(28 days)
The Nidek Multicolor Laser Photocoagulator System MC-500 is intended to be used in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.
The Nidek Multicolor Laser Photocoagulator System MC-500 ("MC-500") is a conventional ophthalmic laser photocoagulator system with treatment light wavelengths of 532 um, 577 nm, and 647 nm. The system is comprised of a diode aim and treatment lasers, graphical user interface, slit lamp and binocular indirect ophthalmoscope delivery units, and a footswitch.
The provided text describes a 510(k) summary for the Nidek Multicolor Laser Photocoagulator System MC-500. This summary focuses on establishing substantial equivalence to a predicate device (Nidek Multi Color Laser Photocoagulator Model MC-300, K042785) through bench testing.
Based on the provided information, here's a breakdown regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not specify quantitative acceptance criteria or provide a table of performance metrics. The assessment relies on a qualitative determination of "substantial equivalence" to a predicate device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | "All necessary bench testing was conducted on the proposed MC-500 to support a determination of substantial equivalence to the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance:
No specific "test set" in terms of patient data or clinical samples is mentioned. The testing conducted was "bench testing." Therefore, information on sample size and data provenance (e.g., country of origin, retrospective/prospective) for a test set is not applicable as it was not a clinical study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
As no clinical test set was used, there were no experts involved in establishing ground truth for such a set based on the provided information. The evaluation was focused on technical performance and equivalence.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical test set was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study was performed or mentioned. The submission is based on bench testing to establish substantial equivalence. Therefore, there is no information on the effect size of AI assistance on human readers.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:
Not applicable, as this device is a laser photocoagulator system, not an AI algorithm. Its performance is evaluated based on its technical specifications and functional equivalence.
7. Type of Ground Truth Used:
The "ground truth" for the substantial equivalence determination was the performance and characteristics of the predicate device (Nidek Multi Color Laser Photocoagulator Model MC-300). The MC-500's performance was compared to the established performance of the legally marketed predicate device through bench testing.
8. Sample Size for the Training Set:
Not applicable, as this is a physical medical device (laser system), not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this device.
In summary, the provided document details a 510(k) submission for a medical device (a laser photocoagulator system) where substantial equivalence was demonstrated through bench testing against a predicate device. It does not involve AI, clinical efficacy studies with patient data, or expert-adjudicated ground truth as would be relevant for an AI/ML medical device.
§ 886.4690 Ophthalmic photocoagulator.
(a)
Identification. An ophthalmic photocoagulator is an AC-powered device intended to use the energy from an extended noncoherent light source to occlude blood vessels of the retina, choroid, or iris.(b)
Classification. Class II.