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.

AI/ML Overview

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.

Summary

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Nuvo-Lase 660 Laser System American Laser Medical, Inc. July 8, 1997

510(k) Summary

97256/

Regulatory Authority:

Safe Medical Devices Act of 1990, 21 CFR 807.92

Company Name/Contact:

Daniel Hoefer American Laser Medical رتون 1832 South 3850 West Salt Lake City, UT 84104 (801) 972-1311, FAX (801) 972-5251

Name of Device:

Trade Name:	NuvoLase 660 Laser System
Common Name:	Ophthalmic Laser Photocoagulator
Classification name: Ophthalmic Laser (per 21 CFR 886.4930)
Product Code: 86 HOF

Predicate Devices:

The NuvoLase 660 is substantially equivalent to the following legally marketed devices: The Prima 532 marketed by Nidek, Inc., and the Oculight GL marketed by IRIS Medical Instruments.

Description of Device:

The NuvoLase Model 660 is a continuous wave frequency-doubled diodepumped Nd: YAG laser system.

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Nuvo-Lase 660 Laser System American Laser Medical, Inc. July 8, 1997

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.

Intended Use:

The NuvoLase 660 Laser System is intended for use in retinal and macular photocoagulation and trabeculoplasty.

Technological Characteristics/Device Comparison:

The NuvoLase 660 Laser System is substantially equivalent to the Nidek Prima 532 and the IRIS Oculight GL Laser Photocoagulator already in commercial distribution. Each of these systems optically pumps an Nd: YAG crystal (NuvoLase 660 and Oculight GL using 808 nm diodes, Prima 532 using flashlamps) to produce laser light at 1064 nm. This light passes through a second crystal which exhibits a non-linear optical response, re-emitting the laser energy at the first harmonic of the 1064 nm line, 532 nm green. The continuous wave beam is then shuttered either mechanically or electro-optically to produce the desired exposure durations.

Each of these devices is intended for use in retinal photocoagulation, iridotomy, and trabeculoplasty. Each is a 532 nm true continuous wave device, generated by a frequency doubled diode pumped Nd: YAG crystal. Laser energy is delivered by equivalent delivery devices in each case.

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.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized caduceus symbol. The caduceus is depicted with a staff entwined by a serpent, representing healing and medicine. The seal is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Daniel Hoefer American Laser Medical, Inc. 1832 South 3850 West Salt Lake City, Utah 84104

OCT - 6 1007

Re: K972561 Trade Name: NuvoLase 660 Laser System Regulatory Class: II Product Code: GEX Dated: July 8, 1997 Received: July 9, 1997

Dear Mr. Hoefer:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Daniel Hoefer

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page of I

K972561 `10(k) Number (if known):

Device Name: NuvoLase 660 Laser System

Indications For Use:

۱۰۰۶

Retinal and Macular photocoagulation
Trabeculoplasty

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (OOE)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K972561

Prescription Use	✓	OR	Over The-Counter Use
(Per 21 CFR 801.109)			(Optional Format 1-2-96)

Regulation Number and Section

§ 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.