(76 days)
The Q-switched Nd: YAG Laser Treatment Head for the Quantum series is intended for use in the medical specialties of plastic surgery and dermatology for applications requiring selective photothermolysis and photo-acoustic effects in target chromophores.
The Q-switched Nd: YAG Laser Treatment Head for the Quantum series is indicated for:
- Removal of dark tattoos
- Treatment of pigmented lesions
The Lumenis Quantum series of IPL/Nd: YAG systems are intense pulsed-light (IPL) and Nd: Y AG laser devices. Each Quantum system is comprised of three main components:
- A system console (including software and control electronics, key-operated power control switch, power-on indicator, emergency shut-off knob and a remote interlock connector);
- A control and display panel;
- One or more delivery handpiece(s), the Treatment Heads.
The Q-switched Nd: Y AG Treatment Head for the Quantum series is a pulsed laser operating at a wavelength of 1064 nanometers. It is an upgrade that can be installed on any Quantum system.
The Q-switched Nd: YAG Laser Treatment Head is a hand held device comprised of the laser head and optics, trigger circuit, safety components and cooling circuit. The Qswitched Nd: YAG Laser Treatment Head is connected to the Quantum console via an umbilical cable and connector.
The provided text describes the Q-switched Nd:YAG Laser Treatment Head for the Lumenis Quantum series. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission states that the device "shares the same indications for use, same principle of operation, same wavelength, same or similar fluence range and spot sizes as the predicate devices." It also notes that a "Clinical Evaluation Report demonstrated the safety and effectiveness of the Q-switched Nd: YAG laser for the claimed indications for use." However, specific quantitative acceptance criteria (e.g., a certain percentage of tattoo removal, reduction in lesion size) and their corresponding performance metrics are not explicitly stated in the provided document. The document relies on substantial equivalence to predicate devices rather than establishing new, specific performance criteria.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Implicit Acceptance Criteria: Safety and effectiveness for: |
- Removal of dark tattoos
- Treatment of pigmented lesions | Reported Performance: "A Clinical Evaluation Report demonstrated the safety and effectiveness of the Q-switched Nd: YAG laser for the claimed indications for use."
(No specific numerical performance metrics were provided in this document as the basis for substantial equivalence). |
| Technical specifications (wavelength, fluence range, spot sizes) comparable to predicate devices | "The technical specifications of the Q-switched Nd: YAG Laser Treatment Head for the Quantum series are similar or identical to those of the predicate MedLite C3 Q-switched Nd: YAG laser system (K011677), the Q-Clear laser system (K033259) and the Q-YAG 5 / Clear Light (K003460)." |
2. Sample size used for the test set and the data provenance
The document mentions "A Clinical Evaluation Report" but does not provide details about the sample size used for the test set, nor does it specify the data provenance (e.g., country of origin, retrospective or prospective nature).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the given text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the given text.
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
A multi-reader multi-case (MRMC) study is not mentioned in the document. The device is a laser treatment head, not an AI-assisted diagnostic or interpretative tool, so an MRMC study related to human reader improvement with AI would not be applicable here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a laser treatment head, which is a physical instrument used for medical procedures, not a standalone software algorithm. Therefore, a "standalone algorithm-only" performance study is not applicable. The "standalone" performance would be its inherent treatment efficacy, which the clinical evaluation report broadly addressed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document refers to a "Clinical Evaluation Report" which demonstrated "safety and effectiveness." This implies that clinical outcomes data (e.g., visual assessment of tattoo removal, reduction in lesion pigmentation, adverse event rates) would have been used as the ground truth. However, the exact methods for defining and measuring this ground truth are not detailed.
8. The sample size for the training set
The document does not mention a training set. This is consistent with a medical device submission focused on substantial equivalence to existing predicate devices, where extensive de novo training data for an algorithm might not be required or relevant in the same way it would be for an AI-powered diagnostic tool. The "Clinical Evaluation Report" would likely involve a test or validation set of patients, not a separate training set as understood in machine learning.
9. How the ground truth for the training set was established
As no training set is mentioned or implied, this information is not applicable.
§ 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.