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Medtronic GTX guide wires are steerable guide wires that are used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for use in the cerebral vasculature. Medtronic steerable exchange wires are used to facilitate the substitution of one diagnostic or interventional device for another.

The Medtronic GTX 12 guidewires are available in nominal 180cm length and 300cm exchange length. They are available with PTFE, silicone or hydrophilic coatings. A portion of the distal length is opaque to allow for visualization under fluoroscopy and markers are etched on the proximal segment of the guide wire to aid in gauging guide wire position relative to the guiding catheter tip.

Here is an analysis of the provided 510(k) summary regarding the acceptance criteria and study information for the Medtronic GTX 12 Guidewire:

Please note: This 510(k) summary describes an in-vitro bench study and animal study for a medical device (guidewire), not an AI/ML powered medical device for which acceptance criteria typically refer to performance metrics like sensitivity, specificity, or AUC. Therefore, much of the requested information (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types for training/test sets, training set sample size) are not applicable or extractable from this type of regulatory document.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are qualitative, focusing on similarity to predicate devices and meeting established safety and performance benchmarks for guidewires, rather than specific quantitative performance metrics typical of AI/ML algorithms. The document emphasizes that the GTX 12 guidewire "met the acceptance criteria and performed similarly to the predicate devices." No specific numerical acceptance criteria (e.g., minimum diameter, maximum tortuous torque) are provided, nor are the exact numerical results for each test. Instead, the document states successful completion ("met the acceptance criteria").

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

• Sample Size for Test Set: Not explicitly stated for each in-vitro test. The document mentions that "a bracketing sample strategy was chosen to support the test requirements" in some cases. For the animal study, the sample size is not specified.
• Data Provenance: The studies are in-vitro bench tests and an animal study. This type of data does not typically have "country of origin" in the same way human clinical data would. It is retrospective in the sense that the testing was performed on manufactured devices, not derived from observations of devices in clinical use over time.

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

Not applicable. This is an engineering and biocompatibility evaluation of a medical device, not a diagnostic AI/ML algorithm that relies on expert interpretation for ground truth.

4. Adjudication Method for the Test Set

Not applicable. This is an engineering and biocompatibility evaluation; no human interpretation or adjudication of results in the traditional sense is mentioned. The tests are designed to yield objective, measurable outcomes.

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

No. MRMC studies are specific to diagnostic AI/ML algorithms to assess human reader performance with and without AI assistance. This document pertains to a guidewire, which is a physical medical device.

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

Not applicable. This is not an AI algorithm. The performance described is inherently "standalone" in that it refers to the physical device's characteristics in bench and animal testing.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is based on engineering specifications, established industry standards (e.g., ISO guidance, ASTM), and performance of legally marketed predicate devices. For example, for dimensional tests, the ground truth would be the specified dimensions of the device itself and comparison to predicate dimensions. For biocompatibility, the ground truth is defined by the toxicological and biological response criteria outlined in standards like ISO 10993-1. For functional tests like Tip Column Stiffness or Torque Energy Transfer, the ground truth is established by acceptable performance parameters typical for such devices, often benchmarked against predicate devices.

8. The Sample Size for the Training Set

Not applicable. This device is evaluated through engineering and biocompatibility testing, not an AI/ML model that requires a training set.

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

Not applicable. No training set is involved for this type of device evaluation.

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The Attain Hybrid guide wire is intended to aid in the placement of Medtronic transvenous left ventricular leads in the coronary vasculature.

The Attain Hybrid Guide Wire is a single use guide wire designed to aid in the placement of Medtronic transvenous left ventricular leads in the coronary vasculature. The guide wires consist of a core wire with springs, and coatings. Near the distal end of the device, the core wire consists of tapers to allow differing support or stiffness levels.

The provided text is a 510(k) summary for the Medtronic Attain Hybrid Guide Wires. It lacks the specific details about acceptance criteria and study data that would allow a comprehensive response to your request. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance metrics from a specific study against acceptance criteria.

However, I can extract and infer some information based on the typical content of such submissions:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not present in the provided text. The document states: "Device verification testing was performed to demonstrate the Attain Hybrid Guide Wires meet established performance criteria and to support equivalency to the referenced predicate devices. Visual, performance and compatibility testing was completed. All design and compatibility requirements were met." This indicates that performance criteria were established and met, but the specific criteria (e.g., tensile strength, kink resistance, pushability, torqueability, coating durability) and the quantitative results are not detailed.

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

This information is not present in the provided text. The document refers to "Device verification testing," but does not mention the sample size for this testing or the provenance of the data.

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

This information is not applicable and not present in the provided text. The device is a physical medical device (guide wire), not an AI or diagnostic imaging system that requires expert interpretation to establish ground truth for a test set. Design verification and validation for such devices typically involve engineering tests, not expert consensus on medical images or diagnoses.

4. Adjudication Method for the Test Set:

This information is not applicable and not present in the provided text for the same reasons as point 3.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

This information is not applicable and not present in the provided text. This type of study is relevant for AI-powered diagnostic tools or systems where human readers interpret results. The Attain Hybrid Guide Wire is a physical medical device.

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

This information is not applicable and not present in the provided text. This concept applies to AI algorithms.

7. The Type of Ground Truth Used:

For a physical device like a guide wire, "ground truth" typically refers to engineering specifications and performance standards rather than medical diagnoses or outcomes data in the way it's used for AI or diagnostic devices. The text mentions "established performance criteria" and "design and compatibility requirements," which would serve as the "ground truth" for the device's functional performance. There is also a mention of "Biocompatibility testing consistent with ISO 10993-1: 2003," which indicates a specific set of accepted standards for biological safety.

8. The Sample Size for the Training Set:

This information is not applicable and not present in the provided text. The concept of a "training set" is relevant for machine learning/AI models.

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

This information is not applicable and not present in the provided text for the same reasons as point 8.

In summary:

The provided document is a 510(k) summary for a physical medical device, not an AI or diagnostic imaging system. Therefore, many of the questions related to AI-specific testing methodologies (like "training set," "ground truth experts," "MRMC studies") are not applicable. The document confirms that "Device verification testing was performed to demonstrate the Attain Hybrid Guide Wires meet established performance criteria" and that "All design and compatibility requirements were met," indicating successful completion of the necessary testing, but it does not delve into the quantitative specifics of those tests or the exact acceptance criteria.

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