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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. For use in adults over the age of 12.

This device is designed for orthodontic use. The screws are made of alloy (ASTM F 136-98). The head of the screw is dual head type. The upper head is a hex type. There is a hole in the screw head through which a wire can be passed to fix the mandible and maxilla in orthodontic treatment. Also, Dual head design of screw mandible and mannia in the screw with the orthodontic appliances (bracket, wire, and elastic band etc.) The tip of the screw is designed available to self-drilling and self-tapping. (Surgeon's option) This device is comprised of screws ranging in diameter of 1.4mm to 2.0mm and in length ranging from 6.0mm to 12mm. These screws are provided non-sterile. Therefore, this device must be sterilized prior to use. Steam sterilization is recommended. Therefore, and device mast Polyethylene package. The top of packaging bag is sealed with sealing strip.

This looks like information from a 510(k) premarket notification for a medical device, specifically the "Dual Top Anchor System Screws". These documents are generally used to demonstrate substantial equivalence to a legally marketed predicate device rather than conducting extensive new clinical studies with defined acceptance criteria in the same way one might for a novel device requiring a PMA.

Therefore, the typical "study that proves the device meets the acceptance criteria" in the context of a 510(k) usually involves comparing the new device's characteristics (material, design, intended use) to those of the predicate device and showing they are substantially equivalent, rather than conducting a full-blown clinical trial with performance metrics.

Based on the provided text, here's a breakdown of the requested information, noting that much of it is not directly applicable or explicitly stated as would be in a clinical study report:

1. Table of acceptance criteria and the reported device performance

In a 510(k) submission, "acceptance criteria" for performance are not typically presented as quantitative metrics with corresponding "reported device performance" values in the same way a clinical trial might. Instead, the acceptance criterion is substantial equivalence to a predicate device. The "performance" is the demonstration that all key attributes (material, intended use, design, potential adverse effects) are either identical or do not raise new questions of safety and effectiveness compared to the predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This 510(k) submission does not describe a "test set" in the context of a clinical study with patients. The "test set" here would refer to the technical and performance characteristics of the "Dual Top Anchor System Screws" being compared to the predicate devices. The data provenance would be internal company data (Jeil Medical Corporation, Korea) on their device's specifications and comparison to publicly available information on the predicate devices. No human subject data (prospective or retrospective) is mentioned for demonstrating equivalence in this document.

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. The "ground truth" for a 510(k) is typically the established safety and effectiveness of the legally marketed predicate devices. No expert panel is described for evaluating a specific "test set" of performance data for the new device. The evaluation is done by the FDA, based on manufacturers' submitted data and comparisons.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no mention of a human-adjudicated "test set" for performance evaluation in this 510(k) summary.

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 pertains to a mechanical medical device (bone screws) and does not involve AI or human readers for diagnostic interpretation.

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

Not applicable. This is not an algorithmic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" implicitly used in a 510(k) is the established safety and effectiveness of the predicate devices as determined by their prior clearance by regulatory bodies (like the FDA). The current device demonstrates equivalence to this established "ground truth" by showing similar characteristics and lack of new safety/effectiveness concerns.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an artificial intelligence or machine learning device.

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

Not applicable. There is no "training set" for this device.

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