Search Results

The iScience Surgical Fiberoptic Illuminator is indicated for illumination during anterior and posterior segment ophthalmic surgery.

The iScience Surgical Fiberoptic Illuminator (FI) is a portable light source intended to provide illumination during anterior and posterior segment ophthalmic surger. It is designed to be used only with the iScience Surgical iTrack Ophthalmic Microcannula to illum nate tissues during advancement into intraocular structures of the anterior and posterior segment.

The FI consists of a splash proof sheet metal enclosure with panel mounted rocker switches for operational control, and a custom light output connector. The FI houses a laster dionel illumination source, and is specific for the iScience Surgical iTrack Ophthalmic Microcannula. The FI is not intended to be sterilized or placed in a sterile enclosure.

The FI has a custom designed light output connector that contains two redundant safety interlock switches. These switches, in conjunction with electronic circuitry in the Fly ensure that laser light can only emanate from the laser aperture when an iScience Surgical iTrack Ophthalmic Microcannula is installed in the connector. The interlock switches independently detect the proper insertion of the iScience Surgical iTrack Ophthalmic Microoannulaipe into thre connector, ensuring that the microcannula is fully engaged and retained in the connector before laser output is enabled.

The provided 510(k) summary for the iScience Surgical Fiberoptic Illuminator (K062259) does not contain the level of detail typically found in a clinical study for medical device clearance. This submission primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and a limited in-vitro test rather than a full clinical study with acceptance criteria and statistical analysis of performance.

Therefore, many of the requested details about acceptance criteria, sample sizes, expert involvement, and ground truth establishment are not explicitly provided in the text. I will extract the information that is available and note when details are missing.

Here's a breakdown based on the provided text:

Acceptance Criteria and Device Performance

The concept of "acceptance criteria" as applied to a quantitative performance metric is not explicitly stated in the document. The study's conclusion is qualitative, focused on the sufficiency of illumination.

Study Details

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated. The study states "enucleated cadaver eyes," implying more than one, but no specific number is given.
   • Data Provenance: Retrospective (cadaveric eyes), country of origin not specified.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not specified. The statement "demonstrated equivalent results" implies an assessment was made, but the number or qualifications of individuals performing this assessment are not provided.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not specified.

4. 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:

   • No, an MRMC comparative effectiveness study was not done. This study is an in-vitro comparison of two illumination devices, not an AI-assisted diagnostic device study. The concept of "human readers improve with AI" is not applicable here.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • This is not an AI algorithm. The study was an in-vitro comparison of two illumination devices, one of which (the subject device) uses a different light source technology than its predicate.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" was the qualitative assessment of "sufficient illumination" for the task of advancing the microcannula into intraocular structures. This would likely be assessed by an expert (e.g., an ophthalmic surgeon), but this is not explicitly stated.

7. The sample size for the training set:

   • Not applicable. This is an in-vitro operational test, not a machine learning model.

8. How the ground truth for the training set was established:

   • Not applicable. This is an in-vitro operational test, not a machine learning model.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device