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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 nonoperative treatment prior to treatment with the device may be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be use with autograft bone.

The Endoskeleton TA® Interbody Fusion Device is comprised of a variety of implant sizes to accommodate various patient anatomy and pathology, and associated instrumentation. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI).

The provided text is a 510(k) summary for the Endoskeleton TA® Interbody Fusion Device. It details the device's indications for use, description, and predicate devices. However, it does not contain specific acceptance criteria, detailed study results, or information about AI/ML algorithm performance.

Here's a breakdown of why I cannot fulfill your request based on the provided text, and what information is present:

Missing Information (and why it's missing from a 510(k) summary of this type):

• Acceptance Criteria and Reported Device Performance Table: This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It typically doesn't include detailed performance criteria and results in the same way a clinical trial report or a PMA (Premarket Approval) application would. The summary states: "The pre-clinical testing performed indicated that the Endoskeleton TA® Interbody Fusion Device is adequate for the intended use," but no specific metrics are given.
• Sample Size for Test Set and Data Provenance: This information is not typically part of a 510(k) summary for a spinal implant. The "testing" mentioned is likely mechanical/bench testing rather than clinical data involving a "test set" in the context of an AI/ML algorithm.
• Number of Experts Used to Establish Ground Truth and Qualifications: Not applicable to this type of device and submission.
• Adjudication Method: Not applicable.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This device is an interbody fusion device, not a diagnostic imaging AI tool.
• Standalone (algorithm only) Performance: Not applicable as it's not an AI/ML device.
• Type of Ground Truth Used: Not applicable.
• Sample Size for Training Set: Not applicable.
• How Ground Truth for Training Set was Established: Not applicable.

Information that is present:

• Device Name: Endoskeleton TA® Interbody Fusion Device
• Indications for Use: For skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1, with or without Grade I spondylolisthesis/retrolisthesis, who have received 6 months of nonoperative treatment. To be used with supplemental fixation and autograft bone.
• Device Description: Comprised of various implant sizes manufactured from medical grade titanium alloy (Ti6Al4V-ELI) and associated instrumentation.
• Predicate Devices: BAK Interbody Fusion Device (Spine-Tech, P950002), Inter Fix Threaded Fusion Device (Sofamor Danek, P970015), Ray Threaded Threaded Cage (Surgical Dynamics, P950019), and Titan Spine Endoskeleton TA® VBR (K032812).
• Performance Testing (General Statement): "The pre-clinical testing performed indicated that the Endoskeleton TA® Interbody Fusion Device is adequate for the intended use."

Conclusion:

This 510(k) summary for the Endoskeleton TA® Interbody Fusion Device demonstrates substantial equivalence to predicate devices based on design, function, materials, and indications for use. It mentions pre-clinical testing, but does not provide the specific detailed performance metrics, acceptance criteria, or study methodologies that would be relevant for an AI/ML device as outlined in your request. The request's format (e.g., ground truth, training/test sets, experts, MRMC studies) is specifically tailored for AI/ML or diagnostic devices, which this interbody fusion device is not.

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