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The Vertiwedge® Intraosseous System is indicated for use in the thoracolumbar spine (TI-L5) for partial replacement of a diseased or damaged vertebral body resected or excised to replace a portion and/or restore the height of a collapsed vertebral body for the treatment of previous trauma (i.e. fracture or tumor) or degenerative spine disease. The system is to be placed within the vertebral body following an osteotomy and supplemented with autograft or allograft and to be used with its contralateral staple; should a physician choose to use fewer than the maximum number of screws, then supplemental fixation must be used to augment stability.

The Vertiwedge® Intraosseous System is intended to restore the integrity of the spinal column even in the absence of fusion in patients with advanced stage turnors involving the thoracolumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

Vertiwedge® Intraosseous System is an intraosseous device that is used as a motion-preservation partial vertebral replacement device in the thoracolumbar spine in the motion-sparing Vertebral Body Osteotomy (VBO®) procedure. The Vertiwedge® Intraosseous device is used within a single osteotomized vertebral body, and it does not span any disc levels nor involve resection of or interference with the discs. The Vertiwedge® Intraosseous device is implanted through an anterior to psoas/oblique approach following an osteotomy of the vertebral body, in a Vertebral Body Osteotomy (VBO®) procedure The Vertiwedge® Intraosseous System consists of the intraosseous wedge (or spacer) with a lateral plate and a unique staple that provides integrated contralateral fixation. The Vertiwedge® Intraosseous System is available in a variety of heights and geometric options to accommodate variations in pathology and patient anatomy. Protrusions on the superior and inferior surfaces grip the osteotomized vedges to aid in expulsion resistance. The Vertiwedge® Intraosseous System is to be filled with autogenous bone graft and/or allogeneic bone graft material, and is to be used with the titanium alloy bone screws and cover plate to provide fixation within the single impacted vertebral body. All implant components are manufactured from Ti-6Al-4V ELI per ASTM F3001 or ASTM F136.

The provided text is a 510(k) Premarket Notification from the FDA for a medical device called the "Vertiwedge® Intraosseous System." This document is primarily concerned with establishing substantial equivalence of a new medical device to existing predicate devices, rather than detailed performance data from a clinical or AI-based study.

Therefore, the information required to answer the prompt (acceptance criteria, study details, sample sizes, expert qualifications, etc., specifically related to AI device performance) is not present in the provided text. The "Performance Data" section solely lists mechanical and material testing standards (e.g., ASTM F2077, ASTM F1877, ASTM F2267) for the physical implant, which are relevant for demonstrating its structural integrity and safety as a physical medical device, not for an AI/software device.

To directly answer your request based on the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not explicitly stated in terms of an acceptance criterion table for an AI device. The document mentions "performance testing requirements" and that the subject device "met performance testing requirements," referring to mechanical and material tests. No specific numerical thresholds or performance metrics for an AI system are given.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. The "tests" mentioned are physical product tests, not data-driven studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable, as there is no data-driven study or ground truth establishment mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) 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.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.

8. The sample size for the training set: Not applicable, as there is no mention of a training set for an AI model.

9. How the ground truth for the training set was established: Not applicable.

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The Interwedge® Standalone Lateral is a standalone lateral lumbar interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L1-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

The Interwedge® Standalone Lateral is to be filled with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone, and is to be used with the two titanium alloy screws which accompany the implant. Should a physician choose to use fewer than these two screws, additional supplemental fixation must be used to augment stability.

The Interwedge® is a lateral standalone intervertebral body fusion device in the lumbosacral spine (L1-S1) intended to provide stability and promote fusion between adjacent vertebrae.

The Interwedge® consists of the intravertebral wedge (or spacer) with a lateral plate and a contralateral staple. The lateral plate, with two or four bones screw options, and the contralateral staple provide the integrated fixation to the construct. The Interwedge device is offered in a range of implant sizes and heights to cater to different patient anatomy. The spacer, lateral plate, and staple components will be additively manufactured from Ti-6A1-4 ELI per ASTM F3001. The sub-components of the staple mechanism and the integrated fixation screws will be machined from Ti-6Al-4V ELI per ASTM F136. A cover plate which is attached to the lateral plate after insertion of the bone screws is manufactured from Ti-6Al-4V ELI per ASTM F136.

This document does not contain an AI/ML device, therefore, the information requested in your prompt is not available in the provided text. The document refers to a medical device called "Interwedge® Standalone Lateral," which is a spinal intervertebral body fixation orthosis. The provided text is a 510(k) premarket notification for this device, outlining its indications for use, technological characteristics, and performance data, all of which are related to a physical implant and not a software algorithm or AI model.

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