(108 days)
The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems is indicated for the following uses:
Pigmented Lesions
Tattoos
The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems consist of an Alexandrite laser head, power supply and deionized water circulator. The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems also contains a Q-switching mechanism which when disabled allows the laser system the capability of producing a laser pulse duration of 0.050 - 0.120 millisecond. The laser head contains the 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 laser system is fully air cooled.
The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems delivers laser energy at a wavelength of 755 nm and pulse duration between 50 and 120 microseconds. 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 Family of Q-Switched Alexandrite Laser (AlexLAZR) systems support 2mm, 3mm, and 4mm nominal spot sizes.
This document is a 510(k) summary for the Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in clinical trial reports or performance testing documentation.
Instead, the document focuses on regulatory approval based on substantial equivalence to already legally marketed devices. This means the manufacturer is asserting that their new device is as safe and effective as existing ones, rather than necessarily performing a new study against specific acceptance criteria.
Therefore, most of the information requested in your prompt is not available in this document.
However, I can extract the following:
1. A table of acceptance criteria and the reported device performance
- Not available. The document does not specify acceptance criteria or report performance data against such criteria. The basis for approval is substantial equivalence to predicate devices, not performance against new, explicit criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/Not available. No new test set data is presented for performance evaluation against acceptance criteria. The approval is based on substantial equivalence to predicate devices already on the market.
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)
- Not applicable/Not available. No new test set requiring expert ground truth is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not available. No new test set requiring adjudication 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
- Not applicable/Not available. This device is a laser system, not an AI or imaging device that would typically involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not available. This device is a laser system, not an algorithm, so a standalone performance study in this context is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not available. No new ground truth is established for this submission. The rationale for approval is based on substantial equivalence to existing, legally marketed devices for which safety and effectiveness have already been established.
8. The sample size for the training set
- Not applicable/Not available. This document describes a physical medical device (laser system), not a software or AI algorithm that would typically have a "training set."
9. How the ground truth for the training set was established
- Not applicable/Not available. As above, no training set is relevant to this device submission.
Summary based on the provided document:
The provided document is a 510(k) Pre-market Notification, which focuses on demonstrating substantial equivalence of the Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems to existing, legally marketed predicate devices. It explicitly states: "The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems has the same intended use, utilizes similar functional features... and matches key design aspects... as the predicate devices."
The determination of substantial equivalence means that "the risks and benefits are comparable to the predicate devices," and therefore, "there are no new questions of safety or effectiveness raised." As such, this document does not contain information on new acceptance criteria, device performance against such criteria, or new studies with test sets, expert ground truth, or training sets. The regulatory pathway chosen (510(k) for substantial equivalence) means such studies are generally not required if the new device is demonstrably similar to existing ones.
§ 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.