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XYPAN Expandable Lumbar 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). This device is to be used with autogenous bone graft and/or allogenous bone graft composed of cancellous and/or corticocancellous bone. XYPAN Expandable Lumbar 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 XYPAN Lumbar Expandable Cage System's implants are interbody fusion devices intended for use as an aid in spinal fixation. They are made of Titanium 6AL-4V Alloy (ASTM F136). These hollow, rectangular implants are offered in a variety of widths, lengths, heights and lordotic angles designed to adapt to a variety of patient anatomies. The implants can be expanded in height after insertion in the unexpanded state using the system instrumentation. The implants have serrations on the superior and inferior surfaces designed for fixation.

• -XYPAN-XT Expandable Cage is to be implanted via transforaminal and posterior approach.
• -XYPAN-XTP Expandable Cage is to be implanted via Anterior to Psoas approach.
• XYPAN-XL Expandable Cage is to be implanted via lateral approach. -

The provided text is a 510(k) summary for the XYPAN Expandable Lumbar Cage System, a medical device for intervertebral body fusion. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of the device's performance against specific acceptance criteria.

The 510(k) summary explicitly states: "Engineering rationales and comparisons between the subject and predicate devices were used to leverage previously conducted performance testing." This means that no new performance study was conducted for the XYPAN Expandable Lumbar Cage System itself to prove it meets acceptance criteria. Instead, its performance is considered substantially equivalent to a previously cleared device (the predicate device) based on similar design, materials, and intended use.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them directly from this document.

However, I can extract information related to the device and the basis for its clearance:

Device Information:

• Device Name: XYPAN Expandable Lumbar Cage System
• Regulation Number: 21 CFR 888.3080
• Regulation Name: Intervertebral Body Fusion Device
• Regulatory Class: Class II
• Product Code: MAX
• Indicated Use: Intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1, with or without up to Grade 1 spondylolisthesis or retrolisthesis. To be used with autogenous and/or allogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment.
• Material: Titanium 6AL-4V Alloy (ASTM F136)
• Predicate Device: AccelFix Lumbar Interbody Fusion Cage System (K190708) from L&K Biomed Co., Ltd.

Basis for Substantial Equivalence (as per the document):

• Identical Indications for Use
• Identical Materials of manufacture
• Identical Structural support mechanism

Because the document relies on substantial equivalence and engineering rationales to a predicate device rather than a new performance study with specific acceptance criteria, most of your requested points cannot be answered directly from the provided text.

Specifically:

1. A table of acceptance criteria and the reported device performance: Not provided, as no new performance study was described.
2. Sample size used for the test set and the data provenance: Not applicable, as no new test set study was described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a physical implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical implant.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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