(256 days)
The Mi-CHORD System is indicated for the replacement of adult mitral chordae tendineae with the patient on cardiopulmonary bypass, with the heart either arrested or fibrillating, and the surgical field under direct visualization.
Direct visualization, in this context, requires that the surgeon is able to see the heart and target tissues in a bloodless field, with or without assistance from an operating telescope or videoscopy.
The Mi-CHORD™ System, shown in Figure 1, is a sterile, single use system, including the Mi-STITCH™ suturing device with its loaded LS-5™ expanded polytetrafluoro-ethylene (ePTFE) suture (Figure 2) and the Mi-KNOT™ device with its loaded Mi-KNOT™ titanium fastener (Figure 3).
The provided text describes a medical device (Mi-CHORD System) and its non-clinical and clinical performance data. However, it does not describe an AI/ML-based device, nor does it contain information about "acceptance criteria" in the context of an AI/ML study, or any "study that proves the device meets the acceptance criteria" in that context.
The document primarily focuses on:
- Device Description: The physical components and their functionality (Mi-STITCH and Mi-KNOT devices, ePTFE suture, titanium fastener).
- Nonclinical/Bench Studies: Biocompatibility, shelf life/sterility, and various engineering bench tests demonstrating mechanical performance, reliability, durability, and material properties. These are traditional engineering and material science tests for a physical medical device.
- Clinical Information: A single-center, single-cohort feasibility study conducted outside the United States (OUS) with 12 patients, focusing on operative times, echocardiographic outcomes, adverse events, and mortality in mitral valve repair.
- Regulatory Aspects: De Novo classification request, indications for use, risks to health, and special controls.
Since the prompt asks for information related to an AI/ML device's acceptance criteria and studies (e.g., sample size for test set, data provenance, expert ground truth, MRMC studies, standalone performance, training set details), the provided text does not contain the information requested in points 2-9 of your prompt. It describes the validation of a physical surgical device, not a classification algorithm or AI system.
Therefore, I cannot fulfill the request as presented, as the necessary information for an AI/ML device's acceptance criteria and proving study is absent from the provided text.
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