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The PASCAL® Laser Indirect Ophthalmoscope is intended for use with the PASCAL Streamline 577 laser or the PASCAL Streamline 532 laser when either of those lasers is used in the treatment of ocular pathology in the posterior segment; retinal photocoagulation, panretinal photocoagulation, focal photocoagulation and grid photocoagulation for vascular and structural abnormalities of the retina and choroid including:

532nm

. macular edema
age-related macular degeneration .
. lattice degeneration
. retinal tears and detachments

577nm

proliferative and nonproliferative diabetic retinopathy .
macular edema .
choroidal neovascularization .
. branch and central retinal vein occlusion
. age-related macular degeneration
. lattice degeneration
retinal tears and detachments .
retinopathy of prematurity .

Intended for use in the treatment of ocular pathology in the anterior segment including:

577nm

iridotomv .
trabeculoplasty .

Device Description

The PASCAL Laser Indirect Ophthalmoscope (LIO) with eye safety filter is a non-sterile, multiple use, delivery device that is worn on the physician's head and is used in conjunction with a compatible hand held ophthalmoscopic examination lens to view and treat the patient's retina. LIOs are used to treat patients in a supine position or who could not otherwise be treated using a slit lamp delivery system.

AI/ML Overview

This document is a 510(k) Pre-market Notification for a medical device called the PASCAL® Laser Indirect Ophthalmoscope. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through clinical studies in the typical sense for AI/software devices.

Therefore, many of the requested sections regarding acceptance criteria and performance against those criteria, especially those pertaining to AI/software performance assessment like MRMC studies, standalone performance, and ground truth establishment, are not applicable to this type of submission.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" and "reported device performance" in this 510(k) is framed around substantial equivalence to predicate devices rather than quantitative performance metrics for a novel functionality. The primary acceptance criteria for a 510(k) submission are that the new device has the same intended use and technological characteristics as a legally marketed device (predicate device) and does not raise new questions of safety and effectiveness.

Acceptance Criteria Category	Specific Criteria (from text)	PASCAL® Laser Indirect Ophthalmoscope Performance (from text)
Intended Use	Same as predicate devices	"The PASCAL® Laser Indirect Ophthalmoscope shares the same indications for use..." (Section VII)
Technological	Similar design features and functional capabilities as predicate devices	"The technological characteristics of the PASCAL® Laser Indirect Ophthalmoscope are substantially equivalent to those of the predicate devices." (Section VI)
Characteristics	Treatment Wavelength: 577 ±2 nm or 532 ±2 nm Aiming Wavelength: 635 +10 nm Eye Filter OD: > 5 @ 532 nm or > 5 @ 577 nm Working Distance: 280 mm Fiber Length: 5 meters Aerial Spot Size: 1060 µm Illumination Source: LED and DC Battery Cooling System: Convection Cooled Air Weight: < 7 lbs.	Treatment Wavelength: 577 ±2 nm or 532 ±2 nm (Matches K111108 for 577nm, and K062336 for 532nm) Aiming Wavelength: 635 +10 nm (Matches both predicates) Eye Filter OD: > 5 @ 532 mm or > 5 @ 577 nm (Matches both predicates) Working Distance: 280 mm (Matches both predicates) Fiber Length: 5 meters (Matches both predicates) Aerial Spot Size: 1060 µm (Matches both predicates) Illumination Source: LED and DC Battery (Different from predicates, but considered "similar" functionality) Cooling System: Convection Cooled Air (Matches both predicates) Weight: < 7 lbs. (Matches both predicates)
Safety and Effectiveness	Does not raise new questions of safety and effectiveness compared to predicates	"The review of the indications for use and technical characteristics demonstrates that the PASCAL® Laser Indirect Ophthalmoscope is substantially equivalent to the predicate devices." (Section VIII)

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

Not applicable. This is a hardware device submission demonstrating substantial equivalence, not a performance study on a test set of data. There is no "test set" of patient data in the context of evaluating an algorithm.

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

Not applicable. There is no test set or ground truth established by experts for algorithmic performance in this submission.

4. Adjudication Method for the Test Set

Not applicable. There is no test set or adjudication method described for an algorithm.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This submission is for a medical device (a laser indirect ophthalmoscope), not an AI/software algorithm intended to aid human readers in diagnostic tasks.

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

No, a standalone algorithm performance study was not done. This device is a delivery system for laser treatment, used by a physician (human-in-the-loop is inherent in its intended use), and does not involve AI or algorithms running independently.

7. The Type of Ground Truth Used

Not applicable. "Ground truth" in the context of expert consensus, pathology, or outcomes data is relevant for evaluating diagnostic or predictive algorithms. This submission is for a laser delivery device, where the "ground truth" relates to its physical and functional specifications meeting pre-defined engineering and safety standards, and its equivalence to devices already on the market.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of an algorithm for this device.

9. How the Ground Truth for the Training Set was Established

Not applicable. There is no training set or ground truth for algorithmic development in this submission.

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