(89 days)
The NuvoLase 660 Laser System is intended for use in retinal and macular photocoagulation and trabeculoplasty.
Indications For Use:
- Retinal and Macular photocoagulation
- Trabeculoplasty
The NuvoLase Model 660 is a continuous wave frequency-doubled diode-pumped Nd: YAG laser system. Treatment beam power output for the NuvoLase 660 laser is adjustable to a maximum of 2.0 Watts continuous wave at 532 nm. The aiming beam is provided by a red diode laser operating at 670 nm. Exposure times for the NuvoLase 660 Laser System (in seconds) are 0.02, 0.05, 0.1, 0.25, 0.5, 1.0, and continuous. Delivery of the beam occurs via Rodenstock RO 5000 LS laser slit lamp, connected to the laser by fiber optic.
Here's a breakdown of the acceptance criteria and the study information for the Nuvo-Lase 660 Laser System, based on the provided text.
Note: The provided document is a 510(k) summary for a medical device submitted in 1997. It describes a substantial equivalence determination rather than a novel clinical effectiveness study with strict acceptance criteria and performance metrics as might be seen for newer AI/machine learning devices. Therefore, many of the requested categories related to AI performance, sample sizes for training/test sets, expert consensus, and comparative effectiveness studies are not applicable or cannot be extracted from this type of document. The study's "acceptance criteria" here refer to demonstrating substantial equivalence to predicate devices, rather than meeting specific performance thresholds for diagnostic accuracy, for example.
Nuvo-Lase 660 Laser System Acceptance Criteria and Study Information
The Nuvo-Lase 660 Laser System gained market clearance through the 510(k) pathway, demonstrating substantial equivalence to legally marketed predicate devices. This means that the "acceptance criteria" were primarily focused on showing that the device has the same intended use and similar technological characteristics, and raises no new questions of safety or effectiveness compared to the predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (based on Substantial Equivalence to Predicate Devices) | Reported Device Performance (as described in the 510(k) Summary) |
|---|---|
| Intended Use Equivalence: Intended for use in retinal and macular photocoagulation and trabeculoplasty. | Intended Use: The NuvoLase 660 Laser System is intended for use in retinal and macular photocoagulation and trabeculoplasty. (Matches predicate devices) |
| Technological Characteristics Equivalence: Similar laser type (continuous wave, frequency-doubled diode-pumped Nd:YAG), wavelength (532 nm), and energy delivery methods compared to predicate devices. | Technological Characteristics: Continuous wave frequency-doubled diode-pumped Nd: YAG laser system. Adjustable to a maximum of 2.0 Watts continuous wave at 532 nm. Aiming beam at 670 nm. Exposure times: 0.02, 0.05, 0.1, 0.25, 0.5, 1.0, and continuous. Beam delivered via Rodenstock RO 5000 LS laser slit lamp. Operates similarly to Nidek Prima 532 and IRIS Oculight GL, using 808 nm diodes to pump Nd:YAG crystal, producing 1064 nm light, then frequency-doubled to 532 nm green. (Similar to predicate devices) |
| Safety and Effectiveness Equivalence: Raises no new questions of safety or effectiveness compared to predicate devices. | Conclusion: The NuvoLase 660 Laser System is substantially equivalent to the Prima 532 marketed by Nidek, Inc. and the Oculight GL marketed by Iris Medical Instruments, already in legal commercial distribution. The materials, design, intended use, method of manufacture, warnings, cautions, and precautions are all substantially the same. (Implies no new safety/effectiveness concerns) |
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable and not provided in the 510(k) summary. A 510(k) submission for this type of laser device in 1997 relies on technical specifications and comparison to predicate devices, not on a clinical "test set" in the context of diagnostic performance or AI validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided. Ground truth establishment in the context of expert review for AI algorithms is not relevant to this type of device and submission.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Adjudication methods are used in studies involving human interpretation or performance evaluation, which is not the primary focus of this 510(k) submission.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
This information is not applicable and not provided. An MRMC study is not relevant for a laser photocoagulator device seeking substantial equivalence based on technical specifications.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
This information is not applicable and not provided. This is a hardware laser system, not a standalone algorithm.
7. The Type of Ground Truth Used
The "ground truth" in this context is the established safety and effectiveness of the predicate devices (Nidek Prima 532 and IRIS Oculight GL) allowed by their prior marketing. The manufacturer asserted that the NuvoLase 660 shared the same fundamental characteristics and intended use, thus making it "substantially equivalent."
8. The Sample Size for the Training Set
This information is not applicable and not provided. There is no "training set" in the context of an AI algorithm, as this is a physical medical device.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided. There is no "training set" or corresponding ground truth establishment in the context of an AI algorithm for this device.
§ 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.