Search Results

The DEPILASE TRIO LASE Laser System is intended for the coagulation and haemostasis of vascular lesions ( 532 and 1064 nm ), the removal and permanent reduction of unwanted hair in Fitzpatrick skin types I -VI, including suntanned skin types (755 and 1064 nm) and the dermatological applications for the non invasive treatment of facial wrinkles (1064 nm).

The DEPILASE TRIO LASE Laser System is based on Nd: YAG and Alexandrite Jaser technology. Within the same system, one optical cavity contains the Nd: YAG crystal, and another optical cavity contains the Alexandrite crystal, which are activated by means of the use of a flashlamp. After each cavity, a red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapeutic and aiming beams are guided down an individual optical fibre delivery system to a focusing handpiece. The laser is used in a noncontact mode.

The DEPILASE TRIO LASE Laser System is designed with 6 major sub-systems:

• a) A high voltage power supply which converts and rectifies the a.c. mains current to provide regulated power for the flashlamp simmer current and main triggering pulse.
• b) A cooling system consisting of an internal water flow circuit together with water to air heat exchanger.
• c) An Nd: YAG laser rod, capable of generating optical pulses at a frequency up to 2 Hz.
• d) An Alexandrite laser rod, capable of generating optical pulses at a frequency up to 2 Hz.
• e) Two optical delivery systems, interfacing the energy from each laser cavity to the patient via an indipendent optical fibre and focusing handpiece.
• The microprocessor based controller which regulates the functions of the laser and allows f) parameter selection by the user.

The provided document is a 510(k) summary for the DEPILASE TRIO LASE Laser System. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving those criteria were met for a new AI/medical device. Therefore, much of the requested information regarding detailed acceptance criteria, specific study designs, sample sizes, expert qualifications, and AI-specific metrics (like MRMC studies or standalone performance) is not present in this type of regulatory submission.

The document asserts substantial equivalence based on intended use and technological characteristics compared to previously cleared devices, implying that if the new device functions similarly and has comparable risks and benefits, then its performance is implicitly acceptable.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: The document does not explicitly state quantitative acceptance criteria in terms of accuracy, sensitivity, specificity, or other performance metrics for the DEPILASE TRIO LASE Laser System itself. The acceptance criteria are implicitly met by demonstrating "substantial equivalence" to predicate devices for specific clinical applications.
• Reported Device Performance: The document states that the DEPILASE TRIO LASE Laser System's "output characteristics are very similar to those of the predicate devices." This is the primary "performance" reported in the context of substantial equivalence. No specific numerical performance results (e.g., success rates for hair removal, lesion coagulation effectiveness percentages) for the DEPILASE TRIO LASE are provided.

2. Sample Size for Test Set and Data Provenance:

• The document does not describe a clinical study or test set for the DEPILASE TRIO LASE Laser System to prove its performance against specific acceptance criteria.
• Instead, it refers to the established performance of predicate devices.
• Therefore, there is no information on a sample size, country of origin, or whether it was retrospective or prospective test data for the Depilase device itself.

3. Number of Experts and Qualifications for Ground Truth:

• Not applicable. The document does not describe a study involving expert-established ground truth for the DEPILASE TRIO LASE Laser System. The "ground truth" for clearance is the regulatory precedent set by the predicate devices.

4. Adjudication Method:

• Not applicable. No ground truth establishment process for a test set is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. This is not an AI-enabled device requiring an MRMC study. The document describes a physical laser system.

6. Standalone Performance Study:

• No. The document's purpose is to demonstrate substantial equivalence to existing devices, not to present a standalone performance study with detailed metrics for the new device. Performance is inferred from equivalence.

7. Type of Ground Truth Used:

• The "ground truth" for the clearance of this device is essentially the regulatory acceptance and clinical history of the predicate devices mentioned (Laserscope Lyra, Altus Medical Aesthetic CoolGlide, Fotona Dualis KTP, Candela GenteLASE GL, GenteLASE II, Cynosure Apogee TSK). These predicate devices would have undergone their own studies and received clearance based on demonstrating efficacy and safety for their respective indications, which then serve as the benchmark for substantial equivalence.

8. Sample Size for the Training Set:

• Not applicable. This is not a machine learning or AI device, so there is no concept of a "training set."

9. How Ground Truth for the Training Set Was Established:

• Not applicable. See point 8.

Ask a specific question about this device