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The MI DeTACH® is indicated for use for temporary or partial occlusion of blood vessels during cardiovascular surgical procedures.

The MI DeTACH® is comprised of a Detachable Aortic Clamp Head and a Delivery System. The MI DeTACH® Detachable Aortic Cross Clamp Head is available in three sizes: Small, Medium, and Large (55mm, and 85mm enqagement pads respectively) which are packaged and distributed separately. The Delivery System is comprised of a Delivery Device and Quick Release Device. The Delivery Device is used to deliver, clamp, deploy, unclamp, and retrieve the Clamp Head from the target occlusion site.

The MI DeTACH® Detachable Aortic Cross Clamp Head works by applying compression forces to the vessel by the padded device jaws. The top jaw is a pivot jaw allowing for parallel closure of the vessel during clamping. The amount of compression applied to the vessel for occlusion or partial occlusion is determined or adjusted by the means of the Delivery Device lever actuated jaw closure mechanism. The Clamp Head device contains ratchets that provide clamping tactile feedback to the user. A clutch mechanism prevents the user from applying excessive forces to the vessel by disengaging the lever from the device when specific force is obtained. Upon successfully clamping, the device locks and the handle is then detached leaving the clamp in the body throughout the duration of the procedure. The Delivery Device is then used to unclamp and remove the Clamp Head from the body upon procedure completion. In the event the Delivery Device becomes compromised during the course of a procedure, the Quick Release Device can be used to unclamp and remove the Clamp Head from the body.

The provided text is a 510(k) summary for the MI DeTACH® vascular clamp. This document is a regulatory submission to the FDA, demonstrating that a new device is "substantially equivalent" to legally marketed predicate devices.

It is crucial to understand that this document does NOT describe the acceptance criteria for an AI/ML device, nor does it describe a study involving AI/ML performance.

The MI DeTACH® is a physical medical device (a vascular clamp), and the "performance data" section refers to non-clinical testing for safety and functional requirements of this mechanical device, not AI/ML performance.

Therefore, I cannot extract the requested information (acceptance criteria, study details for AI/ML, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, training set sizes, or ground truth establishment for a training set) because this document does not pertain to an AI/ML device.

The "Performance Data" section (VII) outlines non-clinical testing performed to support the substantial equivalence of the MI DeTACH® to its legally marketed predicate devices. This includes:

• Design Verification and Validation Testing: This confirmed the product meets its requirements through:
  • Vessel Occlusion Testing
  • Clamping Force Distribution Testing
  • Human Factors/Usability Studies
  • Simulated Use Testing
• Sterilization and Shelf Life Testing: Confirmed product safety and effectiveness for both the sterile clamp head and the non-sterile delivery system, including cleaning, sterility, fatigue, and packaging/transport testing.
• Biocompatibility Testing: Conducted in accordance with FDA guidance and ISO 10993-1, including:
  • Cytotoxicity
  • Sensitization
  • Irritation
  • Acute Systemic Toxicity
  • Pyrogen Testing
  • Hemolysis

The document explicitly states that "Animal testing was not required" and "Clinical testing was not required" to demonstrate substantial equivalence.

In summary, the provided text does not contain any information relevant to the AI/ML-related questions you have asked.

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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.

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