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The ENDOSKELETON® TL Interbody Fusion Device is indicated for use in spinal fusion procedures 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 radiographic studies. Patients should have received 6 months of non-operative treatment with the devices. The device must be used with supplemental fixation that has been cleared by the FDA for use in the lumbar spine. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients with previous non-fusion spinal surgery at the involved level(s) may be treated with the device. It is indicated to be used with autograft bone comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone marrow aspirate.

The ENDOSKELETON® TL Hyperlordotic Interbody Fusion Device (≥ 16°) is 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 radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Patients should have received 6 months of non-operative treatment prior to treatment with the ENDOSKELETON® TL Hyperlordotic Interbody Fusion Device. Patients with previous non-fusion spinal surgery at the involved level(s) may be treated with the device. The Interbody Device is indicated to be used with autograft bone comprised of cancellous and/or corticocancellous bone, demineralized allograft bone marrow aspirate, or a combination thereof. The ENDOSKELETON® TL Hyperlordotic Interbody Fusion Devicemust be used with an integrated Lateral Plate and Bone Screw and additionally must be used with posterior supplemental internal spinal fixation that has been cleared by the FDA for use in the lumbar spine.

The ENDOSKELETON® TL Interbody Fusion Device implants are available in a variety of lengths, widths, and heights for treatment in Lateral Lumbar Interbody Fusion and are designed with a large hollow region in the center to house autograft bone or allograft bone comprised of cancellous and/ or corticocancellous bone, demineralized allograft bone marrow aspirate, or a combination thereof. The new bone formation through the implant is intended to provide long-term structural support and fusion at the implanted disc space. The design incorporates "windows" through the implant to permit visualization of device placement and over time formation of new bone. The superior and inferior surfaces include either the Chemtex® surface treatment or nanoLOCK® surface treatment (MMN™) designed to improve fixation to the adjacent bone. The nanoLOCK® surface technology (MMN™) provides a microscopic roughened surface with nano-scale features. The implants are composed of ASTM F136 Ti 6Al-4V ELI titanium alloy and provided either sterile. An implant holding feature has been incorporated into the trailing surface of the implant to mate with the implant inserter and to facilitate placement of the implant into the interbody space.

The subject submission introduces the ENDOSKELETON® TL Hyperlordotic Interbody Fusion Devices are available in a variety of lengths, widths, and heights for treatment in Lateral Lumbar Interbody Fusion and are designed with a large hollow region in the center to house autograft bone comprised of cancellous and/or corticocancellous bone. The design incorporates "windows" through the Interbody Device to permit visualization of the Interbody Device placement and over time formation of new bone. The new bone formation through the Interbody Device is intended to provide long-term structural support and fusion at the implanted disc space. The Interbody Device is treated with nanoLOCK® Surface Technology (MMN™) designed to improve fixation to the adjacent bone. The nanoLOCK® Surface Technology (MMN™) provides a microscopic roughened surface with nano-scale features.

The subject submission also includes Lateral Plate and Bone Screws which are available in a variety of sizes for stabilizing the Interbody Device. The Lateral Plate has one or two hole(s) for receiving integrated Bone Screws and a feature for attachment to the Interbody Device. The Lateral Plate incorporates a lock cover to resist the integrated Bone Screws from backing out. Holding features have been incorporated into the Interbody Device and associated device components to facilitate placement of the system into the interbody space. The Interbody Device and associated device components are composed of ASTM F136 or ASTM F3001 Ti6Al4V ELI titanium alloy and provided sterile.

The provided text describes the regulatory filing for the Endoskeleton® TL Interbody Fusion Device and Endoskeleton® TL Hyperlordotic Interbody Fusion Device. This document is a 510(k) summary, which is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

Crucially, this document highlights a mechanical device (intervertebral body fusion device) for spinal fusion, not an AI or software-as-a-medical-device (SaMD) product. Therefore, the acceptance criteria and study designs typically associated with AI/SaMD (e.g., performance metrics like sensitivity/specificity, MRMC studies, ground truth establishment by experts, training/test sets) are not applicable here.

The "performance testing" section refers to biomechanical and material testing (e.g., static and dynamic testing per ASTM standards, particulate/wear analysis, bacterial endotoxin testing) to ensure the device's physical properties and biocompatibility are acceptable, and that it can withstand the forces it will encounter in the body.

Here's how to address your request given the provided context:

The acceptance criteria and study detailed in this document are for a physical medical device (spinal implant), not a software/AI medical device. Therefore, the questions related to AI/SaMD performance metrics, ground truth, expert review, and training/test sets are not applicable.

Here's what can be extracted and inferred from the document regarding the acceptance criteria and the study that proves the device meets them, adapted for a mechanical device:

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

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

• Sample Size for Test Set: Not explicitly stated as a "test set" in the context of clinical data for AI. For biomechanical testing, the "worst-case construct" and "worst-case bone screw configurations" were tested. This implies a representative selection of device variations. The exact number of samples tested per ASTM standard is not provided in this summary but would be detailed in the full testing report submitted to the FDA.
• Data Provenance: Not applicable in the sense of patient data. The "data" comes from laboratory and physical testing of the device prototypes.

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

• Not Applicable. This is a physical device; ground truth is established through adherence to engineering standards (ASTM) and physical measurements/tests, not through expert clinical consensus of images or outcomes as would be done for an AI device.

4. Adjudication method for the test set:

• Not Applicable. No human adjudication process is described for this type of device testing. Compliance with ASTM standards is determined by the results of the physical tests.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No. An MRMC study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. This device is a surgical implant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not Applicable. This is a physical implant, not an algorithm.

7. The type of ground truth used:

• Mechanical and Biological Standards: Ground truth is established by adherence to recognized industry standards (ASTM), material specifications (ASTM F136 Ti 6Al-4V ELI, ASTM F3001 Ti6Al4V ELI), and biological compatibility testing requirements (LAL for endotoxins). The "ground truth" is that the device physically performs according to these established engineering and safety benchmarks.

8. The sample size for the training set:

• Not Applicable. There is no "training set" in the context of machine learning for a mechanical device. The design and manufacturing process are refined through engineering principles and iterative testing, not by "training" an algorithm on a dataset.

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

• Not Applicable. As there's no training set, there's no ground truth to establish in this context. The design process for a physical medical device relies on established engineering principles, material science, and prior knowledge from predicate devices.

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