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The SpineWorks Anterior Lumbar Device is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). SW ALD Interbody System implants are to be used with autogenous bone graft and implanted via an anterior, lateral or anterolateral approach. SW ALD Interbody System implants are 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. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

The SpineWorks Anterior Lumbar Device (SW ALD) was developed for the stabilization of the lumbar spinal column. The body of the device is a rounded-trapezoidal shape with two large windows allowing placement of bone graft and facilitating fusion. The superior and inferior surfaces of the devices have a pattern of teeth to provide increased stability and inhibit movement of the implants. SW ALD implants are available in two lordotic configurations (6° and 11°) of various heights and widths to restore lumbar lordosis and the associated sagittal balance. SW ALD implants have three tantalum x-ray markers. The SW ALD device is single-use only.

Materials: Medical grade PEEK (ASTM F2026) machined from Vestakeep i4R extruded bar stock (Evonik Polymers Technologies GmbH, FDA master file MAF #1922). Medical grade tantalum (ASTM F560-08) was used to fabricate the radio opaque markers.

Function: SW ALD devices are used to maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion.

This is a 510(k) premarket notification for a medical device (SpineWorks Anterior Lumbar Device), not an AI/ML medical device. Therefore, the requested information about acceptance criteria, study details, expert involvement, and training/test sets for an AI/ML model is not applicable and cannot be extracted from the provided text.

The document describes material and mechanical testing for the spinal implant to demonstrate substantial equivalence to predicate devices, which is a different type of evaluation from an AI software study.

Here's a breakdown of why I cannot fulfill your request based on the provided text:

• No AI/ML Component: The submission is for a physical medical device (an intervertebral body fusion device) made of PEEK and tantalum. There is no mention of any software, algorithm, or AI/ML component.
• Performance Data Type: The "Performance Data" section (G) refers to "Mechanical testing per the FDA Guidance Document for spinal devices and the information contained in Evonik's master file MAF # 1922." It explicitly mentions "static compression and dynamic compression" tests (ASTM F2077-03) and "subsidence" evaluation (ASTM F2267-04). These are physical and material property tests relevant to an implant, not AI algorithm performance metrics.
• "Acceptance Criteria" for an Implant: For this type of device, "acceptance criteria" would typically refer to specific thresholds for mechanical strength, fatigue life, biocompatibility, and other physical properties described in the referenced ASTM standards and FDA guidance for intervertebral body fusion devices. The text states: "All static and dynamic test results met or exceeded the requirements for intervertebral body fusion devices intended for use in the lumbar spine." This is the core "acceptance criteria" statement for this type of device and its performance.
• Irrelevant AI/ML Study Parameters: All points related to sample size (test/training), data provenance, experts, adjudication, MRMC studies, standalone performance, and ground truth types are specific to the evaluation of AI/ML algorithms and are not present in this physical device submission.

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