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The ROCCIA TLIF and ROCCIA ALIF Cage is indicated for intervertebral body fusion of the spine in skeletally mature patients. The system is designed for use with autogenous bone graft to facilitate fusion and supplemental internal spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. The device is to be used in patients who have had at least six months of non-operative treatment.

The ROCCIA TLIF Cage implants are intended for use in interbody fusions at one or two contiguous levels in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12- L1), following discectomy for the treatment of a symptomatic disc degeneration (DDD), including thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain).

The ROCCIA TLIF and ROCCIA ALIF Cage implants are intended for use at one or two contiguous levels in the lumbar spine, from L1 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The ROCCIA TLIF Cage implants can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.

The ROCCIA® Transforaminal Lumbar Interbody Fusion (ROCCIA® TLIF) and ROCCIA® Anterior Lumbar Interbody Fusion (ROCCIA® ALIF) cages are implants for the primary stabilization and restoration of the physiologic lordosis of the lumbar and thoracic spine. Subject device implants are manufactured from Titanium Alloy Ti6Al4V ELI per ASTM F136. The ROCCIA® TLIF and ROCCIA® ALIF cages are offered in a variety of sizes to facilitate a variety of patient anatomies.

The ROCCIA® instrumentation is ergonomically appropriate and designed as modular components. The instruments are designed to be used with the ROCCIA® Transforaminal Lumbar Interbody Fusion (TLIF) and ROCCIA® Anterior Lumbar Interbody Fusion (ALIF), and are made of materials commonly used to manufacture medical device instruments. The instruments are intended to be cleaned, sterilized, and reused for the purposes of future implantation procedures.

This document is a 510(k) summary for the ROCCIA® TLIF and ROCCIA® ALIF intervertebral body fusion devices. It's a regulatory submission to the FDA, demonstrating substantial equivalence to previously approved devices. Therefore, it does not include information on acceptance criteria for device performance in a clinical study to assess its diagnostic accuracy or effectiveness against a clinical outcome, as would be typical for AI/ML-driven diagnostic devices.

Instead, the "acceptance criteria" here refer to the mechanical performance of the implantable device, which is evaluated against recognized ASTM standards for intervertebral body fusion devices. The "study" proving this is a series of non-clinical, laboratory-based mechanical tests.

Here's the breakdown of the information you requested, based on the provided document:

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

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

This document discusses non-clinical mechanical testing, not clinical studies with patient data. Therefore, the concept of a "test set" and "data provenance" as applied to clinical data does not directly apply. The "sample size" would refer to the number of devices tested in the lab for each mechanical test. This specific number is not explicitly stated in the provided text. The tests are conducted in a laboratory setting, not a clinical one.

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)

This is a non-clinical mechanical performance evaluation. There were no experts establishing ground truth in terms of clinical diagnoses or outcomes, as no human-based diagnostic performance is being evaluated. The "ground truth" for these tests are the established physical properties and behaviors defined by the ASTM standards themselves.

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

Not applicable, as this is non-clinical mechanical testing, not a clinical study requiring human expert adjudication of results.

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 document is for an implantable medical device (intervertebral body fusion cage), not an AI/ML diagnostic or assistive device.

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

Not applicable. This is not an algorithm or AI device.

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

The ground truth used for these tests are the established mechanical testing standards (ASTM F2077-11, ASTM F2267-04, and S-01:2013) for intervertebral body fusion devices. These standards define the parameters and acceptable ranges for static and dynamic loading, subsidence, and expulsion.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

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