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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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The Oxylight 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 Oxylight system is a skin therapy system that uses three major modalities delivered by different attachments powered from a single energy source and operated from a universal control unit. The treatments include, LED Light Panel Therapy (Class 2), Microdermabrasion (Class 1, 510k exempt) and Oxygen Spray. The Oxygen Spray is delivered through the same panel used for LED light therapy and separate handpieces.

The provided document is a 510(k) Pre-market Notification, which focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than providing extensive clinical study data to prove novel efficacy or meet specific acceptance criteria for a new clinical claim. Therefore, much of the requested information regarding acceptance criteria, specific device performance against those criteria, and detailed clinical study methodologies is not available in this document.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present a table of specific clinical acceptance criteria or human-centered performance metrics. Instead, it compares the technical characteristics of the Oxylight device (the "subject device") with predicate devices to argue for substantial equivalence in safety and efficacy.

The relevant "performance data" section focuses on safety testing against recognized electrical and electromagnetic compatibility standards.

2. Sample Size Used for the Test Set and the Data Provenance

The document explicitly states: "Clinical testing was not performed with this device."

Therefore, there is no test set in the sense of a patient cohort, nor data provenance from such a set. The "test article" for safety testing was the device itself (OxyLight / Sapphire 3 OxyLight).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Since no clinical testing was performed, no ground truth was established by experts for a test set in a clinical context.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set was used.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done, as indicated by the statement "Clinical testing was not performed with this device."
The document does not mention any human reader performance or AI assistance.

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

Not applicable. The Oxylight is a physical device (LED panel, microdermabrasion, oxygen spray) for dermatological use, not an algorithm or AI system.

7. The Type of Ground Truth Used

For the purpose of substantial equivalence, the "ground truth" implicitly relies on the established safety and efficacy of the predicate devices with similar technical characteristics and indications for use. For the safety tests conducted, the ground truth was compliance with the specified international safety and EMC standards.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/algorithm-based device requiring a training set.

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

Not applicable, as no training set was used.

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