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The BioCardia Universal Guide Catheter is intended to serve as a conduit for access into the chambers of the heart and coronary vasculature of the heart.

BioCardia Universal Deflectable Guide Catheter

The provided text describes the 510(k) premarket notification for the BioCardia Universal Deflectable Guide Catheter, submitted in 2001. The information focuses on demonstrating substantial equivalence to existing devices rather than a detailed study with acceptance criteria and device performance metrics in the way a modern AI/ML device submission would.

Therefore, many of the requested fields cannot be directly populated from the provided text. I will fill in what is available and indicate when information is not present.

Acceptance Criteria and Study Details for BioCardia Universal Deflectable Guide Catheter

This submission demonstrates substantial equivalence of the BioCardia Universal Deflectable Guide Catheter to predicate devices rather than proving performance against specific acceptance criteria for a novel device. The "acceptance criteria" can be inferred as meeting the safety and effectiveness requirements for its intended use, as demonstrated through in-vitro and animal testing and biocompatibility.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified. The document mentions "in-vitro and animal testing," but doesn't provide the number of samples or animals used.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The nature of "in-vitro and animal testing" suggests controlled lab environments.

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

• Not applicable/Not specified. The assessment appears to be based on physical testing and material compliance rather than expert image interpretation or clinical consensus.

4. Adjudication Method for the Test Set:

• Not applicable/Not specified. This type of adjudication is typically for clinical or image-based studies where expert consensus on a diagnosis is required.

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. The "standalone" performance here relates to the physical and functional testing of the catheter itself, as indicated by "in-vitro and animal testing."

7. The Type of Ground Truth Used:

• For Performance and Safety: Results from "in-vitro and animal testing." This would typically involve objective measurements of device function, durability, and biological response.
• For Biocompatibility: Compliance with ISO 10993-1 standards, likely through laboratory tests and material composition analysis.

8. The Sample Size for the Training Set:

• Not applicable in the context of this device. This is a traditional medical device, not an AI/ML product that utilizes a "training set."

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

• Not applicable.

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