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The Braun Guidewire is intended to fit inside a catheter for the catheter through a blood ressel. These catheters may be used for PTCA and PTA procedures. These guidewires are not intended for use for cerebral,reproductive,or nuerological procedures.

The Braun Guidewire is a steerable, shapeable guidewire. The guidewire is available in a variety of diameters, stiffnesses, and lengths. Certain sizes are extendible to exchange lengths. Extendible guidewires have an attachment at the proximal end of the guidewire which is adanted to receive a Braun Guidewire extension wire. Extending the guides exchange of intravascular devices while maintaining distal guidewire position. The extension is removable and permits the guidewire to be returned to its original length and functionality. The Braun Guidewire extension wire is available in sizes compatible with Braun Guidewire extendible guidewires. The distal end of the extension is adapted to engage the proximal end of the guidewire enabling exchange of intravascular devices while maintaining distal guidewire position. The extension is removable and permits the guidewire to be returned to its original length and functionality.

Here's the analysis of the provided text regarding acceptance criteria and study details. It appears the provided text, K961107, is a 510(k) summary for a medical device (Braun Guidewires and Extension Wires) submitted to the FDA in 1996. This type of document primarily focuses on establishing substantial equivalence to previously cleared devices rather than presenting detailed clinical study data with specific acceptance criteria in the way a modern AI/ML device submission would.

Therefore, many of the requested categories (e.g., sample sizes for training/test sets, ground truth establishment for AI, expert adjudication, MRMC studies) are not applicable to this 1996 medical device clearance for a guidewire. The "acceptance criteria" for such a device are typically related to performance specifications, manufacturing quality, and biocompatibility, which are covered by recognized standards and bench testing, not clinical performance metrics like sensitivity and specificity from a diagnostic study.

Here's what can be extracted and what is not applicable:

Acceptance Criteria and Reported Device Performance

Explanation: The document does not describe acceptance criteria in the way a diagnostic AI device would (e.g., "sensitivity ≥ 90%"). Instead, the core of this 510(k) submission is to demonstrate "substantial equivalence" to predicate devices. This implies that the B. Braun Guidewires and Extension Wires meet the same fundamental safety and effectiveness requirements as the already cleared devices. To achieve this, the new device would have undergone:

• Bench testing: To confirm physical properties, durability, torque characteristics, and other engineering specifications.
• Biocompatibility testing: To ensure the materials are safe for human contact.
• Sterilization validation: To confirm the device can be consistently sterilized.

These tests would have their own internal acceptance criteria (e.g., "tensile strength X N," "torque response Y degrees/cm," "no cytotoxicity observed"), but these are not typically detailed in public 510(k) summaries as they are specific manufacturing and performance specifications.

Study Details (Applicable and Not Applicable)

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Not Applicable: This document does not describe a clinical study with a "test set" in the context of diagnostic performance. The substantial equivalence argument relies on comparison to predicate devices, potentially with bench testing results.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

   • Not Applicable: There is no mention of a clinical study involving experts establishing ground truth for a test set.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not Applicable: No clinical test set described.

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

   • Not Applicable: This is a physical medical device (guidewire), not an AI/ML diagnostic system. No MRMC study was performed.

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

   • Not Applicable: This is a physical medical device, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   • Not Applicable: No ground truth in the context of diagnostic performance is discussed. The "ground truth" for a guidewire would be its physical properties meeting design specifications and its ability to safely function as intended (e.g., tracking through a vessel, enabling device exchange).

7. The sample size for the training set

   • Not Applicable: This is a physical medical device, not an AI/ML system requiring a "training set."

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

   • Not Applicable: No training set described.

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