(15 days)
The DEPILASE TWIN LASE Laser System is indicated for the coagulation and haemostasis of vascular lesions and the removal and permanent reduction of unwanted hair in Fitzpatrick skin types I - VI, including suntanned skin types.
The DEPILASE TWIN LASE Laser System is based on Nd: YAG and Alexandrite laser technology. Within the 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 TWIN 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.
f) The microprocessor based controller which regulates the functions of the laser and allows parameter selection by the user.
The provided text is a 510(k) summary for the DEPILASE TWIN LASE Laser System. This document focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than presenting a de novo study with specific acceptance criteria and performance metrics for a completely new device.
Therefore, the requested information regarding acceptance criteria, device performance, study design (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance) is not available in the provided text.
The core of this 510(k) submission is to show that the DEPILASE TWIN LASE Laser System has the same intended use and similar technological characteristics to predicate devices. The document directly states: "The risk and benefits of the DEPILASE TWIN LASE Laser System are comparable to the predicate devices when used for similar clinical applications. It is therefore believed that there are no new questions of Safety or Effectiveness raised by the introduction of this device."
To address the prompt as much as possible, here's what can be inferred or stated from the text:
-
A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: The implied acceptance criteria for this 510(k) is "substantial equivalence" to previously cleared predicate devices for the stated intended uses. This means the device should possess similar technological characteristics, safety profiles, and effectiveness as the predicate devices. Specific quantitative performance metrics (e.g., success rates, complication rates) are not provided for the DEPILASE TWIN LASE system itself, but rather inferred to be "comparable" to the predicates.
- Reported Device Performance: No specific quantitative performance data (e.g., success rates, adverse event rates from a study) are reported for the DEPILASE TWIN LASE Laser System in this document. The submission relies on the established performance and safety of the predicate devices.
-
Sample size used for the test set and the data provenance: Not applicable. The document does not describe a new clinical study with a test set of data.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set requiring expert ground truth establishment is described.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set requiring adjudication is described.
-
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.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a laser system; the concept of "standalone performance" for an algorithm without human-in-the-loop is not relevant here.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. There is no new clinical study data presented requiring ground truth. The "ground truth" for the submission is the regulatory clearance and established safety/effectiveness of the predicate devices.
-
The sample size for the training set: Not applicable. No training set for a new algorithm or device development is mentioned.
-
How the ground truth for the training set was established: Not applicable.
In summary, the provided text asserts substantial equivalence by comparing the DEPILASE TWIN LASE Laser System's intended use and technological characteristics to several already-cleared predicate lasers. It does not contain information about a specific study design with acceptance criteria, sample sizes, or ground truth establishment for a new clinical performance study of the device itself.
§ 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.