(85 days)
This device is intended for use in: 1. Source of illumination for curing dental restorative materials, 2. Assisting in the whitening process in dental office.
The device is a standard air-cooled argon laser emitting energy at 457 and 502nm. Output energy is less than 450 mW. The delivery system is a fused silica fiber optic system with a stainless steel handpiece. The laser operates on any 120 volt, alternating current, 20 ampere circuit. The unit is about 16" by 10" by 6.7" in dimension and weighs 20 lbs.
The provided text describes a 510(k) summary for a medical device called CYBER-LASE 2000™, an Argon Laser system. The document focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study with acceptance criteria and device performance as one might find for a novel device with clinical endpoints.
Therefore, the requested information elements related to clinical study design, performance metrics, ground truth, experts, and sample sizes for testing and training sets cannot be extracted from this document, as such a study was not the basis for clearance.
However, I can provide the relevant information based on the document's content:
1. A table of acceptance criteria and the reported device performance
The document does not present acceptance criteria and device performance in the manner requested, as it relies on substantial equivalence. The "performance standards" mentioned refer to general regulatory standards for laser products, not specific clinical performance metrics.
| Acceptance Criteria (Not explicitly stated for clinical performance) | Reported Device Performance (Operational Characteristics) |
|---|---|
| Meets legal predicate device characteristics for substantial equivalence | Emits energy at 457 and 502nm |
| Adheres to Performance Standards for Light-Emitting Products (21 CFR 1040.10) | Output energy less than 450 mW |
| Adheres to Performance Standards for Medical Laser Products (21 CFR 1040.11(a)) | Delivery system: fused silica fiber optic with stainless steel handpiece |
| Operates on 120 volt, AC, 20 ampere circuit | |
| Dimensions: 16" x 10" x 6.7"; Weight: 20 lbs |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The device clearance is based on substantial equivalence to predicate devices, not on a clinical performance study with a test set.
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 was established by experts for a test set in this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication was performed for a test set.
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 device is an Argon Laser system, not an AI-powered diagnostic device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an Argon Laser system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The clearance is based on demonstrating the device's technological characteristics and intended use are similar to legally marketed predicate devices, not on clinical performance against a medical ground truth.
8. The sample size for the training set
Not applicable. There is no mention of a training set for an AI/algorithm-based device.
9. How the ground truth for the training set was established
Not applicable. There is no mention of a training set or its ground truth.
§ 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.