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Diagnostic ultrasonic imaging for abdominal, pediatric, small organ, musculo-skeletal, cardiac, peripheral vascular applications in B, M, PWD, Color Doppler and 3D imaging modes.

The SIUI Apogee 3800 is a Digital Ultrasound Imaging System capable of the following operating modes: 2D (B mode), M, Doppler (PWD mode), Color (CFM mode) and 3D. The system is designed for use in linear, convex, phased array and 3D scanning modes and supports linear, convex, phased array and 3D transducers. The system has cine review, image zoom, measurements and calculations, image storage and review, printing and recording capabilities.

This document is a 510(k) summary for the SIUI Apogee 3800 Digital Color Doppler Ultrasound Imaging System. It describes the device, its intended use, and its substantial equivalence to a predicate device (Apogee 3500, K102023).

The summary does not contain any information about acceptance criteria or a study proving that the device meets those criteria, nor does it provide details about reported device performance metrics.

The document primarily focuses on:

• Identification of the device and manufacturer.
• Identification of the predicate device.
• Description of the device's operating modes and capabilities.
• Stated intended uses and clinical applications (abdominal, pediatric, small organs, musculo-skeletal, cardiac, and peripheral vascular, in B, M, PWD, Color Doppler, and 3D modes).
• Safety considerations and compliance with relevant medical device safety standards (NEMA UD 2, UD 3, IEC 60601-1, ISO10993-5, ISO 10993-10).
• FDA's substantial equivalence determination letter.
• Detailed Indications for Use forms for the system and each associated transducer (C3L60C, L8L38C, C5L40C, P3F14C), specifying which clinical applications are "new indications" (denoted by "N") for various modes of operation.

Therefore, I cannot populate the requested table or answer most of the specific questions about the study design, sample sizes, ground truth, or MRMC studies, as this information is not present in the provided text.

The closest information provided is the "Safety Considerations" section, which states: "The Apogee 3800 Digital Color Doppler Ultrasound Imaging System has been tested per the FDA Guidance document Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers issued in September 2008. The device conforms to applicable medical device safety standards. It has been designed to meet the following standards: NEMA UD 2, UD 3, IEC 60601-1, ISO10993-5 and ISO 10993-10." This indicates that the device underwent testing for safety and compliance with general performance standards for ultrasound systems, but it does not detail any specific performance acceptance criteria or the results of such testing related to diagnostic accuracy or effectiveness.

In summary, the provided text does not contain the requested information regarding acceptance criteria, device performance metrics, or details of a study assessing such performance.

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The device is intended for ultrasonic pulsed echo imaging and measurement for abdominal, pediatric, small organs, musculo-skeletal, cardiac and peripheral vascular applications.

Diagnostic ultrasonic imaging for abdominal, pediatric, small organ, musculo-skeletal, cardiac, peripheral vascular applications in B, M, PWD, Color Doppler and 3D imaging modes.

The SIUI Apogee 1000 is a Digital Ultrasound Imaging System capable of the following operating modes: 2D (B mode), M, Doppler (PWD mode), Color (CFM mode) and 3D. The system is designed for use in linear, convex, phased array and 3D scanning modes and supports linear, convex, phased array and 3D transducers. The system has cine review, image zoom, measurements and calculations, image storage and review, printing and recording capabilities.

The provided text is a 510(k) summary for the Apogee 1000 Digital Color Doppler Ultrasound Imaging System. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain information about specific acceptance criteria or a study that proves the device meets those criteria in terms of performance metrics like sensitivity, specificity, or accuracy.

The document focuses on regulatory compliance, safety considerations (acoustic output, electrical safety), and the classification of the device and its transducers for various clinical applications and operating modes. The "Conclusion" section states that "The conclusions drawn from testing of the Apogee 1000 Digital Color Doppler Ultrasound Imaging System demonstrates that the device is as safe and effective as the legally marketed predicate device," but it does not detail what specific performance tests were conducted or what the results were.

Therefore, I cannot provide the requested information. The document does not describe:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method.
5. Multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
6. Standalone (algorithm only) performance study.
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. Sample size for the training set.
9. How the ground truth for the training set was established.

The 510(k) summary provided is primarily a declaration of substantial equivalence based on technical characteristics and safety standards rather than detailed diagnostic performance metrics.

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Diagnostic ultrasonic imaging for abdominal, pediatric, small organ, musculo-skeletal, cardiac, peripheral vascular applications in B, M, PWD, Color Doppler and 3D imaging modes.

Apogee 1100 Digital Color Doppler Ultrasound Imaging System with Convex Array Transducer C3L60C, Linear Array Transducer L8L38C, Convex Array Transducer C5L40C, Phased Array Transducer P3F14C

The provided document is a 510(k) clearance letter from the FDA for an ultrasound imaging system. It primarily lists the approved indications for use for the system and its various transducers. Crucially, it does not contain information about acceptance criteria or specific studies demonstrating the device meets those criteria.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these are not present in the provided text.

The document essentially states what the device is cleared for, not how its performance was evaluated against specific metrics.

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Ultrasonic pulsed echo imaging and measurement for abdominal, pediatric, small organ, cardiac, peripheral vascular applications

The SIUI CTS-5500/CTS-6600 is a portable diagnostic ultrasound system capable of the following operating modes: 2D (B mode), M and B/M. The system is designed for use in linear and convex scanning modes and supports linear and convex transducers. The system has cine review, image zoom, measurements and calculations, printing and recording capabilities. The system consists of probes, main unit, control panel and monitor.

This submission describes a diagnostic ultrasound system (CTS-5500/CTS-6600), not an AI-powered device. Therefore, the provided text does not contain information on acceptance criteria, a study proving device performance against such criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details relevant to AI device assessment.

The document is a 510(k) premarket notification for a traditional medical device, demonstrating substantial equivalence to a predicate device (SIUI CTS-485, K012772) rather than proving performance against specific acceptance criteria in a clinical study as would be required for a novel AI-driven diagnostic.

Thus, I cannot extract the requested information as it is not present in the provided text.

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