(255 days)
The Nutra Light Blue is a non-invasive LED light device is intended/indicated for over- the-counter use. The device delivers low intensity light emitting diodes (LED's) in the blue region at a wavelength of 410 +/- 5 nanometers, for the treatment of mild to moderate inflammatory acne.
The Nutra Light Blue Model: NL-2213, is deviccs that utilize Light Emitting Diodes to provide LED light to the body. The Nutra Light Blue 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 Blue is 410 +/- 5 at 75 mW. The Nutra Light Blue unit contains the power supplies, internal NI-MH rechargeable battery and the control unit. The enclosure and LED lens are made of medical grade biocompatility plastics via injection molding. It has the capabilities to deliver the light to the skin as the unit is moved over the skin surface. The STOP button directly on the unit allows the user to immediately remove all power to the unit. The Nutra Light Blue does not use any software.
The provided text describes the Nutra Light Blue device, which is an LED light device intended for the treatment of mild to moderate inflammatory acne. It is important to note that this document is a 510(k) Summary of Safety and Effectiveness, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed clinical study report with acceptance criteria and comprehensive performance metrics.
Based on the provided information, I can extract the following:
1. Table of acceptance criteria and the reported device performance:
The document does not explicitly state numerical acceptance criteria for clinical performance (e.g., a specific percentage reduction in acne lesions). Instead, it focuses on demonstrating that an "OTC Usability Study" met its goals. The "reported device performance" in this context refers to the outcomes of that usability study.
| Acceptance Criteria (Goals of OTC Usability Study) | Reported Device Performance |
|---|---|
| To attract participants that represented the "intended users" of the device. | All four goals of the study were met. |
| To determine if consumers could correctly self-select using the packaging labeling only. | All four goals of the study were met. |
| To test consumer knowledge of the packaging labeling and user manual and actually assembly, operate and care for the device correctly. | All four goals of the study were met. |
2. Sample size used for the test set and the data provenance:
- Sample Size: 80 participants.
- Data Provenance: The study was an "OTC Usability Study," implying it was conducted for the purpose of this submission and likely prospective, focusing on how consumers interact with the device. The country of origin is not explicitly stated, but given the FDA submission, it's typically understood to be within the US or compliant with US standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The study was a "Usability Study" and not a clinical efficacy trial with expert-assessed outcomes like lesion counts. Therefore, the concept of "ground truth" established by experts in the context of acne treatment efficacy (e.g., dermatologists assessing lesion counts) does not appear to apply to this specific usability study.
4. Adjudication method for the test set:
This information is not provided. As it was a usability study, it's unlikely to have involved the kind of clinical adjudication typically seen in efficacy trials.
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:
This information is not applicable and not provided. The Nutra Light Blue device is a non-AI, LED light therapy device for acne treatment. The document does not mention any AI component or human-in-the-loop performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable and not provided. The Nutra Light Blue device does not use an algorithm for diagnosis or treatment decision-making; it delivers light therapy directly. The document explicitly states: "The Nutra Light Blue does not use any software."
7. The type of ground truth used:
For the usability study, the "ground truth" would be the observed user behavior and responses to survey questions regarding packaging understanding, assembly, operation, and care. It's not a clinical ground truth like pathology or physician diagnosis. The document states the goals were to determine if consumers could "correctly self-select" and "correctly assembly, operate and care for the device." The "all four goals... were met" indicates the usability performance was deemed successful.
8. The sample size for the training set:
This information is not applicable and not provided. The Nutra Light Blue device is a hardware device (LED light therapy) and does not involve AI or machine learning models that require a training set.
9. How the ground truth for the training set was established:
This information is not applicable and not provided for the same reasons as point 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.