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Indications for Use: The Stereotaxis Assert™ Guide Wire is intended to introduce and position over-the-wire catheters and other over-the-wire therapeutic devices within the coronary and peripheral vasculature during PTCA or other intravascular interventional procedures.

The Stereotaxis Assert™ Guide Wire is a steerable guide wire that has a nominal diameter of 0.014 in/ 0.36mm and nominal lengths of 180 cm and 300 cm. The guide wire is designed only for use in conjunction with the Stereotaxis Magnetic Navigation System. The wire is configured with a tapered distal tip and an embedded magnet, which is used for navigating the wire through the vasculature. A hydrophilic coating covers the distal portion of the wire, and a PTFE coating covers the proximal end of the wire. This device is sterilized with 100% ethylene oxide.

The provided document is a 510(k) Summary for the Stereotaxis Assert™ Guide Wire. It describes a medical device, its intended use, technological characteristics, and comparison to a predicate device. It explicitly states that no clinical studies were needed to support the modifications and therefore clinical performance data is not available. This means that the device was not evaluated through a study to meet acceptance criteria in the way envisioned by your request.

Instead, the document details that the device met acceptance criteria based on:

• Physical testing: "The Stereotaxis Assert™ Guide Wire was designed and tested in compliance with the FDA "Coronary and Cerebrovascular Guidewire Guidance" dated January 1995. The device met design input criteria..."
• Preclinical animal performance data: "Testing of the Stereotaxis Assert™ Guide Wire in the swine animal model demonstrated substantial equivalence to the currently marketed predicate device."

Given this, I cannot fill out the requested table for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the traditional sense of a clinical or standalone AI study. The document focuses on demonstrating substantial equivalence to a previously cleared device (K021363) through non-clinical data.

Here's how I can address your request based on the provided text, acknowledging the limitations:

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

The document does not specify quantitative acceptance criteria with reported performance values as would be found in a clinical trial. Instead, it states qualitative criteria and that they were met through non-clinical testing.

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

The document mentions "testing of the Stereotaxis Assert™ Guide Wire in the swine animal model" but does not specify the sample size for this animal study. It also does not specify the country of origin or whether it was retrospective or prospective, although animal studies are typically prospective.

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

This information is not applicable or provided. The "ground truth" equivalent in this context would be the successful navigation and performance in the animal model, observed by the researchers/veterinarians conducting the study, rather than expert interpretation of images or clinical outcomes.

4. Adjudication method for the test set

This information is not applicable or provided. Adjudication methods are typically relevant for human-read clinical studies or analyses requiring consensus on diagnoses or outcomes.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical studies were needed to support the modifications."

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

This concept is not applicable as this is a physical medical device (guide wire), not an AI algorithm. Its performance is inherent in its physical properties and how it functions.

7. The type of ground truth used

For the animal study, the "ground truth" was likely direct observation of the device's performance in vivo within the swine vasculature, assessing its navigability and ability to deliver other devices, in comparison to the predicate device.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of a physical medical device like a guide wire. Design and engineering principles are applied, followed by non-clinical testing.

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

This is not applicable for the reasons stated above.

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Stereotaxis Cronus® Guide Wires are intended to introduce and position over-the-wire catheters and other over-the-wire therapeutic devices within the coronary and peripheral vasculature during PTCA or other intravascular interventional procedures.

The Stereotaxis Cronus Guide Wires are steerable guide wires that have a nominal diameter of 0.014 in/ 0.36mm and nominal lengths from 180 cm to 300 cm. The guide wires are designed only for use in conjunction with the Stereotaxis Magnetic Navigation System. The wire is configured with a tapered distal tip and an embedded magnet, which is used for navigating the wire through the vasculature. A hydrophilic coating covers the distal portion of the wires, and a PTFE coating covers the proximal end of the wires. This device is sterilized with 100% ethylene oxide. The Cronus Guide Wires are conventional 0.014" hydrophilically coated endovascular guide wire modified to accommodate magnetic actuation and control. It is designed to navigate within the vasculature to deliver a suitable catheter or interventional device to a desired site. The finished length of the guide wire is 180cm to 300cm. A taper runs proximal to the distal tip. The pushable shaft is a continuous wire that allows axial force, applied at the proximal end, to be transmitted to the tip of the guide wire. The guide wire is used with an introducer sheath to access the human vasculature.

The provided text describes a 510(k) submission for the Stereotaxis Cronus Guide Wires, which are a modification of an existing device. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria and performance metrics for a new, independent device.

Therefore, the direct answers to some of your questions may not be explicitly available in the provided text, as the nature of the submission does not require a new clinical study with defined acceptance criteria and performance outcomes for the modified device.

Here's an analysis based on the provided information:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria or specific performance metrics as would be found in a study for a novel device. Instead, it states that the device "met design input criteria" and was "substantially equivalent to the currently marketed predicate device."

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

• Physical Testing: The sample size for physical testing is not specified. The provenance would be internal laboratory testing by Stereotaxis, Inc.
• Preclinical Animal Performance Data: The sample size for animal testing (number of swine and canine models) is not specified. The provenance would be preclinical animal studies.

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

Not applicable. This was not a study requiring expert-established ground truth in the context of diagnostic accuracy, as it's a device modification relying on substantial equivalence.

4. Adjudication method for the test set

Not applicable. There was no diagnostic test set requiring adjudication in this submission.

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/diagnostic imaging device and no MRMC study was conducted.

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

Not applicable. This is a medical device, not an algorithm.

7. The type of ground truth used

The "ground truth" in this context is the performance and safety established for the predicate device, against which the modifications are compared to demonstrate substantial equivalence.

• For Physical Testing: Compliance with FDA "Coronary and Cerebrovascular Guidewire Guidance" dated January 1995, and the performance characteristics of the predicate device.
• For Preclinical Animal Performance Data: The established performance and safety profile of the predicate device in animal models.

8. The sample size for the training set

Not applicable. This is a medical device with physical and animal testing, not a machine learning model requiring a training set.

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

Not applicable. See point 8.

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The Stereotaxis Endovascular Guide Wire is intended to introduce and position over-the-wire catheters and other over-the-wire therapeutic devices within the coronary and peripheral vasculature during PTCA or other intravascular interventional procedures.

The Stereotaxis Endovascular Guide Wire is a steerable guide wire that has a nominal diameter of 0.014 in/ 0.36mm and a nominal length of 210/300 cm. The guide wire is designed only for use in conjunction with the Stereotaxis Magnetic Navigation System. The wire is configured with a tapered distal tip and an embedded magnet, which is used for navigating the wire through the vasculature. A hydrophilic coating extends from the base of the distal coil to the proximal end of the wire. This device is sterilized with 100% ethylene oxide.

The Endovascular Guide Wire is a conventional 0.014" hydrophilically coated endovascular guide wire modified to accommodate magnetic actuation and control. It is designed to navigate within the vasculature to deliver a suitable catheter or interventional device to a desired site.

The finished length of the Endovascular Guide Wire is 210cm to 300cm. A taper runs 30cm proximal to the distal tip. The pushable shaft is a continuous wire that allows axial force, applied at the proximal end, to be transmitted to the tip of the guide wire. The Endovascular Guide Wire is used with an introducer sheath to access the human vasculature.

The provided text describes the Stereotaxis Endovascular Guide Wire and its 510(k) summary, aiming for substantial equivalence to predicate devices rather than establishing specific acceptance criteria and proving performance against them through a clinical study with detailed metrics.

Based on the provided information, I can extract the following:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not specify the sample size used for the test set (number of devices, test cases, or animal subjects). It only mentions "Bench testing and preclinical in-vivo testing." The data provenance is not explicitly stated in terms of country of origin, but "preclinical in-vivo testing" suggests animal studies, and "bench testing" refers to laboratory-based evaluations. It's likely prospective for the testing conducted for this submission.

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

The document does not provide any information about experts used to establish ground truth or their qualifications. The evaluation relies on "bench testing and preclinical in-vivo testing," which would typically involve engineering and scientific evaluation rather than expert clinical consensus on a test set.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method. Given the nature of bench and preclinical testing for a guidewire, a formal adjudication process with multiple experts is generally not applicable in the same way it would be for diagnostic AI.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not reported. The information focuses on device performance and substantial equivalence, not on human reader performance with or without AI assistance. This device is a medical instrument, not an AI diagnostic tool.

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

N/A. This device is a physical medical instrument, not an algorithm. Standalone performance as it applies to AI algorithms is not relevant here.

7. The Type of Ground Truth Used

The "ground truth" for this guidewire's performance would be established through objective measurements and observations during:

• Bench testing: Measuring physical properties, mechanical performance, maneuverability, and other relevant characteristics against pre-defined specifications or predicate device performance.
• Preclinical in-vivo testing: Observing the guidewire's ability to navigate vasculature, facilitate catheter delivery, and its interaction with biological systems in an animal model, often assessed against control or predicate devices. This would involve surgical observations and potentially imaging.

8. The Sample Size for the Training Set

N/A. This is a physical medical device. The concept of a "training set" is relevant for machine learning algorithms, not for the development and testing of a guidewire in this context.

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

N/A. As mentioned above, the concept of a training set and its ground truth establishment is not applicable to this type of device. The development process would involve iterative design, prototyping, and testing against engineering specifications and preclinical models.

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