(128 days)
The Nidek Green Laser Photocoagulator Model GYC-1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.
Nidek Green Laser Photocoagulator Model GYC-1000 connected with the Endophotocoagulation Delivery Unit (for sterilized endophoto probe) is an ophthalmological photocoagulation system using a solid state laser (green laser beam) with a wavelength of 532nm. Like conventional laser photocoagulation systems, this system is used in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty when a delivery unit such as the Endophotocoagulation Delivery Unit is connected.
The provided document is a 510(k) premarket notification for a medical device (Nidek Green Laser Photocoagulator Model GYC-1000 connected with the Endophotocoagulation Delivery Unit). This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through extensive clinical studies as might be seen for novel devices.
Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable or not present in this document because the regulatory pathway is different.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document implicitly defines "acceptance criteria" as demonstrating substantial equivalence to the predicate device (Nidek Green Laser Photocoagulator Model GYC-1000, K032085). The performance is shown by verifying and validating that the modified device:
Acceptance Criteria Category | Reported Device Performance |
---|---|
Intended Use | The proposed device shares the same indications for use as the predicate device: ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy, and trabeculoplasty. |
Technological Characteristics | The proposed device maintains the same technological characteristics and principle of operation as the predicate device. Minor differences in endophotocoagulation delivery units (addition of 23G and 25G probes, reduced fiber core diameter, changed cone angle, optional fixed protective filter) are justified as not raising new safety or efficacy concerns. |
Functional Specifications & Performance Requirements | Verification and validation confirmed that the GYC-1000 connected with the proposed Endophotocoagulation Delivery Unit meets its functional specifications and performance requirements. This is supported by bench testing. |
Compliance with International Standards | The device complies with applicable international standards: IEC 60601-1, 60601-1-2, 60601-2-22, 60825-1, and ISO10993-1. |
Safety and Efficacy | The modifications (added probe sizes, reduced fiber core diameter, changed cone angle, added protective filter) were reviewed and justified as not raising new issues of safety or efficacy compared to the predicate device. |
2. Sample size used for the test set and the data provenance:
- Not applicable / Not Specified. This document uses a "Special 510(k)" pathway, which primarily relies on demonstrating that modifications do not significantly alter safety or effectiveness, often through engineering analysis and bench testing, rather than extensive clinical studies with human patient data. The "test set" in this context refers to the modifications and components themselves, rather than a clinical dataset.
- The testing performed was "bench testing" (Page 3).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not Specified. This information is typically relevant for studies involving human interpretation or performance assessment (e.g., of an AI algorithm). The current submission focuses on physical device characteristics and safety/efficacy of modifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not Specified. Adjudication methods are used to establish ground truth in clinical studies, which is not the primary mechanism of demonstration in this 510(k).
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:
- No. An MRMC comparative effectiveness study was not performed. This type of study is relevant for AI-assisted diagnostic devices or algorithms, not for a laser photocoagulator with modified delivery units.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical medical instrument (laser photocoagulator), not an algorithm or AI software. Therefore, the concept of "standalone algorithm performance" doesn't apply.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's substantial equivalence determination is its predicate device (Nidek Green Laser Photocoagulator Model GYC-1000, K032085). The "truth" being established is that the modified device is as safe and effective as the predicate.
- For the specific modifications, the "ground truth" comes from engineering analysis and bench testing to confirm that changes (e.g., fiber core diameter, cone angle) do not negatively impact safety or efficacy, and that the device meets its functional specifications and comply with relevant standards (IEC, ISO).
8. The sample size for the training set:
- Not applicable / Not Specified. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device requiring a training set.
§ 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.