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It is intended that this device, in any system configuration, be removed after the development of solid fusion mass of spinal segments in skeletally mature patients.

The ROCTM Lumbar 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 System is a posterior system used to attain vertebral fusion and/or stabilization in L3-S1. The subject components of this submission are rods, rod connectors, and a rod connector adjustor.

The rods are manufactured from Ti 6Al-4V ELJ conforming to ASTM F136 or CP Titanium conforming to ASTM F67. The offset rod connectors are made of Ti 6Al-4V ELI conforming to ASTM F136 and come in a two sizes to accommodate the patient's anatomy and levels of fusion. The connectors will be used as part of the ROCTM Lumbar System

Here's an analysis of the provided 510(k) summary regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document describes the ROC™ Lumbar System as a spinal fixation device. For such devices, acceptance criteria typically revolve around mechanical strength, durability, and biocompatibility to ensure the device can withstand physiological loads and does not cause adverse biological reactions.

Based on the provided text, the specific acceptance criteria are not explicitly detailed in quantitative terms (e.g., minimum load-bearing capacity in Newtons). Instead, the criteria are implied through substantial equivalence to predicate devices and the performance of mechanical testing.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: The document does not specify the exact sample size (number of constructs or components) used for the mechanical and dynamic testing. It only states that the testing was performed.
• Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given that this is a 510(k) submission for a medical device in the USA, it is highly probable that the testing was conducted in a laboratory setting, likely in the US, according to recognized ASTM standards. This testing would be considered prospective for the purpose of the submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This section is not applicable to this type of device submission. For medical devices like the ROC™ Lumbar System, "ground truth" is established through engineering and biomechanical testing standards, not expert clinical assessment of outcomes for a test set in the way it would be for an AI/CAD diagnostic device. The ground truth here is the adherence to established mechanical performance benchmarks.

4. Adjudication Method for the Test Set:

Not applicable. As noted above, this is a mechanical engineering and materials science assessment, not a clinical study with human adjudication. The results are compared against predicate device performance and industry standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not performed. This type of study is used to assess the effectiveness of diagnostic tools or human-in-the-loop AI systems, which is not relevant for a spinal implant device focused on mechanical performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This is not an algorithmic or AI device. The "performance" being evaluated is the mechanical integrity of the physical implant.

7. The Type of Ground Truth Used:

The ground truth used for this submission is based on established engineering and biomechanical performance standards for spinal fixation devices. Specifically, it relies on:

• ASTM F136 and ASTM F67 standards for material properties.
• Mechanical and dynamic testing results that demonstrate performance substantially equivalent to legally marketed predicate devices (Moss Miami Spinal Fixation and Synthes USS). The "ground truth" for acceptable performance is therefore inferred from the performance of these predicate devices, which have a history of safe and effective use.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning device that requires a training set. The device is a physical implant.

9. How the Ground Truth for the Training Set Was Established:

Not applicable for the same reason as point 8.

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