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The Diagnostic Ultrasound System Xario 200 Model TUS-X200 and Xario 200 Model TUS-X200S 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, intra-operative(abdominal), laparoscopic, pediatric, small organs, 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 Xario200 Model TUS-X200 and Model TUS-X200S 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, the Xario 200 Diagnostic Ultrasound System V6.0, and states that these modifications do not change the intended use of the device. The modifications primarily involve the addition of new transducers and implementation of previously cleared software options. Therefore, the acceptance criteria and study information provided are primarily focused on demonstrating that the new transducers and software features perform as intended and are substantially equivalent to previously cleared devices or features.

Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format for the device's overall performance. Instead, it refers to the device performing "as intended" for the new features based on comparisons to predicate software/devices. The criteria for demonstrating safety and effectiveness likely included successfully fulfilling the intended use, maintaining image quality, and adhering to applicable medical device standards.

Study Information

1. Sample size used for the test set and the data provenance:

   • 2D Wall Motion Tracking: "Representative clinical images of volunteers were obtained." The exact sample size is not specified. The data provenance is implied to be clinical, but the country of origin is not detailed. Given the company is "Toshiba Medical Systems Corporation" in Japan and "Toshiba America Medical Systems, Inc" in the USA, it could be from either or both.
   • Shear Wave: "Bench testing was done using an elasticity phantom." This indicates a non-human, controlled setting. No specific sample size (e.g., number of phantoms or measurements) is provided.
   • Transducers: No specific test set size or data provenance is mentioned for the general performance of the new transducers beyond their listed clinical applications.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified in the provided text. The document states "it was concluded" for 2D WMT and "As concluded in the study" for Shear Wave, implying expert assessment, but details about the number or qualifications of these experts are missing.

3. Adjudication method for the test set: Not specified.

4. 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: Not explicitly stated. The document mentions 2D WMT "compared to predicate software", but this does not describe a comparative effectiveness study involving human readers with and without AI assistance for improved performance. The device itself is a diagnostic ultrasound system, not explicitly an AI-assisted diagnostic tool in the sense of a standalone AI algorithm for interpretation.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document describes bench testing for Shear Wave and clinical image evaluation for 2D WMT. While these tests evaluate the algorithm/feature's performance and output, it's not clear if a standalone algorithm-only performance assessment without any human review or interpretation of the output was conducted or reported. However, for an ultrasound system, the output (images, measurements) is inherently for human interpretation.

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

   • 2D Wall Motion Tracking: The phrase "Representative clinical images of volunteers were obtained" and "performs as intended" suggests a comparison against expected normal cardiac function and/or comparisons with the predicate device's output, likely adjudicated by clinical experts.
   • Shear Wave: "Bench testing using an elasticity phantom" implies a known, controlled physical property as ground truth for measurement accuracy and precision.

7. The sample size for the training set: Not applicable and not mentioned. This document pertains to a diagnostic ultrasound system and its software features, not an AI/ML model that typically requires a training set.

8. How the ground truth for the training set was established: Not applicable, as there is no mention of a training set for an AI/ML model.

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The Diagnostic Ultrasound System Xario 200 Model TUS-X200 and Xario 200 Model TUS-X200S 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 Xario200 Model TUS-X200 and Model TUS-X200S 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 a 510(k) premarket notification for the Toshiba Medical Systems Corporation's Xario 200 Diagnostic Ultrasound System V5.0. This submission focuses on modifications to a previously cleared device (Xario 200, V3.0) and the introduction of new features and transducers.

The document does not describe acceptance criteria or a specific study proving the device meets those criteria in the way one might expect for a new algorithmic device with quantifiable performance metrics. Instead, it describes substantial equivalence to a predicate device and verification/validation testing against recognized standards.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a table of acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy) for an AI component. Instead, it demonstrates performance by stating that the updates "do not raise new questions of safety and effectiveness" and that the added features perform "as expected" and are "substantially equivalent" to predicate devices.

The closest to "reported device performance" is the statement regarding the Superb Micro Vascular Imaging (SMI) feature:

2. Sample size used for the test set and the data provenance:

The document mentions "Representative clinical images of volunteers were obtained to demonstrate that the implementation of SMI onto the subject device performed as expected." However, it does not specify the sample size (number of images or volunteers) used for this performance testing.

Data provenance: The document does not explicitly state the country of origin or if the data was retrospective or prospective. It only mentions "clinical images of volunteers," which suggests prospective data collection in a clinical setting, but further details are not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The document does not specify the number of experts, their qualifications, or how they established the ground truth for any of the performance testing mentioned. This is typical for submissions focused on substantial equivalence where the primary assessment is whether the new features perform comparably to predicate devices, rather than establishing de novo clinical performance metrics against a defined ground truth.

4. Adjudication method for the test set:

The document does not describe 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:

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed or described in this submission. The device is an ultrasound system with modified and new imaging features, not an AI-assisted diagnostic tool that directly aids human readers in interpretation or diagnosis in a quantifiable way measurable by effect size in improved reader performance. The "AI" mentioned (SMI) is an imaging enhancement technique, not an interpretive AI.

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

The performance evaluation described ("SMI was capable of imaging low velocity flow with a significant reduction in clutter noise and was capable of imaging with a high frame rate") appears to be a standalone assessment of the algorithm's technical capabilities in imaging. It describes the intrinsic performance of the SMI algorithm, without explicitly involving human interpretation performance as an outcome measure, which aligns with device modifications for image quality rather than diagnostic AI.

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

The document does not specify a formal ground truth (like pathology or outcomes data) for the evaluation of SMI. The description "SMI was capable of imaging low velocity flow with a significant reduction in clutter noise and was capable of imaging with a high frame rate" implies that the assessment was likely based on qualitative evaluation by imaging experts or quantitative technical measurements of flow and noise reduction, rather than a clinical ground truth for a specific diagnosis.

8. The sample size for the training set:

Ultrasound systems and their imaging enhancements (like SMI, ApliPure, Precision Imaging, etc.) are typically developed through engineering and signal processing, often using simulated data, phantom studies, and then clinical images for refinement and validation. The concept of a distinct "training set" in the context of machine learning, as opposed to engineering development and system optimization, is not mentioned in this document.

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

As no "training set" in the machine learning sense is described, there is no information on how ground truth for a training set was established. The development likely involved iterative engineering adjustments and testing against known benchmarks or expert qualitative assessment of image quality.

Summary of Missing Information:

The provided 510(k) summary is typical for showcasing substantial equivalence for an ultrasound imaging device with updated features rather than a novel AI-driven diagnostic algorithm. Therefore, detailed information about acceptance criteria in terms of clinical performance metrics (sensitivity, specificity), sample sizes for test/training sets, expert qualifications, adjudication methods, or MRMC studies for AI interpretation is largely absent. The focus is on demonstrating that the device remains safe and effective and comparable to previously cleared devices, with new features performing as expected in a technical sense.

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The Diagnostic Ultrasound System Xario 200 Model TUS-X200 and TUS-X200S 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, intraoperative (abdominal), pediatric, small organs, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophageal, and musculoskeletal (both conventional and superficial).

The Xario 200 Model TUS-X200 and TUS-X200S 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 7.5 MHz.

The provided text describes the 510(k) summary for the Toshiba Medical Systems Xario 200 Diagnostic Ultrasound System. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

The information provided does not include acceptance criteria or a study proving the device meets specific performance criteria in the way one might expect for an AI/ML-driven device with quantifiable clinical endpoints (e.g., sensitivity, specificity for disease detection). Instead, the substantial equivalence relies on demonstrating that the new device (Xario 200) has the same intended use and similar technological characteristics as a previously cleared device (Aplio 500/400/300).

Therefore, I cannot populate all sections of your request as they are typically applied to AI/ML device performance studies with concrete statistical metrics for diagnostic accuracy. However, I can extract information related to the device submission and testing.

Here's a breakdown of the available information based on your request:

1. Table of acceptance criteria and the reported device performance

There are no specific acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, AUC) or reported numerical performance metrics in the provided document. The "performance" assessment is based on demonstrating similar functionality and safety compared to a predicate device.

The document states: "The Xario 200 Model TUS-X200 and TUS-X200S, SW Version 1.0, functions in a manner similar to and is intended for the same use as the predicate device."

Acceptance Criteria (Implied for Substantial Equivalence): The Xario 200 system must function in a manner similar to and be intended for the same use as the predicate device (Aplio 500/400/300). It must also meet applicable safety standards.

Reported Device Performance: Not quantified in terms of clinical accuracy metrics, but described qualitatively as "functions in a manner similar to" the predicate device and being a "compact diagnostic ultrasound system by implementing latest technologies."

2. Sample size used for the test set and the data provenance

Not applicable for a substantial equivalence submission of an ultrasound system not primarily based on AI/ML diagnostic performance testing using a specific test set of cases. The testing mentioned appears to be related to safety and functional verification. The document states "Risk Analysis, Verification/Validation testing conducted through bench testing which are included in this submission demonstrates that the requirements for the features have been met."

There is no mention of a clinical test set with patient data for evaluating diagnostic accuracy.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The document does not describe a test set or ground truth established by experts for diagnostic performance evaluation.

4. Adjudication method for the test set

Not applicable. No test set for diagnostic performance evaluation is detailed in the provided information.

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

No. This document does not pertain to an AI-driven device with or without human assistance. It is a traditional diagnostic ultrasound system.

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

No. This is not an AI algorithm.

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

Not applicable for a device performance study of this nature. The "ground truth" here is compliance with safety and functional standards, and equivalence to a predicate device.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. (See #8)

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