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When used with the bone screws, the Integra Spine Vu aPOD Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature 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. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the spacer component may be packed with autogenous bone graft material.

When used with the SpinPlate, the Integra Spine Vu aPOD Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature 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 1 spondylolisthesis at the involved level(s). The interior of the spacer component may be packed with autogenous bone graft material. When used with the SpinPlate, the Integra Spine Vu aPOD Intervertebral Body Fusion Device is intended for use with supplemental fixation.

The Integra Spine Vu aPOD Intervertebral Body Fusion Device, when used with bone screws or bone screws and the SpinPlate, is a stand alone device. If the Integra Spine Vu aPod Intervertebral Body Fusion Device is used only with the SpinPlate then additional supplemental fixation, which has been cleared by the FDA for use in the lumbar spine, must be used to augment stability. This device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.

The Vu aPOD Intervertebral Body Fusion Device consists of lumbar spinal interbody fusion devices as well as instrumentation designed specifically for the implantation of these devices. The Vu aPOD spacers are manufactured from PEEK OPTIMA LT1 polymer per ASTM F2026 while the bone screws and SpinPlate are comprised of Titanium alloy (Ti-6AI-4V ELI) per ASTM F136. Radiographic markers present with the Vu aPOD spacers are comprised of tantalum per ASTM F560. The Vu aPOD Intervertebral Body Fusion Device is for lumbar spinal use at one or two contiguous levels from the L2-L3 to L5-S1 disc levels.

This document is a 510(k) summary for a medical device called the "Integra Vu aPOD Intervertebral Body Fusion Device." It describes the device, its intended use, material composition, and how it compares to a predicate device. Importantly, it includes information about performance standards but explicitly states that no clinical or animal testing was performed.

Therefore, based on the provided text, I cannot answer the requested questions about acceptance criteria, actual device performance, sample sizes, expert involvement, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth for a study proving the device meets acceptance criteria.

The document focuses on demonstrating substantial equivalence to a predicate device through mechanical testing and similarity in design, materials, and other characteristics, rather than through performance in a clinical study.

Here's what I can extract and rephrase from the document regarding "acceptance criteria" and "performance" in the context of this 510(k) submission:

1. A table of acceptance criteria and the reported device performance

Explanation: The performance criteria here are the compliance with specific ASTM mechanical testing standards. The "reported device performance" is the conclusion that the device passed these tests to a degree that demonstrated substantial equivalence to the legally marketed predicate device (K101310). The 510(k) process relies on demonstrating equivalence rather than establishing new clinical safety and effectiveness through a full clinical trial.

For the remaining questions (2-9), the document explicitly states:

"Clinical Testing: There was no clinical or animal testing performed for this submission."

Therefore, I cannot provide answers for the following points as they relate to clinical or AI-based performance studies:

• 2. Sample size used for the test set and the data provenance
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• 4. Adjudication method for the test set
• 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
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
• 8. The sample size for the training set
• 9. How the ground truth for the training set was established

This device falls under a category where mechanical testing for substantial equivalence to an existing device is typically sufficient for 510(k) clearance, rather than extensive clinical studies or AI performance evaluations.

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