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The CONDUIT™ ATP Inserters are intended to be used with the EIT Cellular Titanium® LLIF Cages.

The EIT Cellular Titanium® LLIF Cages with a microscopic roughened surface and micro and nanoscale features are indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S 1. 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 1 spondylolisthesis or retrolisthesis at the involved level(s). These spinal implants are to be used with autogenous bone graft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. EIT Spine LLIF is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The CONDUIT™ ATP Inserters are designed for use during Lumbar Interbody Fusion surgery, specifically using the ATP surgical approach. The inserters have been designed to interface with EIT Cellular Titanium® LLIF Cages (K201605). The reusable instruments are provided non-sterile and made from commonly used orthopedic materials with commonly used manufacturing processes. There are no changes to the implants or other compatible instruments provided with the implants.

The provided text is a 510(k) summary for the CONDUIT™ ATP Inserters, which are surgical tools. It clarifies that these inserters are not a device that uses AI or machine learning. The document describes them as reusable instruments made from orthopedic materials, intended for use in Lumbar Interbody Fusion surgery.

Therefore, the requested information regarding AI/ML device acceptance criteria, performance studies involving AI, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance cannot be provided as these concepts are not relevant to this type of medical device.

The "Performance Data" section of the 510(k) summary indicates that non-clinical testing was conducted to confirm device performance, including:

• Impaction endurance testing
• Formative usability testing
• Thread cyclic testing

These tests are standard for mechanical surgical instruments to ensure their durability and functionality, rather than evaluating AI performance.

The conclusion states that the overall technology characteristics and mechanical performance data lead to the conclusion that the CONDUIT™ ATP Inserters are substantially equivalent to the predicate device, K223671, the CONDUIT™ LLIF Straight Inserters manufactured by DePuy Synthes.

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