(6 days)
Cordis Catheter Sheath Introducers are intended for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.
The system consists of an introducer, a mini-guidewire, and a vessel dilator. The introducer consists of a cannula of co-extruded polyethylene with barium sulfate, a high density polyethylene body, and polyurethane sideport extension. The radiopaque tip is made of a blend of tungsten, polyethylene, and zinc stearate.
• 4 - 11 French
• 3 - 120 cm length
• .035" - .038' mini guidewire
This document is a 510(k) summary for the Cordis Brite Tip Catheter Sheath Introducer, not a study report. Therefore, it does not contain the detailed information about acceptance criteria, device performance, study design, or ground truth establishment that would typically be found in a clinical study report.
The document states that the Brite Tip CSI's are substantially equivalent to previously cleared Brite Tip CSI's. This implies that the device meets the same performance criteria as its predicate device, but it does not specify what those criteria are or how they were tested in this particular submission.
Here's an attempt to address your questions based on the limited information provided in this 510(k) summary, with many answers indicating that the information is not provided in this document:
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A table of acceptance criteria and the reported device performance
This document does not provide a table of acceptance criteria or reported device performance in the context of a clinical study. The "Summary of Safety and Effectiveness" section focuses on establishing substantial equivalence to a predicate device.
Acceptance Criteria Reported Device Performance Not provided Not provided -
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not provided. This document describes a 510(k) submission based on substantial equivalence, not a clinical study involving a test set of data.
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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)
Not applicable. No test set requiring expert ground truth establishment is described in this 510(k) summary.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No formal test set or adjudication method is described.
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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
Not applicable. This is not an AI/imaging device, nor is an MRMC study described.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-based device requiring standalone performance testing in that context.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. The concept of "ground truth" as it relates to clinical data analysis for performance metrics is not relevant to this 510(k) submission, which relies on the concept of substantial equivalence based on device characteristics and intended use.
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The sample size for the training set
Not applicable. This document does not describe the development of an algorithm or model that would require a training set.
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How the ground truth for the training set was established
Not applicable. As there is no training set described, the method for establishing its ground truth is also not applicable.
In summary: The provided document is a 510(k) summary for a medical device (a catheter sheath introducer) seeking market clearance based on substantial equivalence to existing devices, not a study report detailing clinical performance or algorithm validation. Therefore, most of the requested information regarding acceptance criteria derived from clinical studies, test sets, ground truth, and reader studies is not present. The primary "acceptance criterion" for this submission is that the device is substantially equivalent to predicates concerning its design, materials, and intended use.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).