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The SUPRA SCAN™ Delivery System when connected to a compatible laser system is indicated for use in the treatment of ocular pathology of anterior and posterior segments including, retinal photocoagulation, pan retinal photocoagulation for vascular and structural abnormalities of the retina and choroids including:

Proliferative and nonproliferative diabetic retinopathy;
Choroidal neovascularization;
Branch retinal vein occlusion;
Treatment of choroidal neovascularization associated with wet age-related macular degeneration;
Retinal tears and detachments
Macular edema
Retinopathy of prematurity
Iridotomy and trabeculoplasty in angle closure glaucoma and open angle glaucoma.

Device Description

SUPRA SCANTM Delivery System is a scanning laser delivery system that enables the use of proprietary pattern scanning technology when coupling with laser platforms. This offers existing commercially available laser platform the ability to deliver a full spectrum of pattern scanning options.
The Quantel Medical SUPRA SCANTM Delivery System consists of the following system components:
l ) Scanning Laser Delivery System adaptor with scanner controls that may be coupled to a slit lamp type Haag Streit or similar models, and connected to a currently cleared Quantel Medical 577nm retinal photocoagulator (SUPRA 5577.Y-K091581).
2) Scanner control module with LCD/Touch screen, power supply, electronics and clectrical connections.

AI/ML Overview

Acceptance Criteria and Study for Quantel Medical SUPRA SCAN™ Delivery System

This response outlines the acceptance criteria and the study conducted for the Quantel Medical SUPRA SCAN™ Delivery System, as detailed in the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a table of quantitative acceptance criteria with corresponding performance results. Instead, the basis for clearance is substantial equivalence to predicate devices. The primary "performance" demonstrated is that the device met all design specifications and exhibited substantial equivalence to the predicates.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Design Specifications	Met all design specifications	Laboratory testing confirmed the device met all design specifications.
Substantial Equivalence	Equivalent indications for use, safety compliance, similar design features, and functional features to predicate devices.	The SUPRA SCAN™ Delivery System shares the same indications for use and safety compliance, similar design and functional features with the predicate devices (PASCAL Streamline 577 (K111108), IQ 577 (K071687), and Quantel Medical SUPRA SCAN™ Delivery System coupled to a SUPRA 532 (K100678)).
Key Performance Feature	Similar energy output performance at 400 microns spot size compared to predicate devices.	The SUPRA SCAN™ Delivery System offers to treat at 400 microns with equivalent energy output performance.
Clinical Significance of Differences	Any differences from predicate devices should not be clinically significant.	The only difference (maximum spot size of 500 microns vs. 400 microns for PASCAL Streamline 577) was deemed not clinically significant, as the SUPRA SCAN™ Delivery System also supports a 400-micron spot size with equivalent performance.

2. Sample Size for Test Set and Data Provenance

The document does not describe a clinical study with a "test set" in the traditional sense of patient data. The performance claims are based on laboratory testing to verify design specifications and substantial equivalence. Therefore:

Sample Size for Test Set: Not applicable, as no human subject test set was used for performance evaluation in the provided summary.
Data Provenance: Not applicable. The "study" was laboratory testing, implying in-house validation.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Number of Experts: Not applicable. Given the nature of the study (laboratory testing for design specifications and substantial equivalence), no external experts were used to establish ground truth from a clinical perspective.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable, as there was no clinical test set requiring expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study Done: No. The provided information does not mention an MRMC comparative effectiveness study involving human readers. The device is a delivery system for a laser, not an diagnostic imaging tool that would typically be evaluated with MRMC studies.
Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: Not applicable, as no MRMC study was conducted and the device is a laser delivery system, not an AI diagnostic tool.

6. Standalone Performance Study

Standalone Performance Study Done: Yes, in the sense that laboratory testing was conducted to validate and verify that the SUPRA SCAN™ Delivery System met all design specifications. This laboratory testing evaluated the device's intrinsic characteristics and functions without direct human intervention as an evaluator of diagnostic output.

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth for this device's performance evaluation was defined by engineering and design specifications and the characteristics of the predicate devices. The goal was to prove that the device performs according to its intended design and is comparable to legally marketed devices.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. The device is not an AI algorithm that requires a training set of data. Its development would likely involve engineering iterations and testing against specifications, not a data-driven training process.

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

How Ground Truth for Training Set Was Established: Not applicable, as there was no training set for an AI algorithm.

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