(91 days)
The Palomar QYAG Laser Handpiece is indicated at the 1064 nm wavelength for dark ( i.e. dark blue or black) ink tattoo removal, removal of pigmented lesions, including but not limited to, lentigines, nevi, melasma, Becker Nevus-of-Ota and Café-au-Lait birthmarks. The 532 wavelength is indicated for the removal of light (red, orange, yellow or green) ink tattoos and most pigmented lesions (- e.g. lentigines, ephlides). The 1064/532 blended wavelength is indicated for tattoo removal.
The QYAG Laser handpiece is an accessory to the Palomar ICON System, which is composed of a system console, cooling system, power supply and handpiece. Laser energy is produced in the handpiece and delivered directly to the tissue.
Based on the provided text, the QYAG Laser Handpiece is not a device that would typically have acceptance criteria focused on diagnostic accuracy or performance metrics like sensitivity, specificity, or image quality, which are common for AI/ML-based medical devices.
Instead, this document describes a 510(k) Pre-Market Notification for a laser handpiece, which is a regulatory submission demonstrating that the new device is "substantially equivalent" to legally marketed predicate devices. The "performance data" section explicitly states:
"The specifications and indications for use of the QYAG Laser are substantially equivalent to its predicate devices. Thus, do not result in additional safety or effectiveness information."
This indicates that Palomar Medical Technologies, Inc. did not conduct a new study to prove specific performance criteria for the QYAG Laser Handpiece beyond demonstrating its substantial equivalence to previously approved predicate devices. They are asserting that because it's substantially equivalent, it meets the safety and effectiveness standards already established by those predicates.
Therefore, many of the requested points regarding acceptance criteria, study details, expert review, and AI performance are not applicable or cannot be extracted from this document, as the submission relies on substantial equivalence rather than new performance studies with specific metrics.
Here's a breakdown based on the information provided and the regulatory context of a 510(k):
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Applicable (For this 510(k) submission, the primary "acceptance criteria" is demonstrating substantial equivalence to predicate devices, not specific quantitative performance metrics tested in a new study.) | Substantially Equivalent to predicate devices (Palomar Q-YAG 5 ND: YAG LASER SYSTEM K061436, HOYA ConBio, Inc. RevLite Q-Switched Nd:YAG Laser System K083899, Quanta System SPA Q-PLUS T+ IPL LASER SYSTEM K123168, Lutronic Corporation Spectra Laser System K113588). |
2. Sample size used for the test set and the data provenance:
- Not Applicable. The document explicitly states that the device's specifications and indications for use "do not result in additional safety or effectiveness information" beyond what is established for the predicate devices. This implies that no new clinical or performance test set (in the sense of a diagnostic study) was conducted for this 510(k) submission. The evidence for "performance" is based on the substantial equivalence to 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 for evaluating specific performance metrics was described or required for this substantial equivalence claim.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. No new test set requiring adjudication was 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:
- No. This device is a laser handpiece, not an AI/ML diagnostic or assistive tool. MRMC studies are not relevant to its type of function.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This device is a physical laser handpiece, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. No new ground truth for performance evaluation was established for this submission. The "ground truth" for its safety and effectiveness is implicitly derived from the existing approvals of the predicate devices.
8. The sample size for the training set:
- Not Applicable. This is not an AI/ML device, so there is no training set in the context of machine learning.
9. How the ground truth for the training set was established:
- Not Applicable. As above, no training set for machine learning is relevant here.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The "study" that proves the Palomar QYAG Laser Handpiece meets "acceptance criteria" is essentially the 510(k) Pre-Market Notification process itself, where Palomar Medical Technologies, Inc. demonstrated substantial equivalence to four legally marketed predicate devices:
- Palomar Q-YAG 5 ND: YAG LASER SYSTEM (K061436)
- HOYA ConBio, Inc. RevLite Q-Switched Nd:YAG Laser System (K083899)
- Quanta System SPA Q-PLUS T+ IPL LASER SYSTEM (K123168)
- Lutronic Corporation Spectra Laser System (K113588)
The document explicitly states under "6. PERFORMANCE DATA" that "The specifications and indications for use of the QYAG Laser are substantially equivalent to its predicate devices. Thus, do not result in additional safety or effectiveness information."
Under "7. SUBSTANTIAL EQUIVALENCE," it further clarifies: "The QYAG Laser Handpiece is substantially equivalent to its predicate devices when used according to its intended use. The information that is provided in this application demonstrates that the QYAG Laser also shares the same technological characteristics as its predicates."
This means that the "proof" is the successful comparison of the new device's technological characteristics, intended use, indications for use, and potential risks to those of the already approved predicate devices. The FDA, by issuing the 510(k) clearance (K130250), concurred with this assessment of substantial equivalence.
§ 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.