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The Lumfuse-TP cage is intended to be used in spinal fusion procedures for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. When used for these indications, the Lumfuse-TP cage is intended for use with supplemental fixation systems cleared for use in the lumbar spine. These patients should be skeletally mature and have had six months of nonoperative treatment. The Lumfuse-TP cage is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion.

The Lumfuse-TP cage consists of PEEK cages of various lengths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The devices are made from PEEK radiolucent material (ASTM F2026) with embedded tantalum x-ray markers (ASTM F560 or ISO 13782). Two versions of the Lumfuse-TP cage are available: cages coated with medical grade CP Ti (ASTM F1580) and non-coated cages, both of which are provided sterile. The device must be used with supplemental fixation.

The purpose of this submission is to gain initial marketing authorization in the United States for the non-coated, sterile and TPS coated Lumfuse-TP devices. Associated instrumentation has already been cleared in K171630.

The provided text from the 510(k) summary (K173189) does not contain information about the acceptance criteria or a study that proves the device meets specific performance criteria in the context of an AI/algorithm-driven device.

The document describes a medical device called "Lumfuse-TP," which is an intervertebral body fusion device (a PEEK cage for spinal fusion). The submission is for marketing authorization, demonstrating substantial equivalence to predicate devices, rather than proving performance against specific acceptance criteria for an AI system.

Here's a breakdown of why this information is missing, based on the provided text:

• Device Type: The Lumfuse-TP is a physical implant (a PEEK cage). It's not an AI/algorithm-driven device for diagnosis, image analysis, or any other predictive task that would typically involve acceptance criteria like sensitivity, specificity, or AUC, and a specific study to validate such performance.
• Submission Type: This is a 510(k) premarket notification. For physical devices like this, the primary goal is often to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving novel performance against predefined acceptance criteria for AI.
• "Non-clinical testing" (b)(1): This section details mechanical performance tests (Static and Dynamic Axial Compression, Static and Dynamic Compression Shear, Subsidence) according to ASTM standards (F2077-14, F2267-04(2011)). It also mentions cleaning, sterilization, and biocompatibility. These are standard tests for physical implants to ensure safety and function, not AI performance.
• "Clinical testing" (b)(2): The document explicitly states: "Clinical testing was not required to demonstrate substantial equivalence in this premarket notification." This further confirms that a clinical study to assess performance metrics (like those for AI) was not performed or deemed necessary for this submission.

Therefore, I cannot provide the requested table and details because the source document does not pertain to an AI/algorithm-driven medical device and thus does not contain the information requested in your prompt regarding acceptance criteria and performance studies for such a device.

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