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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."

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