(259 days)
The Palomar Lux1540 handpiece is intended for skin resurfacing procedures in addition to dermatological procedures requiring the coagulation of soft tissue.
The Palomar Lux1540 handpiece is an accessory to the StarLux Pulsed Light & Laser System. The handpiece delivers light with a wavelength of 1540 nm. The complete system consists of a power source, chiller, a footswitch, and a handpiece connected to the power unit with an umbilical.
Here's a breakdown of the acceptance criteria and the study information based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Capability to perform fractional photothermolysis (creation of a pattern of microscopic islets of damage at superficial skin layers). | "Performance data was provided showing the Lux1540 is capable of performing fractional photothermolysis, i.e., creation of a pattern (lattice) of microscopic islets of damage at superficial skin layers." |
| Device performs as clinically intended. | "The results from the clinical testing demonstrated that the Lux1540 performs as clinically intended..." |
| No new issues of safety or effectiveness are present. | "...and that no new issues of safety or effectiveness were present." |
Note: The provided 510(k) summary does not specify quantitative acceptance criteria (e.g., a specific percentage of a certain outcome, a defined threshold for adverse events). The criteria are qualitative, focusing on the device's ability to achieve its intended mechanism of action and overall clinical performance without new safety concerns, in line with its predicate device.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "clinical testing" but does not provide the number of subjects or samples used in this testing.
- Data Provenance: Not explicitly stated. The document doesn't specify the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: Not explicitly stated. The document refers to "clinical testing" but does not detail the roles or qualifications of the individuals who assessed the outcomes or established ground truth.
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly stated.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Status
- MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or implied. The study described focuses on the device's performance against its own intended use and safety profile, not a comparison of human reader performance with and without AI assistance.
- Effect Size of Human Readers with AI vs. without AI Assistance: Not applicable, as no MRMC study with AI assistance was conducted or reported.
6. Standalone (Algorithm Only) Performance Study Status
- Standalone Study: The Lux1540 is a physical medical device (handpiece for a laser system), not an AI algorithm. Therefore, "standalone (algorithm only)" performance is not applicable. The performance evaluation is for the device itself.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground-truth appears to be based on clinical observation and assessment by medical professionals regarding the device's ability to perform fractional photothermolysis and achieve its clinically intended effects without new safety issues. There is no mention of pathology, imaging, or specific objective biomarkers being used to establish ground truth in the provided text.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. As the Lux1540 is a physical device and not an AI algorithm, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set Establishment: Not applicable, as there is no "training set." The device's design and manufacturing process would be based on engineering principles and knowledge of laser-tissue interaction for dermatological applications.
§ 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.