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X-PAC® TLIF Expandable Posterior Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. 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 intended to be used with autograft and/or allograft comprised of cortical, cancellous and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. X-PAC® TLIF Expandable Posterior Cage System 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.

X-PAC® LLIF Expandable Lateral Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. 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 intended to be used with autograft and/or allograft comprised of cortical, cancellous and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. X-PAC® LLIF Expandable Lateral Cage System 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 X-PAC® TLIF Expandable Posterior Cage System and X-PAC® LLIF Expandable Lateral Cage System are lumbar interbody fusion systems comprised of a cage implant and surgical instruments. The implants are used to provide structural stability in skeletally mature individuals following discectomy and are placed via a transforaminal or lateral approach. The device is available in various sizes and footprints to accommodate varying anatomy and is designed to allow for intraoperative adjustment in the height of the cage. Surfaces of the upper plate and bottom housing that contact the vertebral endplates are "toothed" to provide stability within the intervertebral space. The outer surface teeth are designed to resist expulsion in all directions. The fenestrated cage contains openings to enhance bony ingrowth and has a bulleted nose for easier entry into the disc space. The implants are manufactured from medical grade titanium alloy per ASTM F136, and ASTM F1472. The X-PAC® TLIF Expandable Posterior Cage System and X-PAC® LLIF Expandable Lateral Cage System implants are single-use, provided non-sterile, and are intended to be steam sterilized before use. The surgical instruments are designed to facilitate precise placement of the device within the intervertebral disc body, and are re-usable, provided non-sterile, and are intended to be cleaned and steam sterilized before each use.

I cannot provide a table of acceptance criteria and reported device performance from the provided text, nor can I describe a study that proves the device meets specific acceptance criteria.

Here's why:

1. Nature of the Document: The provided text is a 510(k) Clearance Letter and 510(k) Summary. These documents primarily focus on demonstrating substantial equivalence to a previously cleared predicate device. They are not designed to present detailed performance data against pre-defined acceptance criteria in the way one would see in a clinical trial report or a performance validation study for a novel device, especially not for sophisticated AI/ML software.

2. Device Type: The device described in the document is an "Intervertebral Body Fusion Device" – specifically, an expandable posterior and lateral cage system. This is a mechanical implant, not a diagnostic AI device or software that would have performance metrics like sensitivity, specificity, or reader improvement.

3. Lack of AI/ML Component: There is no mention of artificial intelligence, machine learning, image analysis, or any software-based diagnostic component in this 510(k) submission. Therefore, questions 2 through 9 regarding test sets, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training sets, and ground truth establishment are not applicable.

Summary based on the provided text:

• Acceptance Criteria & Performance: Not present in the document because this is a mechanical device demonstrating substantial equivalence, not a performance study for an AI/ML diagnostic.
• Sample Size (Test Set): Not applicable. The submission relies on existing testing data for the predicate devices, not a new test set for AI performance.
• Data Provenance: Not applicable.
• Number of Experts/Qualifications: Not applicable.
• Adjudication Method: Not applicable.
• MRMC Study: Not applicable.
• Standalone Performance: Not applicable.
• Type of Ground Truth: Not applicable.
• Sample Size (Training Set): Not applicable.
• Ground Truth Establishment (Training Set): Not applicable.

The submission states that:

• "The purpose of this submission is to expand the indications for use of X-PAC® TLIF Expandable Posterior Cage System and X-PAC® LLIF Expandable Lateral Cage System devices to include use of allograft and bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion."
• "Because the subject device is identical to the previously cleared primary predicate devices (K22374, K222797), it was determined that existing testing data is adequate to support the expanded indications proposed in the current submission."
• "The X-PAC® TLIF Expandable Posterior Cage System and X-PAC® LLIF Expandable Lateral Cage System are substantially equivalent to legally marketed predicates with respect to indications, design, materials, function, operation, and performance."

This indicates that the clearance was based on substantial equivalence to existing, previously cleared devices, making the detailed testing methodology for AI/ML performance questions irrelevant for this specific 510(k) submission.

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