(3 days)
The SurgiLight, Inc. EX-308 Excimer laser, handpieces and laser related accessories is indicated for use for the treatment of psoriasis and for the treatment of vitiligo.
The SurgiLight EX-308 Excimer Laser is a medical device that is capable of emitting a treatment laser beam at a wavelength of 308nm under the quidance of a visible aiming beam. This laser may be used in a pulsed mode at various repetition rates.
This 510(k) submission (K020973) for the SurgiLight, Inc. EX-308 Excimer Laser does not contain the type of detailed information typically found in studies for AI/ML-driven devices. The submission focuses on demonstrating substantial equivalence to a predicate device, primarily through a comparison of technological characteristics and intended use, rather than presenting a performance study against specific acceptance criteria.
Therefore, many of the requested fields cannot be filled based on the provided text, as this device is a laser for medical treatment, not a diagnostic or AI-powered device that relies on performance metrics like sensitivity, specificity, or reader studies.
Here's a breakdown based on the provided text, highlighting what is (and isn't) present:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. This submission doesn't define acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) that would be relevant to an AI/ML device study. The "performance" described is about the laser's physical characteristics and its ability to emit light at a specific wavelength, which are compared to a predicate device for substantial equivalence.
2. Sample size used for the test set and the data provenance
Not applicable. No test set or data provenance related to a performance study for an AI/ML device is mentioned. This submission is for a physical medical device (excimer laser).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth establishment for a test set is discussed, as this is not an AI/ML performance study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method for a test set is mentioned.
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 is not a diagnostic AI/ML device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. Ground truth for an AI/ML performance study is not discussed.
8. The sample size for the training set
Not applicable. No training set is mentioned as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. No training set ground truth establishment is discussed.
Summary of Device and Approval from the Provided Text:
The SurgiLight, Inc. EX-308 Excimer Laser is a medical device designed to emit a treatment laser beam at a wavelength of 308nm for the treatment of psoriasis and vitiligo.
The 510(k) submission (K020973) sought to establish substantial equivalence to existing predicate devices (e.g., PhotoMedix K003705). The core argument for approval was that:
- The candidate and predicate laser devices are of similar technology.
- They have the same intended use (treatment of psoriasis and vitiligo).
- Based on an analysis of overall performance characteristics (implicitly, the physical characteristics and laser output, not clinical outcome studies in this document), no significant differences exist.
The FDA's approval letter confirms the determination of substantial equivalence, allowing the device to be marketed. The submission did not seek new indications for use; it relied on the existing clearances for the predicate devices.
§ 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.