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The CryoCor Model 3100 Series Sheath Kits are intended to facilitate the percutaneous introduction of cardiovascular catheters into the heart, while preventing backflow of blood.

The Model 3100 Series Sheath Introducer Kit consists of various sheath introducers, each packaged in a kit together with a dilator, introducer catheter and guide wire.

The sheath introducer is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A side port with three-way stopcock is provided for air aspiration, fluid infusion, blood sampling and pressure monitoring. A radioopaque marker at the tip of the sheath will aid during placement while utilizing fluoroscopic guidance. There are side holes at the distal end to allow for injection of contrast media.

The dilator is tapered at the distal tip to allow for use of standard needles for trans-septal procedures, and will accommodate a guide wire or needle no larger than 0.038".

The introducer catheter is gradually tapered distally to allow for gradual dilation of entry into vasculature without producing damage.

The guide wire is 0.038" in diameter, 150 cm in length with a "I"-tip configuration. It is supplied in a hoop dispenser with a "J" straightener attached to the distal end. The proximal end of the hoop dispenser has a luer hub to facilitate flushing of the wire.

The provided 510(k) summary for K040552 describes a medical device, the CryoCor Model 3100 Series Sheath Kits, which are Catheter Introducers. The summary focuses on showing substantial equivalence to predicate devices, rather than presenting a detailed study with specific acceptance criteria and performance metrics traditionally associated with validating new clinical claims or complex algorithms.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth types, training set details) are not applicable or not provided in this type of submission.

Here's the information that can be extracted from the provided text:

Acceptance Criteria and Device Performance

Study Information

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

   • Sample Size: Not specified.
   • Data Provenance: Not specified. The studies appear to be bench and pre-clinical comparisons, rather than human clinical trials.

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

   • Not applicable/Not provided. The "test set" likely refers to engineering or bench test samples, not clinical patient data requiring expert ground truth.

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

   • Not applicable/Not provided.

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:

   • No. This device is a physical catheter introducer, not an AI-powered diagnostic tool. MRMC studies are not relevant.

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 concensus, pathology, outcomes data, etc):

   • For performance testing, the "ground truth" would be the engineering specifications and established performance metrics for catheter introducers. For biocompatibility, it's compliance with ISO standards. For sterilization, it's a validated cycle.

7. The sample size for the training set:

   • Not applicable/Not provided. As above, this is a physical device, not an AI model.

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

   • Not applicable/Not provided.

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