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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 CTS-8800 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 SIUI CTS-8800 Digital Ultrasound Imaging System. It describes the device, its intended use, and claims substantial equivalence to a predicate device (Ultrasonix Ergosonix 500 Ultrasound Scanner (K042326)).

However, this document does not contain information regarding specific acceptance criteria for device performance, nor does it describe any study (clinical or otherwise) that proves the device meets such criteria. The document focuses on regulatory compliance, safety considerations (acoustic output, electrical safety), and demonstrating substantial equivalence based on intended use, principles of operation, and technological characteristics to a predicate device.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is a breakdown of what can and cannot be answered:

1. A table of acceptance criteria and the reported device performance

• Cannot be answered from the text. The document does not specify any quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy, image quality metrics) or report specific performance values for the device against such criteria. The "Conclusion" states that the device is "as safe and effective as the legally marketed predicate device," implying performance equivalence, but no specific metrics are given.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cannot be answered from the text. No test set, study, or data provenance is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Cannot be answered from the text. No ground truth establishment or expert involvement for a test set is discussed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Cannot be answered from the text. No adjudication method is mentioned as no test set study is described.

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

• Cannot be answered from the text. The device is an ultrasound imaging system, not an AI-powered diagnostic aide for human readers. No MRMC study or AI assistance is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Cannot be answered from the text. The device is an imaging system, not a standalone algorithm. Performance claims are for the overall system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Cannot be answered from the text. No ground truth is mentioned.

8. The sample size for the training set

• Cannot be answered from the text. No "training set" is relevant or mentioned for this type of device submission. This is not an AI/ML device requiring training data.

9. How the ground truth for the training set was established

• Cannot be answered from the text. Not applicable as there is no training set.

Summary:

The provided 510(k) summary for the SIUI CTS-8800 Digital Ultrasound Imaging System focuses on demonstrating substantial equivalence to a predicate device (Ultrasonix Ergosonix 500 Ultrasound Scanner, K042326) primarily through technical specifications, intended use, and compliance with general safety standards like IEC 60601-1, ISO10993-5, ISO 10993-10, and acoustic output measurements per NEMA UD 2. It does not present any clinical study data or specific performance metrics (like sensitivity, specificity, or accuracy) against predefined acceptance criteria for diagnostic performance. Therefore, almost all specific questions related to acceptance criteria and study data cannot be answered from this document.

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