(55 days)
Nidek Dio-Light Laser System is intended for all cleared Cynosure Photogenica LPIR applications.
Treatment of vascular and pigmented lesions in Dermatology.
Not Found
The provided text describes a 510(k) premarket notification for the "Nidek Dio-Light Laser System". This type of submission relies on demonstrating substantial equivalence to a predicate device rather than conducting new clinical studies to prove safety and effectiveness from scratch. Therefore, many of the typical study-related questions cannot be directly answered from this document.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | The device should be substantially equivalent to a legally marketed predicate device with respect to indications for use, technological characteristics, and safety and effectiveness. This implies that the new device should not raise new questions of safety and effectiveness, and its performance should be comparable to the predicate for similar applications. | The Nidek Dio-Light system is stated to be substantially equivalent to Cynosure's Photogenica LPIR laser system. The document explicitly states: "The risks and benefits of the Nidek Dio-Light are comparable to the predicate device when used for similar clinical applications." And "Since the Nidek Dio-Light laser system is substantially equivalent with respect to indications for use, materials, method of operation and physical construction to the predicate device, we believe it clearly meets the requirement for substantial equivalence..." |
| Regulatory Compliance (General) | Compliance with general controls provisions of the Act, including annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. | The FDA letter grants permission to market the device, subject to these general controls. It assumes compliance with the current Good Manufacturing Practice requirement (21 CFR Part 820). |
| Laser Safety Compliance | Compliance with 21 CFR 1040.10 and 1040.11, FDA regulations for medical laser products. | The document states: "The laser systems manufactured by Nidek Inc. comply with 21 CFR 1040.10 and 1040.11, FDA regulations for medical laser products, as applicable." |
| Indications for Use (Clinical Scope) | The device should be proven safe and effective for its stated indications for use. For a 510(k), this means the indications should be the same as or comparable to the predicate device. | The Nidek Dio-Light Laser System is indicated for: "Treatment of vascular and pigmented lesions in Dermatology." The submission states: "Nidek Dio-Light Laser System is intended for all cleared Cynosure Photogenica LPIR applications," implying the predicate device has established safety and effectiveness for these indications. |
Study Description (Implicit from 510(k) submission):
The "study" in this context is primarily a comparison and demonstration of equivalence to a predicate device, rather than a de novo clinical trial.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable in the context of this 510(k) submission. No clinical "test set" in the traditional sense was used for this specific device's performance evaluation in comparison to a ground truth. Instead, the focus was on demonstrating that the new device's specifications (e.g., wavelength, power, pulse duration) and intended use were highly similar to a device already cleared by the FDA (the predicate).
- Data Provenance: Not applicable. The "proof" of meeting acceptance criteria comes from technical specifications and comparison to the predicate, not from patient data collected for this specific submission. Any clinical data supporting the safety and effectiveness of the predicate device would have been collected previously and would have been part of its 510(k) or PMA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- Not applicable. No ground truth was established by experts for a novel test set in this 510(k) submission. The FDA reviewers and the company's engineers/scientists would have assessed the technical and functional equivalence to the predicate.
4. Adjudication Method for the Test Set
- Not applicable. There was no "test set" requiring adjudication in the context of this 510(k) submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC study was not done. This type of study is for evaluating the impact of an AI algorithm on human reader performance, typically in diagnostic imaging. The Nidek Dio-Light is a surgical laser system, and its premarket notification is for substantial equivalence to an existing device, not for evaluation of an AI diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
- No, a standalone performance study was not done. The Nidek Dio-Light is a physical medical device (laser system), not a software algorithm, so the concept of "standalone performance" for an algorithm does not apply. Its performance is demonstrated through its technical specifications and comparison to the predicate device.
7. Type of Ground Truth Used
- Implicitly, the "ground truth" is the established safety and effectiveness of the predicate device, Cynosure Photogenica LPIR laser system. The Nidek Dio-Light uses this established history as its basis for substantial equivalence. No new, independent ground truth (e.g., pathology, outcomes data) was generated for this specific submission.
8. Sample Size for the Training Set
- Not applicable. This device is a laser system, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As a physical device, there is no training set or associated ground truth establishment for AI.
§ 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.