(49 days)
Nd:YAG (1064nm): The DUOLITE Q-Switched laser is intended for treatment of vascular lesions, pigmented lesions, and for hair removal and the incision, excision, ablation, vaporization of soft tissue for general dermatology. The DUOLITE Q-Switched laser is intended for tattoo removal (blue, black and green tattoo)
Nd: YAG (532nm): The DUOLITE Q-Switched laser is intended for treatment of vascular lesions, pigmented lesions, and for hair removal and the incision, excision, ablation, vaporization of soft tissue for general dermatology. The DUOLITE Q-Switched laser is intended for tattoo removal (red, violet, orange, yellow and brown tattoo)
The device includes a Q-Switched Nd: YAG laser source with 900mJ max energy at 1064 nm and 450mJ max energy at 532 nm wavelengths. The optical delivery system for the two wavelengths is the articulated arm. In addition, the DUOLITE includes a power supply; a cooling system; an optical delivery system; a microprocessor based controller; and safety features to ensure use of the appropriate laser, wavelength and hand piece.
The provided text is a 510(k) summary for the Quanta System DUOLITE laser, which is a predicate device application. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with detailed acceptance criteria and performance metrics. Therefore, many of the requested details about acceptance criteria, clinical study specifics, and ground truth establishment are not typically found or required in a 510(k) summary for a predicate device of this nature.
However, I can extract the relevant information that is present in the document.
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) for a predicate device, explicit "acceptance criteria" in the sense of predefined thresholds for a clinical study endpoint are not presented. Instead, the device's performance is demonstrated through its "Technological Characteristics" being substantially equivalent to the predicate device. The performance comparison is based on technical specifications rather than clinical outcomes.
| Characteristic | Quanta System DUOLITE Reported Performance | Predicate Device (Cynosure Affinity QS K050382) Performance | Acceptance Criteria (Implied by Substantial Equivalence) |
|---|---|---|---|
| Nd:YAG Wavelength | 1064 nm | 1064 nm | Match/be equivalent to predicate |
| 532 nm Wavelength | 532 nm | 532 nm | Match/be equivalent to predicate |
| Pulse Width | 6 ns (for both 1064 nm and 532 nm) | 6 ns (for both 1064 nm and 532 nm) | Match/be equivalent to predicate |
| Fluence (1064 nm) | |||
| @ 2mm spot size | 28 J/cm² | 28 J/cm² | Match/be equivalent to predicate |
| @ 3mm spot size | 12 J/cm² | 12 J/cm² | Match/be equivalent to predicate |
| @ 6mm spot size | 3 J/cm² | 3 J/cm² | Match/be equivalent to predicate |
| Fluence (532 nm) | |||
| @ 2mm spot size | 14 J/cm² | 14 J/cm² | Match/be equivalent to predicate |
| @ 3mm spot size | 6 J/cm² | 6 J/cm² | Match/be equivalent to predicate |
| @ 6mm spot size | 1.5 J/cm² | 1.5 J/cm² | Match/be equivalent to predicate |
| Spot Sizes | 2, 3, and 6mm | 2, 3, 4, and 6mm | Similar spot sizes (DUOLITE offers a subset of the predicate's) |
| Repetition Rate | 1, 2, 5, and 10Hz | 1, 2, 5, and 10Hz | Match/be equivalent to predicate |
| Biocompatible Handpiece Tip | Yes | Yes | Match/be equivalent to predicate |
| Sterilization Method | Same as predicate | Same as predicate | Match/be equivalent to predicate |
| Intended Use / Indications | Same as predicate, with specific tattoo colors listed. | Same as predicate, with specific tattoo colors listed. | Similar intended uses and indications |
| Principles of Operation | Same as predicate | Same as predicate | Match/be equivalent to predicate |
The "acceptance criteria" for a 510(k) in this context is that the device is "as safe and effective as the predicate devices" and that "Minor technological differences...raise no new issue of safety or effectiveness," leading to a determination of "Substantial Equivalence."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a clinical "test set" with a sample size or data provenance in the way one would for a new clinical study. The equivalence is demonstrated through comparison of technical specifications, not patient data.
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. There was no clinical test set requiring expert ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was 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 device is a laser surgical instrument, 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 device is a laser surgical instrument.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No clinical ground truth was established for this 510(k) submission. The "ground truth" for demonstrating substantial equivalence lies in the technical specifications, intended uses, and principles of operation being comparable to the predicate device.
8. The sample size for the training set
Not applicable. There is no "training set" as this is not a machine learning device.
9. How the ground truth for the training set was established
Not applicable. There is no "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.