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The OrthoPulse™ device is intended for use during orthodontic treatment. It is used in conjunction with brackets and wires or aligners and helps facilitate minor anterior tooth movement.

The OrthoPulse'''' device is an intra-oral appliance similar to a plastic sports mouth guard that is intended for use during orthodontic treatment in conjunction with traditional orthodontic treatment with brackets and wires or aligners.

The device achieves its effect by delivering light energy to the bone, accelerating the rate of tooth movement. Light-emitting diodes ("LEDs") are embedded into the mouth-guard on a flexible circuit. Light is directed toward the alveolar surface to facilitate light treatment of the anterior arch segment during orthodontic tooth movement. The intra-oral appliance is designed to treat one arch (upper or lower), and is reversible by the patient to treat the other arch.

OrthoPulse is considered a low level light treatment device and produces light at levels 50-80 mW/cm for the patient. The device is designed to comply with the lamp safety standard (IEC 62471: 2006) and with the general medical device standard IEC 60601-1 3rd Ed.

OrthoPulse includes light with wavelengths in the 850nm range (near infrared) and the treatment protocol is based on a daily treatment session of 5 minutes per arch (maxilla or mandible). The treatment time (session duration) is controlled by the software, along with the number of treatments per day.

OrthoPulse includes an integrated battery for power. The battery is rechargeable via a wireless charging platform / storage case. The device provides a wireless connection to an optional iOS application to enable monitoring of patient compliance with the treatment regimen. No other cable or connection to external devices is required.

The provided text describes the OrthoPulse™ device, which is intended to accelerate tooth movement during orthodontic treatment. While primarily focused on demonstrating substantial equivalence to a predicate device, it also details performance data and mentions "primary effectiveness objectives" achieved through clinical studies. However, explicit acceptance criteria with predefined thresholds are not clearly stated in the document.

Let's extract the available information and structure it to answer your questions.

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

As mentioned, explicit acceptance criteria with numerical thresholds are not provided. However, the primary effectiveness objective of both clinical studies was "statistically significantly faster tooth movement."

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

• Aligner Study (Crossover Study):
  • Sample Size: 21 subjects
  • Data Provenance: Not explicitly stated (country of origin), but it was a prospective crossover study where subjects served as their own control.
• Brackets and Wires Study (Controlled Study):
  • Sample Size: 33 subjects (OrthoPulse group)
  • Data Provenance: Not explicitly stated (country of origin), but it was a controlled study with retrospectively selected matched controls.

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)

This information is not provided in the document. The studies measured "perimetry measurement analysis" and "change in Little's Irregularity Index measurements" as well as "root resorption" from "panoramic dental X-rays." While these measurements require expertise, the document does not specify the number or qualifications of experts involved in these assessments.

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

This information is not provided in the document.

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

This was not an MRMC comparative effectiveness study involving human readers and AI assistance. The study evaluates the effectiveness of the OrthoPulse™ device itself in accelerating tooth movement, not the performance of human readers with or without AI.

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

The OrthoPulse™ device is a physical intra-oral appliance that uses light energy to accelerate tooth movement. It is not an algorithm or AI product in the sense of a software-only diagnostic tool. Therefore, a standalone algorithm performance study is not applicable. The performance reported is that of the physical device used by patients.

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

The "ground truth" (or outcome measures) for the effectiveness of the device seems to be based on:

• Quantitative measurements of tooth movement:
  • Perimeter measurement analysis (aligner study)
  • Change in Little's Irregularity Index measurements (brackets and wires study)
• Radiographic assessment:
  • Evaluation of external apical root resorption from panoramic dental X-rays.
• Clinical observations:
  • Reporting of serious adverse events, gingival recession, and pathological tooth mobility.

These are objective clinical measurements and observations, likely performed by dental professionals.

8. The sample size for the training set

This information is not applicable or not provided. The OrthoPulse™ is a physical device, not an AI model that requires a training set in the conventional sense. The "performance data" section refers to clinical studies to demonstrate device effectiveness, not to train an algorithm.

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

This information is not applicable or not provided as it is not an AI model requiring a training set.

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