(190 days)
The Medlite Q-Switched Laser System is indicated for use in dermatologic and general surgical procedures for coagulation and hemostasis.
The Medlite Q-Switched Laser System is indicated for use in laser skin resurfacing procedures for the treatment of acne scars and wrinkles.
The Medlite Q-Switched Laser is a laser device with a Nd:YAG laser medium, Q-Switched pulse method, Max Power of 30 Watts, Wavelength of 1064 & 532, Power Supply of 110/120 VAC - 50/60 Hz and 220/240 VAC - 50/60 Hz, Pulse Rate of 1, 2, 5, 10, Single Shot, Pulse Duration (nsec) of Less than 20, Beam Delivery via Handpiece using articulated arm, Multimode Beam Quality, and Microprocessor Control.
The provided document is a 510(k) premarket notification for the Medlite Q-Switched Laser. It focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study for meeting specific acceptance criteria in the context of diagnostics or AI performance. Therefore, detailed information typically found in clinical studies assessing device performance against acceptance criteria (like sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or types of ground truth) is not present in this document.
The "acceptance criteria" here are implicit in demonstrating substantial equivalence: the proposed device's features and indications for use must be similar enough to a predicate device.
Here's an attempt to extract relevant information given the limitations of the document:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission, the "acceptance criteria" are not framed as performance metrics (e.g., sensitivity, specificity) but rather as a comparison of specifications and intended use against a predicate device. The "reported device performance" is essentially the listed specifications of the proposed device, which are shown to be identical or sufficiently similar to the predicate.
| Feature / Acceptance Criteria (Comparison Point) | Medlite Q-Switched Laser (K022709, Proposed Device) | Medlite Q-Switched Laser (K014234, Predicate 1) | ThermoLase Laser (K971207, Predicate 2) | Substantially Equivalent? (Yes/No) |
|---|---|---|---|---|
| Indications For Use: | For use in dermatologic and general surgical procedures for coagulation and hemostasis. For use in laser skin resurfacing procedures for the treatment of acne scars and wrinkles. | Identical (for coagulation and hemostasis). Not indicated for acne scars and wrinkles. | Identical (for coagulation and hemostasis). | Yes (with a note for K014234 on resurfacing) |
| Laser Medium: | Nd:YAG | Nd:YAG | Nd:YAG | Yes |
| Pulse Method: | Q-Switched | Q-Switched | Q-Switched | Yes |
| Max Power: | 30 Watts | 30 Watts | 30 Watts | Yes |
| Wavelength: | 1064 & 532 nm | 1064 & 532 nm | 1064 nm | Yes (predicate 2 only 1064, but overall equivalence established) |
| Power Supply: | 110/120 VAC - 50/60 Hz; 220/240 VAC - 50/60 Hz | 110/120 VAC - 50/60 Hz | 117/230 VAC - 50/60 Hz | Yes |
| Pulse Rate: | 1, 2, 5, 10 Hz, Single Shot | 1, 2, 5, 10 Hz, Single Shot | 1, 2, 5, 10 Hz, Single Shot | Yes |
| Pulse Duration (nsec): | Less than 20 | Less than 20 | 6-20 | Yes (within comparable range) |
| Beam Delivery: | Handpiece using articulated arm | Handpiece using articulated arm | Handpiece using articulated arm | Yes |
| Beam Quality: | Multimode | Multimode | Multimode | Yes |
| Microprocessor Control: | Yes | Yes | Yes | Yes |
2. Sample size used for the test set and the data provenance
This document describes a 510(k) submission based on substantial equivalence, not a clinical trial with a "test set" of patient data. Therefore, there is no information on a clinical test set sample size or data provenance. The "test" here involves comparing device specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. "Ground truth" in the sense of clinical annotations by experts is not established for this type of submission. The "ground truth" for the comparison is the published specifications of the predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no clinical test set requiring adjudication.
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 not an AI device, and no MRMC study was performed or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this substantial equivalence claim is the technical specifications and indications for use of legally marketed predicate devices (K971207 and K983054). The comparison is based on documented features rather than clinical outcomes or diagnostic accuracy.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. No training set is involved.
§ 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.