(118 days)
The 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 Acumen Coronary Sinus Visualization System is a steerable angioscopic catheter with a silicone balloon on the distal end. The balloon is intended to displace blood flow to aid in visualization and to provide temporary occlusion during a venogram. The CSVS includes an integrated light source and a camera providing NTSC video output.
The Coronary Sinus Visualization System (CSVS) by Acumen Medical, Inc. underwent in-vitro and in-vivo testing to ensure it met required specifications. However, the provided document does not detail acceptance criteria or specific performance results in a table, nor does it describe a formal study involving expert consensus, MRMC studies, or standalone algorithm performance.
Here's a breakdown of the available information based on your request:
1. A table of acceptance criteria and the reported device performance
The provided text states: "In-vitro and in-vivo testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests."
No specific acceptance criteria or quantitative performance results are provided in the document.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "in-vitro and in-vivo testing" but does not specify the sample size for the test set, the country of origin of the data, or whether the study was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not mention the use of experts to establish ground truth for a test set. This type of detail is typically not provided for a device like this, which is a medical instrument rather than an AI/diagnostic software.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not mention any adjudication method for a test set. Again, this is not typically applicable to the type of device described.
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
The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study. The device is a visualization system and not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document does not describe any standalone algorithm performance. The CSVS is a physical medical device (a steerable angioscopic catheter with a balloon, light source, and camera) and not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not specify the type of ground truth used. Given the nature of the device (visualization and delivery), "ground truth" would likely refer to objective physical or physiological parameters measured during in-vitro and in-vivo testing to ensure the device performs its intended functions (e.g., successful visualization, temporary occlusion, and pathway provision).
8. The sample size for the training set
The document does not mention any training set or its sample size. This is not relevant to a physical medical device.
9. How the ground truth for the training set was established
The document does not mention any training set or how its ground truth was established. This is not relevant to a physical medical device.
In summary:
The provided 510(k) summary for the Acumen Coronary Sinus Visualization System details its intended use, device description, materials, and substantial equivalence to predicate devices based on in-vitro and in-vivo testing. However, it lacks the specific details regarding acceptance criteria, study design, sample sizes, expert involvement, or any AI-related performance metrics that your questions are looking for. This is likely because the device is a physical medical instrument, not an AI or diagnostic software that would require such extensive validation studies with human readers or trained algorithms. The FDA clearance is based on the device demonstrating substantial equivalence to already legally marketed predicate devices, and meeting safety and performance specifications through general in-vitro and in-vivo testing.
§ 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).