(44 days)
Nidek Dio-Light Laser System is intended for the treatment of vascular and pigmented lesions.
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The provided text is a 510(k) summary for the Nidek Dio-Light 60 Surgical Laser System. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, and expert involvement is not available in this type of regulatory submission.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as this is a substantial equivalence submission, not a de novo or PMA where specific performance criteria for new device types would be detailed. The "acceptance criteria" here is fundamentally meeting the standard of being "substantially equivalent" to an existing, legally marketed device (Cynosure's Photogenica LPIR laser system).
- Reported Device Performance: No specific performance metrics (e.g., efficacy rates, precision, accuracy) are reported for the Dio-Light 60 itself in comparison to quantitative criteria. The performance is implied to be comparable to the predicate device.
Table of "Acceptance Criteria" and "Reported Device Performance" (based on substantial equivalence):
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (Cynosure Photogenica LPIR) in terms of: | Declared substantially equivalent to the predicate device. |
| - Indications for Use (treatment of vascular and pigmented lesions) | "Nidek Dio-Light system is substantially equivalent to Cynosure's Photogenica LPIR laser system." |
| - Materials | "substantially equivalent with respect to... materials" |
| - Method of Operation | "substantially equivalent with respect to... method of operation" |
| - Physical Construction | "substantially equivalent with respect to... physical construction" |
| - Risks and Benefits | "The risks and benefits of the Nidek Dio-Light are comparable to the predicate device when used for similar clinical applications." |
| - Compliance with 21 CFR 1040.10 and 1040.11 (FDA regulations for medical laser products) | "The laser systems manufactured by Nidek Inc. comply with 21 CFR 1040.10 and 1040.11, FDA regulations for medical laser products, as applicable." |
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. The document does not describe a clinical performance study with a test set. Substantial equivalence is often demonstrated through comparison of technical specifications, intended use, and safety profiles to a predicate device, rather than a new clinical trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. No test set or ground truth establishment process is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set or adjudication process is described.
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 a surgical laser system, not an AI-powered diagnostic or assistive device for human readers. 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 a hardware device (laser system), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. No ground truth for a performance study is mentioned. The "ground truth" for this submission is the accepted safety and effectiveness of the predicate device.
8. The sample size for the training set
- Not Applicable. This is a hardware device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
- Not Applicable. As above, no training set or ground truth establishment is applicable here.
In summary: The K981447 document is a 510(k) submission primarily focused on demonstrating substantial equivalence to a predicate device, as opposed to presenting a de novo performance study with specific acceptance criteria and detailed clinical trial data typically found in PMA applications or submissions for novel devices. Therefore, much of the requested information regarding performance studies is not contained within this type of regulatory filing.
§ 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.