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The Qualgenix Twin Peaks Lumbar Cage is indicated for intervertebral body fusion with autogenous bone graft material in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment. The Qualgenix Twin Peaks Lumbar Cage is to be used with supplemental fixation.

The Qualgenix Twin Peaks Lumbar Cage consists of lumbar spinal interbody fusion devices in 20mm and 25mm footprints as well as instrumentation designed specifically for the implantation of these devices. The cage is manufactured from PEEK OPTIMA LT1 polymer. Bone graft is intended to be placed in the middle of the device.

The provided text describes a medical device, the Qualgenix Twin Peaks Lumbar Cage, and its 510(k) summary for FDA clearance. However, the document does not contain information related to software performance, AI algorithms, or clinical studies involving human readers or ground truth establishment for diagnostic purposes, which are typically found in submissions for AI/ML-enabled devices.

Instead, this document focuses on the mechanical and material performance of a medical implant and its substantial equivalence to predicate devices. Therefore, I cannot provide a response that includes acceptance criteria and study details relevant to an AI-powered diagnostic device based on the given text.

The information provided pertains to:

• Device Trade Name: Twin Peaks Lumbar Cage
• Manufacturer: Qualgenix
• Indications For Use: Intervertebral body fusion with autogenous bone graft material in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1.
• Device Description: Lumbar spinal interbody fusion devices made of PEEK OPTIMA LT1 polymer, with 20mm and 25mm footprints.
• Predicate Devices: DePuy Spine Lumbar Cages (K081917), SpineArt Juliet Cage (K101710), and Scient'X Tribeca Cage (K080588).
• Performance Standards/Testing: Preclinical testing per ASTM F2077 (static compression, static torsion, dynamic compression), expulsion testing, and ASTM F2267 (subsidence testing). These standards evaluate the physical and mechanical properties of the implant.

Therefore, I cannot fulfill your request for: a table of acceptance criteria and reported device performance (in the context of AI/ML), sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, or ground truth types related to an AI device.

The document states that performance standards were met through preclinical testing to demonstrate substantial equivalence, not through clinical or diagnostic performance studies typical for AI/ML products.

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