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The Kyocera Medical Technologies, Inc. (KMT) Tesera-k Anterior Lumbar Interbody Fusion (ALIF) System is indicated for interbody fusion procedures in skeletally mature patients with disc disease (DDD) in the lumbar spine at one or two contiguous levels from L2 to S1. DDD 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). KMTI Tesera-k ALIF System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six months of nonoperative treatment. The Tesera-k ALIF System implants are available in standalone (Tesera-k SA) and non-standalone (Tesera-k A) configurations.

Tesera-k SA ALIF cages are intended to be implanted from a direct anterior surgical approach only. Tesera-k SA ALIF cages are intended to be used with the coverplate and screws provided. Tesera-k SA ALIF assemblies (cage, screws, coverplate) that contain cages with lordotic angles less than 20° and use all four screws are standalone and require no supplemental fixation. Tesera-k SA ALIF assemblies (cage, screws, coverplate) that contain cages with lordotic angles greater than or equal to 20° or if the surgeon chose to use fewer than four screws are considered non-standalone and require supplemental fixation cleared by the FDA for use in the lumbosacral spine.

Tesera-k A ALIF cages are monolithic and do not interface or mate with any additional implants. Tesera-k A ALIF cages may be implanted from direct anterior or oblique insertion angle. Tesera-k A ALIF cages are non-standalone and require supplemental fixation cleared by the FDA for use in the lumbosacral spine.

The Kyocera Medical Technologies, Inc. (KMT) Tesera-k Anterior Lumbar Interbody Fusion (ALIF) System implants support foraminal height and decompression between lumbar or lumbosacral vertebral bodies during spinal correction and fusion as well as reusable instruments to assist in endplate preparation and implantation. The Tesera-k ALIF System implants are available as a monolith without integrated fixation (Tesera-k A) or as a standalone with integrated fixation (Tesera-k SA) and are additively manufactured from Ti-6Al-4Vper ASTM F2924. The Tesera-k SA constructs includes screws and a coverplate manufactured from Ti-6Al-4V per ASTM F136 from the Tesera SA ALIF System (K193320, K131122, K140106, and K180502). The Tesera-k ALIF implants are sterile packaged and inserted via a direct anterior or oblique anterior surgical approach. The Tesera-k ALIF implants are offered in a variety of sizes and lordosis options to meet patient anatomical needs.

I am sorry, but the provided text does not contain information about acceptance criteria and the study that proves the device meets the acceptance criteria for a medical device that uses AI. The document is an FDA 510(k) clearance letter and summary for a spinal interbody fusion device (Tesera-k ALIF System), which is a physical implant, not an AI or software-based device.

Therefore, I cannot provide details on:

1. A table of acceptance criteria and reported device performance (for AI).
2. Sample size and data provenance for a test set (for AI).
3. Number and qualifications of experts for ground truth (for AI).
4. Adjudication method (for AI).
5. Multi-reader multi-case (MRMC) comparative effectiveness study with AI.
6. Standalone AI performance.
7. Type of ground truth used (for AI).
8. Sample size for the training set (for AI).
9. How ground truth for the training set was established (for AI).

The document focuses on the mechanical performance data (static and dynamic axial compression, compression shear, and subsidence) for the physical implant as per ASTM standards, concluding that the Tesera-k ALIF System is substantially equivalent to predicate devices based on these non-clinical tests.

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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

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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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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