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The Nidek Multi Color Laser Photocoagulator Model MC-300 is indicated to be used in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.

The Nidek Multi Color Laser Photocoagulator Model MC-300 is a diode pumped solid state laser (DPSSL) ophthalmic photocoagulation system that produces three treatment beams: a 532 nm (green) wavelength, a 561 (yellow) wavelength, and a 659 (red) wavelength. The Model MC-300 uses the same wavelength for the aiming beam as the treatment beams, so that the operator can recognize the selected wavelength by the color of the aiming spot. The Model MC-300 splits the pumped laser beam into the aiming and treatment beams so that they can both be controlled separately. The multi-color laser beam is aligned with the respective aiming laser beam in the optical system inside the unit and gathers them in a fiber optic cable. The laser beam is led to the delivery unit via the fiber-optic cable, shaped into the specified spot size in the optical system, and emitted to the affected area (the emission areas of both the therapeutic laser beam and the aiming beam are the same).

This document, a 510(k) summary for the Nidek Multi Color Laser Photocoagulator Model MC-300, does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria.

Instead, it is a premarket notification for a medical device seeking clearance from the FDA based on substantial equivalence to previously cleared predicate devices. Therefore, it does not typically include a standalone performance study with acceptance criteria in the way a new, high-risk device might.

Here's what can be extracted and what is explicitly not available:

1. A table of acceptance criteria and the reported device performance:

• Not provided. This document does not specify quantitative acceptance criteria or report performance against such criteria. The approval is based on substantial equivalence, implying the device performs comparably to the predicate devices, rather than meeting specific performance metrics that are formally tested and reported here.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not provided. No test set or data derived from human or animal subjects is described. The evidence provided is based on a comparison of technological characteristics to predicate devices.

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 test set or ground truth establishment is described for this type of submission.

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 laser photocoagulator, not an AI-assisted diagnostic tool. Therefore, an MRMC study and AI-related effectiveness metrics are irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is a hardware device, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Not applicable. No new ground truth was established for a performance study. The "ground truth" for this submission is implicitly the established safety and effectiveness of the predicate devices.

8. The sample size for the training set:

• Not applicable. This device does not use machine learning, so there is no training set in the context of AI development.

9. How the ground truth for the training set was established:

• Not applicable. As above, no training set is relevant.

Summary of available information relevant to "Acceptance Criteria" implicitly based on Substantial Equivalence:

The document states:

• "The Nidek Multi Color Laser Photocoagulator Model MC-300 has been designed and will be tested in accordance with applicable safety standards." (Section 7. PERFORMANCE DATA)
• "System and component testing was completed based on product specifications and hazard effects determined from the risk analysis." (Section 7. PERFORMANCE DATA)
• The conclusion is that the device "is equivalent to the predicate device with respect to intended use, technological characteristics, and safety and effectiveness." (Section 8. CONCLUSIONS)
• The "Basis of Approval" by the FDA reviewer includes "Predicate Device (PD)" and "Bench Test Data (BTD)" along with "Specifications (SPECS)".

This implies that the "acceptance criteria" for the MC-300 were primarily:

1. Conformance to Applicable Safety Standards: (e.g., electrical safety, laser safety - though specific standards are not listed here).
2. Meeting Product Specifications: (e.g., wavelength, power range, pulse width, repetition rate as listed later in the document).
3. Demonstrating "Substantial Equivalence" to Predicate Devices: This means showing that its intended use, technological characteristics, and safety and effectiveness profile are similar to devices already cleared by the FDA (Nidek Laser Photocoagulator Model GYC-1000 and Lumenis Novus Varia Ophthalmic Laser & Delivery Devices).

Study Proving Device Meets Acceptance Criteria:

The "study" described is a bench test and comparison to predicate devices.

• Bench Test Data (BTD): This is explicitly mentioned as a basis for approval. These tests would have verified the product specifications (e.g., accurate wavelength emission, power output within stated range, pulse duration, etc.) and adherence to safety standards. No specific details of these bench tests (e.g., number of units tested, specific tests performed, results) are provided in this summary, as is typical for a 510(k).
• Comparison of Technological Characteristics: The document outlines that the MC-300 and predicate devices are all Diode Laser Pumped Solid State Lasers (DPSSL) and use similar delivery systems. It states, "The fundamental technical characteristics and device specifications of the Nidek Multi Color Laser Photocoagulator Model MC-300 are the same as those of the predicate devices." (Section 3. SUBSTANTIAL EQUIVALENCE). It further specifies the wavelengths (532 nm, 561 nm, 659 nm), power range (50-2000 mW), pulse width (0.02-3.00 sec), and repetition rate (0.2-1.0 sec), noting that the power output is comparable to a predicate device (Nidek GYC-2000, K980547).

In essence, the "proof" is the successful completion of internal system and component testing to product specifications and a detailed technical comparison, demonstrating that the new device does not raise new questions of safety or effectiveness compared to legally marketed predicate devices.

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The Nidek Green Laser Photocoagulator Model GYC-1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.

The Nidek Green Laser Photocoagulator Model GYC-1000 is a frequency doubled diode pumped solid state (DPSS) laser ophthalmic photocoagulation system that produces a 532 nm (green) wavelength light as the treatment beam. The Model GYC-1000 uses a diode laser (red) with a wavelength of 635 nm as the aiming beam. The green laser beam is aligned with the red aiming laser beam in the optical system inside the unit and gathers them in a fiber-optic cable. The laser beam is led to the delivery unit via the fiber-optic cable, shaped into the specified spot size in the optical system, and emitted to the affected area (the emission areas of both the therapeutic laser beam and the aiming beam are the same).

The Model GYC-1000 can be used to coagulate the target tissue efficiently and safely, and the system can be applied to transpupillary photocoagulation procedures using a slit-lamp or indirect ophthalmoscope and intraocular photocoagulation procedures using an endophotocoagulation probe. The Model GYC-1000 is a smaller, modified version of the Models GYC-1500 and GYC-2000, which were the subject of premarket notification number K980547.

A protective filter may be attached to each delivery unit in the observation optical path so that the operator's eye can be protected from the laser beam if it is reflected from a patient's eve or contact lens during laser emission. The Model G Y C-1000 has a number of delivery units available for use in a variety of ophthalmic procedures:

• Endophotocoagulation Delivery Unit .
• NIDEK Slit-Lamp Delivery Unit
• ZEISS Slit-Lamp Attachable Delivery Unit ●
• HAAG Attachable Slit-Lamp Delivery Unit .
• Binocular Indirect Ophthalmoscope Delivery Unit .
• Combination Delivery Unit for Nidek Nd: YAG laser .

The Nidek Green Laser Photocoagulator Model GYC-1000 acceptance criteria and the study that proves the device meets them are described below based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The device performance is primarily assessed through its adherence to specified safety and performance standards for medical electrical equipment and laser products. The acceptance criteria are implicit in meeting the requirements of these standards.

2. Sample Size Used for the Test Set and Data Provenance

The provided text only mentions "System and component testing" without specifying a sample size in terms of the number of devices tested. It also does not specify the provenance of any data (e.g., country of origin, retrospective/prospective clinical data). The testing appears to be primarily laboratory/bench testing against engineering specifications and international standards, rather than clinical trials with patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The study described is primarily technical testing against established engineering and safety standards, not a study requiring expert-established ground truth for medical diagnoses or outcomes.

4. Adjudication Method for the Test Set

Not applicable. The study described involves compliance testing against technical standards, not a process of adjudicating medical interpretations.

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 laser photocoagulator, not an AI software intended for image interpretation or diagnostic assistance. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this submission.

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 system.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is compliance with established international and Japanese electro-medical and laser safety standards (EN 60601-1, EN 60601-1-2, EN 60601-1-4, IEC 60601-2-22, JIS T1204, and JIS C6802) and product specifications derived from a risk analysis. There is no mention of expert consensus, pathology, or outcomes data as "ground truth" in this context.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical instrument and does not involve AI or machine learning algorithms that require 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.

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