(492 days)
The Photon Vibrating massage Facial Aesthetic Device (Model: UI-200) is intended for over-the-counter use.
LED functional mode
- To emit energy in the blue and red region of the spectrum, specifically to treat mild to moderate acne on the face.
- To emit energy in the blue region of the spectrum to treat mild to moderate inflammatory acne.
Vibrating massage functional mode
As an electrically powered device intended for medical purposes to relieve minor aches and pains.
Photon Vibrating massage Facial Aesthetic Device, Model: UI-200 is a device provided with two operation functions: Vibrating massage and LED light irradiation. The product provided with internal battery and it can be charged by external adaptor.
For LED light irradiation functional, the device provides with two LED irradiation modes: Blue Light working Mode, Blue and Red Light working Mode, which can be switched by Mode button. When the device works in red and blue light working mode, the device provides spectral emission with LED red light (630±10nm) and blue light (415±10nm). In blue light working mode, the device only provide LED blue light output (415±10nm) by the LED lamp module in treatment head.
When the device works in Vibrating massage mode, the vibration can be provided on the stainless steel contactor in treatment head and can provide vibrating massage to facial skin.
The provided document is a 510(k) summary for the "Photon Vibrating massage Facial Aesthetic Device, Model: UI-200." This document primarily focuses on establishing substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria based on studies involving clinical outcomes or diagnostic accuracy. The key "study" described is a usability and self-selection study for an over-the-counter device.
Therefore, many of the typical acceptance criteria and study details for an AI/ML diagnostic device (e.g., number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of regulatory submission and product.
However, I can extract the relevant information regarding the usability study and present the device's technical specifications as its "performance" against its design requirements (which serve as a form of internal acceptance criteria).
Device Acceptance Criteria and Performance (Based on Technical Specifications and Usability Study)
Given that this is a 510(k) submission for an over-the-counter facial aesthetic device, the "acceptance criteria" are primarily related to its safety, electrical performance, biocompatibility, and user-friendliness for lay users, rather than diagnostic accuracy metrics. The "study" described is a usability and self-selection study.
1. Table of Acceptance Criteria (Design Requirements) and Reported Device Performance
| Acceptance Criteria (Related to Device Specifications/Safety) | Reported Device Performance (as tested) | Remarks / Relevance |
|---|---|---|
| LED Functional Mode Parameters | ||
| LED Wavelength (Red) | 630 ± 10 nm | Meets specified range. |
| LED Wavelength (Blue) | 415 ± 10 nm | Meets specified range. |
| LED Power Density (Blue) | 22 mW/cm² | Meets specified value. |
| LED Power Density (Red) | 7.5 mW/cm² | Meets specified value. |
| Vibrating Massage Functional Mode Parameters | ||
| Vibration Frequency (Level 1) | 2.98 MHz | Meets specified range (3MHz ± 5%). |
| Vibration Frequency (Level 2) | 2.96 MHz | Meets specified range (3MHz ± 5%). |
| Vibration Frequency (Level 3) | 2.97 MHz | Meets specified range (3MHz ± 5%). |
| Vibration Frequency (Level 4) | 2.97 MHz | Meets specified range (3MHz ± 5%). |
| Vibration Frequency (Level 5) | 2.97 MHz | Meets specified range (3MHz ± 5%). |
| Output Power | 0.16W | Specified and reported. |
| Biocompatibility | ||
| Compliance with ISO 10993-5 (Cytotoxicity) | Compliance with ISO10993-5 requirements. | Ensured for direct patient contact. |
| Compliance with ISO 10993-10 (Sensitization/Irritation) | Compliance with ISO10993-10 requirements. | Ensured for direct patient contact. |
| Electrical Safety | ||
| Compliance with IEC 60601-1 | Comply with IEC 60601-1 | Basic safety standard for medical electrical equipment. |
| Compliance with IEC 60601-2-57 | Comply with IEC 60601-2-57 | Specific standard for light sources for aesthetic and therapeutic use. |
| Patient leakage current | Comply with IEC 60601-1 | Ensured for patient safety. |
| Electromagnetic Compatibility (EMC) | ||
| Compliance with IEC 60601-1-2 | Comply with IEC 60601-1-2 | Ensures device does not interfere with, or is interfered by, other electrical equipment. |
| Software Verification & Validation | Test conducted | Confirms software functions as intended (per FDA guidance). |
| Usability/Self-Selection for Lay Users | ||
| Ability to properly self-select using labeling | 100% of lay users able to properly self-select. | Crucial for over-the-counter devices to ensure appropriate use. |
| Ability to properly use the device by reading instructions | 100% of lay users able to properly use w/o assistance. | Ensures safe and effective use by target audience. |
2. Sample size used for the test set and the data provenance
For the Usability Study:
- Sample Size: Not explicitly stated as a number, but the report mentions that "Study data was collected and demonstrated that the intended users of the device could successfully follow the instructions and use the device as intended" and "100% of lay users were able to properly self-select themselves using the box labeling and all lay users were able to properly use the device by reading instructions in the user manual without any assistance." While a specific number of participants is not provided, the 100% success rate implies a sample size that was deemed sufficient for this over-the-counter device's usability claim, likely a small, representative group of lay users.
- Data Provenance: Not specified (e.g., country of origin). The study was likely prospective, conducted specifically for this submission to demonstrate lay user comprehension and self-selection.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is not an AI/ML diagnostic device, and the usability study's "ground truth" was simply the observation of whether lay users could successfully self-select and operate the device based on provided instructions. Expert medical opinion was not required for this type of assessment.
4. Adjudication method for the test set
Not applicable. There was no complex "ground truth" requiring adjudication. The assessment was a direct observation of user behavior against clear operational objectives.
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
Not applicable. This is not an AI/ML diagnostic device, nor does it involve human readers or image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical non-AI/ML medical device.
7. The type of ground truth used
The "ground truth" for the usability study was the successful completion of tasks by lay users as described in the device's labeling and user manual. This is a direct observational outcome. For the technical specifications, the ground truth was derived from laboratory bench testing (e.g., electrical safety, EMC, wavelength, power density measurements).
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.