Search Results
Found 2 results
510(k) Data Aggregation
(232 days)
EPILIGHT HAIR REMOVAL SYSTEM, PHOTODERM HR SYSTEM
EpiLight® and PhotoDerm® HR are used for the removal of unwanted hair. EpiLight® and PhotoDerm® HR are also intended to effect stable long-term, or permanent hair reduction in skin types I-V through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regime.
EpiLight® and PhotoDerm® HR are electro-optical medical devices designed for effective photothermal treatment of unwanted hair and its removal.
The provided text is a 510(k) summary for the EpiLight® and PhotoDerm® HR devices, which are electro-optical medical devices for hair removal. The document focuses on establishing substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results for a new AI-powered device. Therefore, much of the requested information regarding AI device performance, sample sizes, ground truth establishment, and MRMC studies is not available in the provided text.
Based on the information given, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly define acceptance criteria in terms of specific quantitative metrics (e.g., sensitivity, specificity, accuracy) for a new device's performance. Instead, it relies on demonstrating "substantial equivalence" to predicate devices through technical comparisons and clinical trials.
The primary performance claim for the EpiLight® and PhotoDerm® HR is:
- Permanent hair reduction: Defined as a long-term stable reduction in the number of hairs regrowing after a treatment regime.
The document states that a technical comparison and clinical trials were performed to establish substantial equivalence. However, no specific performance metrics resulting from these studies are provided in this summary.
| Acceptance Criteria (Implicit from Intended Use) | Reported Device Performance |
|---|---|
| Removal of unwanted hair | Achieved (by substantial equivalence to predicates) |
| Stable long-term, or permanent hair reduction in skin types I-V through selective targeting of melanin in hair follicles | Achieved (by substantial equivalence to predicates) |
| Permanent hair reduction: a long-term stable reduction in the number of hairs regrowing after a treatment regime. | Achieved (by substantial equivalence to predicates) |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "clinical trials were performed by ESC Medical Systems," but it does not provide any details about:
- The sample size of the test set (number of participants or observations).
- The data provenance (e.g., country of origin, retrospective or prospective nature of the data).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide any information regarding experts used to establish ground truth.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The devices described are medical devices for hair removal, not AI-assisted diagnostic tools requiring reader interpretation. Therefore, there is no discussion of human reader improvement with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The devices are physical medical devices for hair removal, not AI algorithms.
7. The Type of Ground Truth Used
Given the nature of the device (hair removal), the "ground truth" for "permanent hair reduction" would most likely be based on clinical observation and measurement of hair regrowth over time following a treatment regime. However, the document does not explicitly state the method for establishing this ground truth (e.g., photographic assessment, hair count, patient self-reporting, etc.).
8. The Sample Size for the Training Set
This question is not applicable as the document describes a physical medical device, not an AI algorithm that undergoes training.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable.
Ask a specific question about this device
(169 days)
PHOTODERM HR SYSTEM
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.
Ask a specific question about this device
Page 1 of 1