Search Results

PASCAL® Streamline 577 (with Accessories) is intended for use 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:

• proliferative and nonproliferative diabetic retinopathy
• macular edema
• choroidal neovascularization
• branch and central retinal vein occlusion
• the treatment of choroidal neovascularization associated with wet 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:

• iridotomy
• trabeculoplasty

The PASCAL® Streamline 577 (with Accessories) is an Optically Pumped Semiconductor Laser (OPSL: solid state) with integrated slit lamp that is intended for use in ophthalmic applications. The PASCAL® Streamline 577 system delivers 577 nm laser light (yellow) at a spot size range of 60 - 400 micrometers (um) to the focal plane of the slit lamp. The integrated slit lamp allows the physician (using a physician selected lens) to deliver the laser light to the treatment site. The treatment laser delivers single pulses or a scanned pattern of 100 to 2000 milliwatts (mW) per pulse duration of approximately 5 - 1000 milliseconds (ms) per pulse. A diode laser (635 nm) provides a visible aiming beam.

Laser light is delivered to the treatment site via the integrated slit lamp or via an optional Laser Indirect Ophthalmoscope (LIO) 577 with eye safety filter for ophthalmic indications.

The physician is able to control the delivery of laser energy using a footswitch.

The PASCAL® Streamline 577 (with Accessories) is comprised of the following functional components:

• Slit Lamp Table with integrated 577 nm laser system:
• 577 nm Laser system control electronics and power supply;
• Control Panel with LCD (liquid crystal display) Touchscreen;
• Keyswitch:
• Emergency Laser Stop Button;
• Footswitch;
• Door Interlock Plug;
• Power cable [4.6 m (15 ft.) long]
• Connector Ports for the table lift power connector, the table lift up/down control connector, the door interlock connector, the footswitch connector, and a USB connector for an optional printer.
• a Rolling base with lockable wheels.
• Printer (optional).
• Slit Lamp with integrated scanning pattern generator (and laser eye safety filter).

Accessories (Optional)

• Laser Indirect Ophthalmoscope (LIO) 577 with eye safety filter.
• Video Teaching System (VTS).
• Physician Elbow Rest.

The provided text does not contain acceptance criteria for a device, nor does it describe a study proving the device meets acceptance criteria in the way typically associated with algorithmic performance (e.g., sensitivity, specificity, AUC).

Instead, this document is a 510(k) Summary for a medical device (PASCAL® Streamline 577), which focuses on demonstrating substantial equivalence to existing predicate devices already on the market. The "study" referenced implicitly in this context is the comparison between the new device's technical characteristics and the predicate devices, rather than a clinical trial or performance evaluation against specific metrics like accuracy or error rates.

Here's how to interpret the provided information within the context of a 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance:

There is no table of "acceptance criteria" for performance metrics like sensitivity or specificity. Instead, the document provides a table comparing the technical characteristics of the new device (PASCAL Streamline 577) to its predicate devices. The "acceptance criteria" here are implicitly that the new device's technical specifications are similar enough to the legally marketed predicate devices to establish substantial equivalence.

Implicit Acceptance Criteria: The new device's specifications (e.g., laser wavelength, power output range, pulse duration) must be within acceptable ranges or comparable to those of the predicate devices. Deviations (like the 577nm vs. 532nm wavelength difference from one predicate) must be justified as not raising new questions of safety or effectiveness.

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

• Test Set Sample Size: None specified. This is not a study involving a "test set" of patient data for performance evaluation in the typical sense of AI/diagnostic devices. The "test" environment would be the performance of the physical device components against engineering specifications.
• Data Provenance: Not applicable in the context of clinical data. The "data" here are technical specifications of medical devices.

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

• Number of Experts/Qualifications: Not applicable. Ground truth for device technical specifications is established through engineering measurements and design documents, not clinical expert consensus on patient data. This section often applies to diagnostic AI.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. There is no clinical "test set" or diagnostic assessment requiring expert adjudication.

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

• MRMC Study: No. The document describes a laser device, not a diagnostic AI or imaging interpretation tool that would typically involve an MRMC study. Therefore, there is no effect size reported for human readers with vs. without AI assistance.

6. Standalone Performance Study:

• Standalone Performance Study: No, not in the sense of an algorithm operating independently on patient data to produce a diagnosis or risk score. The device is a physical laser system, and its "standalone performance" refers to its ability to meet its engineering specifications (e.g., laser power, wavelength accuracy, spot size) which are assessed through internal testing, not a clinical study detailed here.

7. Type of Ground Truth Used:

• Type of Ground Truth: Not applicable in the clinical sense. For a 510(k) submission showing substantial equivalence for a physical device, the "ground truth" for the device itself would be its engineering specifications and the validated performance of its components. For the "indications for use," the ground truth is established by decades of clinical experience with similar laser photocoagulation therapies.

8. Sample Size for the Training Set:

• Training Set Sample Size: Not applicable. This device is not an AI model that requires a training set of data.

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

• Ground Truth for Training Set Establishment: Not applicable, as there is no training set for an AI model.

In summary:

This document is a regulatory submission for a medical laser system. The "acceptance criteria" and "study" described are focused on demonstrating that the device is substantially equivalent to already-approved predicate devices based on its intended use, design features, and functional characteristics, rather than proving performance against clinical metrics through a new clinical trial or AI performance evaluation. The "study" implicitly refers to internal engineering testing and comparison to predicate device specifications.

Ask a specific question about this device