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The Aplio v4.0R001 is intended to be used for the following type of studies: fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transrectail, transvaginal, transesophageal, peripheral vascular and musculo-skeletal (both conventional and superficial).

Elastography is indicated for determining the relative elasticity of a lesion.

The Aplio XG v4.0R001 is a mobile system. This system is a Track 3 device that employs a wide array of probes that include flat linear array, convex linear array, and sector array with a frequency range of approximately 2 MHz to 12 MHz

The provided FDA 510(k) premarket notification for the Toshiba Aplio XG (v4.0R001) SSA-790A Ultrasound System (K092179) focuses on the substantial equivalence of the device to existing predicate devices and the safety considerations. It outlines the intended uses for various transducers and notes the addition of "Elastography (New)" as an intended use for several of them.

However, the document does not contain a detailed description of acceptance criteria for Elastography, nor does it present a specific study proving the device meets particular acceptance criteria with reported performance metrics. The submission is primarily about demonstrating substantial equivalence and safety, not about presenting the results of a performance study with quantitative acceptance criteria for a new feature like Elastography.

The document states: "Elastography is indicated for determining the relative elasticity of a lesion." This is an indication for use, not an acceptance criterion or a performance claim with specific metrics.

Therefore, based on the provided text:

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

• Not provided. The document does not define specific acceptance criteria (e.g., sensitivity, specificity, accuracy, precision for elasticity measurements) or present a table of reported device performance against such criteria for the Elastography feature.

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

• Not provided. The document does not describe any specific test set size for evaluating Elastography performance, nor does it mention the data provenance (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 provided. There is no mention of experts establishing ground truth for a test set related to Elastography in this document.

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

• Not provided. No adjudication method is described.

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:

• Not applicable / Not provided. The document does not describe an MRMC comparative effectiveness study for Elastography, nor does it mention AI assistance. The device is an ultrasound system with a new imaging mode (Elastography), not an AI-powered diagnostic tool in the sense of comparing human reader performance with and without AI.

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

• Not applicable / Not provided. Elastography in this context is an ultrasound imaging mode, which inherently involves a human operator acquiring and interpreting the images. It's not a standalone algorithm without human involvement in its operation or interpretation.

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

• Not provided. No type of ground truth is specified for evaluating the Elastography feature. For a substantial equivalence submission, the primary "ground truth" implicitly relies on established performance of the predicate devices and general safety standards for ultrasound.

8. The sample size for the training set:

• Not provided. As this is not a submission for an AI/CAD system in the modern sense, there is no concept of a "training set" described for the Elastography feature. The development of an imaging mode is typically based on physics and engineering principles, and clinical validation would follow.

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

• Not applicable / Not provided. See point 8.

Summary based on the provided text:

The provided 510(k) summary focuses on establishing substantial equivalence for the Toshiba Aplio XG ultrasound system and its various transducers, especially regarding the addition of "Elastography (New)" as an indication for use. It outlines the safety considerations and references adherence to various IEC and AIUM standards. However, it does not contain the detailed performance data, acceptance criteria, or study methodologies that would typically be associated with proving a novel AI/CAD device meets specific performance claims. For a new imaging mode like Elastography, the FDA's process at that time (2009) would have primarily looked at the technical safety and performance of the imaging modality itself, and the clinical utility for diagnostic purposes would be demonstrated through subsequent clinical literature and use, rather than a single premarket comparison study with specific acceptance criteria detailed in the 510(k) summary itself.

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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, cardiac, cardiac, transrectal, transvaginal, transesophageal, peripheral vascular and musculo-skeletal (both conventional and superficial).

The Aplio XG v4.0 is a mobile system. This system is a Track 3 device that employs a wide array of probes that include flat linear array, convex linear array, and sector array with a frequency range of approximately 2 MHz to 12 MHz.

The provided 510(k) Premarket Notification for the Aplio™ XG (v4.0) SSA-790A Ultrasound System does not contain detailed acceptance criteria, a study proving the device meets those criteria, or specific performance metrics with sample sizes. This document primarily focuses on establishing substantial equivalence to a predicate device (Toshiba Ultrasound Diagnostic System Aplio XG MODEL SSA-790A V3.0 K082119) and outlining the intended uses and associated transducers.

Therefore, many of the requested sections cannot be filled from the provided text.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not present in the provided document. The document lists "Modes of Operation" for various clinical applications and transducers, indicating whether they are "previously cleared by FDA" (P) or a "new indication" (N). However, it does not specify quantitative acceptance criteria (e.g., minimum accuracy, sensitivity, specificity) for these modes or report performance data against such criteria.

The "Modes of Operation" essentially indicate the capabilities of the device rather than its quantitative performance against specific criteria.

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

This information is not present in the provided document. The 510(k) summary focuses on substantial equivalence based on technical specifications and intended use, rather than clinical trial data with test sets.

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

This information is not present in the provided document.

4. Adjudication Method for the Test Set

This information is not present in the provided document.

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

This information is not present in the provided document, and it's highly unlikely for an ultrasound system from 2009. The document does not mention AI.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This information is not present in the provided document, and it's highly unlikely for an ultrasound system from 2009. The device is a diagnostic ultrasound system, implying human operation and interpretation.

7. The Type of Ground Truth Used

This information is not present in the provided document. As no performance studies are detailed, no ground truth methodology is described.

8. The Sample Size for the Training Set

This information is not present in the provided document. The document doesn't describe any machine learning or AI components that would require a "training set."

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

This information is not present in the provided document. (See point 8).

Summary of available information related to acceptance and study:

The provided document is a 510(k) Premarket Notification, which primarily seeks to demonstrate "substantial equivalence" of the Aplio™ XG (v4.0) SSA-790A Ultrasound System to a legally marketed predicate device (Toshiba Ultrasound Diagnostic System Aplio XG MODEL SSA-790A V3.0 K082119).

The "study that proves the device meets the acceptance criteria" in the context of a 510(k) for an ultrasound system typically refers to:

• Conformance to standards: The document explicitly states that the device is "designed and manufactured in conjunction with the Quality System Regulation, IEC 60601-1 (applicable portions), IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, IEC60601-2-37, IEC 62304 and the AIUM-NEMA UD2 Output Measurement Standard as applied to Track 3 Ultrasound systems and the AIUM-NEMA UD3 Output Display Standard." Meeting these recognized standards serves as evidence of safety and effectiveness, implicitly defining an "acceptance criterion" for fundamental device performance and safety.
• Comparison to predicate device: The core of a 510(k) is the comparison to a predicate. The tables detailing "Intended Use" and "Mode of Operation" for each transducer (e.g., PST-25BT, PVT-375MV) show whether a particular mode or application was "previously cleared by FDA" (P) with the predicate device (K082119) or is a "new indication" (N). This implies that the current device is accepted if its performance for existing indications is equivalent to the predicate, and new indications are justified through other means (though not detailed here).

Specifics on "new indications" (N): The document lists several "new indications" (e.g., for transducer PVT-375MV, Fetal and Abdominal applications now include B, M, PWD, Color Doppler, Combined, THI, Dynamic Flow, Power, CHI 2D, and 3D modes as "N"). For these new indications, the submission would typically include data (often bench testing, phantom studies, or limited clinical data) to demonstrate their safety and effectiveness. However, this specific data and its acceptance criteria are not included in this summary.

In essence, the "acceptance criteria" here are mainly regulatory conformance and substantial equivalence to a previously cleared device, rather than detailed, quantitative clinical performance metrics against specific benchmarks as might be seen for novel AI-powered diagnostic devices.

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