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The iScience Surgical Ophthalmic Viscoinjector is a manually operated device for precision delivery of small amounts of viscous fluid such as a sterile viscoelastic solution pre-packaged in a cartridge, for example Healon, HealonGV and Healon5 manufactured by Advanced Medical Optics Inc., and Ocucoat manufactured by Bausch and Lomb.

The iScience Surgical Ophthalmic Viscolnjector consists of a holder for a viscoelastic The loolorios bargreates a manually operated screw driven plunger. For use, a cantridge of viscoelastic solution is placed into the body of the Ophthalmic Viscolnjector. A needle inside the Ophthalmic Viscolnjector pierces the septum of the viscoelastic cartridge as it is seated within the body cavity. The cap from the Ophthalmic Cannage as it is connected to the body to secure the cartridge of viscoelastic solution inside the Viscolnjector. The thumbwheel is rotated clockwise thereby advancing the screw driven plunger to deliver viscoelastic solution. The end of the screw has a bushing that contacts the stopper in the viscoelastic cartridge. As the screw is advanced at a controlled rate the stopper displaces fluid out through the needle that has pierced the septum. The opposite, blunt end of the needle is embedded in a male Luer lock connector. This connector may be mated to a female Luer connector and the viscoelastic solution delivered. Markings on the thumbwheel, cap, and body of the Viscolnjector are provided to assist in determining the number of complete or partial thumbwheel rotations and thus relate to the amount of fluid delivered.

The provided text describes the iScience Surgical Ophthalmic Viscoinjector, a manually operated device for precision delivery of small amounts of viscous fluid. The company submitted a 510(k) premarket notification to the FDA, and the device was determined to be substantially equivalent to previously marketed devices.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The text does not explicitly state numerical acceptance criteria with pass/fail values. Instead, it refers to general guidance and the intrinsic strength of materials. The performance section indicates that the device has been shown to conform to certain standards and practices.

• Strength of device joints
• Static pressure failure
• Delivery of fluid (e.g., viscoelastic solution) |

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

The document does not specify the sample size used for performance testing (e.g., number of devices tested for joint strength, static pressure, or fluid delivery).

The data provenance is not explicitly mentioned as retrospective or prospective, nor is the country of origin of the data provided.

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

This information is not applicable and not provided. The study focuses on the mechanical and functional performance of a medical device, not on diagnostic accuracy requiring expert interpretation of results. The "ground truth" in this context would be objective measurements of physical properties and fluid delivery.

4. Adjudication Method for the Test Set

This is not applicable and not provided. Performance testing involved objective measurements against established engineering principles and standards, not subjective assessments requiring adjudication.

5. 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

This is not applicable. The device is a manually operated ophthalmic viscoinjector, a physical instrument for fluid delivery, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance was not conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable. The device is a mechanical instrument, not an algorithm, and its operation inherently involves human interaction (manual operation).

7. The Type of Ground Truth Used

The "ground truth" for the performance testing appears to be based on:

• Objective Measurements: Such as measurements of joint strength, static pressure at failure, and the volume or precision of fluid delivery.
• Established Industry Standards and Guidance: ISO 7886-1-1994, ANSI/AAMI/ISO 11137-1994, ANSI/AAMI/ISO 11607-1997, and AAMI TIR.
• Engineering Principles: Related to the intrinsic strength of materials and the expected loads during use.

8. The Sample Size for the Training Set

This is not applicable. The device is a mechanical medical instrument, not a machine learning model, so there is no concept of a "training set" in this context.

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

This is not applicable for the reasons stated in point 8.

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The iScience Surgical Ophthalmic Microcannula is indicated for fluid infusion and aspiration, as well as illumination, during surgery.

The iScience Surgical Ophthalmic Microcannula, or iTRACK, is a flexible microcannula designed to allow atraumatic cannulation of spaces in the eye such as the anterior chamber and posterior segment, for infusion and aspiration of fluids during surgery, including saline and viscoelastics. The microcannula incorporates an optical fiber to allow transmission of light to the microcannula tip for surgical illumination and guidance.

This document is for an Ophthalmic Microcannula, a physical surgical device, and not an AI/ML powered device. Therefore, the questions related to AI/ML specific criteria (such as acceptance criteria, study details, ground truth, sample sizes for training/test sets, MRMC studies, etc.) are not applicable here.

The document primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices through:

1. Device Description: Outlining the design and function of the iScience Surgical Ophthalmic Microcannula (iTRACK).
2. Indication for Use: Stating its purpose for fluid infusion and aspiration, and illumination during surgery.
3. Predicate Devices: Identifying existing devices it claims substantial equivalence to (American Medical Devices Endolight, Syntec True Light, Micron Surgical Weiss Retinal Cannula).
4. Technological Characteristics: Asserting that its intended use and technological features do not differ from predicate devices, using similar materials and methods of operation.
5. Performance Data (Non-AI/ML): Mentioning conformance to standards for sterilization, shelf-life, and packaging integrity (e.g., ANSI/AAMI/ISO 11137-1994, ANSI/AAMI/ISO 10993, ANSI/AAMI/ISO 11607-1997). This "performance data" refers to compliance with manufacturing and safety standards, not AI model performance.
6. Conclusion: Stating that due to meeting stated standards and similar technological characteristics to predicate devices, it is substantially equivalent, safe, and effective.

Since the device is not an AI/ML product, it does not have "acceptance criteria" or a "study that proves the device meets the acceptance criteria" in the way an AI/ML model would to demonstrate diagnostic accuracy or clinical effectiveness. Instead, acceptance is based on demonstrating substantial equivalence to existing, legally marketed devices, and adherence to relevant safety and manufacturing standards for medical devices.

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