(128 days)
The PicoSecond Nd: YAG Laser System is intended for use in surgical and aesthetic application in the medical dermatology and general and plastic surgery as follows:
1064nm wavelength:
- Removal of tattoos on all skin type (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, green, blue and purple.
- Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.
532nm wavelength: - Removal of tattoos on Fitzpatrick skin types I-III with the following tattoo colors: red, yellow and orange.
- Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.
The PicoSecond Nd: YAG Laser System is a Nd: YAG solid state laser, which can deliver the energy at picosecond pulse bursts to the skin. The system is composed of laser generator, articulated arm, handpence, laser power supply, cooling system, display and control system.
The PicoSecond Nd: YAG Laser System produces a pulsed beam of coherent near infrared (1064nm) and visible (532nm) light. This beam is directed to the treatment zone by means of an articulated arm coupled to a handpiece. The outputs of the two lasers are designed to be co-linear on the laser rail so that their beam paths are identical as they exit the laser system.
The provided text is a 510(k) summary for the PicoSecond Nd: YAG Laser System. It focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and non-clinical testing. Crucially, it explicitly states "Clinical Testing: It is not applicable." This means that there was no clinical study conducted to prove the device's performance against specific acceptance criteria.
Therefore, I cannot provide the information requested in the prompt, as the provided document indicates that no such study was performed or needed for this 510(k) clearance.
Specifically, the following information cannot be extracted because no clinical study was conducted:
- A table of acceptance criteria and the reported device performance: No clinical performance data is reported.
- Sample sized used for the test set and the data provenance: No test set due to the absence of a clinical study.
- Number of experts used to establish the ground truth... and qualifications: Not applicable.
- Adjudication method: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: "It is not applicable."
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical laser system, not an AI algorithm.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable, as this refers to training data for AI/ML models, which is not relevant here.
- How the ground truth for the training set was established: Not applicable.
The document focuses solely on non-clinical testing to demonstrate substantial equivalence, specifically mentioning:
- Electrical safety and electromagnetic compatibility: Tested against IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, and IEC 60825-1.
- Performance characteristics: Implied through comparison of technical specifications with predicate devices (e.g., wavelengths, pulse energy, pulse duration, repetition rate, spot size). The conclusion states that the maximum pulse energy of the proposed device, while higher than one predicate and lower than another, "can be considered that the propose device can achieve its intended use and is safety." This is a declarative statement based on engineering comparison and non-clinical safety/performance tests, not clinical trial data.
In summary, for this particular 510(k) submission, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" were based on a comparison to legally marketed predicate devices and a battery of non-clinical, bench and lab-based engineering tests to ensure safety and performance equivalence, rather than a clinical trial.
§ 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.