(89 days)
Face Patches (Model: MT-12MA) is an Over-the-Counter (OTC) device intended for treatment of mild to moderate inflammatory acne.
Face Patches (Model: MT-12MC) is an Over-the-Counter (OTC) device intended for treatment of mild to moderate inflammatory acne and full-face wrinkles (including periorbital wrinkles).
The Face Patches, Model: MT-12MA and MT-12MC is an over-the-counter light emitting diode (LED) device.
Model: MT-12MA can emits 415nm and 630nm energy to treat mild to moderate acne. There is a total of 6 LEDs, providing a power intensity of approximately 30 mW/cm².
Model: MT-12MC has 3 modes (mode 1: 630+415nm, mode 2: 630+830nm, mode 3: 590nm), it can emit 630nm and 415 nm energy to treat mild to moderate acne and provide approximately 30 mW/cm²; 630nm and 830nm energy to treat full-face wrinkles and provide approximately 35 mW/cm²; and 590nm energy to treat wrinkles and provide approximately 35 mW/cm². There is a total of 18 LEDs.
The device components include the device containing two face patches, a controller, a charging cable, 120 Mini Dots, goggles and user manual. The user pastes the device on the treatment area, and the device will shut down automatically after a 3-minute after finishing treatment. Users should adjust the treatment time based on different modes and actual treatment situations. The device has one button, and delivery of therapy requires the operator to depress a physical switch on the device.
This FDA 510(k) summary for the Face Patches (MT-12MA, MT-12MC) indicates that no clinical studies were performed, and therefore, no acceptance criteria based on clinical performance are reported.
The submission relies on non-clinical testing to demonstrate substantial equivalence to predicate devices, asserting that these tests are "sufficient to support that the device can be used safely and effectively."
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Since no clinical studies were performed, there are no acceptance criteria related to a device's clinical performance (e.g., sensitivity, specificity, accuracy). The acceptance criteria mentioned are related to compliance with recognized standards for electrical safety, electromagnetic compatibility, biocompatibility, and software validation. The reported "performance" in this context is simply compliance with these standards.
| Test Category | Acceptance Criteria (Compliance with Standards) | Reported Device Performance |
|---|---|---|
| Electrical Safety | IEC 60601-1 ed. 3.2 | Complied |
| IEC 60601-1-11 ed. 2.1 | Complied | |
| IEC 60601-2-57 ed. 1.0 | Complied | |
| EMC | IEC 60601-1-2 ed. 4.1 | Complied |
| Photobiological Safety | IEC 62471 ed. 1.0 | Complied |
| Battery Safety | IEC 62133-2 ed. 1.0 | Complied |
| Biocompatibility | ISO 10993-5 (Cytotoxicity) | Complied |
| ISO 10993-10 (Sensitization) | Complied | |
| ISO 10993-23 (Skin Irritation) | Complied | |
| ISO 10993-11 (Acute Systemic Toxicity) | Complied | |
| USP 151 (Material-mediated Pyrogens) | Complied | |
| Software Verification & Validation | FDA Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Moderate Level of Concern) | Testing conducted and documentation provided as recommended. |
| Usability Validation | IEC 62366-1 and IEC 60601-1-6 | Complied |
| Light Output | Output matches stated specifications | Validated |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. No clinical test set was used. The testing involved non-clinical validation against standards and device specifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. No ground truth for a clinical test set was established as no clinical studies were conducted. The "ground truth" for the non-clinical tests is represented by the established specifications and requirements of the recognized standards.
4. Adjudication Method for the Test Set
Not applicable. No clinical adjudication method was needed since no clinical studies were performed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. No MRMC comparative effectiveness study was done as no clinical efficacy or effectiveness studies were performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This device is a light-emitting device, not an algorithm, so the concept of standalone algorithmic performance is not relevant in the context of typical AI/software device studies.
7. The Type of Ground Truth Used
For the non-clinical tests, the "ground truth" is primarily defined by:
- Recognized international and national standards (e.g., IEC 60601 series, ISO 10993 series, IEC 62471, IEC 62133-2).
- The device's own design specifications (e.g., for light output, power, irradiance, wavelengths, doses, etc.).
- FDA guidance documents (for software validation).
8. The Sample Size for the Training Set
Not applicable. No training set was used as this device is a hardware light-emitting device, not an AI/ML algorithm that requires training data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set was used.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.