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The CLS001 Laser System is intended to effect stable, long-term or permanent hair reduction, in Fitzpatrick skin types I-VI, including sun tanned skin types. Permanent hair reduction is defined as long-term, stable reduction in the number of hairs regrowing after a treatment regime
The CLS001 Laser System is intended to effect coagulation and haemostatis of vascular lesions in Fitzpatrick skin types I-VI, including suntanned skin types.

The CLS001 Laser System is an analog, pulsed Nd: YAG laser utilizing the Nd: YAG crystal as the lasing medium. It operates at the wavelength of 1064 nanometers. Laser activation is controlled by a footswitch mechanism. Physically, the system weighs 66 pounds, is 13.8 inches high, 23.6 inches wide and 17.3 inches deep. The electrical requirements are 220/240 VAC single phase, 50/60 Hz and 8 amps.

Here's an analysis of the provided text regarding the acceptance criteria and study for the K112141 device:

Based on the provided 510(k) summary for the Castle Laser Systems Limited CLS001 Laser System, the following information can be extracted:

Acceptance Criteria and Reported Device Performance

Note: The document explicitly states "Clinical Performance Data: none required." This indicates that the device's acceptance criteria for safety and effectiveness were established through substantial equivalence to predicate devices, rather than through new clinical performance studies demonstrating a specific level of clinical outcome (e.g., a specific percentage of hair reduction or lesion clearance).

Study Details

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not applicable. No clinical test set was used for this device's performance evaluation as clinical performance data was "none required."
   • Data Provenance: Not applicable for a clinical test set. The substantial equivalence argument relies on the established safety and efficacy of the predicate devices (Smartepil and Depilase Yag Lase Plus).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. No clinical test set requiring expert ground truth was performed for this device.

3. Adjudication method for the test set:

   • Not applicable. No clinical test set was performed.

4. 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 medical laser system, not an AI-assisted diagnostic or imaging device, and no MRMC study was conducted.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This is a medical laser system, not an algorithm, and the performance evaluated was substantial equivalence to predicate devices.

6. The type of ground truth used:

   • The "ground truth" for the device's performance is implicitly the established safety and effectiveness of the legally marketed predicate devices. The manufacturer argued that their device is substantially equivalent to these predicates. The specific type of ground truth (e.g., pathology, outcomes data) for the predicate devices' original clearances is not detailed in this document, but their prior clearance implies their performance met a certain standard.

7. The sample size for the training set:

   • Not applicable. There is no mention of a "training set" in the context of an algorithm or AI for this device. The regulatory submission relies on substantial equivalence.

8. How the ground truth for the training set was established:

   • Not applicable. No training set was used.

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