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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.

A guide wire is a flexible wire of a small diameter that serves as a track for directing or passing a device to a vessel, organ or cavity, by threading the device over its length.

The provided document is a 510(k) premarket notification for a medical device called the "Attain Hybrid Guide Wire." It describes the device, its intended use, and the studies performed to demonstrate its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information, specifically focusing on what is available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "The results of the above verification tests met the specified acceptance criteria." However, it does not provide a detailed table outlining specific numerical acceptance criteria for each test and the corresponding reported device performance values. It only lists the types of tests performed.

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

The document does not specify the sample sizes used for any of the bench/performance tests or biocompatibility tests. It also does not mention any human clinical test set for this device; the testing is focused on demonstrating substantial equivalence through bench and biocompatibility testing. Therefore, there is no data provenance (e.g., country of origin, retrospective/prospective) described for a clinical test set.

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

Since the testing described is primarily bench and biocompatibility testing, there is no "ground truth" established by human experts in the context of clinical interpretation or diagnosis. The ground truth for these tests would be derived from the experimental parameters, validated methods, and material characterization.

4. Adjudication Method for the Test Set:

Not applicable, as there is no clinical test set requiring expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. The document describes bench and biocompatibility testing, not a clinical study involving human readers or comparative effectiveness with or without AI assistance. This device is a guide wire, not an AI-powered diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

No. This question is also not applicable. The device is a physical medical instrument, not an algorithm, and therefore does not have "algorithm only" performance.

7. Type of Ground Truth Used:

The ground truth for the studies described would be based on:

• Engineering specifications and standards: For dimensional verification, coating adhesion, tip integrity, deflection force, stiffness, perforation, passage/seal integrity, lubricity, durability, and torque response. These are objective measurements against defined criteria.
• Validated laboratory methods and international standards (e.g., ISO 10993-1): For biocompatibility tests. The "ground truth" here is the adherence to these standards and the established biological responses that indicate safety.
• Validated sterilization and shelf-life protocols: For sterilization validation and shelf life evaluation.

8. Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm that requires a training set. The substantial equivalence is based on physical and biological testing against a predicate device.

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

Not applicable. As established, there is no training set for this device.

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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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