(322 days)
The EpiLight™ Hair Removal System is intended for long term removal of unwanted hair.
The EpiLight TM Hair Removal System is used for the removal of unwanted hair
EpiLight™ Hair Removal System is an electro optic medical device designed for effective photothermal treatment of unwanted hair and its long-term removal
The provided text describes the 510(k) summary for the EpiLight™ Hair Removal System. While it discusses the device's intended use and claims substantial equivalence to predicate devices, it does not provide explicit acceptance criteria in a quantitative format or details of a dedicated study to prove it meets such criteria in the way a modern regulatory submission would.
Instead, the submission relies on a comparison to predicate devices and a general statement about "clearance rates and rate of occurrence of adverse effects."
Here's an analysis of the information provided, fitting it into your requested format as much as possible, with caveats where information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
As explicit quantitative acceptance criteria are not stated in the document, I will infer what the submission implies regarding performance based on the comparison to predicate devices. The "reported device performance" refers to the general claim of being "as safe and as effective" as the predicates.
| Acceptance Criteria (Inferred from Predicate Equivalence Claim) | Reported Device Performance (EpiLight™ Hair Removal System) |
|---|---|
| Long-term removal of unwanted hair | Effective for long-term removal of unwanted hair |
| Acceptable clearance rates (comparable to predicates) | Clearance rates established and compared to published data on predicate devices; deemed "as effective" as predicates |
| Acceptable rate of adverse effects (comparable to predicates) | Rate of occurrence of adverse effects established and compared to published data on predicate devices; deemed "as safe" as predicates |
| Conformance with IEC601.1-1 for electro-medical devices | Conforms with IEC601.1-1 |
| Compliance with 21 CFR 1040.1 FDA laser performance standard (where applicable, despite not being a laser) | Efforts made to comply with 21 CFR 1040.1 where applicable |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: A "multi-center clinical study" was conducted, but the specific number of participants (sample size) in this study is not provided in the document.
- Data Provenance: The document states "ESC Medical Systems has also conducted a multi-center clinical study." The origin of the data (country) is not explicitly mentioned, but ESC Medical Systems is based in Yokneam, Israel. It is a prospective clinical study, as it was "conducted" by ESC Medical.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The study establishes "clearance rates and rate of occurrence of adverse effects," which would typically involve expert assessment, but no details on the number or qualifications of these experts are given.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was one done? No. The study described is a clinical study on the device's effectiveness and safety, not a comparative study of human readers with vs. without AI assistance. The EpiLight™ is a standalone medical device, not an AI-powered diagnostic tool for human readers.
- Effect Size of Human Reader Improvement: Not applicable, as this was not an MRMC study related to AI assistance.
6. Standalone (Algorithm Only) Performance Study
- Was one done? Yes, in principle. The clinical study conducted by ESC Medical Systems on the EpiLight™ Hair Removal System is a standalone performance study. The device is not an algorithm, but a physical electro-optic medical device. The study assessed the device's performance (clearance rates and adverse effects) on its own, without human intervention in the hair removal process itself (though human operators operate the device).
7. Type of Ground Truth Used
The "ground truth" for the clinical study was likely based on:
- Clinical Assessment: Observation of hair clearance (reduction in hair growth/density) over time.
- Adverse Event Reporting: Documentation of any side effects (e.g., skin irritation, burns).
This would typically involve patient follow-ups and physician evaluations. The document states "clearance rates and rate of occurrence of adverse effects... were established," implying a direct clinical observation and measurement of outcomes.
8. Sample Size for the Training Set
The concept of a "training set" is not applicable here in the context of machine learning. The EpiLight™ Hair Removal System is an electro-optic device, not an AI/algorithm that requires a training set. The clinical study performed is a performance evaluation of the manufactured device.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" for this type of device.
§ 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.