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The Oxylight 2.0 is intended for dermatological use by physicians and healthcare professionals for the following: LED Technology is intended for:

-Blue LED 465nm - to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.

-Red LED 625nm- for treatment of superficial, benign vascular and pigmented lesions.

• Yellow LED 590nm - treatment of periorbital wrinkles and rhytides.

Microdermabrasion is intended for exfoliation of the skin.

Oxygen spray is intended to refresh the skin.

The subject device Oxylight 2.0 is a skin therapy system that was modified from the predicate device OxyLight cleared previously under K200104 for the LED Light Panel Therapy (Class 2), Microdermabrasion (Class 1, 510k exempt) and Oxygen Spray (General Wellness). The OxyLight 2.0 system includes two new LED handpieces called MyoLight. The MyoLight handpieces connect to the main unit. The small handpiece (diameter: 3.9 cm, Length: 14 cm) is generally used on the face and the large handpiece (diameter: 6.2 cm, Length: 15 cm) is generally used on the body.

This document is a 510(k) premarket notification for a medical device called OxyLight 2.0. It is primarily focused on demonstrating substantial equivalence to a previously cleared predicate device (OxyLight, K200104) and thus does not contain the typical structure of a study proving a device meets specific clinical acceptance criteria for an AI/algorithm-based device.

The "acceptance criteria" and "device performance" in this context refer to the technical specifications and safety standards that the OxyLight 2.0 must meet to be considered substantially equivalent to its predicate. There is no AI or algorithm involved, and therefore, no performance metrics like accuracy, sensitivity, or specificity relative to a diagnostic task are presented.

Instead, the "study" proving the device meets acceptance criteria primarily involves non-clinical bench testing, electrical safety, electromagnetic compatibility, and biocompatibility.

Here's an analysis based on the provided document, addressing your points where applicable, and noting where the information is not relevant to this type of device submission:

1. A table of Acceptance Criteria and the Reported Device Performance

For this device (OxyLight 2.0), the "acceptance criteria" are not clinical performance metrics for an AI, but rather technical specifications and safety standards aligned with the predicate device. The "reported device performance" is the confirmation that the new device meets these technical specifications and passes the required non-clinical tests.

Note: This table reflects the comparison presented in the 510(k) summary, which is a key part of demonstrating substantial equivalence for physical devices.

Regarding AI/Algorithm-Specific Questions (Not applicable to this 510(k) submission):

This 510(k) submission is for a physical medical device (LED phototherapy and microdermabrasion system), not an AI/algorithm-based diagnostic or assistive software. Therefore, the following points are not applicable to this document:

2. Sample sizes used for the test set and data provenance: No test set of patient data (e.g., images for classification) was used for performance evaluation of an algorithm. The testing was physical device validation.
3. Number of experts used to establish the ground truth for the test set and their qualifications: No ground truth established by experts for an algorithm's performance, as there is no algorithm.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. There is no human-in-the-loop AI assistance being evaluated.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. "Ground truth" in the AI sense is not relevant here.
8. The sample size for the training set: Not applicable, as there is no AI algorithm being developed or trained.
9. How the ground truth for the training set was established: Not applicable, as there is no AI algorithm being developed or trained.

Summary of the Study Proving Device Meets Criteria (Based on the document):

The "study" conducted for the OxyLight 2.0 to prove it meets acceptance criteria (i.e., is substantially equivalent and safe/effective for its intended use) is documented under "8. Non-Clinical Testing".

• Type of Study: Non-clinical validation and verification.
• Tests Conducted:
  • IEC 60601-1:2005/A1:2012: General Requirements for Basic Safety and Essential Performance (electrical safety).
  • IEC 60601-1-2:2014/EN 60601-1-2:2015: Electromagnetic Compatibility (EMC).
  • Biocompatibility Tests per ISO 10993 and FDA Guidance: To ensure materials in contact with skin are safe.
  • Software Validation & Verification Test: For the device's operational software.
  • Bench Testing: To verify the performance of the device's components and outputs (e.g., light wavelengths, energy/power outputs, and the function of the new handpieces).
• Assertions from the document: The applicant states these tests were "conducted to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device."
• Data Provenance (Implicit): The tests were performed in a controlled laboratory setting, adhering to international standards. The data is prospective as it was generated specifically for this submission. The origin is likely the manufacturer or accredited testing labs.
• Clinical Testing: The document explicitly states, "No clinical study is included in this submission." This indicates that substantial equivalence was demonstrated without new clinical trials, relying on the established safety and efficacy of the predicate device and the non-clinical testing of the modifications.

In conclusion, for this specific 510(k) submission, the "acceptance criteria" are the established technical and safety specifications for similar devices, primarily the predicate. The "study" involves comprehensive non-clinical engineering and safety testing to demonstrate that the new device adheres to these specifications and introduces no new safety or efficacy concerns that would preclude a substantial equivalence determination.

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