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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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The ENDOSKELETON® TA 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. Patients should have received 6 months of non-operative treatment prior to treatment with the device may 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). ENDOSKELETON® TA 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 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 requres 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 inxation that has been cleared by the FDA for use in the lumbar spine.

The ENDOSKELETON® TC is indicated for use for anterior cervical interbody fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level from C-3 to C-7. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have received 6 weeks of non-operative treatment prior to treatment with the device. The ENDOSKELETON® TC is indicated to be used with supplemental fixation that has been cleared by the FDA for use in the cervical spine and be used with autograft bone and/ or allograft bone comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone with bone marrow aspirate.

The ENDOSKELETON® TCS System is an anterior cervical intervertebral body fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) (defined as pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) at one disc level from C2 to T1. Patients should have received 6 weeks of non-operative treatment with the device. 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 device is a stand-alone system when used with ENDOSKELETON® TCS integrated screws and when used without the integrated screws it requires additional supplemental fixation cleared for the cervical spine.

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 systems 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 and/or allograft bone comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone with bone marrow aspirate.

The ENDOSKELETON® TO 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. Patients should have received 6 months of non-operative treatment prior to 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). It is indicated to be used with autograft bone and/or allograft bone comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone marrow aspirate.

The ENDOSKELETON® TT 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. Patients should have received 6 months of non- operative treatment prior to 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). It is indicated to be used with autograft bone and/or allograft bone comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone marrow aspirate.

The current Endoskeleton® System is an interbody and vertebral body family comprised of a variety of sizes and geometries to accommodate various patient anatomy and pathology. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI). The center of the implant is hollow and is to be filled with autograft bone and/or allograft bone comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone marrow aspirate. 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 include either the Chemtex® surface treatment or nanoLOCK® surface treatment (MMNTM) designed to improve fixation to the adjacent bone. The nanoLOCK® surface technology (MMN™) provides a microscopic roughened surface with nano-scale features. This submission seeks to expand the indications of these devices to include use with demineralized allograft bone with bone marrow aspirate.

The provided text is a 510(k) premarket notification for a medical device called the "ENDOSKELETON® Interbody Fusion Device" system. This document addresses an expansion of indication for use rather than a new device submission. As such, it does not contain information typically found in a study demonstrating primary device performance against acceptance criteria.

Specifically, the document states: "No performance testing was required or performed, as this modification for this Special 510(k) relates only to the indications for use."

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them because the provided document explicitly states that no such testing was performed for this specific submission.

The submission is for modifying the indications for use of an already cleared device system to include the use of demineralized allograft bone with bone marrow aspirate. The rationale for substantial equivalence is based on:

1. Literature review: The review concluded that there were "no additional risks due to the modification of the indications for these devices to include use with demineralized allograft bone with bone marrow aspirate."
2. Similarities to predicate devices: The intended use, material, surgical technique, surface treatment, sterility, and design of the subject devices are the same as the predicate devices.

In summary, the document does not contain the information requested about acceptance criteria or performance study details.

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The ENDOSKELETON® TA 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 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 prior to treatment with the device is intended to 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). ENDOSKELETON® TA is indicated to be used with autograft bone or allograft bone comprised of cancellous and/ or corticocancellous bone.

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 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 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 or allograft bone comprised of cancellous and/ or corticocancellous bone.

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 comprised of cancellous and/ or corticocancellous bone. 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.

The ENDOSKELETON® TO 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 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 prior to 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). It is indicated to be used with autograft bone comprised of cancellous and/ or corticocancellous bone.

The ENDOSKELETON® TT 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 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 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). It is indicated to be used with autograft bone comprised of cancellous and/ or corticocancellous bone.

The ENDOSKELETON® TC Interbody Fusion Device is indicated for use for anterior cervical interbody fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level from C-3 to C-7. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have received 6 weeks of non-operative treatment with the device. The ENDOSKELETON® TC Interbody Fusion Device is indicated to be used with supplemental fixation that has been cleared by the FDA for use in the cervical spine and autograft bone comprised of cancellous and/ or corticocancellous bone.

The Endoskeleton® TCS Interbody Fusion Device System is an anterior cervical intervertebral body fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) (defined as pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) at one disc level from C2 to T1. Patients should have received 6 weeks of non-operative treatment with the device. The device is indicated to be used with autograft bone or allograft bone comprised of cancellous and/ or corticocancellous bone. The device is a standalone system when used with Endoskeleton® TCS interrated screws and when used without the integrated screws it requires additional supplemental fixation cleared for the cervical spine.

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. This devices. This device is intended for use with supplemental fixation systems cleared 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 or allograft bone comprised of cancellous and/ or corticocancellous bone.

The ENDOSKELETON® TA Vertebral Body Replacement is for use in the thoracolumbar spine (T1 - L5) to replace all or part of a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e. fracture). The ENDOSKELETON® TA Vertebral Body Replacement is intended for use with supplemental internal spinal fixation systems that has been cleared by the FDA for use in the lumbar spine. The ENDOSKELETON® TA Vertebral Body Replacement may be used with bone graft material and/or allogeneic bone graft.

The current Endoskeleton® system is an interbody and vertebral body family comprised of a variety of sizes and geometries to accommodate various patient anatomy and pathology. All implantable components are manufactured from medical grade titanium alloy (Ti6A14V-ELI). The center of the implant is hollow and is to be filled with autograft material. The design incorporates "windows" through the implant to permit visualization of the graft material and, over time, formation of new bone. This submission seeks to expand the indications of these devices to include use with allograft material.

The predicate Endoskeleton® System (K173535, K170399, and K141953) is provided either non-sterile or sterile via gamma irradiation. The Endoskeleton® TA VBR (K032812) was initially manufactured and submitted by Orthovita, Inc (Malvern, PA). Titan Spine has the 510(k) and maintains the device listing for the device.

The provided document is a 510(k) summary for the Titan Spine Endoskeleton® Interbody Fusion Devices and Vertebral Body Replacement Device. This submission is for a modification to the indications for use, specifically to include the use of allograft material. The document explicitly states that no performance testing was required or performed because the modification relates only to the indications for use and not to the device's design, materials, or function.

Therefore, the study design and associated criteria for "device performance" (as would be tested in a typical clinical or technical performance study) are not applicable or reported in this document. The "proving" of acceptance criteria in this context relies on a literature review to establish substantial equivalence with predicate devices, rather than empirical testing of the device itself.

Since the request asks for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of device performance, and the document clarifies that no such testing was conducted, I will state that directly.

Here's the breakdown of the requested information based on the provided document:

1. Table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance

• Sample size for test set: Not applicable. No performance testing was conducted.
• Data provenance: Not applicable. The basis for this 510(k) was a comprehensive literature review.

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

• Not applicable. No test set was used for device performance evaluation. The determination of substantial equivalence was based on a literature review which concluded no additional risks for the modified indications.

4. Adjudication method for the test set

• Not applicable. No test set was used.

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 is a medical device (spinal implant), not an AI/software device. No MRMC study was conducted.

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

• Not applicable. This is a medical device (spinal implant), not an algorithm/software device.

7. The type of ground truth used

• Not applicable in the context of device performance testing. The "ground truth" for the current submission was established through a comprehensive literature review to assess the safety and equivalence of using allograft material with the existing devices.

8. The sample size for the training set

• Not applicable. No training set was used as no AI/software component is involved, and no performance testing was conducted.

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

• Not applicable. No training set was used.

Summary regarding the "study that proves the device meets the acceptance criteria":

For this specific 510(k) submission (K183557), the device itself (Titan Spine Endoskeleton® Interbody Fusion Devices and VBR Device) was not subjected to new performance testing. The application was a "Special 510(k)" for a modification to the Indications for Use, specifically to add the use of allograft material.

The document explicitly states: "No performance testing was required or performed, as this modification for this Special 510(k) relates only to the indications for use." and "A comprehensive literature review was conducted to assess any additional safety concern for the use of these devices with allograft. The review of the literature concluded that there were no additional risks due to the modification of the indications of these devices to include use with allograft and that these devices are substantially equivalent to the predicate devices."

Therefore, the "proof" that the device (with the expanded indication) meets acceptance criteria comes from a comprehensive literature review demonstrating no additional safety concerns or changes in substantial equivalence due to the inclusion of allograft material. This relies on the established performance and safety profile of the predicate devices and existing knowledge regarding allograft use in similar surgical contexts. There were no specific, quantifiable "acceptance criteria" related to a performance study for this particular submission because no such study was deemed necessary.

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