(167 days)
The LaseAway Alexandrite Laser is intended for the cosmetic removal of unwanted hair on adults (18 years or older). The LaseAway Alexandrite Laser System is intended for use only by qualified physicians trained in the safe operation of the system.
The LaseAway Alexandrite Laser System is a medical device which is capable of emitting an invisible treatment laser beam at a wavelength of 755 nm under the guidance of a visible aiming beam. In addition to the standard pulse width of nominally 1 Msec at 1Hz, the LaseAway Alexandrite Laser System will operate up to 3 Hz. Additionally, a single pulse is modulated to provide 6 x 1 Msec pulses at 1.3 Hz.
The provided document is a 510(k) premarket notification for the "LaseAway Alexandrite Laser System," a device intended for cosmetic hair removal. It details the device's description, indications for use, safety features, and a comparison to predicate devices, ultimately claiming substantial equivalence.
However, this document does not contain information on specific acceptance criteria and a study proving the device meets those criteria, as typically found in clinical trial reports or performance validation studies. The 510(k) summary focuses on demonstrating substantial equivalence to already marketed devices, primarily through descriptive comparison of technical specifications and safety standards, rather than presenting a performance study against predefined acceptance metrics.
Therefore, most of the requested information cannot be extracted from this document.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided: The document does not specify quantitative acceptance criteria for device performance (e.g., a certain percentage of hair reduction after a set number of treatments) nor does it present a study with reported performance data against such criteria. The "Conclusion" section states the device is "safe and effective," but this is a general statement from the manufacturer's summary, not a report of specific performance metrics from a study.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided: No test set or clinical study data is reported in this 510(k) summary.
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)
- Cannot be provided: No test set or ground truth establishment process is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided: No test set or adjudication method is 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
- Cannot be provided: This device is a laser system for hair removal, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided: As this is a physical laser device, the concept of "standalone algorithm performance" does not apply in the context of AI or software. Its performance relies on human operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided: Since no specific performance study is detailed, no ground truth methodology is described.
8. The sample size for the training set
- Cannot be provided: No training set is mentioned as part of a performance study.
9. How the ground truth for the training set was established
- Cannot be provided: No ground truth for a training set is mentioned.
§ 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.