(36 days)
The Candela Family of Q-Switched Alexandrite Lasers are indicated for treatment in the following uses:
Pigmented Lesions Tattoos
The Candela Q-Switched Alexandrite Laser consists of an Alexandrite laser head, power supply and deionized water circulator The laser head contains cavity mirrors, pockels cell, solid state laser medium (the Alexandrite rod), and two high intensity xenon flashlamps which excite the laser medium. A calibration port with an internal meter is located on the control panel, which is used to verify the transmission of the optical fiber and handpiece, and to calibrate the output of the handpiece at selected fluence levels. The temperature of the laser head is regulated by the circulation of distilled water at a controlled temperature.
The Candela Q-Switched Alexandrite Laser delivers laser energy at a wavelength of 755 nm and pulse duration between 50 and 120 microseconds. When the Q-switching mechanism is disabled the system has the capability of producing a laser pulse duration of 0.050 - 0.120 milliseconds. The output of this laser is delivered to the area of treatment by means of a lens coupled user replaceable optical fiber with a treatment handpiece attached to its distal end. A trigger switch is used to control the delivery of pulses.
A microprocessor based system controller is used to monitor and direct all system functions. Users of the laser select parameters such as desired energy density (fluence) level and repetition rate and monitor operation via electronic controls and a display panel. The control panel is also used to enable or disable the triggering of the laser, to initiate the calibration feature and to obtain feedback from the system, such as the number of pulses delivered or spot size selected. The Candela Q-Switched Alexandrite Laser supports 2mm, 3mm, and 5mm nominal spot sizes.
The provided text is a 510(k) summary for the Candela Q-Switched Alexandrite Laser. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices.
It is crucial to understand that 510(k) summaries, especially for older or non-AI/software devices, often do not contain the type of detailed clinical study information requested. The purpose of a 510(k) is to show substantial equivalence, not necessarily to prove new high-level efficacy or to conduct comprehensive clinical trials with the rigor you're asking about (e.g., MRMC studies, specific acceptance criteria for performance metrics like sensitivity/specificity).
Based on the provided text, I can answer some of your questions, but many will be marked as "Not Applicable" or "Not Provided" because the document does not contain that information, consistent with the nature of a 510(k) for this type of device.
1. Table of Acceptance Criteria and Reported Device Performance
Not Applicable. The 510(k) summary does not present specific quantitative performance metrics (like sensitivity, specificity, accuracy) or formal acceptance criteria for these metrics for the Candela Q-Switched Alexandrite Laser. The submission focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological features, and design aspects, rather than proving a new level of clinical performance against defined criteria.
2. Sample Size Used for the Test Set and Data Provenance
Not Applicable / Not Provided. The document does not describe a clinical test set in the manner typically associated with AI/software performance evaluation. The substantial equivalence argument is based on the device's design, functional features, and intended use being similar to existing (predicate) devices. There is no mention of a "test set" of clinical cases for performance evaluation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not Applicable / Not Provided. As no test set for clinical performance evaluation is described, there is no mention of experts establishing ground truth for such a set.
4. Adjudication Method for the Test Set
Not Applicable / Not Provided. No test set or performance study is described that would require an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not Applicable / Not Provided. The document does not describe a MRMC comparative effectiveness study, nor does it discuss human reader improvement with or without AI assistance. This device is a laser system, not an AI-powered diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
Not Applicable / Not Provided. This device is a physical laser system, not an algorithm. Therefore, a standalone algorithm performance study is not relevant.
7. Type of Ground Truth Used
Not Applicable / Not Provided. No clinical performance ground truth is mentioned. The "ground truth" for this 510(k) is the established safety and effectiveness of the predicate devices to which it claims substantial equivalence.
8. Sample Size for the Training Set
Not Applicable / Not Provided. Given this is a physical laser system, the concept of a "training set" (as in machine learning) does not apply. The device's design and manufacturing rely on engineering principles, established medical device standards, and the precedent set by predicate devices.
9. How the Ground Truth for the Training Set Was Established
Not Applicable / Not Provided. As there is no "training set" in the context of this device, this question is not relevant.
Summary of Device and 510(k) Approach:
The K081324 submission for the Candela Q-Switched Alexandrite Laser is a classic example of a 510(k) for a physical medical device. The core argument for clearance is substantial equivalence to previously cleared predicate devices, specifically:
- Candela Q-Switched Alexandrite Laser, K073534
- Candela 3630 Laser System (Alexandrite) K063074
- Cynosure Accolade Elite Laser (Alexandrite) K072868 (and K034030, possibly updated in the summary)
The rationale for equivalence is based on:
- Same Intended Use: Treatment of pigmented lesions and tattoos.
- Similar Functional Features: Power output, spot size, repetition rate, energy, fluence.
- Matches Key Design Aspects: Wavelength (755 nm Alexandrite), light generation medium, power supply, cooling, and controls system.
- Similar Methods of Assembly and Operation.
The document states, "Candela believes that there are no new questions of safety or effectiveness raised and the Candela Q-Switched Alexandrite Laser is substantially equivalent to the current legally marketed Candela Q-Switched Alexandrite Laser... in intended use and technological features and therefore the risks and benefits are comparable to the predicate devices."
Therefore, the "acceptance criteria" for this submission were essentially the FDA determining that the new device did not raise new questions of safety or effectiveness compared to the predicates and that its technological characteristics were sufficiently similar to establish substantial equivalence. No explicit quantitative performance metrics or clinical study data of the type requested were provided or required for this 510(k).
§ 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.