(74 days)
The UNIVISION™ Echocardiology System is a network system intended to use digital technology to acquire images from an echocardiogaphy ultrasound system for viewing outside the exam room and long term storage and retrieval on digital media.
UNIVISION™ Echocardiology System is a real-time network system that provides review of echocardiograms either inside or outside the hospital environment. The exams are then archived on optical disc media. The UNIVISION™ Echocardiology System is comprised of three major subsystems: the Image Acquisition Unit (IAU); the Workstation; and the Archive Subsystem.
This document (K964803) describes the UNIVISION™ Echocardiology System, a device for acquiring, viewing, and archiving echocardiography images. However, it does not contain any information regarding acceptance criteria, performance studies, or ground truth establishment.
The document is a Premarket Notification Summary (510(k)) and focuses on demonstrating substantial equivalence to a predicate device (TomTec Imaging Systems' TomTec P90 system). The primary "performance" discussed is the use of MPEG-1 compression and a qualitative statement about image quality.
Therefore, I cannot fulfill the request for information regarding acceptance criteria, detailed performance, or study specifics as this information is not present in the provided text.
Here's a breakdown of why this information is missing based on the provided text:
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Acceptance Criteria and Reported Device Performance: No specific acceptance criteria (e.g., minimum accuracy, sensitivity, specificity, or image quality metrics) are mentioned. The only performance statement is: "The images show no significant difference between the original image from an ultrasound echocardiology system and that from the same image after MPEG-1 compression has been employed." This is a qualitative, not a quantitative, performance claim.
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Sample Size, Test Set, and Data Provenance: No information about a test set, sample size, or data provenance is provided. The document describes the system's function, not a performance study.
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Number of Experts and Qualifications: No experts are mentioned as having been involved in establishing ground truth or evaluating device performance.
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Adjudication Method: Not applicable, as no performance study is described.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No MRMC study is mentioned. The device is for image management and archiving, not for AI-assisted interpretation by human readers.
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Standalone Performance Study: No standalone performance study (algorithm only) is described. The document discusses the system's ability to acquire, transmit, and store images with compression.
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Type of Ground Truth Used: No ground truth is discussed, as no study evaluating diagnostic accuracy or clinical outcomes is presented. The "ground truth" for the compression claim is simply the original uncompressed image.
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Sample Size for Training Set: Not applicable. This is not an AI/ML device that requires a training set in the conventional sense for diagnostic algorithm development.
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How Ground Truth for Training Set Was Established: Not applicable for the same reason as above.
In summary, the provided text describes a medical device's intended use, description, and comparison to a predicate device for the purpose of regulatory clearance (510(k)). It does not contain the detailed performance study information requested.
§ 892.2010 Medical image storage device.
(a)
Identification: A medical image storage device is a hardware device that provides electronic storage and retrieval functions for medical images. Examples include electronic hardware devices employing magnetic and optical discs, magnetic tapes, and digital memory.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.