(86 days)
The NUNA LUX is an Over-the-Counter (OTC) light based device intended for the use in treating full-face wrinkles.
The NUNA LUX is an Over-the-Counter (OTC) light based device intended for the use in treating full-face wrinkles. NUNA LUX is a battery-operated device that uses low power light spectrum at red and infrared, at wavelength of 808 ±5nm, 620 ±5nm emitting optical power in a uniform distribution. The NUNA LUX incorporates a near-infrared LED light source within the optimum Therapeutic Optical Window at 808 nm, optimized for Low Level Light Therapy, and a red LED light source at 620 nm. An optical lens that diffuses the light to produce narrowband, divergent distribution across an 8 cm2 treatment area. The energy output of the 808 nm and 620 nm wavelengths is 62.5 mW/cm2 which produces a beneficial treatment for full-face wrinkles.
The provided document is a 510(k) summary for the NUNA LUX (NUNL528) device, which is an Over-the-Counter (OTC) light-based device intended for treating full-face wrinkles. It primarily focuses on demonstrating substantial equivalence to a predicate device (LYMA Laser, K210823) through non-clinical testing. Crucially, this document does not contain information about a clinical study with acceptance criteria for device performance related to efficacy (e.g., wrinkle reduction) or a multi-reader multi-case (MRMC) comparative effectiveness study.
Therefore, I cannot provide a table of acceptance criteria for device performance based on clinical efficacy or details about human reader improvement with AI. The information below reflects what is available in the document regarding safety and general performance.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
Since this document primarily addresses safety and general device performance through non-clinical testing for substantial equivalence, the "acceptance criteria" are implied by conformity to specific international consensus standards. The "reported device performance" is the confirmation that these standards were met. There are no quantitative efficacy performance metrics provided for wrinkle reduction from a clinical study.
| Acceptance Criteria (Implied by standard conformity) | Reported Device Performance |
|---|---|
| Electrical Safety: Conformity to ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010(R)2012 (Cons. Text) [Incl. AMD2:2021] | Device conforms to this standard. |
| EMC (Electromagnetic Compatibility): Conformity to IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION | Device conforms to this standard. |
| Additional Safety (Home healthcare environment): Conformity to IEC 60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION | Device conforms to this standard. |
| Photobiological Safety: Conformity to IEC 62471 First edition 2006-07 | Device conforms to this standard. |
| Laser Product Safety: Conformity to IEC 60825-1 Edition 2.0 2007-03 | Device conforms to this standard. |
| Biocompatibility (Cytotoxicity): Conformity to ISO 10993-5 Third edition 2009-06-01 | Device conforms to this standard. |
| Biocompatibility (Skin Sensitization): Conformity to ISO 10993-10 Fourth edition 2021-11 | Device conforms to this standard. |
| Biocompatibility (Irritation): Conformity to ISO 10993-23 First edition 2021-01 | Device conforms to this standard. |
| Performance (Skin Temperature): No specific standard or quantitative criterion provided, but "Skin Temperature Testing" was performed. | Testing was conducted, results are not detailed but presumably acceptable. |
| Performance (LED Wavelength and Power Density): No specific standard or quantitative criterion provided, but "LED Wavelength And Power Density Testing" was performed. | Testing was conducted, results are not detailed but presumably acceptable. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes non-clinical testing (lab bench testing) rather than a clinical study with a test set of human subjects. Therefore, the concept of "sample size for the test set" as typically applied to clinical data or patients does not apply here. The testing involved the device in a laboratory setting to verify compliance with safety and performance standards. No information on data provenance relating to human subjects is provided as no human subject data was discussed.
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 section is not applicable. The document details non-clinical laboratory testing against international consensus standards, not a clinical study involving expert assessment of patient data (e.g., for ground truth on disease or condition).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable. There was no clinical test set requiring expert adjudication.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done or at least not reported in this document. This device is an OTC light-based device; there is no AI component or human reader interpretation involved in its intended use as described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. The NUNA LUX is a physical light-based device, not an algorithm. Therefore, "standalone algorithm performance" is not relevant here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical testing described, the "ground truth" was established by international consensus standards for electrical safety, EMC, photobiological safety, laser safety, and biocompatibility. The device's performance was compared against the requirements specified in these standards.
8. The sample size for the training set
This section is not applicable. There is no mention of a "training set" as this device is not an AI/ML algorithm that requires training data.
9. How the ground truth for the training set was established
This section is not applicable as there was 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.