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Stedi Guidewire is intended for use to introduce and position catheters during interventional procedures within the chambers of the heart, including transcatheter aortic valve replacement (TAVR).

The Medtronic Stedi™ Extra Support Guidewire (herein after referred as Stedi Guidewire) is design for use to introduce and position catheters during interventional procedures within the chambers of the heart, including transcatheter aortic valve replacement (TAVR) procedures.

The Stedi Guidewire has a 0.035" diameter and is 275cm in length and composed of two primary components: a core, and a coil. Both components are made of stainless steel. The core wire component is a piece of stainless-steel wire which is ground on the distal end to fit into the coil and provide flexibility. The coil and the ground core are joined in two locations: a proximal bond and a distal weld. The distal end of the Stedi Guidewire is comprised of a preformed 540° curved tip is available in 2 sizes (3cm and 4cm). The Stedi Guidewire has a polytetrafluoroethylene (PTFE) coating applied to the entire length of the device in order to aid in lubricity.

The Stedi Guidewire is sterilized using ethylene oxide, nonpyrogenic, disposable, and for single use only.

Based on the provided FDA 510(k) clearance letter for the Medtronic Stedi Extra Support Guidewire, here's a detailed breakdown of the acceptance criteria and the study information.

It's important to note that the provided document is a 510(k) clearance letter, which focuses on demonstrating substantial equivalence to a predicate device. For medical devices like guidewires, the "studies" primarily consist of non-clinical (bench) performance testing to ensure the new device meets established safety and performance requirements, rather than clinical trials with human subjects in the way AI/software devices typically undergo. Therefore, many of the questions related to human readers, ground truth, and training sets are not applicable in this context.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Medtronic Stedi Extra Support Guidewire are demonstrated through various non-clinical (bench) performance tests. The FDA guidance "Coronary, Peripheral and Neurovascular Guidewires Performance Tests and Recommended Labeling (October 10, 2019)" was utilized to establish these tests. The conclusion states that the device "met all design input requirements based on the intended use."

Here's a table summarizing the types of tests conducted, which imply the acceptance criteria were met by the device's performance in these areas:

Study Details

1. Sample size used for the test set and the data provenance:

   • Sample Size: The document does not specify exact sample sizes for each non-clinical test. However, it indicates "samples were analyzed according to predetermined acceptance criteria" for the various bench tests. In medical device bench testing, sample sizes are typically determined statistically to ensure sufficient power to detect differences or to demonstrate compliance with specifications.
   • Data Provenance: The data is generated from non-clinical bench testing performed by Medtronic Inc. This is not clinical data (i.e., no patient data is involved). It is prospective in the sense that the tests were designed and executed to evaluate the new device.

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

   • N/A. For this type of medical device (guidewire), ground truth is established through engineering specifications, material science standards (e.g., ISO standards), and performance benchmarks derived from predicate devices and historical data. It does not involve human expert consensus in the diagnostic sense. The "experts" are the engineers, material scientists, and testers who design and conduct the tests and interpret the results against predetermined specifications.

3. Adjudication method for the test set:

   • N/A. Adjudication methods like "2+1" or "3+1" are relevant for clinical studies or studies involving human interpretation of data (e.g., image analysis). For bench testing of a guidewire, results are quantitative or qualitative against predetermined engineering specifications, and "adjudication" typically refers to the pass/fail criteria established for each test.

4. 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:

   • No. This is a physical medical device (guidewire), not an AI/software device that assists human readers/clinicians, so an MRMC study is not applicable.

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

   • N/A. This is a physical medical device, not an algorithm. The "standalone" performance is the device's performance in the bench tests, independent of its use in a patient for the initial testing and FDA clearance.

6. The type of ground truth used:

   • The "ground truth" for each test is based on pre-established engineering specifications, material standards (e.g., ISO), and performance characteristics derived from the predicate device and FDA guidance documents. For example, the "ground truth" for tensile strength is a minimum force value, for biocompatibility it's compliance with ISO 10993, and for dimensions it's adherence to specified tolerances.

7. The sample size for the training set:

   • N/A. This is a physical medical device undergoing non-clinical testing, not a machine learning model, so there is no "training set."

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

   • N/A. As there is no training set for a physical device, this question is not applicable.

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The Medtronic Steerant Super Stiff Guidewire is intended to facilitate catheter placement and exchange during diagnostic or interventional procedures in the aorta. The guidewire is not indicated for coronary or neuro vasculature.

Steerant™ Super Stiff Guidewire (herein after referred to as Steerant) is a 0.035" diameter PTFE coated stainless steel guidewire. The Steerant guidewire is offered in 200 cm and 260 cm lengths and incorporates a flexible tip section and inner 8 cm radiopaque tungsten coil for enhanced visibility. The Steerant guidewire is offered in single and double curve tip configurations. The Steerant guidewire is sterile, non-pyrogenic, disposable and for single use only.

The provided text is a 510(k) premarket notification for a medical device (Steerant Super Stiff Guidewire). It focuses on demonstrating substantial equivalence to a predicate device, not on proving the device meets individual acceptance criteria for an AI/software component through a study.

Therefore, the information required to answer your prompt, specifically concerning acceptance criteria, study design for AI performance, sample sizes for training and test sets, expert involvement, and ground truth establishment, is not present in the provided document.

The document details the device's physical characteristics, indications for use, and a comparison to predicate and reference devices. It mentions "Non-Clinical Performance Data" and states that "All the predetermined acceptance criteria were met and results passed to support a determination of substantial equivalence." However, it does not elaborate on what those criteria were for the performance of the device (e.g., accuracy, sensitivity, specificity for an AI algorithm), nor does it describe a study involving humans and AI assistance or algorithm-only performance.

The "Non-Clinical Performance Data" section lists various engineering and regulatory tests such as:

• Design Verification Testing
• Design Validation Testing
• Sterilization Validation per requirements of ISO 11135
• Biocompatibility Testing per the requirements of ISO 10993-1
• Packaging Design Verification Testing per requirements of ISO 11607
• Shelf Life Testing

These are standard tests for a physical medical device and do not involve AI or software performance evaluation in the manner described in your prompt.

In summary, this document does not contain the information needed to answer your request about acceptance criteria and study data for an AI-powered medical device.

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