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The Resolve Anterior Cervical Plate System is intended for anterior cervical fixation of the cervical spine (C2-C7) as an adjunct to fusion in skeletally mature patients. Specific indications include: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The Resolve Anterior Cervical Plate (ACP) System is intended for anterior cervical fixation of the cervical spine (C2-C7) as an adjunct to fusion in skeletally mature patients. The system consists of non-sterile, single use plates and screws that are manufactured from titanium alloy (Ti-6Al-4V). The plates have an integrated active locking mechanism, are offered in various lengths, and accommodate constrained and variable screws. The system includes non-sterile, reusable instruments designed to facilitate proper implantation/explantation of the plates and screws.

The provided FDA document, K251436, describes the Resolve Anterior Cervical Plate System, a medical device. The document states that the substantial equivalence of the device was demonstrated through performance criteria identified in the FDA guidance document "Spinal Plating Systems – Performance Criteria for Safety and Performance Based Pathway".

While the document confirms that non-clinical mechanical tests were performed and met acceptance criteria, it does not provide the specific numerical acceptance criteria or the reported device performance in a table format. Nor does it detail a clinical study with human readers or specific ground truth methodologies. The information focuses on non-clinical mechanical testing for spinal plating systems.

Therefore, the following information is extracted and inferred based only on the provided document:

Acceptance Criteria and Device Performance Study (as per provided document)

1. Table of Acceptance Criteria and Reported Device Performance

The FDA document states that the device "meets or exceeds the acceptance criteria stated in the 'Spinal Plating Systems - Performance Criteria for Safety and Performance Based Pathway' guidance document." However, the specific numerical acceptance criteria from this guidance document and the precise numerical results of the Resolve Anterior Cervical Plate System are not provided in this submission.

2. Sample Size for the Test Set and Data Provenance

The document describes non-clinical mechanical testing, not a clinical study involving a test set of human subjects or patient data.

• Sample Size: Not applicable in the context of human data. For mechanical testing, the "worst-case configuration" was tested. The specific number of mechanical test samples is not detailed.
• Data Provenance: Not applicable as it refers to non-clinical, laboratory-based mechanical testing.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. The "ground truth" here is adherence to mechanical performance standards, not expert clinical interpretation.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving reader agreement. This describes non-clinical mechanical testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was an MRMC study done? No. The document describes non-clinical mechanical tests for a spinal implant, not an AI/imaging device requiring human-in-the-loop evaluation.
• Effect size of human readers with AI vs without AI assistance: Not applicable.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a physical spinal implant, not an algorithm or AI software. Therefore, there is no standalone algorithm performance.

7. Type of Ground Truth Used

The "ground truth" for this device's performance evaluation is established by meeting predetermined mechanical performance specifications outlined in the FDA guidance document "Spinal Plating Systems – Performance Criteria for Safety and Performance Based Pathway" and relevant ASTM standards (ASTM F1717 for mechanical tests; ASTM F2052, ASTM F2213, ASTM F2182 for MR safety).

8. Sample Size for the Training Set

Not applicable. This refers to non-clinical mechanical testing of a physical device, not an AI model requiring a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. No training set for an algorithm was involved.

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