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The FS Aligner System is intended for minor anterior tooth movement in patients with permanent dentition (second molars). The FS Aligner System positions teeth by way of continuous gentle force.

FS Aligner is an aligner system which offers a solution to those patients who want a simple, aesthetic system of removable aligners to correct minor anterior mal-alignments in patients with permanent dentition (second molars) without the use of conventional wire and bracket orthodontic technology. The system consists of a series of clear, lightweight, flexible, plastic aligners. Each aligner applies incremental progressive force to reposition teeth to a more ideal alignment as prescribed by the treating dental practitioner.

The provided text describes the 510(k) summary for the FS Aligner device, claiming substantial equivalence to predicate devices (Invisalign and Red, White & Blue). It does not contain acceptance criteria for device performance or a study demonstrating the device meets such criteria.

Instead, the submission relies on:

1. Biocompatibility studies: These were conducted to demonstrate the safety of the material used in the FS Aligner.
2. Substantial Equivalence: The primary argument is that the FS Aligner is technologically similar to and intended for the same use as legally marketed predicate devices.

Therefore, many of the requested details about acceptance criteria and a performance study are not available in the provided text.

Here is a breakdown of what can be extracted and what is explicitly stated as not conducted:

Request 1: A table of acceptance criteria and the reported device performance

Information Not Available: The document does not define specific acceptance criteria for performance (e.g., accuracy of tooth movement, percentage of cases successfully treated) for the FS Aligner, nor does it report performance metrics against such criteria. The device's "performance" is implicitly considered equivalent to the predicate devices based on its technological characteristics and intended use.

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

Information Not Available: No clinical or performance test set (as in, a group of patients or cases evaluated for the device's efficacy) was used for the FS Aligner. The document explicitly states: "Clinical testing has not been conducted on this product."

Request 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)

Information Not Available: Since no clinical or performance test set was used, there was no ground truth established by experts for performance evaluation of the FS Aligner.

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

Information Not Available: As no clinical or performance test set was used, no adjudication method was applicable.

Request 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

Information Not Available: The device is an orthodontic aligner, not an AI-assisted diagnostic or imaging tool. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is irrelevant and was not conducted.

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

Information Not Available: The FS Aligner is a physical medical device (aligner system), not a standalone algorithm. Therefore, "standalone algorithm performance" is not applicable in this context. While its manufacturing process involves a "computerized version of the set up providing information similar to a 'blueprint' for the technician," the device itself is not a software algorithm.

Request 7: The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Information Not Available: As no clinical or performance test set was used to evaluate device efficacy, no ground truth types for such a study are reported. The "ground truth" implicitly assumed for regulatory clearance is that the predicate devices are safe and effective, and the FS Aligner is substantially equivalent.

Request 8: The sample size for the training set

Information Not Available: The document does not describe the development of a predictive algorithm or AI model requiring a "training set." The manufacturing process for FS Aligner involves manual repositioning guided by a computerized blueprint, not machine learning model training.

Request 9: How the ground truth for the training set was established

Information Not Available: As no training set for an algorithm is described, how its ground truth was established is not applicable.

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Red, White & Blue is a series of three, clear, lightwelght, plastic retainers intended to be used to correct minor to internediate anterior tooth mal-alignments in patients with permanent dentition (second molars) by moving teeth progressively to a final, treated state.

Red, White & Blue is a relainer system which offers a solution to those patients who want a simple, aesthetic system to correct minor to intermediate tooth mal-alignments without the use of conventional wire and brucket orthodontic technology. The system consists of a scrics of three, clear lightweight, plastic retainers. Each appliance applics incremental tooth correction by means of repositioning the anterior teeth. In this way, the patient's tecth will get progressively closer to the desired final state.

The dental practitioner will make dental improssions of his patient's tecth and select the anterior tecth that are to be repositioned. The impressions or a model of the tecth made from the improssion is then sent to AOA along with a prescription form. The teeth selected for treatment are cut from the model and progressively repositioned. After each repositioning, AOA will create a corresponding appliance for a total of three active appliances. Depending upon the complexity of the case, it is possible that a patient may require less or more than the series of three appliances. The Red, White & Blue retainers are mailed to the dental practitioner, who in turn, will provide them to their patient with the instructions for use.

This 510(k) premarket notification is for a dental device, not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study design, and performance metrics for an AI/ML device, such as sample sizes for test and training sets, ground truth establishment, expert qualifications, and MRMC studies, is not applicable and not available in the provided document.

The document describes the "Red, White & Blue" orthodontic retainer system and claims substantial equivalence to the Invisalign system.

Here's the relevant information provided:

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

This information is not applicable and not provided in the document as this is not an AI/ML device. The document focuses on regulatory clearance based on substantial equivalence to a predicate device.

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

Not applicable for a physical medical device. The document does not describe a "test set" in the context of an AI/ML algorithm.

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 for a physical medical device.

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

Not applicable for a physical medical device.

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 for a physical medical device.

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

Not applicable for a physical medical device.

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

Not applicable for a physical medical device. The "ground truth" for this device would be its ability to correct minor to intermediate anterior tooth mal-alignments, which is assessed through clinical use and comparison to predicate devices, not specific "ground truth" data points for an algorithm.

8. The sample size for the training set:

Not applicable for a physical medical device.

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

Not applicable for a physical medical device.

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