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The Renovis S141 Lumbar Interbody Fusion is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis at the involved level(s). Renovis S141 System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six months of non-operative treatment. The Renovis S141 System must be used with supplemental fixation cleared by FDA for use in the lumbar spine.

The Renovis S141 Lumbar Interbody Cage System is FDA cleared as K143126. This application describes a manufacturing change to the K143126 S141 Ti6Al4Vcages; internal dimensional changes; additional cages geometries; and a packaging change. The new name of the system is the Renovis S141 Lumbar Interbody Fusion System (S141 System).

The S141 System includes cages of a variety of lengths, widths, heights, and lordosis to suit the individual pathology and anatomical conditions of the patient. The different shape of the footprint allows for different surgical approaches for insertion.

The Ti6Al4V is compliant with ASTM F136-13 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications.

The system also includes instruments which are manufactured from stainless steel in compliance with ASTM A564-13 Standard Specification for Hot-Rolled and Cold-Finished Age-Hardening Stainless Steel Bars and Shapes.

This document describes the Renovis S141 Lumbar Interbody Fusion System, a medical device, and primarily focuses on its substantial equivalence to a predicate device, rather than providing details on a study that proves its performance against acceptance criteria in the context of algorithm-based device performance. The information provided is for a 510(k) premarket notification, which establishes substantial equivalence to a legally marketed predicate device, not necessarily a performance study against predefined acceptance criteria for an AI/algorithm-driven device.

Therefore, many of the requested sections related to acceptance criteria for algorithmic performance, sample sizes for test sets, expert ground truthing, MRMC studies, and standalone algorithm performance cannot be extracted from this document, as they are not applicable to the type of information presented.

However, I can provide information based on what is available in the document regarding the device's characteristics and the types of testing performed for substantial equivalence.

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

The document does not explicitly state acceptance criteria for the device in the format of a clinical or algorithmic performance study with specific metrics (e.g., sensitivity, specificity, AUC). Instead, it relies on substantial equivalence to a predicate device and bench testing results. The "performance" reported relates to the mechanical and biological safety of the modified device components.

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

This information is not provided in a way that aligns with an algorithmic device test set. The document refers to "testing" that was "successfully conducted" for mechanical and biological properties. No sample size for a "test set" in the context of data for an algorithm is mentioned. Data provenance (country of origin, retrospective/prospective) is also not applicable or mentioned.

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)

Not applicable. This device is a physical implant, not an AI/algorithm-driven diagnostic or prognostic tool that would require expert ground truthing of data.

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

Not applicable, as there is no "test set" in the context of an algorithm's performance and associated ground truth adjudication.

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 a physical medical implant (lumbar interbody fusion system), not an AI-assisted diagnostic or therapeutic device. Therefore, MRMC studies are not relevant.

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 algorithm.

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

Not applicable. The "ground truth" for this device would relate to its physical properties, material composition, and biological safety as measured by laboratory tests and adherence to standards, which are inherently objective measurements rather than interpretations requiring expert consensus on imaging or clinical data.

8. The sample size for the training set

Not applicable. This device does not involve a training set as it is not an AI/algorithm-driven system.

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

Not applicable, as there is no training set for this device.

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