(90 days)
The Nidek Frequency Doubled Nd: YAG Laser is intended to be used in all clinical applications for which an Argon Laser would be used in ophthalmic surgery, including but not limited to Retinal and Macular Photocoagulation; Iridotomy and Trabeculoplasty.
The Nidek GYC-1500/2000 Solid State Photocoagulators are frequency doubled Nd: YAG lasers producing a characteristic 532 nanometer (nm) wavelength light as A 633nm helium-neon (HeNe) laser is used for the aiming beam treatment beam. source. The doubling process of the 1064nm wavelength results when the infrared beam goes through a special crystal, which is an optical dielectric that exhibits a non-The 532nm - Green - wavelength is produced by linear optical response. harmonic generation of the 1064nm laser beam. The laser treatment beam is delivered through the cornea to the target tissue by an optical delivery system which is mounted either on a slit lamp microscope or binocular indirect microscope. Tissue may also be treated inter-operatively by direct radiation from a fiber optic end-ocular probe or a optical deliver system mounted on an operating microscope. The beam may be further manipulated by accessory contact lenses or near contact "aspheric" lenses. An aiming beam is provided by the system to indicate the target tissue prior to the treatment exposure. The desired treatment parameters of power exposure duration, and spot size are selected as required. The location and operation of all controls and indicators is described in the Nidek Prima Frequency Doubled Nd:YAG Operator Manual. Treatments are always started with the lowest applicable exposure and the dosage is increased until the desired effect is obtained.
This document is a 510(k) summary for the Nidek Models GYC-1500 and GYC-2000 Solid State Ophthalmic Laser Photocoagulator. This submission is an amendment to a previous 510(k) (K951079) to add two new indications: iridotomy and trabeculoplasty. The document primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the device description and software validation process.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not contain acceptance criteria in the traditional sense of numerical performance targets (e.g., sensitivity, specificity, accuracy) for an AI/CADe device. This is a medical device submission for a laser photocoagulator, not an algorithm, and the "acceptance criteria" here refer to regulatory requirements for demonstrating substantial equivalence. The "performance" is intrinsic to the device's function as a laser.
However, based on the context of the submission, the implicit "acceptance criteria" and "performance" are as follows:
| Acceptance Criteria (Implied Regulatory) | Reported Device Performance |
|---|---|
| Safety: Device operates without undue risk to patients or users. | Not explicitly quantified with metrics, but implied by: |
| - The device is a frequency-doubled Nd:YAG laser producing a 532 nm wavelength, similar to Argon lasers commonly used in ophthalmic surgery. | |
| - A 633nm HeNe laser is used for aiming, indicating tissue prior to treatment. | |
| - Treatments are always started with the lowest applicable exposure, with dosage increased until the desired effect is obtained, indicating user control and safety protocols. | |
| - "There are no significant changes or modifications from the predicate products that affects safety, effectiveness, or the intended use of the product." (Section 6) | |
| Effectiveness: Device performs its intended clinical applications. | Not quantified with clinical outcomes data in this document, but established by: |
| - Intended Use: "The Nidek Frequency Doubled Nd: YAG Laser is intended to be used in all clinical applications for which an Argon Laser would be used in ophthalmic surgery, including but not limited to Retinal and Macular Photocoagulation; Iridotomy and Trabeculoplasty." (Section 4 and Indications For Use page) | |
| - Substantial Equivalence: Demonstrated through comparison to predicate devices (Ophthalas 532 by Alcon, Cerlas G by CeramOptec, Oculight GL by Iris, and previous Nidek GYC-1500/2000 K951079). The submission states the purpose is to add iridotomy and trabeculoplasty, implying the core functionality for other applications (retinal and macular photocoagulation) was previously established. | |
| Software Validation: Software ensures reliable and safe operation. | Nidek has "implemented the software development process which is described and defined in the Software Development Procedure." This includes: |
| - Hazard (risk) analysis and mitigation. | |
| - Design reviews at each phase (specifications, coding, module/integration testing). | |
| - Verification that specifications address design requirements. | |
| - Validation through module and integration testing, ensuring specifications and system requirements are met. | |
| - Engineering and Quality Assurance management review of documentation and reports to assure system specifications and requirements have been met. (Section 9) | |
| Technical Specifications: (e.g., wavelength, power) consistent with intended use and predicate devices. | - Wavelength: 532 nanometer (nm) (green) for treatment, 633nm for aiming. |
| - Power: GYC-1500 has max. power of 1.5W, GYC-2000 has max. power of 2.0W. These are the same models as previously cleared (K951079), with the current application adding indications, not changing core power specifications. (Section 3 and 5) |
2. Sample size used for the test set and the data provenance
The document does not describe a "test set" in the context of an algorithm or AI model evaluation. This is a 510(k) submission for a physical medical device (laser). Therefore, there is no mention of a traditional "sample size" of patient data or data provenance (country of origin, retrospective/prospective) for algorithm testing.
The "test" described pertains to software validation which involves testing the software against its specifications and system requirements. This is internal software testing, not clinical data evaluation for device performance as a diagnostic or AI tool.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As described in point 2, there is no "test set" in the context of an algorithm requiring expert-established ground truth. The "ground truth" for this device's performance would be the physical properties of the laser and its effectiveness in specified surgical procedures, typically assessed through clinical studies (which are not detailed in this summary for the new indications, as the submission relies on substantial equivalence).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no "test set" for an algorithm requiring an adjudication method.
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 is not an AI or CADe device. An MRMC study would not be relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable to "ground truth" for an algorithm. For a physical device like a laser, the "truth" is established by its physical specifications (power, wavelength), its established mechanism of action in ophthalmic surgery, and the prior regulatory clearances of similar devices for similar indications. The addition of "iridotomy and trabeculoplasty" relies on the substantial equivalence to predicate devices that are already cleared for these procedures, implying historical clinical evidence supports their efficacy and safety.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device, so there is no "training set" or corresponding ground truth establishment process.
§ 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.