(24 days)
The Bright device is intended to be used for the treatment of wrinkles, rhytides and fine lines in the periorbital region.
The Bright is an over-the-counter device that uses light emitting diodes to emit red light (660 nm) during treatment. The device includes a control unit, a treatment surface and a protective cap that fits over the treatment surface area of the device when not in use. The device controls consist of a single on/off activation button. The rechargeable battery included in the device can be charged using a USB cable that is supplied.
The provided document is a 510(k) summary for the Bright device, a light-emitting diode (LED) therapy device intended for the treatment of wrinkles, rhytides, and fine lines in the periorbital region. The purpose of this 510(k) notice is to demonstrate substantial equivalence to a previously cleared device, the Tanda Max OTC (K110735), after modifications to create a smaller version.
Based on the provided text, the device is not an AI product, but rather a physical medical device (LED therapy device). Therefore, the specific questions related to AI device performance, sample sizes for test sets and training sets, expert adjudication, MRMC studies, standalone algorithm performance, and ground truth establishment for AI models are not directly applicable or discussed in this document.
The document focuses on demonstrating that the modified Bright device maintains the same safety and effectiveness as its predicate device despite physical changes.
Here's a breakdown of the requested information based on the provided text, with an emphasis that this is for a physical device, not an AI model:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Methods/Standards) | Reported Device Performance |
|---|---|
| IEC 60601-1:2005 (General Safety) | Functioned as intended |
| IEC 60601-1-2 Ed 4.0 2014-02 (EMC) | Functioned as intended |
| IEC 62304 Ed 1.0 (Software Life Cycle) | Functioned as intended |
| ISO 10993-1 (Biocompatibility) | Functioned as intended |
| IEC 62471 (Photobiological Safety) | Functioned as intended |
| ISO 14971 (Risk Management) | Functioned as intended |
| Output Power (mW/cm²) | Identical to predicate |
| Treatment Cycle Time | Identical to predicate |
| Treatment Regimen | Identical to predicate |
| Skin Contact Sensor | Preserved |
| Temperature Sensor | Preserved |
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable or provided for a physical device's performance testing in this context. The document describes engineering and safety standard compliance testing for hardware and software, not a clinical trial with a "test set" of patients in the way an AI model would be evaluated. The testing is focused on the device's physical and electrical characteristics and adherence to recognized standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable or provided. The "ground truth" for a physical device's safety and performance is established by its compliance with recognized engineering, safety, and biological standards, as well as its functional specifications. It does not involve expert consensus on medical images or diagnoses in the way an AI medical device would.
4. Adjudication Method for the Test Set
This information is not applicable or provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation (e.g., radiology reads) where there can be disagreement among experts. This document describes compliance testing against established standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not pertinent to this physical LED therapy device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone algorithm performance study was not done. This device is a physical LED therapy device, not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's safety and performance is based on compliance with established international and national engineering, safety, and biocompatibility standards (e.g., IEC 60601-1, ISO 10993-1). Additionally, its functional characteristics (e.g., output power, treatment cycle, sensor operation) were compared to the cleared predicate device.
8. The Sample Size for the Training Set
This information is not applicable or provided. "Training set" refers to data used to train an AI model. This document describes the manufacturing and testing of a physical medical device.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable or provided as it relates to AI model training data, not a physical device.
§ 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.