(93 days)
The Nutra Light Red is a non-invasive LED light device is intended/indicated for over- the -counter use for the treatment of periorbital wrinkles, and rhytides
The NutraLuxe Red, Model NL-2212 is a device that utilizes Light Emitting Diodes to provide LED light to the body. The NutraLuxe Red is a visible light source of high spectral purity. They provide uniform or "hot-spot" free illumination. The output is pre-tuned to one wavelength with a narrow spectral bandwidth. The output wavelength of Red is 650 +/- 5 at 80 mW. The NutraLuxe Red unit contains the power supply, internal NI-MH rechargeable battery and the control unit. The enclosure and LED lens are made of medical grade biocompatibility plastics via injection molding. It has the capabilities to deliver the light to the skin as the unit is moved over the STOP button directly on the unit allows the user to immediately remove all power to the unit. The Nutra Light Red does not use any software.
Here's an analysis of the provided text, focusing on acceptance criteria and study details for the Nutra Light Red device:
Important Note: The provided text does not describe acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for an AI/algorithm-based medical device. Instead, it details an OTC Usability Study and compliance with electrical, EMC, photobiological safety standards, and biocompatibility for a light-emitting diode (LED) device. This is a crucial distinction. The questions in your prompt are more aligned with the evaluation of algorithmic diagnostics, which this device is not.
However, I will extract the information as best as possible to align with your request, interpreting "acceptance criteria" here as the goals of the usability study and "reported device performance" as the outcome of that study.
Acceptance Criteria and Study Details for Nutra Light Red (Based on provided text)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Study Goals) | Reported Device Performance (Study Outcome) |
|---|---|
| To attract participants that represented the "intended users" of the device | Met |
| To determine if consumers could correctly self-select using the packaging labeling only | Met |
| To test consumer knowledge of the packaging labeling and user manual | Met |
| To accurately assemble, operate, and care for the device correctly | Met |
| Compliance with Electrical Safety (IEC 60601-1:2012) | Complies |
| Compliance with EMC (IEC 60601-1-2) | Complies |
| Compliance with Photobiological Safety (IEC 62471) | Complies |
| Compliance with Basic Safety and Performance of Non-Laser Light (IEC 60601-2-57) | Complies |
| Biocompatibility (ISO 10993) | Demonstrated compliance |
2. Sample Size and Data Provenance for the Test Set
- Sample Size: 80 participants
- Data Provenance: Not explicitly stated, but the study was an "OTC Usability Study," implying it was conducted with representative consumers. No country of origin is specified. It is a prospective study as it involved participants performing tasks with the device.
3. Number of Experts and Qualifications for Ground Truth
- Not applicable for this device and study. This device is an LED light therapy device, and the study was a usability study, not a diagnostic accuracy study requiring expert-established ground truth for a test set. The "ground truth" here was the successful completion of tasks by consumers.
4. Adjudication Method for the Test Set
- Not applicable. There was no ambiguity in "ground truth" (i.e., whether tasks were performed correctly). The study aimed to see if participants could correctly perform actions and understand labeling, not to make a diagnostic determination that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This was not an AI/algorithm-based device, nor was it a diagnostic tool where human readers would be evaluated with and without AI assistance.
6. Standalone (Algorithm Only) Performance Study
- No. The device does not contain an "algorithm" in the sense of an AI model that would have standalone performance. It is a hardware device. The "performance data" presented relates to its physical and usability characteristics. The document explicitly states: "The Nutra Light Red does not use any software."
7. Type of Ground Truth Used
- For the usability study: The ground truth was the observed behavior and understanding of the 80 participants when interacting with the device, packaging, and user manual. Whether they could correctly perform actions (assemble, operate, care for) and understand labeling constituted the "ground truth" of usability.
- For safety and compliance: The ground truth was established international standards and regulatory requirements (e.g., IEC, ISO).
8. Sample Size for the Training Set
- Not applicable. This device does not use an AI or machine learning algorithm, therefore there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set, there is no ground truth for it.
Summary of Device and Study Type:
The Nutra Light Red is a non-invasive LED light device for treating periorbital wrinkles and rhytides, intended for over-the-counter use. The "study" described in the 510(k) summary is primarily an OTC Usability Study to ensure consumers can understand and safely operate the device without professional assistance. Other "performance data" relates to compliance with electrical, electromagnetic compatibility (EMC), photobiological safety, and biocompatibility standards, which are standard requirements for medical devices. This document does not describe the evaluation of an AI or algorithmic diagnostic 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.