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The Radifocus Optitorque Angiographic Catheter is indicated for use in cardiac and vascular procedures. It is designed to deliver radiopaque media, guide wires, catheters, and therapeutic agents to selected sites in the vascular system. The different shapes are designed to selectively engage arteries from access sites such as the femoral, radial, and brachial artery.

The Radifocus Optitorque Angiographic Catheter is comprised of a two-layer construction featuring stainless steel mesh sandwiched between layers of polyurethane and polyamide elastomers. The shaft inner layer and outer layer contain barium sulfate for visibility and contrast under fluoroscopy. A soft tip is attached to the distal portion of some 4 Fr and all 5 Fr and 6 Fr catheters except those with a pigtail design; a soft tube is attached to the distal portion of 5 Fr and 6 Fr catheters with a pigtail design; the 4 Fr products are available with or without a soft tip. Constructed of flexible, supple polyurethane that is permanently welded to the catheter shaft, the soft tip and soft tube are designed to minimize trauma to the vessel wall. There is no change to the design of the device as a result of this submission.

The device is offered in lengths of 65-120 cm. French sizes and shaft inner diameters are as follows:

It is a disposable device intended for single use only. This device is individually packaged and sterilized by ethylene oxide gas.

The provided 510(k) summary describes a medical device, the Radifocus Optitorque Angiographic Catheter, and its performance testing. However, it does not include information about AI/ML device performance, human reader studies, or ground truth establishment relevant to AI/ML. The entire document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and biocompatibility testing for a material change.

Therefore, many of the requested items related to AI/ML device performance, sample sizes for test/training sets, expert qualifications, and ground truth establishment cannot be extracted from this document.

Here's the information that can be extracted, along with explanations for the missing items:

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

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

This document describes non-clinical performance and biocompatibility testing for a physical medical device. It does not refer to "test sets" in the context of AI/ML models or clinical data. The testing was performed on "samples" of the device, both non-aged and accelerated aged (3 years). The exact number of samples for each test is not specified, only that "All samples tested met the standard applicable to each test."

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 is not applicable to the information provided. The document concerns a physical medical device and its non-clinical performance, not an AI/ML device that requires expert-established ground truth from clinical images or data.

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

This is not applicable to the information provided. The document concerns a physical medical device and its non-clinical performance, not an AI/ML device that requires adjudication of expert labels.

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

No such study was conducted or reported in this document. This filing is for a conventional medical device, not an AI/ML diagnostic aid. The document explicitly states: "This 510(k) does not include data from clinical tests."

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

This is not applicable as the device described is not an algorithm or AI/ML product.

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

For the non-clinical performance tests, the "ground truth" or acceptance criteria were derived from recognized consensus standards (ISO, ASTM, USP) and the manufacturer's own internal standards for device functionality and safety. For biocompatibility, it was based on ISO 10993 standards and FDA G95-1 guidance.

8. The sample size for the training set

This is not applicable. There is no AI/ML model or "training set" relevant to this device.

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

This is not applicable. There is no AI/ML model or "training set" relevant to this device.

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The Radifocus Optitorque Angiographic Catheter is intended for cardiac and vascular procedures. It is designed to deliver radiopaque media, guide wires, catheters, and therapeutic agents to selected sites in the vascular system. The different shapes are designed to selectively engage arteries from access sites such as the femoral, radial, and brachial artery.

The Radifocus Optitorque Angiographic Catheter is a two-layer construction comprised of a stainless steel mesh sandwiched between layers of polyurethane polyamide elastomer. The polyurethane polyamide elastomer contains barium sulfate for visibility and contrast under fluoroscopy. The Catheter has a "soft-tip" whose purpose is to minimize trauma to the vessel wall. The soft-tip is a flexible, supple polyurethane tip that is permanently welded to the catheter shaft.

The provided text is a 510(k) summary for the Radifocus® Optitorque™ Angiographic Catheter. It states that the device is substantially equivalent to a previously cleared device (K992051) and thus does not contain a typical study with acceptance criteria and performance metrics for a new device. Instead, the justification for substantial equivalence relies on the fact that the device is identical in design, materials, and principle of operation to the predicate device, and a risk/hazard analysis was conducted.

Therefore, many of the requested details about acceptance criteria, performance, sample sizes, expert involvement, and ground truth establishment are not applicable or cannot be extracted from this document, as a new clinical performance study was not required or submitted for this specific 510(k).

Here's an attempt to address the points based on the provided text, indicating where information is not available:

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

2. Sample size 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 as a formal performance study on a test set (clinical or otherwise with specific sample sizes) for this new 510(k) was not conducted. The submission relies on substantial equivalence to a predicate device.

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 provided as a specific clinical performance study requiring expert ground truth establishment for this 510(k) was not conducted.

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

This information is not provided as a specific clinical performance study requiring adjudication for this 510(k) was not conducted.

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

An MRMC study was not conducted, as this is a medical device (angiographic catheter), not an AI-assisted diagnostic tool.

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

This is not applicable as the device is an angiographic catheter and does not involve an algorithm. The "Principle of Operation / Technology" states it "is operated manually or by a manual process."

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

This information is not applicable to this type of device submission. The performance justification relies on compliance with standards for material safety, sterility, and mechanical/physical specifications rather than a comparative ground truth for diagnostic accuracy.

8. The sample size for the training set

This information is not applicable as this is a medical device (angiographic catheter) and does not involve a "training set" in the context of an algorithm or AI model development.

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

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

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The RADIFOCUS® Optitorque Angiographic Catheter is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the vascular system.

The RADIFOCUS® Optitorque Angiographic Catheter is a two-layer construction comprised of a stainless steel mesh sandwiched between layers of polyurethane polyamide elastomer. The polyurethane polyamide elastomer contains barium sulfate for visibility and contrast under fluoroscopy. The Catheter has a "soft-tip" whose purpose is to minimize trauma to the vessel wall. The soft-tip is a flexible, supple polyurethane tip that is permanently welded to the catheter shaft. The soft tip is approximately 0.51.5 mm long on the 4Fr. Optitorque Catheter. It is approximately 1.02.5mm long on the 5 and 6Fr. Optitorque Catheters.

Device Acceptance Criteria and Performance Study

1. Table of Acceptance Criteria and Reported Device Performance

The device documentation does not explicitly list quantitative acceptance criteria in a table format. Instead, it states that the performance of the RADIFOCUS® Optitorque Angiographic Catheter is substantially equivalent to the predicate device (Angiographic Catheter, K863137/A) based on a series of verification tests. This "substantial equivalence" acts as the overarching acceptance criterion. The performance is reported in the context of demonstrating this equivalence.

2. Sample Size for Test Set and Data Provenance

The document does not specify a distinct "test set" in the context of patient data or clinical trials. The performance verification refers to engineering tests and material characterization performed on the device itself. Therefore, sample sizes would relate to the number of catheters or components subjected to these physical and chemical tests. The document does not provide these specific sample sizes.

Data Provenance: The data provenance is internal to the manufacturer (Terumo Medical Corporation) as these are verification tests performed on the device by the company. There is no mention of country of origin for external data, retrospective or prospective studies involving patients.

3. Number of Experts and Qualifications for Establishing Ground Truth for Test Set

Not applicable for this type of device and study. The "ground truth" for the engineering and material tests would be the established scientific principles, consensus standards (e.g., ISO-10993 for biocompatibility), and the performance characteristics of the predicate device (K863137/A). This doesn't involve expert medical review of a patient-derived test set to establish ground truth.

4. Adjudication Method for the Test Set

Not applicable. There is no clinical test set requiring adjudication. The verification tests are objective measurements against defined criteria or internal specifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is a medical device submission (510(k)) for an angiographic catheter, not an AI/imaging diagnostic device. Therefore, a multi-reader multi-case comparative effectiveness study involving human readers and AI assistance is not relevant and was not conducted.

6. Standalone (Algorithm Only) Performance Study

No. This submission is for a physical medical device (catheter), not an algorithm or software. Therefore, a standalone algorithm performance study was not conducted.

7. Type of Ground Truth Used

The ground truth used for demonstrating the device's performance is based on:

• Engineering specifications and test methodologies: For mechanical properties like tensile strength, rigidity, torque transmission, flow rate, and tip flexibility.
• Biocompatibility standards: Specifically, ISO-10993 for the biological evaluation of medical devices.
• Performance of the legally marketed predicate device (K863137/A): The primary ground truth for demonstrating "substantial equivalence" is the established safety and effectiveness profile of the predicate device.

8. Sample Size for the Training Set

Not applicable. There is no training set as this is not a machine learning or AI-based device.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set.

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