(103 days)
No! No! Skin is indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.
Not Found
The provided text describes the FDA's decision to deem the "No! No! Skin™" device substantially equivalent for the treatment of mild to moderate acne based on a clinical trial. However, it does not explicitly state acceptance criteria in a quantitative table or the specific reported device performance values. It focuses more on the type of study and its outcome rather than numerical criteria and results.
Based on the provided text, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from FDA's Decision) | Reported Device Performance (Inferred from FDA's Decision) |
|---|---|
| Demonstrate statistically and clinically significant improvement in: | A statistically and clinically significant improvement in the time to improvement and time to resolution of mild to moderate acne. |
| - Time to improvement of mild to moderate acne | Assessed as improved compared to sham treatment. |
| - Time to resolution of mild to moderate acne | Assessed as improved compared to sham treatment. |
- Note: The document does not provide specific numerical thresholds for "statistically and clinically significant improvement" or the exact performance metrics (e.g., mean time to resolution in days). It focuses on the conclusion drawn from the study.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated. The document mentions "data from a randomized, sham-controlled, double-blinded, clinical trial," but the number of participants is not provided.
- Data Provenance:
- Country of Origin: Radiancy (Israel) LTD. is the applicant, suggesting the study could have been conducted in Israel or elsewhere, but the document does not explicitly state the study's location.
- Retrospective or Prospective: The study was a "randomized, sham-controlled, double-blinded, clinical trial," which by its nature is a prospective study.
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)
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: The assessment was carried out by "blinded investigators." Their specific qualifications (e.g., dermatologists, medical professionals) are not detailed, but their role as "investigators" implies medical expertise in evaluating acne.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- The document mentions "blinded investigators" assessed the improvement and resolution of acne. The specific adjudication method (e.g., consensus, single reader, majority vote) is not specified.
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 device is not an AI-assisted diagnostic tool. It is a device for treating acne. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance is not applicable and was not performed. The study described is a clinical trial comparing the device's effectiveness to sham treatment.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable as the device is a physical treatment device, not an algorithm. The "performance" in this context refers to its clinical efficacy in treating acne when used by individuals, not an algorithmic assessment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The ground truth was established by clinical assessment / outcomes data by blinded investigators. They assessed the "time to improvement and time to resolution of mild to moderate acne." This implies a subjective or semi-objective clinical evaluation of acne severity and progression by trained medical professionals.
8. The sample size for the training set
- The concept of a "training set" is not applicable here as this is a physical medical device undergoing a clinical trial for efficacy, not a machine learning algorithm that requires training data.
9. How the ground truth for the training set was established
- As the concept of a "training set" is not applicable, this question is also 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.