(263 days)
The Medline ReNewal Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheter is inteacardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.
The Medline ReNewal Reprocessed AcuNav Diagnostic Ultrasound Catheters 8F are licensed for single use only. The catheter is optimized for intracardiac scanning. With the catheter, the physician can maneuver the imaging plane located inside the catheter tip to see the region of interest. The physician can steer the catheter to optimize tissue visualization. The catheters are to be used only on systems with which they have been tested and found compatible.
The provided text is a 510(k) summary for a reprocessed medical device, specifically an ultrasound catheter, and does not describe an AI/ML powered device. Therefore, information regarding acceptance criteria and studies proving the device meets those criteria for an AI/ML powered device cannot be extracted from this document.
The document focuses on demonstrating substantial equivalence of a reprocessed device to a legally marketed predicate device, primarily through non-clinical testing of functional performance, material characteristics, cleaning validation, biocompatibility, and sterilization validation. It does not contain details about a study evaluating an AI/ML algorithm's performance.
To answer your request, if this were an AI/ML powered device, the following information would typically be present in a separate study report or detailed within the 510(k) submission, and would not be found in a standard summary like the one provided:
- Acceptance Criteria Table and Reported Performance: This would specify metrics like sensitivity, specificity, AUC, F1-score, accuracy, etc., and the target thresholds, along with the actual performance achieved by the AI model.
- Sample Size and Data Provenance: Details on the number of cases/samples in the test set, and whether the data was retrospective or prospective, and its geographical origin.
- Ground Truth Experts: The number and qualifications of experts who established the ground truth labels for the test set.
- Adjudication Method: How discrepancies among experts were resolved (e.g., 2+1, 3+1, majority vote).
- MRMC Comparative Effectiveness Study: If human readers were involved, details on a multi-reader, multi-case study to assess AI's impact on human performance, including effect sizes.
- Standalone Performance: If the AI algorithm's performance was evaluated independently without human intervention.
- Type of Ground Truth: The method used to establish the true diagnosis (e.g., expert consensus, biopsy, surgical findings, long-term outcomes).
- Training Set Sample Size: The number of data points used to train the AI model.
- Training Set Ground Truth: How the ground truth for the training data was established (often a multi-stage process, possibly involving automated methods, expert review, or existing clinical records).
In summary, the provided document relates to a reprocessed physical medical device and not an AI/ML enabled device. Therefore, it does not contain the information required to answer your specific questions about an AI/ML device's acceptance criteria and validation study.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).