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The ENDOSKELETON® TAS Interbody Fusion device 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 discogence 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 or retrolisthesis at the involved level(s). Patients should have received 6 months of nonoperative treatment prior to treatment with the device is a standalone system that is intended to be used with the bone screws provided and requires no additional supplementary fixation. The Device is indicated to be used with autograft bone and/or allograft bone comprised of cancellous bone and/or demineralized allograft bone with bone marrow aspirate.

Hyperlordotic Devices ≥16°: The ENDOSKELETON® TAS 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 with the devices. The device is indicated to be used with autograft bone and/or allograft bone comprised of cancellous bone and/ or demineralized allograft bone with bone marrow aspirate.The ENDOSKELETON® TAS Hyperlordotic Interbody Fusion Device must be used with a posterior supplemental internal spinal fixation that has been cleared by the FDA for use in the lumbar spine must be used with a posterior supplemental internal spinal fixation that has been cleared by the FDA for use in the lumbar spine.

The ENDOSKELETON® TAS and ENDOSKELETON® TAS Hyperlordotic Interbody Fusion device implants are available in a variety of Anterior Lumbar Interbody Fusion (ALIF) sizes with a variety of lordotic angles, to accommodate patient anatomy; Hyperlordotic implants are those defined by a lordotic angle ≥16°. Implants are designed with a large hollow region in the center to house autograft bone or allograft bone comprised of cancellous and/ or corticocancellous bone. 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 the graft material and over time formation of new bone. The superior and inferior surfaces of the IBDs have been acid etched through a previously cleared process called Chemtex® and the IBDs may have also received Titan Spine's 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 implant system includes integrated fixation (screws) for stabilizing the implants when placed in the interbody space. An implant holding feature has been incorporated into the trailing surface of the implant to mate with the implant holder, and to facilitate placement of the interbody space. Screws include internal hex drive features matched to instrumentation for implantation. All implantable components are manufactured from medical grade titanium alloy (Ti-6Al-4V-ELI) and may be provided either sterile or non-sterile.

The purpose of this special 510(k) submission is to add a plate to the Endoskeleton® TAS and TAS Hyperlordotic System. The ENDOSKELETON® TAS Plate is available in a variety of sizes corresponding to the sizes of ENDOSKELETON® TAS and ENDOSKELETON® TAS Hyperlordotic Interbody Fusion Device implants. The Plate design incorporates a lock to secure it to the Interbody Fusion Device implant and is engaged after the plate is placed on the anterior face of the ENDOSKELETON® TAS or ENDOSKELETON® TAS Hyperlordotic Interbody Fusion Device implant to resist the integrated screws from backing out. The system includes a holding feature on the plate to mate with the inserter to facilitate placement onto the ENDOSKELETON® TAS or ENDOSKELETON® TAS Hyperlordotic Interbody Fusion device implant. The subject plate does not include nanoLOCK™ (MMN™) surface treatment, as it does not interface with the bone. The subject Endoskeleton® TAS Plate is only provided sterile by gamma irradiation.

ENDOSKELETON® TAS Plate resists integrated screws from backing out. These plates do not qualify as supplemental fixation and may only be used with ENDOSKELETON® TAS and ENDOSKELETON® TAS Hyperlordotic Interbody fusion devices 12mm and above.

The provided text is a 510(k) summary for the Endoskeleton® TAS Plate, an intervertebral body fusion device. While it describes the device, its intended use, and states that performance bench testing was conducted, it does not provide the detailed information requested regarding the acceptance criteria, specific study results, sample sizes, ground truth establishment, or expert involvement for AI device evaluation.

Therefore, I cannot fully answer your request based on the provided document. The document describes a traditional medical device (implantable plate), not an AI/ML powered device.

However, I can extract what is implied about performance testing for this mechanical device:

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

The document states: "Performance bench testing, including locking plate resistance to screw push-out, was performed to demonstrate substantial equivalence."

• Acceptance Criteria (Implied): The locking plate must demonstrate sufficient resistance to screw push-out to ensure substantial equivalence to predicate devices and maintain safe and effective function. Specific quantitative criteria (e.g., minimum force required to push out a screw) are not provided in this summary.
• Reported Device Performance: The document concludes that based on this testing, the device is "substantially equivalent to the predicate devices." No specific performance values or metrics are reported.

The remaining questions (2-9) are largely irrelevant as this document describes a physical medical device and its bench testing, not an AI-powered device or a clinical study that would involve human readers, ground truth establishment through expert consensus, or training sets for AI models.

To address points 2-9, the information would typically come from a submission for an AI/ML-powered medical device, which would detail diagnostic performance studies.

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