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The Selethru PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

The Selethru PTCA Balloon Dilatation Catheter is a rapid exchange (RX) PTCA Balloon Catheter used for the purpose of dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The Selethru is a sterile, single-use, intravascular medical device with a working length of 142cm. The proximal shaft is PTFE coated stainless steel tube, which allows for exceptional pushability and a smooth transition to the distal shaft, which is composed of an outer tube, an inner tube, and a balloon. A hydrophilic coating is applied to the distal section. The semi-compliant balloons are available in diameters ranging from 1.5-4.0mm and lengths from 10-30mm, and have a rated burst pressure of 16 atm. The proximal shaft of the catheter has two marker sections of 5mm length that aid in gauging dilatation catheter position relative to the guiding catheter tip (marker located closest to the dilatation catheter adaptor is for femoral guiding catheters and the other marker is for brachial guiding catheters). The distal shaft of the catheter has an integrated shaft system. The shaft has a combination of single lumen and dual lumen tubing. One lumen is used for inflation of the balloon with contrast medium. The other lumen, in the distal shaft, permits the use of a guide wire to facilitate advancement of the dilatation catheter to and through the stenosis to be dilated. The guidewire enters the catheter tip and advances coaxially out the distal Rx port, thereby allowing both coaxial guidance and rapid exchange of the catheter with a single standard length guidewire. Two radiopaque Platinum/Iridium marker bands are located within the balloon segment to aid in positioning the balloon in the stenosis, and are designed to provide an expandable segment of known diameter and length at a specific pressure. The design of this dilatation catheter does not incorporate a lumen for distal dye injections and distal pressure measurements.

This is a medical device submission, not an AI/ML product. The document describes a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Catheter (Selethru PTCA Balloon Dilatation Catheter). Therefore, the requested information regarding AI/ML device performance, such as sample sizes for test/training sets, ground truth establishment by experts, adjudication methods, or MRMC studies, is not applicable.

The document does, however, provide information about the acceptance criteria and performance of this traditional medical device.

Here's an analysis of the provided text, focusing on the device's performance and acceptance criteria:

1. Table of acceptance criteria and the reported device performance:

The document states that both in vitro performance tests and biocompatibility tests were conducted. The crucial summary statement is: "The test results met all acceptance criteria and ensure that the Selethru Catheter design and construction are suitable for its intended use as recommended by the Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (FDA; September 8, 2010)."

While specific numerical acceptance criteria values are not provided in this summary, the types of tests performed indicate the areas where performance was assessed against established criteria.

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

This information is not provided in the given text. For in vitro and biocompatibility tests, sample sizes would typically be determined by relevant ISO standards or FDA guidance documents for medical devices. The data provenance would be laboratory testing data.

3. 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)

This information is not applicable as this is a physical medical device, not an AI/ML product requiring expert ground truth for image interpretation or diagnosis. Biocompatibility and in vitro test results are evaluated against established scientific and engineering standards by qualified laboratory personnel.

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

This information is not applicable for the same reasons as point 3.

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 information is not applicable as this is not an AI/ML device designed to assist human readers.

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

This information is not applicable as this is a physical medical device, not an algorithm.

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

For the in vitro tests, the "ground truth" is defined by engineering specifications and performance standards (e.g., burst pressure measured by a transducer, dimensional measurements validated against design drawings). For biocompatibility tests, the "ground truth" is defined by biological response measurements against established safety thresholds (e.g., cell viability in cytotoxicity tests, hemolysis rates, pyrogenicity assays) based on recognized standards (e.g., ISO 10993 series).

8. The sample size for the training set

This information is not applicable as this is a physical medical device, not an AI/ML product that undergoes a "training" phase.

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

This information is not applicable as this is a physical medical device, not an AI/ML product.

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