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The biocardia morph universal deflectable guide catheter is intended to provide a pathway through which medical instruments, such as balloon dilatation catheters, guidewires, or other therapeutic devices may be introduced into the peripheral vasculature or chambers and coronary vasculature of the heart.

The BioCardia 8F Morph® DNA Deflectable Guide Catheter is a sterile, single use, bi-directional deflectable guide catheter. When the handle is fully actuated, the distal tip deflects to a minimum 135° arc in either of two directions with a nominal curve distance of 30 mm. The catheter tip includes a fluoroscopic marker to help visualize the tip location. The Morph DNA handle includes a brake to hold the deflection angle, an integrated hemostasis valve with a swiveling sideport, and 3-way stopcock.

The BioCardia 8F Morph DNA Deflectable Guide Catheter is a sterile, single-use, bi-directional deflectable guide catheter. Its intended use is to provide a pathway for medical instruments (like balloon dilatation catheters, guidewires, or other therapeutic devices) into the peripheral vasculature or chambers and coronary vasculature of the heart.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

Since this is a submission for substantial equivalence to a predicate device, the acceptance criteria are largely demonstrated by ensuring the new device's performance is comparable to the predicate and meets relevant safety standards. The document doesn't explicitly list numerical 'acceptance criteria' in the traditional sense with specific thresholds. Instead, it lists various tests conducted to confirm that modifications did not negatively impact performance. The "Reported Device Performance" for each test is that the device "did not affect the ability to meet all product specification requirements," implying successful adherence to the established performance characteristics for guide catheters.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not explicitly stated for each test. For in-vivo testing, it was a "Single Swine Model." For benchtop and package integrity tests, it's typically a statistically significant number of units, but the exact count is not provided in this summary.
• Data Provenance: The studies were conducted by BioCardia, Inc. as part of their 510(k) submission. These are internal validation studies, not indicating specific country of origin or whether they were retrospective or prospective beyond the stated testing methods. Benchtop and package integrity tests are inherently prospective, as is the single swine model.

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

Not applicable. This is a medical device for providing access, not a diagnostic device that requires expert interpretation for a "ground truth" establishment in the traditional sense (e.g., for image analysis). The "ground truth" for this device's performance relates to its physical and functional specifications meeting engineering standards and biological safety. The "experts" involved would be the engineers, toxicologists, and biologists conducting and evaluating the studies against established ISO and ASTM standards and FDA guidance. Their qualifications are not detailed in this summary.

4. Adjudication method for the test set

Not applicable in the context of diagnostic interpretation, as this is a medical device. Performance is evaluated against objective engineering specifications and biological safety standards.

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-assisted diagnostic device, nor does it involve "human readers" in its intended use.

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

Not applicable. This is a physical medical device, not a software algorithm.

7. The type of ground truth used

The "ground truth" for this device is based on:

• Engineering Specifications: Successful adherence to predefined dimensions, force tolerances, deflection angles, and functional requirements.
• Relevant ISO and ASTM Standards: Compliance with recognized international and national standards for medical devices, biocompatibility, sterilization, and packaging.
• FDA Guidance: Adherence to FDA's recommendations for medical device evaluation.
• Biological Response: Demonstrated safety and compatibility in in-vitro and in-vivo (swine model) biological tests.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model that requires a training set.

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

Not applicable.

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