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The Guiding Catheters with PC Polymer Coating are indicated to aid the percutaneous placement of guide wires, balloon dilatation catheters, and other devices required for peripheral and coronary artery transcatheter diagnosis and therapy. The guiding catheters are not intended for use in the cerebral vasculature.

The 6 Fr, 7 Fr, and 8 Fr Guiding Catheters with PC Polymer Coating have shaft nominal outside diameters of 0.079", 0.092", and 0.104" with nominal inside diameters of 0.064", 0.075", and 0.087", respectively. The guiding catheters are available in lengths of 65 cm, 85 cm, 100 cm, and 110 cm. Distal side holes and different curve styles are available. The inner and outer surfaces of the guiding catheter are coated with a hydrophilic polymer. The catheter hub is disk shaped and injection molded onto the shaft. The shaft is an extruded thermoplastic with an embedded stainless steel braided wire extending from the hub to the radiopaque tip. A hub-to-shaft kink protector is included. The tip is made of a low durometer radiopaque thermoplastic and is heat welded to the end of the catheter shaft. The guiding catheters are packaged in Tyvek/Mylar heat sealed sterilization pouches and gas sterilized by ethylene oxide.

This submission is for a medical device (Guiding Catheters) and not an AI/ML powered device, so most of the requested information (related to AI/ML studies, ground truth, expert consensus, etc.) is not applicable. However, I can extract the relevant information regarding acceptance criteria and performance testing for this device.

Here's the summary of the acceptance criteria and the study for the Guiding Catheters:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document states that "The 6 Fr and 8 Fr guiding catheters of each manufacturer were tested." This implies at least two sizes of the applicant's device (6 Fr and 8 Fr) and two sizes of the predicate device (6 Fr and 8 Fr) were used for testing. The exact number of individual units tested within each size is not specified.
• Data Provenance: This was an in vitro performance testing and biocompatibility testing. The data originates from laboratory testing conducted by the manufacturer, Biocompatibles Cardiovascular Inc.

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

This is not applicable as the submission pertains to a medical device's physical and biological properties rather than an AI/ML algorithm requiring expert interpretation of data.

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

This is not applicable for a physical device's performance testing.

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

This is not applicable as the submission pertains to a medical device and not an AI/ML system.

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

This is not applicable as the submission pertains to a physical medical device.

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

The "ground truth" for this device's performance is based on established engineering and biological standards for catheter functionality and safety. This includes:
* Engineering Standards: Bench testing for tensile strength and shaft wall strength.
* Biocompatibility Standards: Established tests for toxicity, irritation, pyrogenicity, and blood compatibility, likely performed according to ISO standards or similar guidelines.
* Comparison to Predicate Device: The predicate devices (Cordis Corporation 6 Fr and 8 Fr Brite Tip® Guiding Catheters) serve as a de facto "ground truth" or benchmark for technological characteristics.

8. The sample size for the training set

This is not applicable as the submission pertains to a physical medical device, not an AI/ML algorithm requiring a training set.

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

This is not applicable as the submission pertains to a physical medical device.

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