The OcuLight GL is a semiconductor-based ophthalmic laser photocoagulator which delivers true continuous wave green laser light. It will only be used in conjunction with three fiber optically coupled delivery devices which have received prior FDA-premarket clearance: the IRIS Slit Lamp Adapter (K912918 for retinal photocoagulation and K913430 for laser trabeculoplasty), the IRIS EndoProbe (K894841), and the IRIS Laser Indirect Ophthalmoscope (K903288).

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and supporting studies:

Based on the provided text, it is not possible to describe acceptance criteria or a study that proves the device meets specific acceptance criteria in the way a modern AI/ML device submission would. The document is a 510(k) summary for a medical device (OcuLight GL laser photocoagulator) from 1996, which predates advanced AI/ML algorithms and their associated rigorous validation frameworks.

The document focuses on demonstrating substantial equivalence to existing predicate devices, a common pathway for medical device clearance. This process typically involves showing that the new device has the same intended use, technological characteristics, and safety/effectiveness profile as legally marketed devices, rather than meeting specific performance thresholds against a defined ground truth.

Therefore, many of the requested data points (sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, ground truth for training/test sets, training set sample size) are not applicable or mentioned in this type of 510(k) summary for a hardware-based laser device from that era.

Below is an attempt to structure the available information per your request, with significant caveats where information is missing or not relevant to the context of this device type and submission era.

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
(Implicit) Substantial Equivalence to Predicate Devices:	The OcuLight GL is stated to be substantially equivalent to other legally marketed laser photocoagulator devices, including the IRIS Medical OcuLight SL (K894841), Coherent Novus 2000® (K913127), and Alcon Ophthalas® 532 (K932062). This implies meeting the safety and effectiveness standards demonstrated by these predicates for "retinal photocoagulation and laser trabeculoplasty."
(Implicit) Consistent Intended Use: Perform retinal photocoagulation and laser trabeculoplasty by an ophthalmologist.	The device's intended use is explicitly stated as "retinal photocoagulation and laser trabeculoplasty to be performed by the ophthalmologist," aligning with the predicate devices.
(Implicit) Technological Characteristics: Deliver continuous wave green laser light for treatment, and red laser light for aiming.	The OcuLight GL "is a semiconductor-based laser photocoagulator console which delivers true continuous wave green laser light." It also uses a "second visible red (630-650 nm) semiconductor CW laser is used for aiming." The document details the specific wavelengths and continuous wave nature.
(Implicit) Compatibility with Prior Cleared Delivery Devices:	The OcuLight GL "will only be used in conjunction with three fiber optically coupled delivery devices which have received prior FDA-premarket clearance: the IRIS Slit Lamp Adapter (K912918, K913430), the IRIS EndoProbe (K894841), and the IRIS Laser Indirect Ophthalmoscope (K903288)."

Note: The acceptance criteria here are inferred from the 510(k) summary's focus on substantial equivalence. There are no explicit performance metrics (e.g., sensitivity, specificity, accuracy) defined or evaluated against a ground truth as would be expected for an AI/ML device.

Detailed Information (as far as available from the text):

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not applicable/Not provided. This document does not describe a clinical study with a "test set" in the context of an AI/ML algorithm. The demonstration of substantial equivalence relies on comparing technical specifications and intended use with predicate devices, rather than a clinical trial with a defined patient cohort.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. No "test set" or ground truth establishment by experts for performance evaluation is described.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not provided.
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:
- No. This is a hardware device for surgical procedures (laser photocoagulation), not an AI/ML diagnostic or assistive tool for human readers. Therefore, an MRMC study related to readers improving with AI assistance is not relevant or described.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable/No. This device is a laser system operated by a human ophthalmologist; there is no "algorithm only" performance to evaluate.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. The concept of "ground truth" for evaluating an AI/ML algorithm's output is not relevant to this type of device submission. The efficacy and safety are deemed equivalent to predicate devices, which would have had their own clinical data or established safe use.
The sample size for the training set:
- Not applicable/Not provided. This device does not involve a "training set" in the context of machine learning.
How the ground truth for the training set was established:
- Not applicable/Not provided.

Summary

{0}------------------------------------------------

K960971

AIG 28 MB

510(k) Summary IRIS Medical Instruments, Inc. OcuLight GL

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Theodore A. Boutacoff IRIS Medical Instruments, Inc. 340 Pioneer Way Mountain View, CA 94041 415-962-8100

Contact Person: (same as above)

Date Prepared: March 7,1996

Name of Device and Name/Address of Sponsor

OcuLight GL

IRIS Medical Instruments, Inc. 340 Pioneer Way Mountain View, CA 94041

Classification Name

Ophthalmic Laser Photocoagulator CFR Section: 886.4390 Product Code: 86 HOF

Predicate Devices

The OcuLight GL Laser Photocoagulator system is substantially equivalent to other currently legally marketed laser photocoagulator devices including IRIS Medical OcuLight SL Laser Photocoagulator System (K894841), the Coherent Novus 2000® Laser Photocoagulator system (K913127); the Alcon Ophthalas® 532 Laser Photocoagulator System (K932062).

{1}------------------------------------------------

Intended Use

The intended use of this device is retinal photocoagulation and laser trabeculoplasty to be performed by the ophthalmologist.

Technological Characteristics and Substantial Equivalence

The OcuLight GL is a semiconductor-based laser photocoagulator console which delivers true continuous wave green laser light. The OcuLight GL uses infrared (808 nm) semiconductor diode laser light as the primary source of energy which is then wavelength converted to a visible green (532 nm) laser light for delivery to the patient's eye and treatment. A second visible red (630-650 nm) semiconductor CW laser is used for aiming.

The OcuLight GL is substantially equivalent to other currently legally marketed laser photocoagulator devices including the Coherent Novus 2000® Laser Photocoagulator system (K913127); the Alcon Ophthalas® 532 Laser Photocoagulator System (K932062); as well as the IRIS Medical OcuLight SL Laser Photocoagulator System (K894841). All of these predicate devices are indicated for retinal photocoagulation using slit lamp delivery, endophotocoagulation probes, and the laser indirect ophthalmoscope; and for laser trabeculoplasty using slit lamp delivery. The Coherent Novus 2000 uses an argon gas laser as the treatment laser. The colors of the treatment beam are blue (488 nm) and green (514 nm). A moving filter is used to restrict delivery of only green laser light when desired. Power delivered is true continuous wave. The color of the treatment beam for the Alcon Ophthalas 532 is green (532 nm). This beam is generated from a frequency-doubled Nd: Y AG laser which is optically pumped by arc lamps and acousto-optically Qswitched. Power delivered is pulsed. The color of the treatment beam for the IRIS Medical OcuLight SL is infrared (810 nm). This beam is generated directly from a semiconductor laser diode. Power delivered is true continuous wave.

Device Description

Regulation Number and Section

§ 886.4390 Ophthalmic laser.

(a)
Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.(b)
Classification. Class II.