(59 days)
Ulike Reglow Light Therapy Device is an over the counter device that is intended for use in the treatment of full face wrinkles and treatment of mild to moderate inflammatory acne.
Ulike Reglow Light Therapy Device adopts light emitting diodes (LED) in the 630mm ± 10nm,830nm ± 10nm,590mm±10nm and 465nm±10nm spectrum to irradiate on the face to realize its therapeutic effect. The Ulike Reglow Light Therapy Device adopts the form of a mask that contains LEDs on the inner surface of the main unit. A controller is connected to the main unit to control the device, such as turn on/off the device, switch mode. Power adapter is provided to charge the battery contained in the controller. To use the device, user should place the mask over the face and use the controller to operate. To prevent irradiation of LED lights to eyes during the treatment, Ulike Reglow Light Therapy Device has incorporated protective eye-shield which blocks light energy from LEDs.
The provided text describes the regulatory clearance for the "Ulike Reglow Light Therapy Device (UM10)" based on its substantial equivalence to predicate devices. It does not present any clinical study data or acceptance criteria related to the device's performance for its intended therapeutic effects (wrinkle reduction and acne treatment).
Instead, the document focuses on non-clinical performance data for safety and electrical characteristics required for FDA clearance. Therefore, I cannot generate the requested table or answer several of your questions (1, 5, 6, 7, 8, 9) because the information is not present in the provided text.
The text does mention the following:
- Acceptance Criteria for Non-Clinical Tests: The acceptance criteria for the non-clinical tests (biocompatibility, electrical safety, light safety, software, usability) are that the device "passed" the respective standards (e.g., ISO 10993, IEC 60601 series, IEC 62471). Specific numerical performance metrics for these tests are not provided.
- Study Proving Device Meets Acceptance Criteria: The study proving the device meets the acceptance criteria is the performance of the listed non-clinical tests.
Here's what can be extracted from the document regarding the non-clinical tests:
1. Table of Acceptance Criteria and Reported Device Performance (for Non-Clinical Tests)
| Test Category | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing Within a Risk Management Process, documented, as recognized by FDA. Includes: ISO 10993-10:2021 (Skin sensitization), ISO 10993-23:2021 (Irritation), ISO 10993-5:2009 (In Vitro Cytotoxicity). | "The following testing was performed to, and passed, including: ISO 10993-10:2021, ISO 10993-23:2021, ISO 10993-5:2009." ("passed" implies meeting the standards' requirements) |
| Electrical Safety | IEC 60601-1:2005+A1:2012+A2:2020 (General requirements for basic safety and essential performance); IEC 60601-1-2:2014+A1:2020 (Electromagnetic disturbances); IEC 60601-1-11:2015+A1:2020 (Home Healthcare Environment); IEC 60601-2-57:2011 (Non-laser source equipment); IEC 60601-2-83:2019 (Home light therapy equipment); IEC 62133-2:2017 (Secondary cells/batteries - Lithium systems). | "Electrical safety and EMC testing was performed to, and passed, as per the following standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-57, IEC 60601-2-83, IEC 62133-2." ("passed" implies meeting the standards' requirements) |
| Light Safety | IEC 62471:2006 (Photobiological safety of lamps and lamp systems). | "Light Safety: IEC 62471:2006. (Implied: Passed, based on overall conclusion of substantial equivalence)" |
| Software V&V | Basic Documentation Level standards, demonstrating all software requirement specifications are met and all software hazards mitigated to acceptable risk levels. | "System testing presented in this 510(k) demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels." |
| Usability | IEC 60601-1-6 (Usability) and FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices, issued on FEBRUARY 2016." | "The product usability has been evaluated and validated according to the following standard and FDA guidance: IEC 60601-1-6, Applying Human Factors and Usability Engineering to Medical Devices." (Implied: Passed/validated) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable. The document discusses non-clinical tests (electrical safety, biocompatibility, etc.) performed on the device itself, not on a human test set. There is no mention of a clinical test set.
- Data Provenance: Not applicable for clinical data. The tests are general product safety and performance tests against international standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. There is no mention of an expert panel or ground truth establishment for a clinical test set as no clinical study data is presented.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There is no clinical test set mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, this document does not describe an MRMC study. The device is a light therapy device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm-based device that would require standalone performance evaluation in the context of diagnostic AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. There is no clinical study data for therapeutic efficacy presented in this document. The ground truth for the non-clinical tests is compliance with published international industry standards.
8. The sample size for the training set
- Not applicable. This document is for a medical device (light therapy) which implies physical product testing, not a machine learning model that would require a training set.
9. How the ground truth for the training set was established
- Not applicable. (See #8)
§ 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.