(86 days)
The LC100 diode laser system is indicated for hair removal and permanent hair reduction. Permanent hair reduction is defined as a long-term, stable reduction in the number of re-growing hairs after a treatment regime.
The LC100 is also indicated for photocoagulation of dermatological vascular lesions, including port wine stains, telangiectasia, angioma, hemangioma, spider nevi, and other benign vascular lesions; photothermolysis of blood vessels (treatment of facial and leg veins); removal of benign pigmented lesions, including lentigines, nevi, chloasma, and café-au-lait; incision/excision, ablation and coagulation (homeostasis) of soft tissue.
The LC100 is indicated for use in patients with skin types I-VI, including tanned patients.
The LC100 delivers infrared laser light with a wavelength of 810 nm, a selectable pulse duration of 50 - 1000 ms. The corresponding fluence is delivered through a 12x12 or 12x6 mm handpiece tip. The laser pulses are generated at a maximum pulse repetition frequency of 3.3 Hz.
The complete system consists of a, chiller, a footswitch, and a handpiece containing diode bars connected to the power unit with an umbilical. In standard use, the handpiece is pressed against the patient's skin and a light pulse is delivered when the footswitch is depressed. The handpiece tip is water-Laser cooled to provide active skin cooling. parameters and other system features are controlled from the user interface panel on top of the laser unit, which provides an interface to the system computer.
The provided document is a 510(k) summary for the Palomar LC100 Diode Array Laser System, which is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. This type of submission does not typically include the kind of detailed study data (like acceptance criteria tables, sample sizes for test/training sets, ground truth establishment, MRMC studies, or standalone performance) that would be present in a Clinical Study Report or a more extensive Premarket Approval (PMA) application.
The document primarily focuses on establishing substantial equivalence by comparing the LC100 to predicate devices (Palomar SLP 1000 Diode Laser and LightSheer Diode Array Laser) through a description of its system and intended use. It explicitly states: "The differences in the specifications of the LC100 laser and the predicate device do not result in different performance or raise new questions of safety or efficacy. Based on the foregoing, the LC100 Diode Conclusion: Array Laser System is substantially equivalent to the legally-marketed claimed predicate device."
Therefore, based solely on the provided text, I cannot provide the specific details requested in your prompt because they are not present in this 510(k) summary.
Here's what I can extract or infer based on the nature of a 510(k) submission:
- Acceptance Criteria and Reported Device Performance: Not explicitly stated in a quantitative table. The "acceptance criterion" for a 510(k) is typically substantial equivalence to a predicate device, meaning it performs as safely and effectively as the predicate without raising new questions of safety or efficacy. The "reported device performance" is essentially that it is considered substantially equivalent to the predicate devices for its stated indications for use.
- Study Proving Acceptance Criteria: The "study" is the submission itself, which argues for substantial equivalence by comparing the LC100's specifications and intended use to those of the predicate devices. This is generally a comparative analysis rather than a traditional clinical study with detailed performance metrics.
- Sample Size for Test Set and Data Provenance: Not applicable/not provided. This is not a study that involved a test set in the sense of a clinical trial.
- Number of Experts and Qualifications: Not applicable/not provided. Ground truth establishment with experts is not detailed for this type of submission.
- Adjudication Method: Not applicable/not provided.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable/not provided. These are complex studies not typically required or included in a 510(k) for a laser system.
- Standalone Performance: Not applicable/not provided as a distinct study. The comparison is against predicate devices.
- Type of Ground Truth Used: Not applicable/not provided as this is not a diagnostic device requiring external validation of its output against a 'ground truth.'
- Sample Size for Training Set: Not applicable/not provided. This device is not an AI/ML algorithm that would have a training set.
- How Ground Truth for Training Set was Established: Not applicable/not provided.
In summary, the provided document is a regulatory submission for substantial equivalence, not a detailed clinical performance study. The information requested regarding explicit acceptance criteria, detailed study design, sample sizes, and ground truth establishment is not typically found in this type of 510(k) summary.
§ 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.