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The Precision Align aligners are indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The Precision Aligners positions teeth by way of continuous gentle force.

The Precision Aligner is a series of clear, light weight thermoformed plastic aligners designed to be worn in sequence to facilitate the movement to the teeth to the final desired position. The sequential aligners introduce incremental movements that move teeth by way of gentle continuous force. The aligners are to be worn 20 to 22 hours a day and are to be removed for eating and for cleaning. Generally the typical wear time for each aligner is a two weeks duration prior to being replaced by the next aligner in sequence. A digital or traditional mold impression of the patient's dentition is provided by a dental health professional (e.g. orthodontist or dentist). From the digital data of the patient's dentition, a specialized orthodontic CAD/CAM software is used to develop treatment plan. Using the software, dental technicians design a series of intermediate models corresponding to each stage of treatment, gradually realigning the patient's teeth according to the dental health profession's prescription. The prescribing doctor reviews and approves the model scheme and treatment plan before the molds/models are produced. Once approved, the specialized orthodontic software is used to generate standard format 3D files which are used to physically produce each model/mold in the treatment plan for aligner fabrication. Precision Align Co. produces the aligner trays by thermal forming a plastic sheet over each model in the treatment plan. The trays are provided to the dental health care professional who provides them to the patients in sequential stages, confirming fit and design. The dental health professional monitors treatment from the moment of the first aligner is delivered to when the final aligner is finished and treatment is complete. The aligners are held in place by pressure and can be removed by the patient at any time.

The provided text describes the regulatory clearance of a medical device (Precision Align Aligners) and outlines non-clinical performance data. However, it explicitly states that no clinical performance data was deemed necessary to support the device's clearance. Therefore, a study proving the device meets acceptance criteria regarding clinical performance (like diagnostic accuracy, efficacy, or improvement over human readers) does not exist within this document.

The document focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing and comparison of technological characteristics.

Here’s the information based on the provided text, with an emphasis on the absence of clinical study data:

1. Table of Acceptance Criteria and Reported Device Performance

Since no clinical study was performed, the acceptance criteria are not for clinical performance but for manufacturing accuracy, biocompatibility, and material properties.

2. Sample Size for Test Set and Data Provenance

As no clinical study was conducted, there is no "test set" in the context of clinical performance or diagnostic accuracy.

For the internal manufacturing validation:

• Sample Size: Not explicitly stated, but "all the aligners included in the study" passed for initial fitness evaluation.
• Data Provenance: Internal validation conducted by Precision Align LLC.

For biocompatibility:

• Material testing was conducted by "the material manufacture."
• Finished device cytotoxicity testing was performed on "the final manufactured Precision Align Aligners."
• Sample Size: Not specified for these tests.
• Data Provenance: Not specified beyond being conducted by the material manufacturer or Precision Align LLC.

3. Number of Experts and Qualifications for Ground Truth for Test Set

Not applicable, as no clinical study or diagnostic accuracy study with a "test set" requiring expert ground truth was performed.

For the internal manufacturing validation:

• "Expert" for fitness evaluation: A "trained physician." No further details on qualifications or number of physicians.
• Ground Truth: The subjective assessment of "excellent fit" by the trained physician.

4. Adjudication Method for the Test Set

Not applicable, as no clinical study requiring adjudication was performed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was done, as the document explicitly states: "there was no clinical testing necessary to support this device." The device is an orthodontic aligner, not an AI-assisted diagnostic tool for which MRMC studies would typically be conducted.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. The device is a physical orthodontic aligner, not an algorithm, and no clinical performance study was conducted.

7. Type of Ground Truth Used

For the non-clinical tests:

• Dimensional Accuracy: Instrumental measurements compared against predefined tolerance (0.150mm).
• Aligner Fit: Subjective assessment of "excellent fit" by a trained physician.
• Biocompatibility: Results of specific biological tests (e.g., cytotoxicity, irritation, sensitization) evaluated against ISO 10993 standards.
• Material Properties: Measurements from standard ASTM tests.

8. Sample Size for the Training Set

Not applicable. This document does not describe the development or training of an AI algorithm, but rather the clearance of a physical medical device.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no AI algorithm training set is described.

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