(169 days)
The PhotoDerm® HR is intended for the removal of unwanted hair.
The PhotoDerm® HR is used for the removal of unwanted hair.
PhotoDerm® HR is an electro optic medical device designed for effective photothermal treatment of unwanted hair and its removal.
This document describes a 510(k) premarket notification for the PhotoDerm® HR device, which is an electro-optic medical device designed for the photothermal treatment and removal of unwanted hair. The submission asserts substantial equivalence to several predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific acceptance criteria in a quantitative or qualitative manner (e.g., "hair reduction of X% after Y treatments"). Instead, the acceptance is based on demonstrating "substantial equivalence" to predicate devices. The performance data presented refers to general outcomes without numerical targets.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices in safety and effectiveness for unwanted hair removal. | "clearance rates and rate of occurrence of adverse effects of the PhotoDerm® HR were established." |
| "This data was compared to published data on the clearance rate and adverse effects of predicate devices." | |
| "It is ESC's opinion that this comparison demonstrates that the PhotoDerm® HR is as safe and as effective as the predicate devices in the removal of unwanted hair." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The text mentions "a multi-center clinical study," but the number of subjects or test cases is not provided.
- Data Provenance:
- Country of Origin: Not explicitly stated for the clinical study. However, the submitter, ESC Medical Systems, Ltd., is based in Yokneam, ISRAEL.
- Retrospective or Prospective: Not explicitly stated, but clinical studies for 510(k) submissions are typically prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The study described focuses on "clearance rates and adverse effects," which would typically be assessed by clinical investigators or medical professionals, but their specific number, role in establishing ground truth, or qualifications are not detailed.
4. Adjudication Method for the Test Set
This information is not provided in the document. The text does not describe any specific adjudication process for evaluating the clinical outcomes.
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 section is not applicable. The PhotoDerm® HR is an electro-optic medical device for hair removal, not an AI or imaging device designed to be read by human readers. Therefore, an MRMC study and
assessment of AI assistance for human readers were not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This section is not applicable. The PhotoDerm® HR is a physical medical device (an electro-optic system), not a software algorithm. Its performance is inherent to its operation in interaction with a patient, not a standalone algorithmic output.
7. The Type of Ground Truth Used
The ground truth used for assessing the PhotoDerm® HR's performance was primarily based on:
- Clinical Outcomes (Clearance Rates): The effectiveness of the device in removing unwanted hair.
- Safety Data (Adverse Effects): The occurrence and nature of any negative side effects.
These are clinical endpoints directly observed and measured during the multi-center clinical study.
8. The Sample Size for the Training Set
This information is not applicable. The PhotoDerm® HR is a physical device, and the submission describes clinical validation, not the training of a machine learning model. Therefore, there is no "training set" in the context of AI/ML.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as point 8.
§ 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.