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510(k) Data Aggregation
(263 days)
The Diagnostic Ultrasound System is applicable for adults and pediatric patients. It is intended for use in pediatric, small organ (breast, thyroid, testicles, prostate), musculoskeletal (conventional), musculoskeletal (superficial), peripheral vessel and dermatological exams.
The Paragon XHD Diagnostic Ultrasound System is a mobile software controlled ultrasonic system. Its function is to acquire and display ultrasound data in B-Mode, Color Flow Doppler, Power/Dirpower mode or the combination of these modes. The system can also measure anatomical structures and offer software analysis packages performance to provide information based on which the competent health care professionals can make the diagnosis. The Paragon XHD Diagnostic Ultrasound System consists of the main unit, an ultrasound probe, power adapter, connecting cable.
The provided document is a 510(k) summary for the Shenzhen Wisonic Medical Technology Co., Ltd. Paragon XHD Diagnostic Ultrasound System. This document outlines the device's characteristics and its substantial equivalence to predicate devices, focusing on safety and performance.
However, the document does NOT contain information about acceptance criteria and the study that proves the device meets the acceptance criteria from an AI/algorithm performance perspective. Instead, it discusses the device's compliance with electrical safety, EMC, biocompatibility, and general performance standards for an ultrasound system.
Therefore, I cannot extract the requested information regarding AI/algorithm performance acceptance criteria, test set details, expert consensus, MRMC studies, or standalone algorithm performance, as these are not discussed in the provided text.
The information given pertains to the ultrasound system itself, not an AI component within it. The closest approximation to "performance testing" in the document describes evaluating "clinic measurement accuracy and system sensitivity," which are general ultrasound system performance metrics, not related to an AI algorithm that would have specific acceptance criteria like sensitivity, specificity, or AUC.
Without further information describing an AI component and its validation, I cannot fulfill your request in full detail. If there was an AI component, the provided document does not elaborate on its specific validation.
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(38 days)
The ExactVu High Resolution Micro-Ultrasound System is intended for use by qualified medical professionals for diagnostic ultrasound imaging or fluid flow analysis of the human body; the intended uses are:
Small Organ (prostate) Transrectal
The system may be used with patients of all ages, but is not designed for pediatric or fetal use.
The ExactVu high resolution micro-ultrasound system is intended for use by qualified medical professionals for diagnostic ultrasound imaging, data processing and quidance of puncture and biopsy. The ExactVu System is comprised of transducers responsible for ultrasound signal generation and recording, a needle guide and a main unit that controls the transducers, processes the acoustic data, and processes and displays images.
The provided FDA 510(k) summary for the ExactVu High Resolution Micro-Ultrasound System does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria related to its diagnostic performance.
The document primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and compliance with safety standards rather than clinical performance metrics.
Specifically, the "Summary of Clinical Tests" section on page 10 explicitly states: "The ExactVu System, transducers and needle guide, subject of this submission, did not require clinical studies to support the determination of substantial equivalence."
Therefore, I cannot fulfill your request for the following information based on the provided text:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- If a standalone performance (algorithm only) was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
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