(79 days)
The Epi-Star Surgical Laser System is intended to be used for Plastic Surgery and Dermatology, with the intended uses for the treatment of vascular and pigmented lesions and for the removal of hair in skin types I - VI.
The Epi-Star Surgical Laser System is an 800 nm continuous wave device coupled with cooling accessory. The Epi-Star laser is self-limiting in the size of spots (2, 3, 4, and 5mm), output power, dwell time, density and fluence rates. The Epi-Star Surgical Laser can achieve fluence rates of up to 400 J/cm² when coupled with the cooling accessories. The treatment parameters for the classifications of various skin types is provided. The Epi-Star laser can be coupled with either a scanner handpiece that has a cooling window (Model A) or with a scanner and cold air system (Model B).
Here's an analysis of the provided text regarding the acceptance criteria and study for the Nidek Epi-Star Surgical Laser System:
Based on the provided text, the device is the "Epi-Star Surgical Laser System, Models A and B." This submission is an amendment (K013864) to a previously cleared device (K990119) to allow for higher fluence rates.
1. Table of acceptance criteria and the reported device performance:
The document primarily focuses on the modification of increasing the allowed fluence rates. It does not explicitly state acceptance criteria in a quantitative, measurable format with target values. Instead, it describes performance in terms of safety and intended function.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety of higher fluence rates for intended uses (vascular and pigmented lesions, hair removal). | "A preclinical animal study was conducted to determine the safety of the Epi-Star Surgical Laser System with the higher fluence rates. The Epi-Star Surgical Laser System was found to perform as intended." "The Epi-Star Surgical Laser System with the higher fluence rates was found to perform as intended during validation testing and in preclinical animal studies." |
| Device performs as intended for its specified indications for use. | "Performance testing was conducted on the Epi-Star Surgical Laser System. System and component testing was completed based on product specifications and hazard effects determined from the risk analysis. ... The Epi-Star Surgical Laser System was found to perform as intended." |
| Substantial equivalence to predicate device. | "The modifications to the Epi-Star Laser System allow for higher fluence rates of up to 400 J/cm2... The Epi-Star Surgical Laser System is substantially equivalent to the current Epi-Star Surgical Laser System in commercial distribution." |
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not specified beyond "preclinical animal study."
- Data provenance: Preclinical animal study. The country of origin is not specified, but given the submitter's location (Fremont, CA, USA) and FDA submission, it's likely the study was conducted in the US or under protocols adhering to US standards. It is a prospective study as it was conducted to determine safety with higher fluence rates.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The "ground truth" for the animal study would likely be based on pathological examination of tissue samples from the treated animals, but the experts involved are not detailed.
4. Adjudication method for the test set:
This information is not provided in the document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
This device is a surgical laser system, not an AI-powered diagnostic or interpretive device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not reported.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is a physical medical device (surgical laser), not a standalone algorithm. Therefore, a standalone algorithm performance study is not applicable and was not reported.
7. The type of ground truth used:
For the preclinical animal study, the ground truth would have been established through direct observation and histopathological examination of the treated animal tissues to assess safety and efficacy (e.g., degree of lesion treatment, hair follicle damage, absence of adverse tissue reactions) at the higher fluence rates.
8. The sample size for the training set:
This information is not applicable as the device is not an AI/machine learning model that requires a training set in the typical sense. Performance testing and the animal study evaluate the physical device's function.
9. How the ground truth for the training set was established:
This information is not applicable for the same reason as above.
§ 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.