(28 days)
The 7F Acumen Coronary Sinus Visualization System is intended to aid in the visualization of the coronary sinus, provide temporary occlusion during a venogram, and to provide a pathway for delivery of transvenous devices to the coronary sinus and coronary vasculature of the heart.
The 7F Acumen Coronary Sinus Visualization System (CSVS) is a single-use percutaneous catheter intended to aid in the visualization of the coronary sinus, provide temporary occlusion during a venogram, and to provide a pathway for delivery of transvenous devices to the coronary sinus and coronary vasculature of the heart.
The provided document K062084 for the Acumen Medical, Inc. 7F Acumen Coronary Sinus Visualization System is a 510(k) summary and an FDA clearance letter. It states that appropriate testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests to demonstrate substantial equivalence to its predicate device (Acumen Coronary Sinus Visualization System, K042381). However, the document does not provide specific details about the acceptance criteria, study design, or performance metrics.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor the details about sample sizes, ground truth establishment, or specific study types. The document explicitly states that the new device is "either identical or substantially equivalent to existing legally marketed predicate product" in terms of its intended use, method of operation, methods of construction, and materials.
To answer your questions based only on the provided text:
1. A table of acceptance criteria and the reported device performance:
This information is not explicitly provided in the document. The document states: "Appropriate testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests." However, the specifications themselves are not detailed.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the document.
3. 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):
This information is not provided in the document. The testing mentioned appears to be related to meeting required specifications for a medical device's components and functionality, rather than a clinical study requiring expert ground truth for interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the document.
5. 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 in the document. The device is a "Coronary Sinus Visualization System," a physical catheter, not an AI-assisted diagnostic tool for image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not provided in the document. As mentioned, this is a physical catheter, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
This information is not provided in the document. The testing described appears to be engineering/performance testing for a physical device rather than a diagnostic accuracy study.
8. The sample size for the training set:
This information is not provided in the document. This is a physical device, and the concept of a "training set" for an algorithm is not applicable here.
9. How the ground truth for the training set was established:
This information is not provided in the document.
§ 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).