(63 days)
The Pioneer catheter is intended to facilitate placement and positioning of catheters within the peripheral vasculature. The Pioneer catheter also provides an intraluminal cross-sectional ultrasound image of the area of interest to facilitate placement of guidewires beyond stenotic lesions (e.g., sub-total, total or chronic total occlusions) prior to additional intervention (i.e. PTCA, stent, etc.). The Pioneer catheter is not indicated for use in the coronary or cerebral vasculature.
The Pioneer Catheter is designed to facilitate the placement and positioning of catheters within peripheral vasculature. The Pioneer Catheter also provides an intraluminal cross-sectional ultrasound image of the area of interest to facilitate placement of guidewires beyond stenotic lesions (e.g., sub-total, total or chronic total occlusions) prior to additional intervention (i.e., PTCA, stent, etc.).
The provided text is a 510(k) summary for the Pioneer Catheter, a medical device. This summary describes the device and its intended use, but it does not contain any information about acceptance criteria or a study proving the device meets those criteria.
The document explicitly states that "No technological changes have been made to the proposed Pioneer Catheter. This submission covers an update to the indication for use to include appropriate applications." and "The purpose of the submission is to clarify the indications to include appropriate applications as supported by prior testing and published literature."
Therefore, based solely on the provided text, I cannot answer the questions regarding acceptance criteria and a study proving their fulfillment. The submission is focused on a change in the indicated use, not on new performance testing.
However, I can extract the following information that is mentioned or implied:
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A table of acceptance criteria and the reported device performance: Not provided in the document. The document states "No technological changes have been made," implying that prior performance data (likely from K013363 and K031920) was deemed sufficient and no new performance data was generated for this specific submission.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided. This submission relies on "prior testing and published literature" but does not detail that testing.
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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 provided.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided.
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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. The Pioneer Catheter is a physical medical device (a catheter with ultrasound capabilities), not an AI algorithm.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The Pioneer Catheter is a physical medical device, not an AI algorithm.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not explicitly stated, as no new study data is presented. The reliance on "prior testing and published literature" suggests that any ground truth would have been established within those previous studies.
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The sample size for the training set: Not applicable. This is not an AI device.
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How the ground truth for the training set was established: Not applicable. This is not an AI device.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).