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The Diagnostic Ultrasound Systems Aplio a550 Model CUS-AA550. Aplio a450 Model CUS-AA450, and Aplio a Model CUS-AA000 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), pediatric, small organs, trans-vaginal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophageal, musculo-skeletal (both conventional and superficial) and laparoscopic.

The Aplio a550 Model CUS-AA550, Aplio a450 Model CUS-AA450 and Aplio a Model CUS-AA000 are mobile diagnostic ultrasound 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 20 MHz.

This document describes the premarket notification (510(k)) for the Canon Medical Systems Corporation's Aplio a550, Aplio a450, and Aplio a Diagnostic Ultrasound Systems, V4.0. The submission aims to demonstrate substantial equivalence to a previously cleared predicate device (K182427).

Summary of Acceptance Criteria and Device Performance (Based on "Improvements to previously cleared functionality" table):

Detailed Information about the Study:

1. A table of acceptance criteria and the reported device performance:
   (See table above)
   The acceptance criteria are implied by the "Comments" column in the "Improvements to previously cleared functionality" table. The reported device performance is stated as "Improvement" for these features, along with specific benefits.

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

   • Sample Size: The document does not specify exact sample sizes (e.g., number of patients or images) for the "Bench Assessment" performance testing. It generally states that "testing conducted, which are included, demonstrates that the requirements for the features have been met" (Section 16).
   • Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given that no clinical studies were required and the testing involved "Bench Assessment," it implies that the performance evaluation was likely conducted in a controlled, non-clinical environment, possibly using phantom or simulated data, or internally curated datasets.

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

   The document does not mention the use of experts to establish ground truth for the "Bench Assessment" performance testing. This type of testing typically relies on predefined technical specifications, simulation models, or controlled experimental setups rather than human expert consensus for ground truth.

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

   No adjudication method is described, as the testing appears to be "Bench Assessment" focusing on technical performance endpoints rather than human interpretation accuracy.

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 MRMC comparative effectiveness study was done. The document explicitly states: "No clinical studies were required to demonstrate safety and efficacy of the Aplio a550, Aplio a systems" (Section 16). The improvements listed are related to visualization, automation, and expanded applicability of existing modes, not diagnostic accuracy requiring human reader studies.

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

   The "Bench Assessment" performance testing described for features like "Doppler Luminance," "Auto E/A," "Measurement in volume rendering view," "Auto EF," "Stress Echo Color/Doppler," and "Vascularity Index" would fall under a form of standalone performance evaluation. This indicates that the functionalities were assessed directly against their technical specifications or expected outcomes.

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

   For the "Bench Assessment" performance testing, the ground truth would likely be based on:

   • Technical Specifications: Conformance to predefined performance parameters for image quality, measurement accuracy, or automation efficiency.
   • Expected System Behavior: Verification that the new or improved features function as designed, e.g., the 3D effect for Doppler Luminance, or calculation accuracy for Auto E/A.
     These are not clinical ground truths like pathology or expert consensus on a diagnosis.

8. The sample size for the training set:

   This document is for a 510(k) premarket notification for diagnostic ultrasound systems and does not contain information about "training sets" in the context of deep learning or AI. The listed improvements are functionality enhancements rather than new AI algorithms requiring extensive training data.

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

   As no training set (in the AI/deep learning context) is mentioned or relevant to the described updates in this submission, the method for establishing ground truth for a training set is not applicable and not provided. The changes are described as "modifications to a cleared device" and "improvements upon existing features" (Section 14).

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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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Esaote's Model 6200 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small Organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Intraoperative (Neurological), Laparoscopic and Other: Urologic.

The 6200 system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

Esaote's Model 6250 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small Organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Intraoperative (Neurological), Laparoscopic and Other: Urologic.

The 6250 system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

The Virtual Navigator software option for Esaote models 6200 and 6250 is intended to support a radiological clinical ultrasound examination (first modality) and follow percutaneous procedures or surgical operations providing additional image information from a second imaging modality (CT, MR, US and PET). The second modality provides additional security in assessing the morphology of the ultrasound image. Virtual Navigator can be used in the following application: Abdominal, Gynecological, Musculoskeletal, Obstetrics, Pediatric, Urologic, Small Organs, Intraoperative (Abdominal), Intraoperative (Neurological), Peripheral Vascular and Transcranial for radiological examinations only.

The second modality image is not intended to be used as a standalone diagnostic image since it represents information of a patient that could not be congruent with the current (actual) patient position and shall therefore always been seen as an additional source of information.

The Virtual Navigator tracking system is contraindicated for patients, personnel and other people who use an electronic life support device (such as a cardiac pacemaker or defibrillator).

Both 6200 and 6250 upgrades are mainframe ultrasound systems used to perform diagnostic general ultrasound studies. The primary modes of operation are for both systems: B-Mode, Tissue Enhancement Imaging (TEI), M-Mode, Multi View (MView), Doppler (both PW and CW), Color Flow Mapping (CFM), Amplitude Doppler (AD), Tissue Velocity Mapping (TVM), 3D and 4D, Elastosonography. Both 6200 and 6250 models are equipped with a LCD color display where acquired images and advanced image features are shown.

The Virtual Navigator is a software option designed to support a radiological clinical ultrasound examination (first modality) and follow a percutaneous procedure providing additional image information from a 2nd imaging modality (CT, MR, US and PET). The user is helped in assessing the patient anatomy by displaying the image generated by the 2nd modality.

Both 6200 and 6250 models including the Virtual Navigator software option have been cleared via 510(k) 153277.

Both 6200 and 6250 upgrades, defined herein, combine the cleared features of both 6200 and 6250 models with new capabilities, listed below:

• . Implementation of the MyLabRemote feature on both 6200 and 6250 upgrades
• । Addition of in Elastosonography (ElaXto) analysis in Intraoperative (Neurological) application on both 6200 and 6250 upgrades
• -Management of Quantitative Elastosonographic analysis (QElaXto) in Abdominal application on 6200 upgrade
• -Implementation of the Automatic Nuchal Translucency feature on both 6200 and 6250 upgrades
• -Addition of new probes on both 6200 and 6250 upgrades

Furthermore, the Virtual Navigator upgrade, defined herein, combine the cleared features of the Virtual Navigator with new software capabilities compatible to both 6200 and 6250 upgrades related to the Virtual Navigator software option and listed below:

• Availability in Intraoperative (Abdominal) and Intraoperative (Neurological) applications in the Virtual Navigator upgrade environment
• -Availability of Elastosonography (ElaXto) analysis in Intraoperative (Abdominal) and Intraoperative (Neurological) applications in the Virtual Navigator upgrade environment
• -Availability of Quantitative Elastosonographic analysis (QElaXto) for Abdominal application in the Virtual Navigator upgrade environment
• -Navigation software new user interface on Virtual Navigator upgrade

The marketing names for 6200 and 6250 upgrades will be called MyLabEight respectively.

The different versions of 6200 and 6250 models and their upgrades are differentiated by part numbers.

Both 6200 and 6250 upgraded models are manufactured under an ISO 9001 and ISO 13485 certified quality system.

The provided document is a 510(k) Premarket Notification from Esaote S.p.A. to the FDA for their 6200 Ultrasound System and 6250 Ultrasound System. This document outlines the general intended uses and provides some technical specifications and conformity to safety standards. It does not contain information about the acceptance criteria for a specific AI-powered device, nor does it detail a study proving such a device meets those criteria, as there is no mention of an AI-powered device beyond the "Virtual Navigator" which is described as supporting, not replacing, human radiological review.

The document states: "The Virtual Navigator software option for Esaote models 6200 and 6250 is intended to support a radiological clinical ultrasound examination (first modality) and follow percutaneous procedures or surgical operations providing additional image information from a second imaging modality (CT, MR, US and PET). The second modality provides additional security in assessing the morphology of the ultrasound image. Virtual Navigator can be used in the following application: Abdominal, Gynecological, Musculoskeletal, Obstetrics, Pediatric, Urologic, Small Organs, Intraoperative (Abdominal), Intraoperative (Neurological), Peripheral Vascular and Transcranial for radiological examinations only. The second modality image is not intended to be used as a standalone diagnostic image since it represents information of a patient that could not be congruent with the current (actual) patient position and shall therefore always been seen as an additional source of information."

This description indicates that the Virtual Navigator is an image fusion tool for enhanced visualization, not an AI diagnostic system with specific numerical performance metrics. Therefore, the requested information (acceptance criteria, specific study results, sample sizes, expert involvement, and ground truth for AI performance) is not present in this document.

The document focuses on demonstrating substantial equivalence of the ultrasound systems and the Virtual Navigator software option (which appears to be an image fusion tool, not an AI with diagnostic capabilities as typically understood in the context of acceptance criteria measured by metrics like AUC, sensitivity, specificity, etc.) to previously cleared predicate devices. The "Summary of Clinical Tests" explicitly states: "No clinical tests were performed."

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria and a study proving an AI device meets them using only the provided text. The document is primarily a regulatory filing for a medical imaging device and its software features, demonstrating safety and performance equivalence, not a detailed report on the validation of an AI diagnostic algorithm against predefined performance metrics.

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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 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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