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The catheter is intended for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.

The AcuNav Crystal Ultrasound catheter is disposable and 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 catheter is to be used only on systems with which they have been tested and found compatible.

The provided text is a 510(k) summary for the AcuNav Crystal Ultrasound Catheter. It outlines the device's characteristics and its substantial equivalence to a previously cleared predicate device. However, it explicitly states that clinical data was not required to establish substantial equivalence because the new device uses the same intended use, technology, and principles as the predicate device.

Therefore, the document does not contain information regarding a study that proves the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy (e.g., sensitivity, specificity). It only lists non-clinical tests related to safety and manufacturing standards.

Consequently, I cannot provide the requested information about acceptance criteria for device performance, given that no such performance study was conducted or presented in this 510(k) summary.

Here's what can be inferred from the document regarding non-clinical acceptance criteria:

• Acceptance Criteria for Non-Clinical Performance (Implicit): The device is expected to conform to various safety and manufacturing standards. The "acceptance criteria" for these would be successful adherence to the requirements of the listed standards.

• Study Proving Device Meets Acceptance Criteria (Non-Clinical): The document states: "The device has been evaluated for acoustic output, biocompatibility, sterilization, packaging, shelf life as well as thermal, electrical, electromagnetic and mechanical safety and has been found to conform with applicable medical device safety standards." This is the "study" proving it meets these non-clinical acceptance criteria.

Specifically, the document does NOT contain the following information that would be relevant to a clinical performance study:

• A table of acceptance criteria and reported device clinical performance (e.g., diagnostic accuracy metrics).
• Sample size used for a test set (clinical).
• Data provenance (e.g., country of origin of clinical data, retrospective or prospective).
• Number of experts used to establish ground truth for a test set and their qualifications.
• Adjudication method for a test set.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done.
• If a standalone (algorithm only) performance study was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• The sample size for the training set (as no AI algorithm requiring a training set is mentioned for performance).
• How the ground truth for the training set was established.

In summary, based on the provided text, no clinical performance study was conducted or described because the device demonstrated substantial equivalence through technological comparison and adherence to non-clinical safety standards.

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