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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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The deflectable catheter system is indicated to provide a pathway through which diagnostic and therapeutic transvenous devices are introduced within the chambers and coronary vasculature of the heart, and for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus.

The Medtronic SelectSite Model C304 Deflectable Catheter System is designed to facilitate the introduction of transvenous devices within the chambers and coronary vasculature of the heart and the introduction of leads in the left heart via the coronary sinus.

The Model C304-S59 deflectable catheter has a single lumen for passage of transvenous devices with a maximum outer diameter of 5.6 French (1.9 mm) and a usable length of 30 cm.

The Model C304-L69 deflectable catheter has a single lumen for passage of transvenous devices with a maximum outer diameter of 5.6 French (1.9 mm) and a usable length of 40 cm.

The deflectable catheter features a deflecting distal section controlled by the deflectable catheter handle for placement of transvenous devices within the chambers of the heart and for coronary sinus cannulation. The body of the deflectable catheter is radiopaque for visibility on fluoroscopy.

The provided text describes a 510(k) summary for the Medtronic SelectSite™ Model C304 Deflectable Catheter System. This document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria or reporting on a clinical effectiveness study with specific performance metrics for the device itself.

Therefore, much of the requested information regarding acceptance criteria, performance metrics, sample sizes for test and training sets, expert qualifications, adjudication methods, and ground truth types is not available in the provided text, as these are typically part of a clinical trial or performance study, which this summary does not detail beyond "In Vitro testing".

Here's what can be extracted based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified. The study mentioned is "In Vitro testing".
• Data Provenance: Not specified, but "In Vitro testing" implies laboratory-based testing, not human data.

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

• Number of Experts: Not applicable, as this was an "In Vitro testing" study.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set:

• Adjudication Method: Not applicable, as this was an "In Vitro testing" study.

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:

• MRMC Study: No. This is a medical device (catheter) and the study described is "In Vitro testing", not an AI diagnostic tool involving human readers.

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

• Standalone Performance Study: Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

• Type of Ground Truth: For the "In Vitro testing", the ground truth would be based on engineering specifications, physical measurements, and adherence to established standards (e.g., ISO-10993 for biocompatibility) to verify the device's design and performance.

8. The sample size for the training set:

• Sample Size: Not applicable. This document describes "In Vitro testing" for a physical device, not an AI model that requires a training set.

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

• Ground Truth Establishment: Not applicable.

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