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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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The Diaqnostic Ultrasound System Xario 100 Model TUS-X100 and Xario 100 Model TUS-X100S are indicated for the visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diaqnosis in the following clinical applications: fetal, abdominal, intra-operative(abdominal), laparoscopic, pediatric, small orqans, neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional), musculo-skeletal (superficial), cardiac adult, cardiac pediatric, trans-esoph(cardiac) and peripheral vessel.

The Xario100 Model TUS-X100 and Model TUS-X100S are mobile diagnostic ultrasound systems. These systems are Track 3 devices that employ 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 describes modifications to an ultrasound system (Xario 100 TUS-X100 and TUS-X100S V3.0) and the testing conducted to support its substantial equivalence. The information is presented in the context of a 510(k) premarket notification to the FDA.

Here's an analysis of the acceptance criteria and study information, based only on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a quantitative table within the document. Instead, the document focuses on demonstrating that the modified device functions similarly to the predicate device and meets safety and performance standards. The "reported device performance" is described qualitatively as improving needle visualization.

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

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

The document mentions a "study" for the BEAM feature but does not specify the sample size used for the test set. It also does not provide information on the data provenance (e.g., country of origin, retrospective or prospective nature of the data).

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)

The document does not provide any information regarding the number of experts used to establish ground truth or their qualifications.

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

The document does not specify any adjudication method used for the test set.

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

The document describes a study comparing "an existing imaging mode with the needle enhancement feature" but does not indicate if it was a multi-reader multi-case (MRMC) comparative effectiveness study with human readers assessing improvement with AI assistance. The "BEAM" feature is described as improving needle visualization, but no effect size or specific metrics on human reader improvement are provided.

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

The "BEAM" feature is integrated into the ultrasound system to assist in needle visualization. While the study confirmed the device's ability to improve needle visualization, it's not explicitly stated if this was a standalone algorithm-only performance evaluation, separate from how a human would then use that improved visualization. The context suggests it’s a feature within the system for human use.

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

The document does not specify the type of ground truth used for the performance study of the "BEAM" feature. It only mentions that the study "confirmed that the subject device improves needle visualization," but not how that improvement was objectively measured or validated against a ground truth.

8. The sample size for the training set

The document does not mention a training set or its sample size. This implies that the submission does not detail an AI/machine learning model in the sense of requiring a "training set" in the context of the described modifications. The "BEAM" feature might be a signal processing or image enhancement technique rather than a classic AI model requiring a distinct training phase.

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

Since no training set is mentioned (see point 8), this information is not applicable/not provided in the document.

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The Diagnostic Ultrasound System Xario 100 Model TUS-X100 and TUS-X100S are 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, pediatric, small organs, trans-vaginal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatric), peripheral vascular, and musculo-skeletal (both conventional and superficial).

The Xario 100 Model TUS-X100 and TUS-X100S are mobile diagnostic ultrasound systems. These systems are Track 3 devices that employ a wide array of probes including flat linear array, convex, and sector array with frequency ranges between approximately 3 MHz to 10 MHz.

The provided text is a 510(k) Summary for a Toshiba Xario 100 diagnostic ultrasound system. This document outlines the general characteristics of the device and its intended use, but does not contain specific information about acceptance criteria, device performance studies, sample sizes for test or training sets, expert qualifications, adjudication methods, or MRMC studies.

The document states:

• "Design Control Activities including risk management following the ISO14971, verification/validation testing and Acoustic Output testing (UD3, 2004) were conducted through bench testing are included in this submission. This documentation includes testing which demonstrates that the requirements for the features have been met." (Section 15. SAFETY and 16. TESTING)

This statement indicates that verification and validation testing was performed, and requirements were met, but it does not provide the details of those tests, the acceptance criteria, or the reported performance. The 510(k) summary is a high-level overview and directs to the full submission for detailed documentation.

Therefore, I cannot extract the specific information you requested as it is not present in the provided text. The document confirms that testing was done to demonstrate that the device meets requirements, but the details of what those requirements are and the results of the tests are not included here.

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