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The Adcura® Sagittae® Lateral Lumber Interbody Fusion Devices are indicated for interbody fusion in patients with degenerative disc disease (DDD) at one 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. Supplemental fixation is required with Adcura Sagittae® Lateral Lumbar Interbody Fusion Devices. Additionally, the Adcura devices are intended to be used with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine (e.g. posterior pedicle screw and rod systems, and anterior screw and rod systems). Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation.

The Adcura® Sagittae® Lateral Lumber Interbody Fusion Devices are manufactured out of medical grade Ti-6Al-4V (Grade 5) and Ti-6A-4V (ELI) alloy that conforms to ASTM F1472 and ASTM F136 respectively. This submission of the Sagittae® Lateral Lumbar Interbody Fusion Devices includes minor feature design modifications to the implants and add instruments to the surgical set.

This document is a 510(k) Premarket Notification for a medical device (Adcura® Sagittae® Lateral Lumbar Interbody Fusion Devices), not an AI/ML device. Therefore, the provided text does not contain any information about acceptance criteria or a study proving an AI/ML device meets them.

The 510(k) summary focuses on the mechanical performance data of the physical interbody fusion device and compares its design to previously cleared predicate devices. The "Performance Data" section explicitly states:

"Minor design modifications to the Adcura Sagittae® Lateral Lumbar Interbody Fusion Devices cleared under K200816, K190193, and K181531 have been evaluated mechanically through static and dynamic axial compression and compression shear performance testing per ASTM F2077."

This indicates testing of the physical hardware, not an AI algorithm.

To answer your request, I would need a document describing the testing and validation of an AI/ML medical device.

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