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The Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System is indicated for intervertebral body fusion procedures in skeletally mature patients with cervical degenerative disc disease at one level from C2-T1. Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six weeks of non-operative treatment prior to implantation.

The Renovis Tesera SC ACF System is a stand-alone system when used with the cover plate and screws provided, and requires no additional supplemental fixation. When used as a stand-alone system, the cages require the use of three (3) screws and the cover plate assembly.

When used without the cover plate and three screws the Renovis Tesera SC ACF System is a non-stand-alone system and requires additional supplemental fixation cleared by the FDA for use in the cervical spine to augment stability.

The Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System includes the Tesera Trabecular Titanium (T3) cages, bone screws (self-drilling and self-tapping options) and anterior cover plate assembly. When used with the cover plate and screws, the Tesera SC ACF System requires no supplementary fixation systems. The screws protrude through the interbody portion of the device into the adjacent vertebral bodies, stabilize the vertebral body and reduce the likelihood of expulsion of the implant. The Tesera Trabecular Titanium (T3) cages have windows in the side for visualization of the bone graft. The accompanying cover plate is designed to resist screw back-out and must be used when the screws are implanted. When used without the cover plate and screws, the Tesera SC ACF cages require supplemental fixation.

The Renovis Tesera SC ACF System cages are available in a variety of sizes (widths, height, depths, and bone screw sizes) to suit the individual pathology and anatomical conditions of the patient. The cages are additively manufactured then machined from Titanium alloy (Ti-6A1-4V). The bone screws are manufactured from Titanium alloy (Ti-6Al-4V) and the cover plate assembly is manufactured from Titanium alloy (Ti-6Al-4V) and Nitinol alloy. The implants are provided to the end user sterilized through gamma irradiation.

The system also consists of reusable instrumentation used to implant the cages, screws, and cover plate assembly.

This document describes the Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System, a medical device. The information provided focuses on its substantial equivalence to predicate devices rather than detailing specific acceptance criteria and study results for device performance against those criteria in a tabular format. The FDA 510(k) summary typically assesses substantial equivalence based on similar intended use, design, materials, and performance testing to legally marketed devices, rather than establishing new, specific performance acceptance criteria for each submission.

However, based on the provided text, I can infer the types of performance criteria addressed through mechanical testing and report the nature of these studies.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria with corresponding performance results in the way one might see for a diagnostic AI algorithm. Instead, it lists the mechanical performance tests conducted and asserts that "Differences between the Renovis Tesera SC ACF System and the predicate devices do not raise new issues of safety or effectiveness." This implies that the device met the performance expectations established by the predicate devices and relevant ASTM standards.

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

The document describes bench testing, meaning the "test set" consists of physical devices subjected to mechanical and material property tests.

• Sample Size for Test Set: Not explicitly stated for each test, but standard ASTM methods typically define minimum sample sizes for such tests.
• Data Provenance: This is not applicable in the usual sense for clinical data, as this is mechanical bench testing of devices (not human data). The tests were conducted to evaluate the physical and mechanical properties of the device itself.

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

Not applicable. For mechanical bench testing, "ground truth" is established by the standardized test methods (e.g., ASTM standards) themselves, which define the conditions, measurements, and interpretation of results. Experts are involved in designing and conducting the tests according to these standards, but there isn't a "ground truth" established by expert consensus on, for example, an image reading.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies or expert reviews where there's variability in interpretation (e.g., of medical images) that needs to be resolved to establish a robust ground truth. For mechanical tests, the results are quantitative measurements against predefined standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is a medical device for surgical implantation, not a diagnostic AI algorithm. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this submission.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a physical implant, not an algorithm.

7. Type of Ground Truth Used

For the performance testing mentioned:

• Mechanical Performance: The "ground truth" is established by adherence to recognized ASTM (and ISO) standards for material properties and mechanical performance. These standards define acceptable ranges for strength, fatigue life, corrosion resistance, etc., for intervertebral body fusion devices.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device. There is no "training set" in the context of machine learning algorithms. The design and manufacturing process are refined through engineering principles, material science, and iterative testing, not through a "training set" of data.

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

Not applicable, as there is no training set for a physical device. The design and manufacturing are based on established engineering principles, material science, and adherence to relevant industry standards for safety and efficacy of medical implants.

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