(196 days)
The Palomar Q-YAG 5™ Nd: YAG laser system is indicated at the 1064 nm wavelength for skin resurfacing with or without adjuvant preparation, dark ink tattoo removal (e.g.) black ink), removal of pigmented lesions, including, but not limited to, lentigines, nevi, melasma, and café-au-lait, and the removal or lightening of hair. The 532 mm way nevels gth is indicated for the removal of red ink tattoos, treatment of vascular lesions, including facial and leg veins, telangiectasias, angiomas, hemangiomas, portwine stains, and most pigmented lesions (e.g., lentigines, ephlides).
The 1064/532 nm blended wavelength is indicated for tattoo removal.
The complete system consists of a power supply unit, a cooling unit, a foot switch, and the handpiece that connects the laser unit and cooling unit using an umbilical cord. In standard use, the handpiece is held against the treatment area and the light pulse is delivered when the foot-switch is depressed. Laser parameters and other system features are controlled from a display panel located on the front of the power supply unit.
The provided 510(k) summary for the Palomar Q-YAG 5™ Nd:YAG Laser System does not contain details of a study with acceptance criteria and reported device performance in the typical format of a clinical or performance study for a machine learning or AI device.
Instead, the submission relies on the device's compliance with existing FDA performance standards for laser products and claims substantial equivalence to a legally marketed predicate device. This is a common pathway for medical devices that are not primarily software or AI-driven and do not introduce new fundamental technology or mechanisms of action.
Therefore, many of the specific details requested (like sample sizes for test sets, ground truth establishment for AI, MRMC studies, etc.) are not applicable or not provided in this type of submission.
Here's a breakdown based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Compliance with 21 CFR §1040.10 (Performance Standards for Laser Products) | The device complies with 21 CFR §1040.10. |
| Compliance with 21 CFR §1040.11 (Specific Purpose Laser Products – e.g., medical lasers) | The device complies with 21 CFR §1040.11. |
| Safety and Effectiveness substantially equivalent to predicate device (Continuum Electro-Optics, Inc. Medlite™ C3 Q-Switched:Nd:YAG Laser and Palomar Q-YAG 5™ Nd:YAG Laser System) | "The data presented in the 510(k) premarket notification support the safety and effectiveness of the device and do not raise new questions of safety or efficacy. Based on the foregoing, the Palomar Q-YAG 5™ Nd:YAG Laser System is substantially equivalent to its legally-marketed predicate devices." |
2. Sample size used for the test set and the data provenance:
- Not applicable in the context of a clinical performance study with discrete test sets. This 510(k) relies on compliance with laser product performance standards and a substantial equivalence claim, not a de novo clinical trial with a defined test set. The "data presented in the 510(k)" would likely refer to engineering and bench testing data to demonstrate compliance with the physical and electrical safety standards of laser devices, rather than data from a clinical test set for algorithmic performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no mention of a ground truth established by experts for a test set, as this is not an AI or diagnostic interpretation device requiring such a process.
4. Adjudication method for the test set:
- Not applicable. No mention of a test set or adjudication method.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. This type of study is typically done for AI or diagnostic devices to show improved human performance with AI assistance. It is not relevant for a laser system like this.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a laser system, not an algorithm.
7. The type of ground truth used:
- Not applicable. The "ground truth" for this device's performance is its adherence to established laser safety standards (21 CFR §1040.10 & 1040.11) and the demonstrated equivalence of its physical and functional specifications to the predicate device.
8. The sample size for the training set:
- Not applicable. This device is a hardware laser system, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set or ground truth establishment in this context.
§ 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.