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The Renovis S128 Anterior Lumbar Interbody Fusion (ALIF) System 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 or retrolisthesis at the involved level(s). Renovis S128 ALIF 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 S128 ALIF System is a stand-alone device and is intended to be used with the cover plate and screws provided and requires no additional supplementary fixation. The anterior cover plate must be utilized whenever the device is implanted using the bone screws provided. Should the physician choose to use fewer than the four screws provided, additional supplemental fixation cleared by the FDA for use in the lumbar spine must be used. Supplemental fixation, cleared by the FDA for use in the lumbosacral spine, must be used with implants ≥20°.

The Renovis S128 Anterior Lumbar Interbody Fusion (ALIF) System is FDA cleared as K131122 and K140106 (sterile implants). This application describes additional cages offerings (new lengths, widths, and lordosis) and a packaging change.

The S128 ALIF 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. S128 ALIF System cages are standalone for devices <20° when implanted with the coverplate and screws. Implants are offered in Ti6A14V and PEEK with Tantalum marker pins. Titanium cages are additively manufactured then machined to the final cage dimensions. PEEK implants are manufactured using traditional methods.

The Ti6Al4V conforms to the chemical and mechanical requirements of ASTM F136-13 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications
The PEEK is compliant with ASTM F2026-17 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications.The Tantalum is compliant with ASTM F560-17 Standard Specification for Unalloyed Tantalum for Surgical Implant Applications.

The S128 ALIF System cages that are the subject of this application are gamma sterilized.

The system also includes instruments to allow for implant determination, trialing and disc preparation. Instruments are manufactured from stainless steel in compliance with ASTM A564/M564-13e1 Standard Specification for Hot-Rolled and Cold-Finished Age-Hardening Stainless Steel Bars and Shapes.

This document describes the FDA's decision regarding the Renovis S128 Anterior Lumbar Interbody Fusion (ALIF) System and focuses on its substantial equivalence to previously cleared devices rather than a study about AI performance. Therefore, many of the requested categories are not applicable.

Here's the information extracted and interpreted based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a typical "acceptance criteria" table with specific performance metrics for an AI device. Instead, it focuses on demonstrating substantial equivalence for a medical implant (ALIF System) by meeting established standards and performing tests relevant to its physical properties and function.

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

• Sample Size for Test Set: Not applicable. This document describes the substantial equivalence of a physical medical implant (ALIF System) based on engineering tests, not a software device or AI algorithm evaluated on a data test set. The "tests" mentioned (Dynamic Shear Compression, Expulsion) refer to physical testing of the device itself.
• Data Provenance: Not applicable for an AI or software study. The data is generated from physical material and mechanical testing of the device components.

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

• Not applicable. Ground truth, in the context of expert consensus, is not relevant for this type of device submission. The "ground truth" for the device's physical properties is established by adherence to ASTM standards and validated engineering test methods performed by qualified laboratories.

4. Adjudication method for the test set:

• Not applicable. There is no human expert adjudication of test results in the sense of consensus on medical images or diagnoses for this device. The physical tests are governed by standardized protocols.

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 submission is for a physical medical implant, not an AI or software device that would involve human readers or AI assistance.

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:

• The "ground truth" for this medical device's performance is based on established engineering standards and validated physical test methods. For example, ASTM F2077-14 for intervertebral body fusion devices sets the benchmark for acceptable mechanical performance. Material composition adherence to ASTM F136-13, F2026-17, F560-17, and A564/M564-13e1 provides the "ground truth" for material specifications. Sterilization validation using AAMI/ANSI/ISO standards establishes the "ground truth" for sterility.

8. The sample size for the training set:

• Not applicable. This is not an AI or machine learning device that requires a training set.

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

• Not applicable. No training set is involved for this type of device.

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