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The ORTHO MI SYSTEM is indicated for use as 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. It is intended for single use only.

The ORTHO MI SYSTEM is indicated for use as 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. It is intended for single use only.

The screw diameters and lengths vary as shown below. It is made of a machined piece of Ti-6Al-4V ELI titanium alloy (ASTM F 136-13).

These size combinations are the same across all model types (Double Head, Wing, Slot) with exception case.

The provided document is an FDA 510(k) Premarket Notification for the "ORTHO MI SYSTEM," an endosseous dental implant (orthodontic anchor screw). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through extensive studies like those required for PMA (Premarket Approval).

Therefore, the document explicitly states: "No clinical data were necessary for the demonstration of substantial equivalence." This means there was no study performed to prove the device meets acceptance criteria in the way a clinical study for an AI/CADe device would.

Instead, acceptance criteria are met through bench testing demonstrating compliance with relevant performance and safety standards, and ensuring the device's technical characteristics and indications for use are substantially equivalent to marketed predicate devices.

Here's a breakdown of the missing and implied information based on the provided text:

Acceptance Criteria and Device Performance

Since no clinical study was conducted, there are no "acceptance criteria" in the sense of clinical performance metrics (like sensitivity, specificity, or reader improvement). The acceptance criteria are tied to bench test performance against established standards and the demonstration of substantial equivalence to predicate devices.

Study Information (as requested, but largely N/A for this 510(k) submission)

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not applicable. No clinical test set was used. The "test set" for this submission would refer to the physical devices subjected to bench testing according to the specified standards. The number of devices tested is not detailed, but it would have been sufficient to meet the requirements of the standards cited.
   • Data Provenance: Not applicable. No biological or clinical data was collected from patients or subjects. The data derived from physical testing of the device hardware.

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

   • Number of Experts/Qualifications: Not applicable. There was no ground truth determination by experts in a clinical context. Bench testing relies on objective measurements against engineering and materials standards.

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

   • Adjudication Method: Not applicable. No human interpretation requiring adjudication was involved.

4. 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:

   • MRMC Study: No. This device is an orthodontic anchor screw, a physical implant, not an AI/CADe system. Therefore, no MRMC study was performed.

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

   • Standalone Performance: Not applicable. This is a physical medical device, not an algorithm.

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

   • Type of Ground Truth: Not applicable in a clinical sense. The "ground truth" for this device's performance is adherence to established engineering, materials, sterilization, and biocompatibility standards, and demonstrating physical properties consistent with predicates.

7. The sample size for the training set:

   • Training Set Sample Size: Not applicable. This is a physical medical device, not a machine learning algorithm requiring a training set.

8. How the ground truth for the training set was established:

   • Ground Truth for Training Set: Not applicable.

In summary, the provided document details a 510(k) submission for a physical medical device (orthodontic anchor screw). These submissions do not typically involve clinical trials or studies like those conducted for AI/CADe devices, and therefore, most of the questions regarding clinical performance metrics, expert adjudication, or AI model training are not applicable. The "proof" of meeting acceptance criteria lies in comprehensive non-clinical (bench) testing demonstrating compliance with relevant consensus standards and establishing substantial equivalence to previously cleared predicate devices.

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