(211 days)
The Affinity QS laser is intended for treatment of vascular lesions, pigmented lesions, and for hair, tattoo removal, and the incision, excision, ablation, vaporization of soft tissue for general dermatology.
The Affinity QS Q-Switched Nd:YAG Laser is a Q-Switched, frequency doubled laser system. It provides both 1064nm and 532nm wavelengths. Laser emission activation is by foot switch. Overall weight of the laser is 180 lbs., and the size is 25" x 15" x 78" (LxWxH). Electrical requirement is 230 VAC, 20A, 50-60 Hz, single phase.
The provided text is a 510(k) summary for the Cynosure Affinity QS Q-Switched Nd:YAG Laser system. Based on this document, the following information can be extracted regarding acceptance criteria and the study (or lack thereof) proving the device meets them:
1. A table of acceptance criteria and the reported device performance
Based on the provided K050382 510(k) summary, specific acceptance criteria and detailed device performance metrics are not present. The submission primarily relies on demonstrating substantial equivalence to a predicate device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as quantifiable performance metrics for "acceptance." | The device is deemed "safe and effective for the treatment of vascular and pigmented lesions, for hair and tattoo removal, and for the incision, excision, ablation, vaporization of soft tissue for general dermatology" by demonstrating substantial equivalence to the predicate device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The 510(k) summary explicitly states under "Nonclinical Performance Data" and "Clinical Performance Data" that there is "none". This indicates that no specific test set was used for performance evaluation of this device as part of this submission, nor is there any data provenance.
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)
Since there was no "Clinical Performance Data" or "Nonclinical Performance Data" provided for this specific device in this 510(k) submission, there is no information on experts used to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
As no performance data was submitted, there is no adjudication method described for a test set.
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
The document does not mention any MRMC comparative effectiveness study, nor does it pertain to AI assistance. This device is a laser system, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable as the device is a laser system, not an algorithm. Therefore, no standalone performance study was done in the context of an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Since no performance data was submitted for this device, there is no mention of the type of ground truth used.
8. The sample size for the training set
Given that no performance data was submitted and the device is a physical laser system (not an AI algorithm), there is no training set sample size mentioned.
9. How the ground truth for the training set was established
As there is no training set for this type of device and submission, there is no information on how ground truth for a training set was established.
Summary of the Study that Proves the Device Meets the Acceptance Criteria:
The 510(k) summary explicitly states "Nonclinical Performance Data: none" and "Clinical Performance Data: none."
Instead of performance studies, this 510(k) submission primarily relies on demonstrating substantial equivalence to an already legally marketed predicate device, the Medlite C6 Q-Switched Nd:YAG Laser system. The document states:
"The Affinity QS laser system has identical indication for use, the same principle of operation, and essentially the same wavelength range and pulse energy range as the predicate device."
Therefore, the "study" proving the device meets the acceptance criteria (implicitly, that it is safe and effective for its intended uses) is the legal and regulatory argument of substantial equivalence, rather than new performance data generated specifically for the Affinity QS laser. The FDA's letter confirms that they "reviewed your Section 510(k) premarket notification... and have determined the actived [sic] device is substantially equivalent... for the indications for use stated... to legally marketed predicate devices."
§ 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.