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The RX Takeru PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion in the coronary artery or bypass graft stenosis for the purpose of myocardial perfusion. This product (balloon models 2.0-5.0 mm) is also indicated for the post-delivery expansion of balloon expandable stents.

Device Description

Rx Takeru PTCA Balloon Dilatation Catheter (Rx Takeru) is a rapid exchange type of balloon dilation catheter, which consists of a distal tube, guidewire transition tube, balloon, radiopaque marker(s), mid tube, proximal tube, core wire, hub, and strain relief. A balloon is attached to the distal end of the catheter, and it can be inflated and deflated using the inflation device connected to the hub at the proximal end. Rx Takeru has a guidewire lumen at the distal end of the catheter through which a guidewire can be inserted, and also an opening along the guidewire transition tube to the guidewire port for the exit of a guidewire.

The maximum compatible diameter of a guidewire used together with Rx Takeru in a PTCA procedure is 0.014 inches. Additionally, guiding catheters with a diameter of 5 or 6 Fr have been deemed to be compatible with Rx Takeru. The nominal inflated balloon diameters range from 1.5 mm to 5.0 mm with balloon working lengths of 6 mm to 30 mm. The catheter working length is 1450 mm.

AI/ML Overview

This document describes the performance testing and acceptance criteria for the RX Takeru PTCA Balloon Dilatation Catheter.

1. A table of acceptance criteria and the reported device performance

The document states that the RX Takeru "met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs." Specific numerical acceptance criteria and reported performance values are not provided in the given text.

The performance tests conducted include:

Test Type	Acceptance Criteria Not Explicitly Stated but "Met"	Reported Performance Not Explicitly Stated but "Adequate"
Dimensional Verification	Met	Adequate for intended use
Balloon Preparation	Met	Adequate for intended use
Deployment and Retraction	Met	Adequate for intended use
Balloon Rated Burst Pressure	Met	Adequate for intended use
Balloon Fatigue (Repeat Inflations)	Met	Adequate for intended use
Balloon Compliance	Met	Adequate for intended use
Balloon Inflation and Deflation Time	Met	Adequate for intended use
Catheter Bond Strength	Met	Adequate for intended use
Flexibility and Kink Test	Met	Adequate for intended use
Torque Strength	Met	Adequate for intended use
Radiopacity	Met	Adequate for intended use
Coating Integrity	Met	Adequate for intended use
Particulate Evaluation	Met	Adequate for intended use
Balloon Rated Burst Pressure (in Stent)	Met	Adequate for intended use
Balloon Fatigue (Repeat Inflations; in Stent)	Met	Adequate for intended use
Transportation Testing	Met	Adequate for intended use
Shelf Life Testing	Met	Adequate for intended use
Biocompatibility Tests:
Cytotoxicity	Met	Biocompatible for intended use
Sensitization	Met	Biocompatible for intended use
Intracutaneous Reactivity	Met	Biocompatible for intended use
Acute Systemic Toxicity	Met	Biocompatible for intended use
Pyrogen	Met	Biocompatible for intended use
Hemocompatibility (in vivo thromboresistance, hemolysis, complement)	Met	Biocompatible for intended use
Genotoxicity (mouse lymphoma, bacterial reverse mutation, in vivo cytogenetics assay)	Met	Biocompatible for intended use

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

The document does not specify the sample sizes used for each of the performance or biocompatibility tests. All the tests mentioned are "in vitro" (bench) tests and biocompatibility tests conducted according to international standards (ISO 10993-1). There is no mention of human subject data, therefore, data provenance in terms of country of origin or retrospective/prospective nature is not applicable.

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

This information is not applicable. The tests performed are laboratory-based physical and chemical tests, and biocompatibility studies. "Ground truth" in the context of expert review for diagnostic devices is not relevant here. The "truth" is established by the results of the specified test methodologies and their adherence to predetermined acceptance criteria.

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

This information is not applicable. As these are not studies involving human interpretation or subjective assessments, adjudication methods are not relevant.

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

There is no mention of an MRMC comparative effectiveness study, AI assistance, or human reader improvement. This device is a PTCA balloon dilatation catheter, not a diagnostic imaging device with AI components.

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

This information is not applicable. The device is a physical medical device (catheter), not an algorithm or software. Therefore, standalone algorithm performance is not relevant.

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

The "ground truth" for the performance tests relies on adherence to established engineering and material science specifications, validated test methods (e.g., those recommended by FDA guidance documents like "Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters"), and international standards (e.g., ISO 10993-1 for biocompatibility). The "truth" is whether the device physically performs according to these criteria.

8. The sample size for the training set

This information is not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" for its development or evaluation as described in this document.

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

This information is not applicable for the same reason as point 8.

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