(258 days)
The Dealight Intense Pulsed Light (IPL) is indicated for use in surgical applications requiring selective photohermolysis (photocoagulation or coagulation) and hemostasis of soft tisse in the medical specialties of general and plastic surgery, and dermatology. Intense Pulsed Light Energy/Wavelengths (590-1200 nm) are indicated for: The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent1, hair reduction in skin types I-V through selective targeting of melanin in hair follicles. 1 Permanent hair reduction is defined as a long-term stable reduction in the number of hairs re-growing after a treatment regimen.
The Dealight Intense Pulsed Light (IPL) is comprised of the following main components: - A light / laser system console (including software and control electronics) - A control and display panel - Air cooling system - A hand-piece with cut off filters -
The provided text is a 510(k) summary for the Dealight IPL device, which is an Intense Pulsed Light system. It details the product description, intended use, and the rationale for substantial equivalence to a predicate device. However, it does not contain the specific information required to complete the requested table and answer the study-related questions.
The 510(k) summary is a premarket notification to the FDA, demonstrating that the device is at least as safe and effective as a legally marketed predicate device. It typically focuses on comparing technical specifications, operating performance, and intended uses rather than presenting new clinical study data with detailed acceptance criteria and performance metrics in the way a clinical trial report would.
Therefore, most of the information requested in your prompt is not available in the provided document.
Here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document. Typically, for a device like IPL, acceptance criteria would involve specific percentages of hair reduction, safety endpoints (e.g., adverse events below a certain threshold), or treatment efficacy metrics (e.g., clearance rates for pigmentation). | The document states the device is indicated for "stable long-term, or permanent hair reduction in skin types I-V through selective targeting of melanin in hair follicles." It also refers to the definition of "Permanent hair reduction is defined as a long-term stable reduction in the number of hairs re-growing after a treatment regimen." However, no quantitative performance metrics (e.g., 70% hair reduction at 6 months) are provided. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not available. The document does not describe a new clinical study with a test set. The claim of substantial equivalence is made against a predicate device.
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):
- Not applicable/Not available. No new test set data or expert-established ground truth is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not available. No new test set data is described.
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:
- No. This device is an IPL system for hair removal/dermatological applications, not an AI-assisted diagnostic device that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware-based medical device, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable/Not available. No new clinical study data with ground truth is described. The device's safety and effectiveness are established by demonstrating substantial equivalence to a predicate device, which implies the predicate device had established its ground truth in previous studies.
8. The sample size for the training set:
- Not applicable/Not available. This is a hardware device, not an AI algorithm requiring a training set in the conventional sense.
9. How the ground truth for the training set was established:
- Not applicable/Not available. See point 8.
Summary of available information from the document:
- Rationale for Substantial Equivalence: The Dealight is deemed substantially equivalent to "Lumenis's/ESC Family of IPL' systems (K030342)" based on comparable technical specifications, operating performance features, general physical configuration, and intended uses.
- Safety and Effectiveness Information: The device conforms with federal regulations and performance standards 21 CFR 1040.10 and 21 CFR 1040.11 for medical laser systems.
In essence, the provided 510(k) summary focuses on regulatory compliance and equivalence to an already approved device rather than a detailed presentation of a newly conducted clinical study with specific acceptance criteria and detailed performance data.
§ 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.