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It is intended that this device, in any system configuration, be removed after development of solid fusion mass of spinal segments in skeletally mature patients. The ROC Lumbar Plating System is intended for posterior, non-cervical pedicle fixation in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities: severe spondylolisthesis (grades 3 and 4), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, spinal tumor and failed previous fusion (pseudarthrosis). The ROC Lumbar Plating System is indicated for placement in L3 - S1.

The ROC Lumbar Plating System is a spinal fixation system that consisting of a variety of nonsterile, single use implants that facilitates the surgical correction of spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development.

This document is a 510(k) summary for the Alphatec Spine ROC Lumbar Plating System. It focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and mechanical performance data, rather than clinical performance (e.g., diagnostic accuracy or treatment efficacy). Therefore, the requested information regarding acceptance criteria, study details for device performance, expert involvement, and ground truth establishment is not entirely applicable in the context of this specific regulatory submission.

However, I can extract and interpret the available information to address your request in the most relevant way possible for this type of medical device submission.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on demonstrating that its mechanical and dynamic performance characteristics are equivalent to, or better than, predicate devices and satisfy recognized consensus standards for posterior lumbar fixation.

Study Details for Device Performance

1. Sample Size used for the test set and the data provenance:
   This submission relies on nonclinical performance data, specifically mechanical and dynamic testing. The document does not specify a "sample size" in terms of human subjects or patient data. Instead, it would refer to the number of device components or assemblies tested. This information is not provided in the summary document. The "data provenance" would be laboratory testing conducted by or for Alphatec Spine, not patient data from a specific country or retrospective/prospective study.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Not applicable. For mechanical testing, the "ground truth" is defined by established engineering standards and specifications (e.g., ASTM standards for spinal implants) and the performance of predicate devices. There wouldn't be "experts" establishing a ground truth in the same way as for diagnostic accuracy studies.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   Not applicable. Adjudication methods typically relate to clinical trial outcomes or image interpretation where human judgment is involved. Mechanical testing results are objective measurements against defined standards.

4. 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 a spinal implant, not a diagnostic or AI-powered device. Therefore, MRMC studies and AI assistance metrics are irrelevant.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable. This is a physical medical device, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For the mechanical and dynamic testing, the "ground truth" is established by:

   • Recognized consensus standards: These are industry-accepted standards (e.g., ISO, ASTM) that define test methods, performance requirements, and acceptable ranges for spinal implant characteristics.
   • Guidance documents: Specific FDA guidance documents, such as "Spinal System 510(k)s - Guidance for Industry and FDA Staff," provide recommendations for testing to demonstrate safety and effectiveness.
   • Predicate device performance: The performance of previously cleared, substantially equivalent devices serves as a benchmark.

7. The sample size for the training set:
   Not applicable. This device does not involve machine learning or AI, so there is no training set in that context.

8. How the ground truth for the training set was established:
   Not applicable, as there is no training set.

Summary of Non-Applicability:

It is crucial to understand that this 510(k) summary is for a physical medical implant (spinal plating system), not a diagnostic algorithm, AI-powered device, or a drug. The regulatory pathway for such a device primarily focuses on demonstrating:

• Substantial Equivalence: That the device is as safe and effective as a legally marketed predicate device.
• Biocompatibility: That the materials are safe for use in the human body (implicitly covered by "material composition is identical to numerous other Alphatec Spine products that have been cleared").
• Mechanical Performance: That the device can withstand the forces and stresses it will encounter in the body without failure, as demonstrated by nonclinical bench testing against established standards.

Therefore, many of the questions asked, which are highly relevant for AI/ML-based diagnostic devices or clinical effectiveness studies, do not apply to this specific 510(k) submission for a spinal implant.

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