(84 days)
The DEPILASE TWIN YAG Laser System is intended for the coagulation and haemostasis of vascular lesions (1064 and 532 nm wavelengths), the removal and permanent reduction of unwanted hair in Fitzpatrick skin type I - VI and the dermatological use for the non invasive treatment of facial wrinkles (1064 nm wavelength).
The DEPILASE TWIN YAG Laser System is based on Nd: YAG laser technology. Within the system, an optical cavity contains the Nd: YAG crystal, which is activated by means of the use of a flashlamp, with the option of frequency doubling the fundamental laser wavelength, from 1064 nm to 532 nm. The frequency doubling wavelength is obtained by passing with the laser radiation through a special crystal called Second Harmonic Crystal (SHC). After the 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 optical fibre delivery system to a focusing handpiece. The laser is used in a non-contact mode.
The DEPILASE TWIN YAG Laser System is designed with 5 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 3 Hz
d) An optical delivery system, interfacing the energy from the laser to the patient via an optical fibre and focusing handpiece.
e) 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 YAG Laser System. It focuses on demonstrating substantial equivalence to a predicate device rather than describing a performance study with specific acceptance criteria and detailed results.
Therefore, most of the information requested regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not present in the provided document.
Here's a breakdown of what can and cannot be extracted:
1. A table of acceptance criteria and the reported device performance
- Not present. The document does not specify quantitative acceptance criteria for device performance or report specific performance metrics from a study. It asserts "The DEPILASE TWIN YAG Laser System output characteristics are very similar to those of the predicate device" but provides no data.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not present. No test set or clinical study data is described. The submission relies on substantial equivalence to a previously cleared device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not present. No ground truth establishment for a test set is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not present. No adjudication method is described because no test set or clinical study is detailed.
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 for dermatological applications, not an AI-based diagnostic tool that would typically involve human readers or MRMC studies. No such study is mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a laser device, not an algorithm. Standalone performance is not relevant in the context of this device type as it's not an AI/software-as-a-medical-device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not present. No ground truth is described because no clinical performance study is detailed.
8. The sample size for the training set
- Not applicable/Present (indirectly). This device is a physical laser system, not a machine learning algorithm that requires a "training set" in the conventional sense. The "training" for this device would refer to its design, engineering, and manufacturing process based on established laser technology. The comparison focuses on the predicate device, the Laserscope Lyra (K020021), which serves as the benchmark for equivalence.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set for an AI algorithm is involved.
Summary of Device and Equivalence Claim (from the document):
The DEPILASE TWIN YAG Laser System is an Nd:YAG laser system for dermatological applications.
Intended Use: Non-invasive treatment of facial wrinkles (1064 nm laser emission). Other indications mentioned in Appendix F include: coagulation and haemostasis of vascular lesions (1064 and 532 nm wavelengths), and removal and permanent reduction of unwanted hair in Fitzpatrick skin type I - VI.
Substantial Equivalence Claim: The device is claimed to be substantially equivalent to the Laserscope Lyra (K020021) Nd:YAG laser for the non-invasive treatment of facial wrinkles.
Basis for Equivalence:
- Identical intended use for facial wrinkles.
- Technologically identical characteristics: flashlamp pumped Nd:YAG laser rod generating 1064 nm light, delivered via optical fiber and focusing handpiece.
- "Very similar" output characteristics to the predicate device.
- Both are microprocessor-controlled.
- Both use Class I aiming beams.
- Both use internal closed-loop water-air heat exchange for thermal control.
- Risk and benefits are comparable to the predicate device for similar applications.
The document does not detail a study conducted with the DEPILASE TWIN YAG Laser System to prove it meets specific acceptance criteria. Instead, it argues that its device is equivalent to a legally marketed predicate device, relying on the predicate's prior clearance and established safety and effectiveness.
§ 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.