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The Diaqnostic Ultrasound System Xario 100 Model TUS-X100 is indicated for the visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, intra-operative (abdominal), laparoscopic, pediatric, small orqans, neonatal cephalic, adult cephalic, trans-rectal, trans-vaqinal, musculo-skeletal (conventional), musculo-skeletal(superficial), cardiac adult, cardiac pediatric, trans-esoph(cardiac) and peripheral vessel.

The Xario 100 Model TUS-X100 is a mobile diagnostic ultrasound system. This system is a Track 3 device that employs a wide array of probes including flat linear array, convex linear array, and sector array with frequency ranges between approximately 2 MHz to 12 MHz.

The provided text is a 510(k) summary for the Toshiba Medical Systems Corporation's Xario 100 Diagnostic Ultrasound System, V5.0. It primarily focuses on demonstrating substantial equivalence to a previously cleared device (Xario 100, V3.0, K143046) and does not contain detailed information about specific acceptance criteria or a clinical study proving device performance against those criteria.

The submission outlines modifications to an already cleared device, including software updates (Luminance), a new transducer (for transesophageal use, PET-512MD), and a new feature (Touch Command Screen). The document concludes that these modifications do not change the intended use and that the device is safe and effective based on internal design control activities, risk management, verification/validation testing, and conformance to international standards.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details of a specific study proving device performance, as this information is not present in the provided text. The document refers to "Design Control Activities including risk management," "verification/validation testing," and "Acoustic Output testing," but does not detail the specific criteria or results of these tests in a way that allows for a direct answer to the request.

However, I can extract information related to other aspects of your request:

1. Table of Acceptance Criteria and Reported Device Performance:

Not explicitly provided in the document. The document states that "Design Control Activities including risk management... verification/validation testing and Acoustic Output testing (UD3, 2004) were conducted and included in this submission," and that the device "is in conformance with the applicable parts of the IEC60601-1 (2005), IEC 60601-1-2:2007, IEC 60601-2-37 (2007), IEC 62304 (2006), AIUM RTD2-2004 Output Display and ISO 10993-1 standards." However, the specific acceptance criteria and detailed performance metrics from these tests are not included here.

2. Sample Size Used for the Test Set and Data Provenance:

Not specified in the provided text. The document refers to "verification/validation testing" but does not detail the sample size or the nature (e.g., country of origin, retrospective/prospective) of the data used for testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not specified in the provided text. The document refers to validation testing but does not mention the use of experts for ground truth establishment.

4. Adjudication Method for the Test Set:

Not specified in the provided text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of Human Improvement with AI vs. Without AI Assistance:

Not applicable. The device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool that would typically involve a MRMC study for human reader improvement with AI. The document describes software modifications (Luminance) and new hardware (transducer, Touch Command Screen) for the ultrasound system itself.

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

Not applicable, as this is a diagnostic ultrasound system.

7. The Type of Ground Truth Used:

Not explicitly stated for any specific test. The document refers to conformance with various IEC and ISO standards and AIUM guidelines, implying that performance was evaluated against established technical and safety requirements, rather than clinical ground truth like pathology or outcomes data in the context of an AI algorithm.

8. The Sample Size for the Training Set:

Not applicable. This document describes a traditional medical device (ultrasound system) clearance, not an AI/ML-based device that would typically have a "training set."

9. How the Ground Truth for the Training Set was Established:

Not applicable for the same reason as point 8.

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