The statement "Engineering analysis and performance testing" refers to bench testing and mechanical properties, not patient data.

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: No clinical "test set" with ground truth established by experts is described for this type of device and submission.

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

• Not Applicable: No clinical "test set" with expert adjudication is described.

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 device is an anterior cervical plate system (a mechanical implant), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance would not be relevant.

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

• Not Applicable: This device is a surgical implant, not an algorithm.

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

• Not Applicable: For demonstrating substantial equivalence of a mechanical device, ground truth in the clinical sense (e.g., pathology) is not typically established. Performance is evaluated through engineering analyses, mechanical testing (e.g., fatigue strength, pull-out strength), and material properties compared to predicate devices.

8. The sample size for the training set

• Not Applicable: No "training set" in the context of AI or clinical data is described. The "engineering analysis and performance testing" would involve a sample size of physical devices tested, but that is not referred to as a "training set."

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

• Not Applicable: As there is no training set described in this context, no ground truth establishment method for it is applicable.

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