(15 days)
The DEPILASE YAG LASE PLUS Laser System is intended 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 YAG LASE PLUS 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. 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 YAG LASE PLUS 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 YAG LASE PLUS Laser System. This document focuses on establishing substantial equivalence to previously cleared devices rather than on presenting results from clinical trials with specific acceptance criteria and performance data in the format requested.
Therefore, many of the requested sections regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment cannot be fulfilled from the provided text. The document describes the device, its intended use, and argues for its substantial equivalence to predicate devices (Laserscope Lyra K990718 and Altus Medical Aesthetic CoolGlide K991798). It does not contain information about new studies conducted to prove the performance of the DEPILASE YAG LASE PLUS Laser System against specific acceptance criteria.
Here's an attempt to address the request based only on the provided information, noting where information is absent:
Acceptance Criteria and Device Performance Study
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Clinical Performance | Not explicitly stated as specific quantifiable metrics (e.g., success rate, safety endpoints) for this device. The document implies that performance is comparable to predicate devices. | Not explicitly reported for this device in the provided text. The document states that "The risk and benefits of the DEPILASE YAG LASE PLUS Laser System are comparable to the predicate devices when used for similar clinical applications." This implies historical performance of predicate devices is acceptable. |
| Technical Performance | Not explicitly stated as quantifiable metrics. The document implies technical equivalence to predicate devices. | The device ("DEPILASE YAG LASE PLUS Laser System output characteristics are very similar to those of predicate devices"). The device is described as having "identical characteristics" (flashlamp pumped Nd:YAG, 1064nm, optical fiber delivery, focusing handpiece) to predicate devices. |
| Safety | Not explicitly stated as quantifiable objectives. Implied: no new safety concerns compared to predicate devices. | "It is therefore believed that there are no new questions of Safety or Effectiveness raised by the introduction of this device." The device uses Class I aiming beams, which "pose no hazard to the user," similar to predicate devices. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable/not provided. The submission is based on substantial equivalence to predicate devices, not on a new clinical study with a test set of patients.
- Data Provenance: Not applicable/not provided for a new clinical study. The "data" referenced relates to the established safety and effectiveness of the predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable/not provided. No new test set data requiring expert-established ground truth is presented in this 510(k) summary.
- Qualifications of Experts: Not applicable/not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable/not provided.
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
- MRMC Study: No. This device is a laser system, not an AI-assisted diagnostic or imaging device used by human readers in the context of an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Study: Not applicable. This is a medical device (laser system), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not applicable for this device's submission in the provided text. The submission relies on the established safety and effectiveness track record (implied outcomes data, clinical experience, and regulatory clearance) of the predicate devices.
8. The sample size for the training set
- Sample Size: Not applicable/not provided. This document does not describe the development or training of an algorithm.
9. How the ground truth for the training set was established
- Ground Truth Establishment: Not applicable/not provided.
Summary of what the document does provide regarding its "proof":
The "study" in this context is a substantial equivalence argument to predicate devices cleared by the FDA. The proof is based on demonstrating:
- Identical Intended Use: The DEPILASE YAG LASE PLUS Laser System has the same indications for use as the predicate devices (coagulation and haemostasis of vascular lesions, and permanent reduction of unwanted hair in Fitzpatrick skin types I-VI, including suntanned skin).
- Similar Technological Characteristics: All utilize flashlamp pumped Nd:YAG laser rods, generating light at 1064nm, delivered via optical fiber and focusing handpiece, microprocessor controlled, use Class I aiming beams, and internal closed-loop water-air heat exchange for cooling.
- Comparable Performance (Implied): The output characteristics are "very similar" to predicate devices, and risks and benefits are comparable.
Therefore, the "proof" is a regulatory argument for equivalence rather than a detailed report of a new clinical investigation with quantifiable acceptance criteria.
§ 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.