(134 days)
Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology, Dermatologic and General Surgical Procedures for Coagulation and Hemostasis.
Specific Indications:
1064 nm wavelength
- . Tattoo Removal (dark ink: blue and black)
- Dermal Pigmented Lesions; including, but not limited to: Nevus of Ota, Lentigines, Nevi, . Melasma and Cafe-au-lait
- Removal or lightening of hair with or without adjuvant preparation. .
- . Skin Resurfacing for Acne Scars and Wrinkles
- Benign cutaneous lesions; including, but not limited to: striae and scars (excludes the 650nm . wavelength)
- Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral . part of the scar (excludes the 650nm wavelength)
532 nm Wavelength (nominal delivered energy of 585 nm and 650 nm with the Optional Multilite Dyc Laser Handpiece)
- Tattoo removal (light ink: red, sky blue, green) .
- Vascular Iesions including but not limited to: port wine birthmarks, telangiectasias, spider . angioma, cherry angioma, spider nevi
- Epidermal Pigmented lesions; including, but not limited to: cafe-au-lait birthmarks, solar . lentiginos, senile lentiginos, Becker's nevi, Freckles, Nevus spilus, seborrheic keratosis
- Skin Resurfacing for Acne Scars and Wrinkles .
- Benign cutaneous lesions; including, but not limited to: striae and scars, (excludes the 650nm . wavelength)
- Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral . part of the scar (excludes the 650nm wavelength)
The RevLite Q-Switched Nd: YAG Laser System consist of an electrically powered Console, in which laser energy produced within the system is delivered to the tissues by means of an articulated arm, Handpiece Adaptor and specially designed handpieces. The user ectivates laser emission by means of a footswitch.
The provided text is a 510(k) Summary for a medical laser system and does not contain information about a study comparing the device to acceptance criteria in the manner typically seen for AI/ML-based medical devices (e.g., performance metrics, expert reviews, ground truth establishment). Instead, this document focuses on demonstrating substantial equivalence to predicate devices.
Therefore, many of the requested points regarding acceptance criteria, study design, and performance metrics (especially those related to AI/ML product evaluation) cannot be extracted from this specific document.
Here's what can be extracted based on the provided text, and where gaps exist:
Acceptance Criteria and Device Performance (Based on Substantial Equivalence)
The "acceptance criteria" in this context are not quantitative performance thresholds in the way one might expect for an AI/ML diagnostic. Instead, they are met by demonstrating that the proposed device has the same intended use, technological characteristics, and performance characteristics as legally marketed predicate devices, thereby establishing it is "as safe, as effective, and performs as well as the predicate devices."
The study that proves the device meets "acceptance criteria" is essentially the substantial equivalence comparison presented in the document itself, rather than a separate clinical trial or technical performance study with a defined test set.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (vs. Predicates) |
|---|---|
| Intended Use Equivalence | Proposed device's intended use (Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology, Dermatologic and General Surgical Procedures for Coagulation and Hemostasis, plus specific wavelength indications for Tattoo Removal, Pigmented Lesions, Hair Removal, Skin Resurfacing, Benign Cutaneous Lesions, and Reduction of red pigmentation in hypertrophic and keloid scars) is deemed equivalent to predicate devices. Slight clarifications were made for pigmented lesions. |
| Technological Characteristics Equivalence | The proposed device and primary predicate device (K103118) have identical technological characteristics: Q-switched Nd:YAG laser, 1064nm/532nm wavelengths, 7-20 ns pulse duration, 1.6 J energy, 1-8 J/cm² fluence, 2-8.5mm spot sizes, 1-10 Hz repetition rate, and similar physical/electrical specifications. Other predicate devices have similar core technologies but with some variations in specific parameters (e.g., pulse duration, energy, fluence). |
| Performance Characteristics Equivalence | Implied by the identical/similar technological characteristics and intended uses. The document states: "The RevLite Q-Switched Nd:YAG Laser System is as safe, as effective, and performs as well as the predicate devices." No specific performance metrics (e.g., accuracy, sensitivity, specificity) for treating conditions are provided, as this is a device modification for clarification rather than a new performance claim. |
2. Sample size used for the test set and the data provenance
The document does not describe a test set, sample size, or data provenance because it's a 510(k) submission based on substantial equivalence to predicate devices, not on a new clinical performance study with a test cohort. The "study" here is primarily a comparison of specifications and intended uses with existing approved devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No new test set or ground truth establishment relevant to an AI/ML context is mentioned.
4. Adjudication method for the test set
Not applicable. No test set or adjudication process 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
Not applicable. This is a laser system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a laser system, not an AI-based algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The "ground truth" for this submission is established through the regulatory clearance of predicate devices, validating their safety and effectiveness for their stated intended uses and technological characteristics.
8. The sample size for the training set
Not applicable. This document does not describe an AI/ML device with a training set.
9. How the ground truth for the training set was established
Not applicable. This document does not describe an AI/ML device with a training set.
§ 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.