(449 days)
The Infrared Red Blue LED Light Heat Beauty Machine is an hand-held over-the-counter phototherapy device, the red and infrared light is intended for the use in treating wrinkles on the face and the blue light is intended for the treatment of the mild to moderate inflammatory acne. This device is indicated for adults only.
The proposed device Infrared Red Blue LED Light Heat Beauty Machine, is a over-the-counter device hat uses low power light spectrum at red blue and infrared LED, at wavelength of 625±5nm, 465mm, 850±5nm emitting optical power in a uniform distribution. The device is composed of a handpiece for delivery of light energy, base unit for charging and storage when not in use, and A.C.charging adapter. It is a hand-held light emitting diode (LED) device for treatment of wrinkles on face and mild to moderate inflammatory acne designed for home use.
The provided text describes a 510(k) premarket notification for the "Infrared Red Blue LED Light Heat Beauty Machine." This document focuses on demonstrating substantial equivalence to predicate devices based on non-clinical testing and comparison of specifications, rather than detailing a specific clinical study with acceptance criteria and device performance evaluation in the typical sense of a diagnostic or AI-powered medical device.
Therefore, the requested information regarding acceptance criteria, performance from a clinical study, sample sizes for test and training sets, expert qualifications, ground truth establishment, and MRMC studies is largely not applicable or not provided in this document, as the submission relies on non-clinical tests and comparisons to existing devices for substantial equivalence.
Here's a breakdown of the information that can be extracted and an explanation of why other requested details are missing:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists compliance with specific international standards as the "acceptance criteria" for non-clinical aspects. The reported "device performance" in this context refers to its conformity with these standards and a comparison of its specifications to predicate devices. There are no specific performance metrics (e.g., sensitivity, specificity, accuracy) like one would find for a diagnostic device.
| Acceptance Criteria (Non-Clinical Standards Compliance) | Reported Device Performance (Conformity) |
|---|---|
| IEC 60601-1 (Basic Safety & Essential Performance) | Comply with IEC 60601-1, IEC 60601-1-11 |
| IEC 60601-1-2 (EMC) | Comply with IEC 60601-1-2 |
| IEC 60601-1-11 (Home Healthcare Environment) | Comply with IEC 60601-1, IEC 60601-1-11 |
| IEC 60601-2-57 (Non-laser light source equipment) | Not explicitly stated as "comply," but listed as a standard the device met. It's implied compliance. |
| IEC 62471 (Photobiological Safety) | Comply with IEC 62471 |
| ISO 14971 (Risk Management) | Not explicitly stated as "comply," but listed as a standard the device met. It's implied compliance. |
| ISO 10993-5 (In Vitro Cytotoxicity) | Comply with ISO 10993-1, ISO 10993-5 and ISO 10993-10 |
| ISO 10993-10 (Irritation & Skin Sensitization) | Comply with ISO 10993-1, ISO 10993-5 and ISO 10993-10 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable / Not Provided for clinical data. The document explicitly states: "Clinical data was not including in this submission."
- For the non-clinical tests (electrical safety, biocompatibility, photobiological safety, EMC), sample sizes and data provenance are not detailed, as these are typically conducted in a laboratory setting per standard requirements.
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 / Not Provided. There was no clinical test set requiring expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable / Not Provided. No clinical test set.
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:
- Not Applicable. This is not an AI-powered device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable / Not Provided for clinical data. For the non-clinical tests, ground truth is established by adherence to the specified international standards and measurement methodologies defined within those standards.
8. The sample size for the training set:
- Not Applicable. This device is not an AI/machine learning product and therefore does not have a "training set" in that context.
9. How the ground truth for the training set was established:
- Not Applicable. No training set.
§ 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.