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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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It is intended that this device, in any system configuration, be removed after the development of solid fusion mass. The ROC™ Lumbar Plating when intended to arovide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the lumbosacral spine: severe spondylolisthesis (grades 3 and 4), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, 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 intended to improve stability of the lumbosacral spine. There are a variety of implants that can be used for this procedure including; lumbar plates, botts, offset links and locking nuts. All components are made from titanium alloy, Ti 6Al 4V meeting specifications of ASTM F136.

This 510(k) summary is for a spinal implant system, not an AI/ML powered device. Therefore, much of the requested information regarding AI/ML device studies (e.g., sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, ground truth establishment) is not applicable.

However, I can extract the relevant information about the non-clinical performance testing that was performed for this device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size: Not explicitly stated in the 510(k) summary for mechanical testing. Standard testing typically involves multiple samples to achieve statistical significance.
• Data provenance: The performance data was generated through physical testing of the device components/system. This is laboratory-based testing, not human or clinical data.

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

• Not applicable. The "ground truth" for mechanical performance is established by engineering standards (e.g., ASTM F136 for material, and other mechanical testing standards for static and dynamic performance) and the results obtained from the tests themselves. It does not involve expert clinicians establishing a "ground truth" in the way it would for AI diagnostic algorithms.

4. Adjudication method for the test set

• Not applicable. This refers to consensus reaching among experts for AI/ML ground truth, which is not relevant for physical device testing against engineering standards.

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 a physical implant, not an AI/ML diagnostic tool.

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

• Not applicable. This device is a physical implant, not an AI/ML algorithm.

7. The type of ground truth used

• The "ground truth" for the device's performance is established by:
  • Engineering Standards: Adherence to material specifications (ASTM F136).
  • Mechanical Testing Results: The quantitative and qualitative outcomes of static and dynamic load testing.
  • Predicate Device Performance: The established safety and effectiveness profile of existing, legally marketed predicate devices to which this device demonstrated substantial equivalence.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device; there is no training set.

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

• Not applicable. This is not an AI/ML device; there is no training set.

Ask a specific question about this device