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The Nobel Biocare Onplant Orthodontic System is an implant intended to be surgically placed subperiosteal in the palatal region of the mouth for use as an anchor for orthodontic procedures in patients who have completed skeletal growth and maturity.

The Nobel Biocare Onplant Orthodontic System is an implant with components made of titanium intended for subperiosteal placement in the palatal region of the mouth to provide an anchor for orthodontic procedures. The system includes Implants, Cylinders, Abutments, Orthodontic Wire, Hand Instruments, Cover Screws and accessories.

This looks like a 510(k) pre-market submission for a dental device, specifically an orthodontic implant system. It describes the device, its intended use, and identifies predicate devices. However, this document does not contain any information regarding acceptance criteria or a study proving device performance against such criteria.

The provided text is a summary of safety and effectiveness from a 510(k) submission, along with the FDA's clearance letter. The purpose of a 510(k) is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove effectiveness or meet specific performance criteria through new studies. Often, for devices like this, substantial equivalence is established through comparison of materials, design, and intended use to existing devices that have already demonstrated safety and effectiveness in the market.

Therefore, I cannot fulfill your request for the following sections because the information is not present in the provided text:

1. A table of acceptance criteria and the reported device performance: This document does not establish specific performance criteria or report performance data.
2. Sample size used for the test set and the data provenance: No clinical or performance studies are described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no test set or ground truth establishment is described.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable; no such study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is not an AI/algorithm device.
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.

Summary of what's provided:

• Device Name: Nobel Biocare Onplant Orthodontic System
• Intended Use: An implant intended to be surgically placed subperiostally in the palatal region of the mouth for use as an anchor for orthodontic procedures in patients who have completed skeletal growth and maturity.
• Predicate Products: Various Nobel Biocare components (Cylinders, Abutments, Cover Screws, Abutment Replica, Hand Instruments), Linkow Blade Implant (Steri-Oss), Orthodontic Wire (Dentaurum, Star Dental).
• Regulatory Status: Cleared by FDA as substantially equivalent to predicate devices (K980460).

To find the kind of information you are looking for (acceptance criteria and detailed study results), you would typically need to consult a different type of document, such as a pre-market approval (PMA) application for a Class III device (which this device is classified as, but cleared via 510(k) with substantial equivalence to older devices), or specific clinical study reports if they were conducted and made public. In a 510(k) for a device like this, the focus is on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often without requiring new clinical performance data if the technological characteristics are similar.

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