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The Diagnostic Ultrasound System 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, intraoperative (abdominal), pediatric, small organs (including thyroid, breast, testicle), trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophageal, musculo-skeletal (both conventional and superficial), laparoscopic and thoracic/pleural.

This system provides high-quality ultrasound images in the following modes of operation: B (2D), M, Color Doppler (blood-flow imaging), Doppler (PWD, CWD, Power) (blood-flow spectrum), Combined (B/M; B/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD), Precision Imaging, Apli Pure, Micro Pure, BEAM, TDI, Shear wave, Elastography, SMI (ADF), 2D Wall Motion Tracking, Smart Sensor3D, 3D Color (Volume color), 4D, STIC, STIC Color, Fusion, Smart Navigation, ATI, CHI (Per FDA approved contrast agent prescribing information), Shadow Glass. This system is suitable for use in hospital and clinical settings by physicians or legally qualified persons who have received the appropriate training.

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

The provided document describes the Canon Medical Systems Corporation's Aplio a550, Aplio a450, and Aplio a Diagnostic Ultrasound System, Software V5.1. While it outlines many aspects of the device and its substantial equivalence to predicate devices, it does not contain information regarding a specific clinical study with acceptance criteria and reported device performance in the format requested.

The document states: "Risk Analysis and Verification/Validation testing conducted through the bench testing which is included in this submission demonstrate that the requirements for the new and improved features have been met. Additional performance testing, using test data and volunteer studies, were conducted to assess improvements to existing features. Results of all these studies demonstrate that the features included in this submission meet specifications and perform as intended."

This statement indicates that testing was performed, but it lacks the specific details required to populate the requested table and answer questions about sample size, ground truth, expert qualifications, adjudication, or MRMC studies.

Therefore, I cannot fulfill all parts of your request with the provided input. However, I can infer some general information about the device and the nature of the testing mentioned:

Since this is a 510(k) submission for a diagnostic ultrasound system, the acceptance criteria would typically revolve around demonstrating substantial equivalence to a predicate device. This usually involves showing that the new device has the same intended use, fundamental technological characteristics, and performs as safely and effectively as the predicate device(s).

The "performance testing, using test data and volunteer studies" likely focused on proving the functionality of new and improved features, and that any modifications did not negatively impact existing functionalities.

Here's what can be inferred and what is missing based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information for specific studies:

2. Sample size used for the test set and the data provenance: Not specified. The document mentions "test data and volunteer studies" but gives no numbers or details on provenance (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not specified.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not specified. The document does not mention any comparative effectiveness study with human readers with and without AI assistance. The features described (like LI-RADS Checklist, Workflow Navigator, Smart Optimization) are assistive tools, but a formal MRMC study demonstrating an "effect size" (improvement in human performance) is not described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not explicitly detailed. The new features like LI-RADS Checklist and Smart Optimization imply algorithmic components, and their "requirements" were met, but specific standalone performance metrics are not provided. Given the nature of a diagnostic ultrasound system (where the human user is always in the loop), a purely standalone algorithm evaluation might not be the primary focus for the entire system at this clearance level.

7. The type of ground truth used: Not specified. For an ultrasound system, ground truth could be a combination of expert consensus readings, follow-up imaging, biopsy results (especially for features like LI-RADS or BI-RADS), or surgical findings, but these are not explicitly mentioned for the reported studies.

8. The sample size for the training set: Not applicable and not specified. This document describes a medical device, specifically an ultrasound system with software enhancements, not an AI/ML model that typically undergoes specific "training" on a dataset in the conventional sense. The "test data" mentioned refers to verification and validation data.

9. How the ground truth for the training set was established: Not applicable and not specified, as this isn't a traditional AI/ML training context.

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The Diagnostic Ultrasound System Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800 and Aplio i700 Model TUS-AI700 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), pediatric, small organs(thyroid, breast and testicle), trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatic), peripheral vascular, transesophageal, musculo-skeletal (both conventional and superficial), laparoscopic and Thoracic/Pleural. This system provides high-quality ultrasound images in the following modes B mode, M mode, Continuous Wave, Color Doppler, Pulsed Wave Doppler and Combination Doppler, as well as Speckle-tracking, Tissue Harmonic Imaging, Combined Modes, Shear wave, Elastography, and Acoustic attenuation mapping. This system is suitable for use in hospital and clinical settings by physicians or legally qualified persons who have received the appropriate training.

The Aplio i900 Model TUS-Al900, Aplio i800 Model TUS-Al800, and Aplio i700 Model TUS-Al700, V5.1 are mobile, compact diagnostic ultrasound systems which implement the latest technologies. 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 30 MHz.

The provided text does not contain specific acceptance criteria or details of a study explicitly proving the device meets acceptance criteria in the format typically expected for AI/ML device evaluations (e.g., sensitivity, specificity, AUC thresholds). Instead, it describes a substantial equivalence submission for an ultrasound system, focusing on comparing its features and performance with predicate devices.

However, based on the information provided, I can infer the "acceptance criteria" and the "study" in a broader sense of device performance validation, particularly regarding changes and new features.

Here's an interpretation based on the provided text:

Acceptance Criteria and Device Performance for Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1

The submission focuses on establishing substantial equivalence for an updated ultrasound system (Software V5.1). The "acceptance criteria" can be broadly interpreted as ensuring that the new and improved features perform as intended and/or are substantially equivalent to existing features or predicate devices, without introducing new safety or effectiveness concerns.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document mentions "bench testing and clinical evaluation" and "additional performance testing, using test data and volunteer studies." However, it does not provide specific sample sizes for these test sets, nor does it specify the country of origin of the data or whether it was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

The document does not specify the number of experts used or their qualifications for establishing ground truth for any test sets. The "LI-RADS Checklist" and "Workflow Navigator" features reference ACR and ASE guidelines, implying expert consensus underlies these guidelines, but not directly for validating the device's implementation.

4. Adjudication Method for the Test Set:

The document does not describe any adjudication method (e.g., 2+1, 3+1) for establishing ground truth or evaluating device performance in a multi-expert setting.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The document does not report a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with AI vs. without AI assistance, nor does it provide any effect size for such a comparison. The device is a diagnostic ultrasound system, and while it has "smart" features, it's not presented as an AI-assisted diagnostic tool that directly impacts human reader interpretation in a comparative effectiveness study as typically found for CADe/CADx devices.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:

The document does not provide specific standalone performance metrics (e.g., sensitivity, specificity, AUC) for any of its "smart" or improved features. The description focuses on functionality, workflow improvement, and image quality enhancements within the context of a diagnostic ultrasound system used by a clinician.

7. Type of Ground Truth Used:

The document does not explicitly state the type of ground truth used for evaluating the device's performance. The nature of an ultrasound system update suggests that ground truth would likely be established through:

• Clinical observation/expert assessment: For image quality, workflow efficiency, and visualization improvements.
• Conformance to guidelines: For features like the LI-RADS Checklist (ACR guidelines) and Workflow Navigator (ASE guidelines).
• Technical specifications/measurements: For aspects like processing speed (iBeam+), resolution (Sensor 3D), and detection range (SMI G4).

8. Sample Size for the Training Set:

This information is not provided in the document. As this is an ultrasound system submission focusing on feature updates and substantial equivalence, the concept of a "training set" in the context of machine learning for novel AI algorithms is not explicitly addressed in the provided summary. While "Smart Fetal Heart," "Smart Optimization," and "SMI G4" might incorporate machine learning components, no details on their training are given.

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

This information is not provided in the document, as no details about a "training set" or its ground truth establishment are mentioned.

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