(280 days)
The Accord Media Ultra Renew Plus is intended to be used:
LED functional mode
- To emit energy in the red and blue region of the spectrum, specifically to treat mild to moderate acne on the face.
- To emit energy in the red region of the spectrum for the treatment of periorbital wrinkles.
Ultrasonic functional mode
- As an electrically powered device intended for medical purposes to relieve minor aches and pains.
The Ultra Renew Plus is a hand held, mains powered, device used for the treatment of acne, periorbital wrinkles, and the relief of minor aches and pains. The Ultra Renew Plus combines two (2) functional modes of operation, LED and ultrasonic. The LED functional mode provides narrow bandwidth spectral output in the blue (415 ± 5 nm) and red (650 ± 5 nm) ranges. The ultrasonic functional mode operates at a fixed frequency of 3 MHz ± 5%. The Ultra Renew Plus uses a supplied power adaptor.
The provided text describes non-clinical testing for the Ultra Renew Plus device, focusing on electrical safety, electromagnetic compatibility, label comprehension, self-selection, and usability studies. It does not contain information about clinical studies with specific acceptance criteria related to therapeutic efficacy for acne, wrinkles, or pain relief, or mention any training sets, ground truth establishment for such clinical claims, or MRMC studies.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Study Category | Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|---|
| Electrical Safety | Meet requirements of IEC 60601-1 | The Ultra Renew Plus was tested and shown to meet the requirements of IEC 60601-1. |
| EMC | Meet requirements of IEC 60601-1-2 | The Ultra Renew Plus was tested and shown to meet the requirements of IEC 60601-1-2. |
| Label Comprehension | Minimum of 90% of participants correctly understood the majority of variables tested. | A minimum of 90% of participants correctly understood the majority of the variables tested. |
| Self-Selection | Not explicitly stated, but implies high percentage of correct self-selection. | 95% of participants self-selected correctly. |
| Usability | Not explicitly stated, but implies users can follow instructions and use the device safely and effectively. | Observational, open-ended, and close-ended data demonstrated that subjects understand how to use the various functions of the device based on the instruction manual, and were able to follow instructions and use the device in a safe and effective way. |
| Software V&V | Meet requirements of FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" for safe functioning. | Software verification and validation was successfully conducted to demonstrate the safe functioning of the device. |
2. Sample Size and Data Provenance for Test Set
- Label Comprehension Study:
- Sample Size: 61 subjects
- Data Provenance: Conducted in a "typical retail / mall environment." (Implies prospective, likely multi-center within one country, but specific country not stated).
- Self-Selection Study:
- Sample Size: 61 subjects
- Data Provenance: Conducted in a "typical retail / mall environment." (Implies prospective, likely multi-center within one country, but specific country not stated).
- Usability Study:
- Sample Size: 25 subjects
- Data Provenance: Conducted in a "typical retail / mall environment." (Implies prospective, likely multi-center within one country, but specific country not stated).
3. Number of Experts and Qualifications for Ground Truth for Test Set
Not applicable for the non-clinical studies described. These studies focused on user interaction and understanding, rather than expert-defined medical conditions or outcomes.
4. Adjudication Method for Test Set
Not applicable. The studies involved user questionnaires and observations for label comprehension, self-selection, and usability, not expert adjudication of medical results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The provided text describes non-clinical engineering and human factors testing. There is no mention of an MRMC comparative effectiveness study comparing human readers with and without AI assistance. The device itself is not a diagnostic AI tool, but a therapeutic device.
6. Standalone (Algorithm Only) Performance Study
No. The device is a physical, hand-held therapeutic device. The "software verification and validation" mentioned is for the device's internal software for safe functioning, not a standalone algorithm used for disease detection or diagnosis.
7. Type of Ground Truth Used for Test Set
For the non-clinical studies:
- Label Comprehension: Ground truth was the correct understanding of the device label's content, assessed via questionnaires.
- Self-Selection: Ground truth was whether subjects correctly identified if the device was appropriate for them based on the label.
- Usability: Ground truth was the successful and safe operation of the device by users according to instructions, assessed via observation and questionnaires.
8. Sample Size for the Training Set
Not applicable. The document describes non-clinical testing and does not mention any "training set" in the context of machine learning or AI algorithms for therapeutic efficacy.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set for a machine learning algorithm is discussed.
§ 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.