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The Gish Tubing and Connectors with GBS™ Coating are indicated for use in surgical procedures to provide a conduit for extracorporeal blood flow when interconnecting components of the bypass circuit. It is designed to operate at flow rates of one (1.0) to six (6.0) liters per minute for periods up to six (6) hours.

The Gish Tubing and Connectors with GBS™ Coating are used in surgical procedures to provide a conduit for extracorporeal blood flow when interconnecting components of the bypass circuit. Specifically they are used in connecting oxygenators, reservoirs, filters, heat exchangers and other devices used in surgical procedures. The tubing is polyvinyl chloride (PVC). The connectors are polycarbonate of various configurations such as straight, "Y", Leur and reducer types.

The components of this system which have contact with the fluid path are sterile and nonpyrogenic.

All materials of the Gish Tubing and Connectors are biocompatible and coated with a proprietary coating.

The Gish Tubing and Connectors with GBS™ Coating may be purchased separately or preconnected with tubing and other components of an extracorporeal circuit

This looks like a 510(k) submission for a medical device called "Gish Tubing and Connectors with GBS™ Coating." The document primarily focuses on establishing substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a dedicated study to prove direct performance against those criteria.

Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, sample size for training set) are not applicable or cannot be extracted from the provided text.

Here is an attempt to answer the questions based only on the provided text, noting where information is not available:

1. A table of acceptance criteria and the reported device performance

   The document does not provide a table of explicit, quantitative performance acceptance criteria (e.g., specific thresholds for tensile strength, flow rate consistency, or biocompatibility metrics) nor does it report detailed quantitative performance against such criteria. The "performance" described is in the context of general safety and functional requirements.

   Acceptance Criteria Description (Implicit)	Reported Device Performance (Summary)
   Safety and Effectiveness	Subjected to extensive safety, performance, and validations.
   Functional Requirements	Meets all its functional requirements.
   Performance Specifications	Meets performance specifications.
   Biocompatibility	All materials are biocompatible and coated with a proprietary coating.
   Sterility & Non-pyrogenic	Components in contact with fluid path are sterile and nonpyrogenic.
   Flow Rate Capability	Designed to operate at flow rates of 1.0 to 6.0 liters/minute.
   Duration of Use	Designed for periods up to six (6) hours.
   Equivalence to Predicate Device	Equivalent in safety and efficacy to its predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   Not explicitly stated. The document mentions "various performance tests" and "final testing for the systems" but does not give specific sample sizes or details about data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   Not applicable. This device is a cardiopulmonary bypass component, not an interpretive diagnostic device that would typically rely on expert-established ground truth in this manner for a 510(k) submission. Performance is assessed through engineering, biocompatibility, and functional testing.

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

   Not applicable. This concept typically relates to consensus building among human readers for diagnostic studies, which is not the methodology described for this hardware device.

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 study focuses on a medical device (tubing and connectors) for extracorporeal blood flow, not an AI or diagnostic imaging system that would involve human readers.

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

   Not applicable. This is not an algorithm or AI device. The device's performance is inherently "standalone" in its primary function as a physical conduit. The "performance" refers to its physical and material properties and its function in the bypass circuit.

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

   Not explicitly detailed, but based on the nature of the device (cardiopulmonary bypass tubing), the "ground truth" for performance would be established through a combination of:

   • Engineering specifications and standards: Adherence to defined physical and mechanical properties (e.g., burst pressure, flow resistance, tensile strength).
   • Biocompatibility testing: In vitro and in vivo studies to ensure material safety and compatibility with blood and tissues.
   • Functional testing: Simulation of intended use conditions (e.g., flow rate, duration).
   • Sterility and pyrogenicity testing: Adherence to standards for sterile medical devices.

8. The sample size for the training set

   Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established

   Not applicable. This is not a machine learning or AI device that requires a training set.

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