(75 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 consists of an Alexandrite laser head, a Q-switching mechanism, a power supply and a deionized water circulator. 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 Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems is fully air cooled.
The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems delivers laser energy at a wavelength of 755 nm with a nominal pulse width of 50 nanoseconds. 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 supports 2mm, 3mm, and 4mm nominal spot sizes.
The provided text is a 510(k) summary for a medical device called the "Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems." This document does not describe a study to prove the device meets acceptance criteria, but rather asserts substantial equivalence to predicate devices based on similarities in intended use, functional features, and design aspects.
Therefore, many of the requested details, such as a table of acceptance criteria and reported device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, multi-reader multi-case studies, and standalone performance, are not applicable or not provided in this type of regulatory submission.
The document primarily focuses on establishing that the new device is as safe and effective as existing, legally marketed predicate devices, and thus does not require new clinical studies to demonstrate efficacy against specific acceptance criteria.
However, I can extract the relevant information from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not applicable / Not provided. The document states that the new device "has the same intended use, utilizes similar functional features (including power output, spot size, repetition rate, energy, and fluence) and matches key design aspects (including wavelength, light generation medium, power supply, cooling and controls system)" as the predicate devices. It relies on the predicate devices' established safety and effectiveness rather than presenting new performance data against specific acceptance criteria.
2. Sample size used for the test set and the data provenance:
- Not applicable / Not provided. This 510(k) summary does not describe a test set or clinical study to establish performance for the new device. It relies on substantial equivalence to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. Ground truth establishment for a test set is not described as no new clinical study data is presented.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. Adjudication methods are not discussed as no new clinical study data is presented.
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. This device is a laser system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a laser system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable / Not provided. Ground truth refers to the verified condition against which a diagnostic device's performance is measured. Since this document establishes substantial equivalence of a treatment device rather than presenting new diagnostic performance data, a new "ground truth" for the device's efficacy is not established in this submission. Its effectiveness is inferred from the predicate devices' established efficacy.
8. The sample size for the training set:
- Not applicable / Not provided. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable / Not provided. This is not an AI/ML device that requires a training set.
Summary of what the document does state regarding acceptance criteria and "proving" it:
The document asserts that the Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems meets its intended purpose by demonstrating substantial equivalence to existing, legally marketed predicate devices.
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Acceptance Criteria (Implicit via Substantial Equivalence): The device is "accepted" if it is determined to be substantially equivalent to predicate devices in:
- Intended Use: "Pigmented Lesions" and "Tattoos".
- Technological Features: Similar functional features (power output, spot size, repetition rate, energy, fluence) and key design aspects (wavelength, light generation medium, power supply, cooling, controls system).
- Safety and Effectiveness: Risks and benefits are comparable to predicate devices, raising no new questions of safety or effectiveness.
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Study Proving Acceptance:
- Type of "Study": This is a premarket notification (510(k)) submission based on the principle of substantial equivalence, not a clinical trial or performance study against pre-defined acceptance criteria.
- Method of Proof: The submission describes the new device and compares it to the predicate devices, highlighting their similarities. The "proof" is based on the argument that because the new device is so similar to legally marketed and safe/effective predicate devices, it is also safe and effective.
- Conclusion: "Based on the similarities in indications for use, design features, and functional features the Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems has been shown to be substantially equivalent to the current legally marketed predicate devices."
Predicate Devices Used for Comparison:
§ 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.