Search Results

The SMI Cardiovascular Patch is intended for cardiovascular patching.
The Solinas Medical, Inc. SMI Cardiovascular Patch is indicated for cardiovascular patching.

The SMI Cardiovascular Patch is comprised of a knitted polyethylene terephthalate (polyester) fabric covered silicone sheet and with a thin nickel-titanium (nitinol) alloy mesh. It is provided in various sizes and as flat and curved shapes. The SMI Cardiovascular Patch in the flat configuration is 2 cm x 7.5 cm and the following curved sizes: 6, 7, 8, 9, and 10 mm diameters, 4.5 cm length, and 360° arc angle. A manufacturing change was also made to bond the polyester fabric to the silicone.

The provided text describes a medical device, the SMI Cardiovascular Patch, and its 510(k) submission for regulatory clearance. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. However, it does not contain the detailed information required to answer all parts of your request, particularly regarding clinical studies, AI performance, ground truth establishment for AI, or multi-reader multi-case studies.

Here's an analysis of what information can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance

The document lists performance tests but does not explicitly state quantitative "acceptance criteria" alongside specific numerical "reported device performance." Instead, it broadly states that the device "meets the performance specifications" and has "results that are substantially equivalent to the predicate device."

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. The tests mentioned are "bench mechanical testing," which implies physical samples of the device, not patient data. Therefore, data provenance, retrospective/prospective nature, and country of origin are not applicable in this context.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. As this is a 510(k) for a physical medical patch based on bench testing, the concept of "experts establishing ground truth" for test sets of clinical data is not applicable here. The "ground truth" for these tests would be the measurement standards and testing protocols themselves.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided and is not applicable for bench mechanical testing. Adjudication methods are typically associated with clinical studies involving interpretation of medical images or patient outcomes.

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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study, human readers, or AI in the provided text. This submission pertains to a physical cardiovascular patch, not an AI-powered diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

There is no mention of any algorithm-only or standalone performance testing, as the device is a physical cardiovascular patch and not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical (bench) testing, the "ground truth" would be the established physical and mechanical properties measured according to standardized test methods (e.g., ASTM standards for tensile strength, burst strength, etc.). There is no mention of expert consensus, pathology, or outcomes data, as these are clinical ground truths.

8. The sample size for the training set

There is no mention of a training set, as this submission is for a physical medical device and not an AI/ML algorithm.

9. How the ground truth for the training set was established

Not applicable, as there is no training set mentioned.

Ask a specific question about this device