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The Medtronic Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The guiding catheter is intended to be used in the coronary or peripheral vascular system.

Medtronic 6F Taiga Guiding Catheter is an intravascular catheter that is supplied sterile and intended for single use only. The primary function of the 6F Taiga Guiding Catheter is to provide a pathway through which therapeutic devices are introduced. Medtronic 6F Taiga Guiding Catheter has a 6F outer diameter (0.082") and is be available in variety of curves and lengths, identical to the predicate Medtronic Taiga Guide Catheter. The various curves and lengths available, will allow the catheter to accommodate the varying patient vascular system anatomies

The Medtronic 6F Taiga Guiding Catheter is a physical medical device, not an AI/ML device. Therefore, the questions related to AI/ML specific aspects such as human readers, AI assistance, training sets, and ground truth for AI algorithms are not applicable.

Based on the provided text, the acceptance criteria and the study that proves the device meets them are as follows:

1. Table of Acceptance Criteria and Reported Device Performance

The device is a modified version of a legally marketed predicate device (Medtronic 6F Taiga™ Guiding Catheter - K083422). The modification involves a specification related to the soft tip component. Therefore, the acceptance criteria are generally based on demonstrating substantial equivalence to the predicate device through performance/bench testing and biocompatibility testing. The specific acceptance criteria for each test are not explicitly detailed in the provided summaries (e.g., specific thresholds for tensile strength or kink resistance). Instead, the document states that tests were conducted "in accordance to the relevant FDA guidance to demonstrate substantial equivalence."

For the modified soft tip component, two specific tests were performed on the subject device to demonstrate substantial equivalence to the predicate:

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

The document does not explicitly state the sample size (number of units) used for each specific bench test. It mentions that "Performance/Bench Testing" was conducted, and "biocompatibility tests were conducted." The testing is described as non-clinical data. The provenance of the data is from Medtronic Vascular, the manufacturer. The data is retrospective in the sense that it's reported after the tests were conducted for the 510(k) submission.

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

This question is not applicable as the device is a physical medical device and its performance is evaluated through objective bench testing and biocompatibility assessments, not through expert-driven ground truth establishment for an AI/ML algorithm.

4. Adjudication Method for the Test Set

This question is not applicable for the same reasons as point 3. Bench tests have objective measurements and pass/fail criteria, not subjective adjudication by experts.

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 question is not applicable as the device is a physical medical device and not an AI/ML-assisted diagnostic tool.

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

This question is not applicable as the device is a physical medical device and not an AI/ML algorithm.

7. The Type of Ground Truth Used

For a physical device, the "ground truth" for performance is typically defined by:

• Engineering Specifications/Standards: Each bench test will have predefined acceptance limits or ranges derived from engineering design specifications and relevant industry standards (e.g., ISO, ASTM) and FDA guidance for catheters.
• Predicate Device Performance: For substantial equivalence, the performance of the subject device is compared against the established performance characteristics of the predicate device.
• Biocompatibility Standards: Ground truth for biocompatibility is established by international standards like ISO 10993-1, which outlines the requirements for biological evaluation of medical devices.

8. The Sample Size for the Training Set

This question is not applicable as the device is a physical medical device and does not involve AI/ML requiring a training set.

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

This question is not applicable as the device is a physical medical device and does not involve AI/ML requiring a training set or its associated ground truth establishment.

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The Medtronic Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The guiding catheter is intended to be used in the coronary or peripheral vascular system.

The 6F Taiga™ Guiding Catheter is a single lumen catheter with an atraumatic tip, which provides a pathway for therapeutic devices to be introduced into the coronary or peripheral vascular system.

The provided text describes the 510(k) summary for the Medtronic 6F Taiga™ Guiding Catheter, which is a medical device, not an AI/ML-enabled diagnostic device. Therefore, the requested information regarding acceptance criteria, study details, and AI-specific metrics (like MRMC studies, standalone performance, training sets) is not applicable to this document.

The document explicitly states: "No clinical investigation has been performed for this device."

Instead, the submission for this device relies on non-clinical data and demonstrating substantial equivalence to a predicate device.

Here's a breakdown of what is relevant from the provided text:

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

Since this is not an AI/ML diagnostic device, there are no "acceptance criteria" in the sense of performance metrics like sensitivity, specificity, or AUC. The acceptance criteria for this device would have been related to engineering and non-clinical performance (e.g., integrity, deliverability, lubricity), which are summarized as:

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

Not applicable. No clinical investigation or test set for performance evaluation was conducted. The evaluation was based on non-clinical (engineering) tests.

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. There was no clinical test set requiring expert ground truth.

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

Not applicable. No clinical test set.

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-enabled 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-enabled device.

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

Not applicable for clinical performance. The "ground truth" for this device's evaluation would be defined by engineering standards and specifications, confirmed through non-clinical testing.

8. The sample size for the training set:

Not applicable. This is not an AI/ML-enabled device.

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

Not applicable. This is not an AI/ML-enabled device.

Study that proves the device meets the acceptance criteria:

The study proving the device meets the acceptance criteria is summarized as "Non-clinical Data: passed all design verification and validation testing." This indicates a series of engineering tests (e.g., mechanical tests, material compatibility, dimensional verification, flow rate, torque response, etc.) were conducted to ensure the device performs as intended and meets its specifications. The specific reports for these tests are not detailed in this summary but would be part of the full 510(k) submission.

Conclusion from Data:

Medtronic Vascular concluded that the 6F Taiga™ Guiding Catheter is substantially equivalent to the predicate devices based on its indications for use and fundamental scientific technology, supported by the successful completion of non-clinical design verification and validation testing.

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