Search Results

Cardio Vision® MICS Aortic Clamps are indicated for use for temporary or partial occlusion of blood vessels during surgical procedures.

Cardio Vision® MICS Aortic Clamps are reusable stainless steel vascular clamps provided with DeBakey tooth design. The closure mechanisms permit the surgeon to adjust the amount of tension applied to the vessel. The length and design of the clamps can be important to keep the devices out of the field of vision of the operative site. Three basic models are available to accommodate the individual needs of the surgeon and the procedure based on the anatomy of the site. Standard Clamp - Ring-handled clamp with ratchet closure o 2nd Generation Clamp -- Handleless clamp with manual screw 0 mechanism closure Clamp by Glauber - Handleless clamp with screw mechanism closure. o The clamp is positioned and removed by means of an applicator and remains wholly within the thorax throughout the duration of the procedure. The device is provided non-sterile for steam sterilization by the user.

This document describes a 510(k) summary for the Cardio Vision® MICS Aortic Clamps, a vascular clamp. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in the manner of an AI/ML powered device. Therefore, many of the requested categories for a comprehensive device study (especially those related to AI/ML performance, human readers, and ground truth establishment) are not applicable or not explicitly detailed in this type of submission for a mechanical device.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" for a mechanical device like a vascular clamp is typically linked to functional requirements and safety, rather than statistical performance metrics like sensitivity/specificity for an AI algorithm. For this 510(k) submission, the "acceptance criteria" are implied by demonstrating substantial equivalence to predicate devices in terms of intended use, technological characteristics, and safety. The reported "performance" is a comparison to these predicates.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document states "Bench and animal testing was performed to assess clamp force and aortic tissue damage." However, specific sample sizes for these tests are not provided in this summary.
• Data Provenance: The document does not explicitly state the country of origin for the animal testing, but the submitter (Cardiomedical GmbH) is from Germany. The testing itself is described as "bench and animal testing," indicating it was likely conducted in a controlled environment as part of the device development and validation. It is prospective testing for the device's validation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Not Applicable in the context of this device. For a mechanical device like a vascular clamp, "ground truth" is not established by expert consensus on observational data (like medical images). Instead, the performance (e.g., clamp force, tissue damage) is measured directly in controlled laboratory and animal settings, often against established engineering standards or comparative data from predicate devices.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods (like 2+1, 3+1) are relevant for subjective assessments, typically in image interpretation or diagnostic tasks involving multiple human readers. For the objective measurement of clamp force or tissue damage, such a method is not used.

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

• Not Applicable. This is a mechanical device, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is irrelevant.

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

• Not Applicable. This device does not involve an algorithm.

7. The Type of Ground Truth Used

• For this mechanical device, the "ground truth" implicitly refers to objective measurements of physical properties (e.g., clamp force, assessment of aortic tissue damage) obtained through laboratory and animal testing. This is not "expert consensus, pathology, or outcomes data" in the typical sense for diagnostic devices, but rather direct empirical data on the device's mechanical function and biological interaction.

8. The Sample Size for the Training Set

• Not Applicable. There is no "training set" as this is not an AI/ML device.

9. How the Ground Truth for the Training Set was Established

• Not Applicable. There is no "training set" or corresponding ground truth establishment process for this type of mechanical device.

Ask a specific question about this device