(92 days)
The Lux1540 and Lux2940 fractional combined treatment is intended for dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, dyschromia and pigmented lesions.
The Lux1440 and Lux2940 fractional combined treatment is intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, dyschromia and pigmented lesions.
The complete platform consists of a cart, console with an internal power supply and electronics, chiller, and a footswitch. Each handpiece individually attaches to the console via a connection port.
Here's an analysis of the provided text regarding acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary (K101506) does not explicitly state specific acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy, or quantitative measures of wrinkle reduction) that need to be met for the device to be considered effective.
Instead, the submission focuses on demonstrating substantial equivalence to predicate devices. The "performance data" section states:
"Clinical studies were conducted to evaluate safety and effectiveness when combining either the Lux1540 and Lux2940 or the Lux1440 and Lux2940 for treatment of wrinkles, dyschromia and pigmented lesions. The specifications and indications for use of the handpieces are substantially equivalent to the predicate devices based on the data provided in Premarket Notification and comparison of the technical characteristics. Thus, these handpieces do not result in additional safety or effectiveness information."
This implies that the acceptance criteria are met if the device's technical characteristics, specifications, and observed safety and effectiveness (as determined in the clinical studies) are deemed comparable to the legally marketed predicate devices. The study's purpose was to support this claim of substantial equivalence.
Without explicit performance targets, a table would look like this:
| Acceptance Criterion (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Safety and effectiveness for dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue, including treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, dyschromia, and pigmented lesions, when combining Lux1540/Lux2940 or Lux1440/Lux2940 handpieces. | "Clinical studies were conducted to evaluate safety and effectiveness when combining either the Lux1540 and Lux2940 or the Lux1440 and Lux2940 for treatment of wrinkles, dyschromia and pigmented lesions." The submission concluded: "The specifications and indications for use of the handpieces are substantially equivalent to the predicate devices based on the data provided in Premarket Notification and comparison of the technical characteristics. Thus, these handpieces do not result in additional safety or effectiveness information." This indicates the studies supported the equivalence claim for the stated procedures and conditions. |
| Substantial equivalence of technical characteristics, mechanism of action, intended use, and physical properties to predicate devices. | The submission explicitly states: "The Lux1540, Lux1440 and Lux2940 Handpieces are substantially equivalent to their predicate devices when used according to its intended use. This decision is based on the information that is provided in this 510(k) Premarket Notification which demonstrates that the handpieces share the same technological characteristics, mechanism of action, intended use and physical properties when compared to their predicates." |
2. Sample Size Used for the Test Set and the Data Provenance
The provided summary does not specify the sample size used for the clinical studies. It only states that "Clinical studies were conducted."
The data provenance (e.g., country of origin, retrospective/prospective) is also not mentioned in the provided document.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the 510(k) summary. The document mentions "Clinical studies were conducted to evaluate safety and effectiveness," but it does not detail the methodology for establishing ground truth, the number of experts, or their qualifications.
4. Adjudication Method for the Test Set
The 510(k) summary does not describe any adjudication method for the test set or clinical study outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study (comparing human readers with and without AI assistance) was not conducted or described. This device is a laser handpiece, not an AI-driven diagnostic tool that would typically involve human readers interpreting images.
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 medical laser handpiece, not an algorithm or AI system for diagnosis or interpretation. The device's performance is inherently tied to its physical application by a human operator.
7. The Type of Ground Truth Used
While "clinical studies" were mentioned to evaluate "safety and effectiveness," the specific type of "ground truth" used is not explicitly stated. Given the nature of the device (laser for skin treatment), it's likely that the evaluation of effectiveness involved clinical assessments by physicians (e.g., visual grading of wrinkle reduction, assessment of lesion clearance), potentially with objective measures like photography or skin analysis, and safety would be assessed through adverse event monitoring. However, the document does not elaborate on these details.
8. The Sample Size for the Training Set
The provided summary does not mention a training set sample size. This is expected as the device is a physical handpiece, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as the device is a physical handpiece and does not utilize a "training set" in the context of machine learning or AI models.
§ 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.