Search Results

The Vision Hollow Fiber Oxygenator with HA Coating is indicated for use in procedures requiring the extracorporeal oxygenation of and carbon dioxide removal from human blood. It is designed to operate at a blood flow rate of one (1.0) to eight (8.0) liters per minute for periods of up to six (6.0) hours.

The Gish Vision Hollow Fiber Oxygenator with hyaluronan based coating (HA), Coating consists of a hollow fiber membrane oxygenator and extracorporeal heat exchanger. The hollow fiber membrane consists of a polypropylene gas permeable mat. The unique mat design increases the interaction between blood and gas, creating a highly efficient blood oxygenator. The heat exchanger consists of a one piece, stainless steel bellows confiqured heat exchanger as the primary element to effect heat exchange. This element is encased by a polycarbonate housing, which directs the blood through the outside convolutions of the stainless steel bellows, and therefore effects heat exchange while minimizing priming volume. All materials of the heat exchanger are biocompatible and coated with a proprietary coating. The device allows for trapping and removal of air. Oxygenated blood is delivered to the patient through the tubing and appropriate cannula. Blood flow is driven by a roller pump or centrifugal pump connected through the tubing. The Gish Vision Hollow Fiber Oxygenator with HA Coating may be purchased separately or preconnected with tubing and other components of an extracorporeal circuit.

Here's an analysis of the provided text regarding acceptance criteria and study details:

This document describes a medical device submission (510(k)) for a blood oxygenator. It does not describe an AI/ML-based medical device. Therefore, many of the questions regarding AI/ML-specific study design (like ground truth establishment, training sets, multi-reader studies, effect sizes) are not applicable to this document.

However, I can extract the information relevant to a traditional medical device submission for the Vision Hollow Fiber Oxygenator with HA Coating.

Acceptance Criteria and Device Performance for Vision Hollow Fiber Oxygenator with HA Coating

Evaluation Summary:
The provided document is a 510(k) summary for a traditional medical device, the Gish Vision Hollow Fiber Oxygenator with HA Coating. It outlines the device's characteristics, intended use, and a generic statement about safety, performance, and validation testing. It does not provide specific numerical acceptance criteria or detailed results of tests performed to demonstrate compliance. Instead, it relies on demonstrating substantial equivalence to predicate devices (Vision Hollow Fiber Oxygenator, K961530, and Vision Hollow Fiber Oxygenator with Guardian Coat, K023381).

In the context of the provided document, the "acceptance criteria" are implied to be that the new device performs equivalently to the predicate devices and meets its functional requirements and performance specifications, without introducing new safety concerns.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated. The document refers to "extensive safety, performance, and validations" and "various performance tests." However, specific sample sizes for these tests (e.g., number of devices tested, number of in-vitro runs, number of animal studies if applicable) are not provided.
• Data Provenance: Not specified. The document states "Final testing for the systems includes various performance tests." It does not mention clinical data, country of origin, or whether the data was retrospective or prospective. Given the device type and 510(k) pathway, it's highly likely that the "testing" refers to bench testing, in-vitro studies, and potentially pre-clinical animal studies, rather than human clinical trials for a blood oxygenator, especially if substantial equivalence is claimed to existing predicate devices.

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

• Not Applicable. This is a traditional medical device submission, not an AI/ML device requiring human expert annotation for ground truth. The "ground truth" for this type of device is established through objective engineering and biological performance metrics (e.g., oxygen transfer efficiency, pressure drop, hemolysis rates) and comparison to established predicate device performance.

4. Adjudication Method for the Test Set

• Not Applicable. As there are no human experts establishing ground truth via consensus, there is no adjudication method in the sense of AI/ML evaluation. Device performance is determined by objective measurements against specifications.

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

• Not Applicable. This is not an AI/ML device.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This is not an AI/ML device.

7. The Type of Ground Truth Used

• Objective Performance Metrics and Comparison to Predicate Devices. The "ground truth" for this device's performance and safety is based on:
  • Engineering Specifications: Meeting predefined performance characteristics (e.g., blood flow rates, oxygen transfer efficiency, pressure drop).
  • Biocompatibility Standards: Adherence to established standards for material safety.
  • Predicate Device Performance: The primary "ground truth" for substantial equivalence is the established safety and effectiveness profile of the legally marketed predicate devices, against which the new device is compared. This comparison implies the new device must perform at least as well as, and not worse than, the predicate devices without raising new questions of safety or effectiveness.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/ML device, so there is no "training set."

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

• Not Applicable. This is not an AI/ML device.

Ask a specific question about this device