(159 days)
Nutra Light Advanced is intended/indicated for over the counter use for the treatment of mild to moderate acne and for the treatment of periorbital wrinkles and rythides.
Nutra Light Advanced is a visible light and/or heat source with high spectral purity. The device is made of Lustran ABS 348 with clear cover lenses covering the LED light sources. The device has two exchangeable heads; with one head emitting narrow band blue light at 410mm for the treatment of mild to moderate acne vulgaris, the other head emits red light at 650mm for the treatment of periorbital wrinkles and rhytides. The device consists of a basic-hand-held, battery operated control unit and two optional (Blue and Red LED) interchangeable heads, which allows the operator to select either the blue or red operation. The STOP button directly on the unit allows the user to immediately remove all power to the unit. The device does not allow the operator to select the red and blue light simultaneously.
The provided text is a 510(k) summary for the Nutra Light Advanced device, focusing on demonstrating substantial equivalence to predicate devices rather than presenting a detailed study with specific acceptance criteria and performance metrics of the device itself.
Therefore, many of the requested points cannot be answered from the provided document as it does not describe a clinical study in the way typically required for a novel device proving its efficacy against acceptance criteria. Instead, it relies on demonstrating similar technical characteristics to already approved devices.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The document states that the device has been tested and found in compliance with performance standards (e.g., IEC 60601-1, EMC 60601-1-2, IEC 60601-2-57, ISO 10993-5, ISO 10993-10) but does not list specific acceptance criteria (e.g., a certain percentage reduction in acne lesions) or the device's measured performance against such criteria. The basis for approval is substantial equivalence to predicate devices, implying their performance is accepted.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. As no clinical study is described, there's no test set in the context of device efficacy. The "tests" mentioned are nonclinical performance data related to electrical safety, EMC, and biocompatibility, not clinical outcomes.
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)
This information is not provided. Ground truth would be relevant for a clinical study assessing efficacy, which is not described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Adjudication methods are typically used in clinical trials to resolve discrepancies in expert assessments, which is not applicable here.
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 provided. The device is an LED light device for acne and wrinkles, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided. This question is not applicable to a physical light therapy device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided. As no clinical efficacy study is detailed, no ground truth related to clinical outcomes is discussed. The "ground truth" for the nonclinical performance data would be the defined standards themselves (e.g., passing a specific electrical safety test).
8. The sample size for the training set
This information is not provided. Training sets are relevant for machine learning algorithms, which is not what this device is.
9. How the ground truth for the training set was established
This information is not provided. Not applicable for this device type.
Summary of available information regarding acceptance criteria and "study" (nonclinical data):
The "study" presented is a series of nonclinical performance tests to ensure the device meets safety and engineering standards and demonstrates substantial equivalence based on technical specifications rather than a clinical efficacy trial.
| Acceptance Criteria Category | Specific Criteria (from referenced standards) | Reported Device Performance |
|---|---|---|
| Electrical Safety | IEC 60601-1:2005; ANSI/AAMI ES60601-1: 2005 + CORR. 1 (2009) + A2 (2010); CAN/CSA C22.2 No.60601-1-08 incorporates Corrigendum 2; June 2011: General requirements for basic safety and essential performance of medical electrical equipment. | Tested and found in compliance. |
| Electromagnetic Compatibility (EMC) | EMC 60601-1-2:2014 Medical Electrical Equipment- Part 1-2: General Requirements for basic safety and essential performance-Collateral Standard: Electromagnetic disturbances-Requirements and tests. | Tested and found in conformity. |
| Specific Light Source Safety | IEC 60601-2-57, Medical electrical equipment-Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use. | Tested and found in compliance. |
| Biocompatibility (In Vitro Cytotoxicity) | ISO 10993-5, Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity, 1999. | Tested and found in compliance. |
| Biocompatibility (Irritation & Hypersensitivity) | ISO 10993-10. Biological Evaluation of medical devices-Part 10: Tests for irritation and delayed-type hypersensitivity, 1996. | Tested and found in compliance. |
| Substantial Equivalence (Primary "Criteria") | The device's technical specifications and intended use are similar enough to predicate devices such that it raises no new questions of safety and effectiveness. This includes matching wavelengths (410nm and 650nm), similar treatment duration, and similar treatment regimen to the predicate devices (Nutra Light Blue K132838 and Nutra Light Red K141308). The only difference (interchangeable heads) must not raise new safety/effectiveness concerns. | Wavelengths: 410nm (blue light) and 650nm (red light) - Matches predicates. |
| Treatment Duration: Same as predicates. | ||
| Treatment Regimen: Similar to predicates. | ||
| Interchangeable Heads: This feature was deemed not to raise new issues of safety and effectiveness. | ||
| Conclusion: Substantially equivalent to predicate devices. |
In essence, the "acceptance criteria" for K150370 were primarily met by demonstrating compliance with recognized safety and performance standards for medical electrical equipment and establishing substantial equivalence to previously approved devices based on similar technology and intended use, rather than a de novo clinical efficacy study with defined clinical endpoints.
§ 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.