(430 days)
The indications for use of the IRL VasoScan™ intravascular ultrasound catheter are for the visualization of the lumen and structure of the coronary arteries in patients affected by atherosclerosis who are suitable candidates for percutaneous transluminal coronary angioplasty (PTCA).
The indications for use of the IRL VasoScan™ intravascular ultrasound imaging system are for the visualization of the lumen and structure of the coronary arteries in patients affected by atherosclerosis who are suitable candidates for percutaneous transluminal coronary angioplasty (PTCA). The IRL VasoScan™ intravascular ultrasound catheter is for use only with the IRL VasoScan™ intravascular ultrasound imaging system.
The outer body of the IRL VasoScan™ intravascular ultrasound catheter is manufactured from Vestamid 12. The transducer consists of a 64-element array, supported on a polyimide film. The IRL VasoScan™ intravascular ultrasound catheter has a usable length of 1350mm and is designed to provide high quality intra-arterial ultrasound images of the coronary arteries. The IRL VasoScan™ intravascular ultrasound catheter is designed to be combined with conventional coronary angiography for the purposes of diagnosis, assistance with the choice of therapeutic modalities and assessment of the immediate outcome of such treatment.
The provided text is a 510(k) summary for the IRL VasoScan™ intravascular ultrasound catheter, which is a submission to the FDA for market clearance. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and device performance results in the format requested.
Therefore, the information required for the requested table and study details regarding acceptance criteria and performance of the device is not present in the provided text.
The document states that "Qualification testing covering biocompatibility, mechanical strength, electrical safety and imaging has been performed and has proved that, when used according to the instructions provided, the IRL VasoScan™ intravascular ultrasound catheter will operate as intended." However, it does not provide specific acceptance criteria or the results of these tests in a quantifiable manner.
Here's an assessment based on the available information:
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A table of acceptance criteria and the reported device performance:
This information is not provided in the document. The document generally states that "All testing was supportive of the claims (i.e. indications for use)," but no specific performance metrics or acceptance thresholds are given. -
Sample size used for the test set and the data provenance:
This information is not provided. The document mentions "Qualification testing" and "Biocompatibility tests" but does not detail sample sizes or the nature (e.g., human, animal, in vitro) or origin of the data. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. The testing mentioned is for the device's physical and functional properties, not diagnostic accuracy requiring expert interpretation of results. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided. As above, the testing described does not involve a diagnostic test where adjudication would typically be relevant. -
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 provided. The device is an intravascular ultrasound catheter, which is a diagnostic imaging tool itself, not an AI-assisted diagnostic system. Therefore, an MRMC study with AI assistance is not applicable here. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not provided. The device is a physical catheter that generates images for human interpretation, not an algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not explicitly stated in terms of ground truth for diagnostic accuracy, as the testing described focuses on the device's functional integrity. The ground truth for biocompatibility would be standard biological assays, mechanical strength would be engineering standards, etc., but these are not detailed. -
The sample size for the training set:
This information is not provided. The document describes a medical device, not a machine learning algorithm that requires a training set. -
How the ground truth for the training set was established:
This information is not provided. Not applicable for this type of device.
In summary, the provided text describes a 510(k) submission for an intravascular ultrasound catheter, focusing on its functional description, intended use, and substantial equivalence to a predicate device based on general qualification testing. It does not contain the detailed performance study information with acceptance criteria that would typically be found for a diagnostic accuracy claim or an AI/software as a medical device (SaMD) submission.
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.