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The ARTISAN™ Space Maintenance System is indicated for use as temporary implants to stabilize and support autograft, autograft extenders, allograft, and bone void fillers and/or fractured bone segments with or without bone plates or titanium mesh in bony defects of oral maxillofacial anatomy.

The ARTISAN™ Space Maintenance System is intended for temporary use in oral maxillofacial surgical reconstruction and dental regeneration procedures for maintaining space during bone grafting procedures and to support soft tissue until bone formation.

The ARTISAN™ Space Maintenance System is a comprehensive, allinclusive system which contains a variety of implants designed to temporarily reconstruct bony deficiencies common to the oral cavity that are not intrinsic to the stability of the bony structure. Bony deficiencies may be naturally occurring osseous defects, surgically created osseous defects, or osseous defects created from traumatic injury to the bone.

The ARTISAN™ Space Maintenance System includes a selection of Socket Preservation screws which are designed to aid in extraction socket grafting while simultaneously supporting the original gingival margins and papilla. The system contains a porous titanium mesh (with only one size of 76mm x 44mm x 0.2mm), titanium allov mesh fixation screws (with sizes of 1.2mm or major diameters x 4mm or 6mm or 10mm or 10mm or 12mm or 14mm lengths, and with sizes of 1.4mm maior diameters x 3mm or 5mm or 7mm lengths), titanium allov tenting screws (with sizes of 1.2mm or 1.4mm major diameters x 8mm or 10mm or 12mm or 14mm lengths x 5mm head diameter), and titanium allov socket preservation screws (with sizes of 1.2mm or 1.4mm major diameters x 14mm or 18mm or 20mm lengths x 3/4mm or 4/5mm or 5/6mm head diameters). When used as indicated, this system provides a semi-protected space to stabilize, support, and protect bone graft (autograff, autograft extenders, allograft, and bone void fillers) by minimizing soft-tissue collapse into the graft recipient site.

The provided document is a 510(k) summary for the ARTISAN™ Space Maintenance System, primarily focused on obtaining appropriate MRI labeling. It details the device, its predicate devices, and the non-clinical tests performed to demonstrate substantial equivalence and MRI safety. However, this document does not describe a clinical study that proves the device meets acceptance criteria in the context of human performance or comparative effectiveness with AI.

Instead, the "acceptance criteria" here refer to proving substantial equivalence to legally marketed predicate devices, a requirement for 510(k) clearance by the FDA. The "study" that proves the device meets these criteria is a series of non-clinical (bench) tests and analyses, not a human-in-the-loop clinical trial.

Therefore, many of the requested sections about human studies, sample sizes, ground truth establishment, expert qualifications, and MRMC studies are not applicable based on the provided text.

Here's a breakdown of the available information:

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

2. Sample size used for the test set and the data provenance

This document describes non-clinical (bench) testing, not human subject testing. Therefore, "sample size" refers to the number of device units tested. The document does not specify the exact number of units tested for each non-clinical test. Data provenance is internal laboratory testing by Medtronic Sofamor Danek.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This was a non-clinical bench study. "Ground truth" was established based on engineering standards (ASTM) and the physical properties and performance of the devices themselves, measured with scientific instruments.

4. Adjudication method for the test set

Not applicable. This was a non-clinical bench study.

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 document describes a 510(k) submission for substantial equivalence and MRI labeling, based on non-clinical testing. It does not involve AI or human readers evaluating medical cases.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical medical implant, not an algorithm or software. The "standalone" performance here refers to the device's physical and MRI characteristics, which were assessed independently in bench tests.

7. The type of ground truth used

For the substantial equivalence tests (mechanical properties), the "ground truth" was derived from the performance of the predicate devices and established engineering standards (e.g., ASTM F543-02). For MRI safety tests, the "ground truth" was based on specified MRI safety criteria and standards (e.g., ASTM F2052-06, F2213-06, F2182-11, F2119-07).

8. The sample size for the training set

Not applicable. There is no concept of a "training set" in this non-clinical bench testing context for a physical medical device.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of non-clinical device testing.

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