(90 days)
The Sharplan Model 5000 Alexandrite Surgical Laser System is intended for use in dermatology for the treatment of vascular lesions.
The Sharplan Model Alexandrite Laser System is a medical device which capable of emitting an invisible pulsed treatment laser beam at a wavelength of 755 nm under the guidance of a visible aiming beam. This laser can be utilized in either the continuous or timed exposure modes of operation
This looks like a 510(k) summary for a medical device that was cleared based on substantial equivalence to a predicate device, rather than through a study demonstrating direct device performance against acceptance criteria. Therefore, most of the requested information (like specific acceptance criteria, sample sizes, expert involvement, and ground truth methodologies) is not present in the provided document.
Here's an attempt to answer based only on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria or reported device performance for the Sharplan Model 5000 Alexandrite Laser System in a study against specific benchmarks. The clearance is based on substantial equivalence to a predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No test set or clinical data proving direct device performance was presented. The clearance states: "No new indications were sought in this premarket notification and no clinical data was presented."
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 applicable. No ground truth establishment by experts for a test set is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set or adjudication process 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 an AI-assisted device, and no MRMC study was conducted or referenced.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a laser system, not an algorithm, and no such standalone performance evaluation is mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No specific ground truth was established for the Sharplan Model 5000 Alexandrite Laser System's performance, as its clearance was based on substantial equivalence.
8. The sample size for the training set
Not applicable. This document describes a medical device cleared through substantial equivalence, not an algorithm developed with a training set.
9. How the ground truth for the training set was established
Not applicable. No training set or ground truth establishment for a training set is mentioned.
Summary based on the Provided 510(k) Document:
The Sharplan Model 5000 Alexandrite Laser System was cleared based on its substantial equivalence to a predicate device, the Cynosure PhotoGenica LP Dermatological Vascular Lesion Laser (K963094).
- Basis for Clearance: The manufacturer "believes that no significant differences exist" between their device and the predicate device "From both a design and clinical perspective, the predicate and candidate laser devices, are of the same technology and have the same intended use."
- Performance Data: "No new indications were sought in this premarket notification and no clinical data was presented."
- Intended Use: The device is "intended for use in dermatology for the treatment of vascular lesions."
Therefore, the study proving the device meets acceptance criteria in the traditional sense of a performance study against specific metrics is not provided in this document. Instead, the "proof" is the argument of substantial equivalence based on technological and intended use similarities to an already legally marketed device.
§ 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.