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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.

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.

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.

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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The SUPRA SCAN™ Delivery System when connected to a compatible laser system is indicated for use in the treatment of ocular pathology of anterior 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;
• · Age-related macular degeneration;
• · Retinal tears and detachments
• · Macular edema
• · Iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open angle glaucoma.

SUPRA SCAN™ 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 SCAN™ Delivery System consists of the following system components:

• 1. Scanning Laser Delivery System adapter 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 532nm retinal photocoagulator (SUPRA 532).
• 2. Scanner control module with LCD/Touch screen, power supply, electronics and electrical connections.

Here's an analysis of the provided text regarding the acceptance criteria and study for the SUPRA SCAN™ Delivery System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes the SUPRA SCAN™ Delivery System's equivalence to a predicate device rather than setting specific numerical acceptance criteria for performance in a clinical study. The "acceptance criteria" here are implicitly whether the device meets the specifications and safety standards of the predicate device, or relevant international and US standards. The "reported device performance" is essentially a comparison of its technical specifications to those of the predicate.

Given the nature of the submission (510(k) for substantial equivalence), the acceptance criteria are primarily that the device's technical characteristics, safety profile, and intended use are sufficiently similar to the predicate device.

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

The document explicitly states: "Clinical Conclusion: No Clinical information is required." This indicates that no clinical test set (i.e., human patient data) was used for this 510(k) submission. Therefore, there is no sample size for a test set, nor data provenance (country of origin, retrospective/prospective).

The evaluation was based on non-clinical performance data, which involved laboratory testing to validate and verify that the device met all design specifications and was substantially equivalent to the predicate device. The provenance of this non-clinical testing data would be from the manufacturer's (Quantel Medical, France) internal labs.

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

As no clinical data or test set involving human patients was used, no experts were used to establish ground truth for a clinical test set. The evaluation relied on technical specification comparisons and adherence to established engineering and safety standards.

4. Adjudication Method for the Test Set

Since no clinical test set was utilized requiring expert interpretation, no adjudication method was employed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Status and Effect Size

No MRMC comparative effectiveness study was done. The submission solely focuses on demonstrating substantial equivalence to a predicate device through technical and safety performance comparisons, not on evaluating human reader improvement with AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Status

This device is a laser delivery system, not an AI algorithm. Therefore, the concept of "standalone (algorithm only)" performance is not applicable in this context. The device is intended for use by a trained ophthalmologist (human-in-the-loop product).

7. Type of Ground Truth Used

For this 510(k) submission, the "ground truth" was established by engineering specifications, international and US safety standards, and the technical characteristics of the predicate device. The primary ground truth was compliance with these established benchmarks rather than clinical outcomes or expert consensus on clinical findings.

8. Sample Size for the Training Set

No training set data is mentioned or relevant, as this is a physical medical device, not an AI/machine learning algorithm that requires training data.

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

Not applicable, as there is no training set for this type of device.

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