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The CoreLink® M3™ Stand-Alone Anterior Lumbar System is a standalone interbody fusion system indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radios. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The device may be used with supplemental fixation.

Hyperlordotic implants (>20° lordosis) must be used with supplemental fixation (e.g. posterior fixation) that are cleared by the FDA for use in the lumbar spine. The system is indicated to be used with autograft bone. Patients should have received 6 months of non- operative treatment prior to treatment with the devices.

The implants are intended to be used with the bone screws and lock provided. The system is designed to be a 3-screw implant, and all three (3) screws must be used. The accompanying lock must be used anytime the device is used with any number of screws. If the physician chooses to use less than the recommended number, then additional supplemental fixation in the lumbar spine must be used to augment fixation.

The CoreLink® M3™ Stand-Alone Anterior Lumbar System is available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The CoreLink® M3TM Stand-Alone Anterior Lumbar System consists of an interbody cage, locking plate, and three (3) bone screws. System components are manufactured from either titanium alloy (Ti-6A1-4V ELI) conforming to ASTM F136 and ISO 5832-3 or additively manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F3001. The 8°, 15°, and 20° lordotic cages may be used as a standalone system. The M3 Stand-Alone Anterior Lumbar System M3 Stand-Alone Anterior Lumbar System 25° - 30° lordotic cages must be used with supplemental internal spinal fixation systems (i.e. posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine.

This document is a 510(k) Premarket Notification from the FDA regarding the CoreLink® M3™ Stand-Alone Anterior Lumbar System. It does not describe an AI/ML medical device and therefore does not contain information typically associated with acceptance criteria and study designs for such devices (e.g., performance metrics like sensitivity/specificity, ground truth establishment by experts, or MRMC studies).

The "performance data" section refers to non-clinical mechanical testing of the interbody fusion device, not performance related to algorithms or human reader improvement.

Therefore, I cannot fulfill the request as the provided text does not contain the necessary information about AI/ML device performance, acceptance criteria, or related study details.

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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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