(327 days)
For MK-660, MK-66USBO, MK-020:
The Aduro Light Beauty Mask (Model: MK-660, MK-66USBO, MK-020) emits energy in the red and blue region of the spectrum, specifically indicated to treat full face wrinkles and/or mild to moderate acne.
For MK-66USBA, MK-02A:
The Aduro Light Beauty Mask (Model: MK-66USBA, MK-02A) is intended to emit light in the blue region of the spectrum, specifically indicated to treat mild to moderate acne on the face.
For MK-66USBB, MK-02B:
The Aduro Light Beauty Mask (Model: MK-66USBB, MK-02B) is an over the counter device that is intended for the use in the treatment of full-face wrinkles.
For MK-660, MK-66USBO, MK-02O:
The Aduro Light Beauty Mask (Model: MK-660, MK-66USBO, MK-020) is a facemask-shaped device, which makes use of specific light spectral characteristics and directly applies light onto the face skin surface. The Aduro Light Beauty Mask can emit light with two different center wavelengths. The blue light (465nm) is intended to help reduce the appearance of mild to moderate inflammatory acne. Red light (640nm) is intended to improve the appearance of wrinkles. There are a total of 66 LEDs to provide power intensity of about 30mw/cm2.
The user wears the mask on their face for the treatment, and the device will shut down automatically after finishing a 10-minute treatment.
For MK-66USBA, MK-02A:
The Aduro Light Beauty Mask (Model: MK-62A) is a facemask-shaped device, which makes use of specific light spectral characteristics and directly applies specified light onto the face. The Aduro Light Beauty Mask can emit the blue light (465nm) which is intended to help reducing the appearance of mild to moderate inflammatory acne. There are a total of 66 LEDs to provide power intensity of about 30mw/cm².
The user wears the mask on their face for the treatment, and the device will shut down automatically after finishing a 10-minute treatment.
For MK-66USBB, MK-02B:
The Aduro Light Beauty Mask (MK-66USBB, MK-02B) is a facemask-shaped device, which makes use of specific light spectral characteristics and directly applies specified light onto the face. The Aduro Light Beauty Mask can emit the red light (640nm) which is intended to improve the appearance of wrinkles. There are a total 66 LEDs to provide power intensity of about 30mw/cm². The user wears the mask on their face for the treatment, and the device will shut down automatically after finishing a 10-minute treatment.
The provided text describes a 510(k) summary for the Aduro Light Beauty Mask, which aims to demonstrate substantial equivalence to previously cleared predicate devices. This type of submission relies on comparisons to existing devices rather than new clinical effectiveness studies for the product itself. Therefore, the data provided is primarily about comparative equivalence for safety and basic performance metrics, rather than a full-fledged clinical study proving specific acceptance criteria for AI algorithm performance or human-in-the-loop improvements.
Based on the document, here's a breakdown of the requested information, with an emphasis on what is available and what is not in this type of regulatory submission:
Acceptance Criteria and Device Performance (Based on Substantial Equivalence)
The acceptance criteria are implicitly defined by the characteristics of the predicate devices. The "reported device performance" is the comparison showing that the subject device's specifications are within an acceptable range or are substantially equivalent to the predicates.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Implied by Predicates) | Reported Device Performance (Aduro Light Beauty Mask) |
|---|---|---|
| For MK-660, MK-66USBO, MK-020 (Red and Blue Light - Wrinkles & Acne) | MMSphere (Predicate 1): Emits energy in red, blue, and amber regions for wrinkles and/or mild to moderate acne. Treatment time 20 mins/day, 3-7 times/week. Wavelengths: Red: 605nm, Blue: 465nm, Amber: 625nm. Power Density: Red: 2.45mW/cm², Blue: 1.33mW/cm². LED Therapy Device (Predicate 2 - Primary): Red light for periorbital wrinkles, blue light for mild to moderate inflammatory acne. Treatment time 3-5 minutes each treatment. Wavelengths: Red: 630nm±5nm, Blue: 415nm±5nm. Power Density: Red: 80mW/cm²±10%, Blue: 50mW/cm²±10%. FaceLITE (Predicate 3): For full-face wrinkles. Wavelengths: Red: 630nm+/-10nm. Treatment time 600 seconds (10 minutes). | Emits energy in red and blue regions, specifically indicated to treat full face wrinkles and/or mild to moderate acne. Wavelengths: Red: 640nm±10nm, Blue: 465nm±10nm. Power Density: 30mW/cm² (total). Treatment Time: 10 minutes/day, 3 times per week. Power Supply: 3.7Vdc 2600mAh Lithium battery, Adapter for charging only: Input 100-240Vac, Output 5Vdc, 2A. LEDs as Irradiance Source. Face: Location for Use. OTC: Environment of Use. |
| For MK-66USBA, MK-02A (Blue Light - Acne) | MMSphere (Predicate 1): (as above, includes blue light for acne). LED Therapy Device (Predicate 2 - Primary): (as above, includes blue light for acne). Neutrogena Light Therapy Acne Mask+ (Predicate 3): Emits energy in red and blue regions for mild to moderate acne. Treatment time 600 seconds (10 minutes). Wavelengths: Red: 620-640nm, Blue: 425-450nm. | Intended to emit light in the blue region, specifically indicated to treat mild to moderate acne on the face. Wavelength: Blue: 465nm±10nm. Power Density: 30mW/cm². Treatment Time: 10 minutes/day, 3 times per week. Power Supply: 3.7Vdc 2600mAh Lithium battery, Adapter for charging only: Input 100-240Vac, Output 5Vdc, 2A. LEDs as Irradiance Source. Face: Location for Use. OTC: Environment of Use. |
| For MK-66USBB, MK-02B (Red Light - Wrinkles) | MMSphere (Predicate 1): (as above, includes red light for wrinkles). LED Therapy Device (Predicate 2 - Primary): (as above, includes red light for wrinkles). FaceLITE (Predicate 3): For full-face wrinkles. Wavelengths: Red: 630nm+/-10nm. Treatment time 600 seconds (10 minutes). | Intended for the treatment of full-face wrinkles. Wavelength: Red: 640nm±10nm. Power Density: 30mW/cm². Treatment Time: 10 minutes/day, 3 times per week. Power Supply: 3.7Vdc 2600mAh Lithium battery, Adapter for charging only: Input 100-240Vac, Output 5Vdc, 2A. LEDs as Irradiance Source. Face: Location for Use. OTC: Environment of Use. |
| Safety and EMF Standards | Compliance with relevant IEC and ISO standards for medical electrical equipment, electromagnetic disturbances, home healthcare, light source equipment, and biocompatibility. Generally IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-57, ISO 10993-5, ISO 10993-10. | The device has been evaluated for safety and performance through testing against: ES 60601-1, IEC 60601-1-11, IEC 60601-2-57, IEC 60601-1-2, IEC 62366-2 (Lithium systems), ISO 10993-5, ISO 10993-10. This indicates compliance with the safety and EMC standards found in the predicate devices. |
| Biocompatibility | Compliance with ISO 10993 series (e.g., ISO 10993-1, ISO 10993-5, ISO 10993-10). | Compliance with ISO 10993-1, ISO 10993-5, ISO 10993-10. |
Note: The document explicitly states: "The treatment time of the subject device is different than the predicate devices. However, it is considered to be within an acceptable range and does not raise concerns regarding safety and effectiveness, and new clinical studies were not considered to be necessary for the subject device." This indicates that while not identical, the differing treatment time was deemed acceptably similar.
Regarding the study proving the device meets acceptance criteria (Note: This is NOT an AI/algorithm study as per the typical questions, but rather a regulatory premarket submission for an LED light therapy device):
This document is a 510(k) Summary, which is designed to demonstrate substantial equivalence to a previously cleared device, rather than proving de novo effectiveness through a full clinical trial with "acceptance criteria" in the sense of an algorithm's performance metrics (e.g., sensitivity, specificity). The "study" mentioned here refers to the non-clinical testing and comparison to predicates.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable in the context of human clinical trial test sets. The "test set" here refers to the physical device undergoing non-clinical bench testing to ensure it meets safety and performance standards (e.g., wavelength accuracy, power output, electrical safety, biocompatibility). The document does not specify the number of devices tested.
- Data Provenance: The document explicitly mentions "Non-clinical Testing" being performed. It does not provide details on the country of origin for this testing or whether it was retrospective or prospective, but these would typically be lab-based, prospective tests on manufactured units.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This concept is not applicable to this type of device submission. Ground truth, in the context of AI, usually refers to expert-labeled data (e.g., radiologists labeling medical images). For an LED light therapy device, "ground truth" relates to measurable physical parameters and safety standards, verified by engineering and quality control processes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 (two experts agree, third resolves discrepancy) are used for establishing ground truth in clinical data for diagnostic or AI-assisted devices. This document describes the substantial equivalence of a light therapy device based on physical characteristics and safety standards.
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, an MRMC comparative effectiveness study was explicitly NOT done. This type of study demonstrates the clinical utility of a device, often for diagnostic tools or AI. The document states in the "Note" section (Page 13): "new clinical studies were not considered to be necessary for the subject device." This strongly indicates that the approval was based on demonstrating equivalence to predicates through technical and safety data, not new clinical effectiveness data. Therefore, there is no effect size related to human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical light therapy mask, not an AI algorithm. There is no standalone algorithm performance to evaluate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" here is based on established engineering and safety standards and specifications (e.g., specified wavelengths, power densities, electrical safety standards like IEC 60601 series, and biocompatibility standards like ISO 10993 series). Device performance is measured against these technical specifications, not against clinical outcomes or expert consensus on clinical findings in patient data.
8. The sample size for the training set:
- Not applicable. This is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. As this is not an AI algorithm, there is no training set or ground truth establishment method for it.
In summary: The provided document is a 510(k) summary for a physical medical device (LED light therapy mask), not an AI-powered diagnostic or therapeutic algorithm. Therefore, many of the questions related to AI algorithm acceptance criteria, test sets, ground truth establishment, and multi-reader studies are not applicable to this submission. The "study" proving acceptance criteria is the collection of non-clinical bench testing data and a comprehensive comparison of the device's technical specifications and safety profile to those of legally marketed predicate devices, demonstrating "substantial equivalence."
§ 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.