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This device is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only.

Anchor plus / Neo Anchor plus is a dental titanium alloy for the fabrication of Porcelain-Fused-to-Metal Dental Crowns, Bridges, and implant-supported prosthesis substructures, which is composed of 98% of titanium bearing titanium color.

I am sorry, but there is no information about acceptance criteria or a study proving device performance in the provided text. The document is a 510(k) summary for a dental device (Anchor plus / Neo Anchor plus Orthodontic Screw) seeking substantial equivalence to predicate devices. It focuses on comparing the new device to existing ones rather than presenting detailed performance studies or acceptance criteria.

The key points of the provided text are:

• Device: Anchor plus / Neo Anchor plus (Orthodontic Screw)
• Purpose: To provide absolute orthodontic anchorage to establish a good and stable occlusion for patients and improve facial esthetics. It is temporarily placed and removed after treatment.
• Predicate Devices:
  • Nobel Biocare USA. Inc. Nobel Biocare's InPlant™ Orthodontic Anchor System (K000643)
  • Jeil Medical Corporation Dual Top Anchor Systems Screws (K033767)
• Comparison: The applicant states the intended use, principle of usage, and operating features are identical to the predicate devices, with no significant differences raising new safety or effectiveness questions.
• Safety and Performance: The summary states the device "has been subjected to extensive safety, performance, and product validations prior to release" and "Safety tests have been performed to ensure the devices comply with applicable industry and US regulations," along with a review of literature for biocompatibility. However, no specific acceptance criteria or study results are presented.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size, data provenance for the test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study.
6. Standalone performance study.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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