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The ATS-1 OTC is generally indicated to treat dermatological conditions and specifically indicated to treat mild to moderate inflammatory acne vulgaris. It is intended for over-the-counter use.

The ATS-1 OTC is a handheld, electrically powered device that uses LEDs (light emitting diodes) to produce therapeutic blue light.

The provided text does not contain detailed information about specific acceptance criteria or a dedicated study proving the device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to previously cleared predicate devices.

The key points from the document regarding performance are:

• Claim of Substantial Equivalence: TRIA Beauty claims that the ATS-1 OTC's performance data is substantially equivalent to predicate devices, especially their previously cleared ATS-1 (K060567).
• Performance and Consumer Usability Data: The submission states that "Performance and consumer usability data is submitted with this 510(k) notification." However, the details of this data, including specific metrics, sample sizes, or study methodologies, are not present in the provided excerpt.
• No New Questions of Safety or Efficacy: The document states that "performance and consumer usability data demonstrates that any technological differences or changes in labeling do not raise new questions of safety or efficacy or alter the device's intended therapeutic effect in comparison to the predicates." This implies that the current device performs comparably to the predicates and does not introduce new risks or reduce effectiveness.

Given the information, a table of acceptance criteria and reported performance cannot be generated as those details are not explicitly provided. Similarly, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone studies, and ground truth methodologies for any explicit performance study are not detailed.

The document primarily relies on the concept of substantial equivalence to predicate devices. This means that instead of conducting a new study to meet specific, quantifiable acceptance criteria, the manufacturer aims to show that their new device is as safe and effective as a device already on the market.

Based on the provided text, the specific information requested in your prompt cannot be fully provided because the document focuses on demonstrating substantial equivalence rather than detailing a specific de novo performance study with explicit acceptance criteria.

The lack of this information is typical for devices seeking 510(k) clearance based on substantial equivalence, especially when the device is an iteration of an already cleared product from the same manufacturer. The FDA's 510(k) process often relies on comparative data and pre-existing knowledge about the safety and effectiveness of predicate devices, rather than requiring extensive new clinical trials with predefined performance metrics for every submission.

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