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The Diagnostic Ultrasound Systems Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800, Aplio i700 Model TUS-AI700 and Aplio i600 Model TUS-AI600 are indication 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-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediat, transesophageal, musculo-skeletal (both conventional and superficial) and laparoscopic.

The Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800, Aplio i700 Model TUS-AI700 and Aplio i600 Model TUS-AI600, V3.1 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 30 MHz.

The provided text is a 510(k) summary for the Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1. It describes the device's indications for use, its substantial equivalence to predicate devices, and the performance testing conducted. However, the document does not describe a study involving human readers or AI assistance to improve human reader performance. It focuses solely on the device's technical capabilities and its equivalence to other cleared devices. Therefore, I cannot provide details on MRMC studies or human reader improvement with AI assistance based on this document.

For the aspects that are covered, here is the information:

1. Table of Acceptance Criteria & Reported Device Performance:

The document describes performance testing for several features, primarily focusing on proving substantial equivalence to predicate devices and meeting specifications. Specific numerical acceptance criteria are not explicitly detailed in this summary, but the reported device performance implies that the features met specifications and performed as intended.

2. Correct quantitative measurement results (Velocity and Direction). | 1. Color mapping image depicted correctly in terms of spatial distribution of moving bubbles using a wire phantom and test data.
3. Quantitative measurement results (Velocity and Direction) obtained correctly using a string phantom, a flow phantom, and test data. |
   | Breast Scan Guide | Correct display of locational information of an object of interest in the X-ray image (matching breast body mark location in ultrasound with lines calculated from X-ray image locational data). | Correctly displays the locational information of an object of interest in the X-ray image, specifically, the location information of the breast body mark in the ultrasound system matches with the lines calculated using the locational data directly obtained from the X-ray image. |
   | 3D Wall Motion Tracking | Meeting specifications and performing as intended. | Met specifications and performed as intended. |
   | 2D Wall Motion Tracking | Meeting specifications and performing as intended. | Met specifications and performed as intended. |
   | Smart Fusion | Meeting specifications and performing as intended. | Met specifications and performed as intended. |
   | 2nd Console | Meeting specifications and performing as intended. | Met specifications and performed as intended. |

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

The document mentions "test data phantom and in a clinical evaluation" for Limb Volume Measurement, and "a wire phantom and test data" or "a string phantom, a flow phantom and test data" for Contrast Vector Imaging. However, specific sample sizes for these test sets are not provided. The provenance of the "clinical data" / "test data" and "volunteer studies" is not specified (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

The document does not mention the use of experts to establish ground truth for the described performance tests. The testing appears to rely on physical phantoms and "test data" which would likely have inherent or pre-defined ground truth based on their construction or known properties, or clinical data where the "truth" is established by the device's calculations or outputs being compared against an expected outcome or another measurement method.

4. Adjudication Method for the Test Set:

No information regarding adjudication methods (e.g., 2+1, 3+1, none) is provided. This type of information is usually relevant for studies involving human readers or subjective interpretations, which are not detailed here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, a MRMC comparative effectiveness study was not done according to the provided text. The document describes technical performance testing and "clinical evaluation" but no studies involving human readers evaluating the device's impact on their performance, either with or without AI assistance. The submission focuses on device functionality and substantial equivalence.

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

The performance testing described ("correctly calculated", "depicted correctly", "obtained correctly") relates to the device's algorithmic performance in specific modes and features using phantom and possibly clinical data. This would fall under standalone performance assessment, as it's evaluating the device's output directly against a known or expected result, rather than a human's interpretation.

7. The Type of Ground Truth Used:

The ground truth for the tests described appears to be:

• Physical Phantoms: For Limb Volume Measurement (test data phantom), Contrast Vector Imaging (wire phantom, string phantom, flow phantom). These phantoms are designed with known properties or simulated conditions that serve as ground truth.
• Expected Results/Specifications: For the calculations and depictions, and for the improvements to existing features, the "ground truth" is implied to be that the device's output matches its design specifications and performs as intended.
• Clinical Data: Used in conjunction with phantoms for Limb Volume Measurement. The nature of the ground truth within this clinical data (e.g., pathology, clinical outcomes, or another validated measurement method) is not explicitly stated, but it would logically be a reference standard for the values being calculated (fractional limb volume, EFW).
• X-ray Image Data: For Breast Scan Guide, the locational information from the X-ray image serves as the ground truth against which the ultrasound system's display of the breast body mark is compared.

8. The Sample Size for the Training Set:

The document is a 510(k) summary for an ultrasound system, not explicitly an AI/ML device per se, although it does mention "Smart Navigation" and "Smart 3D". It outlines performance testing for new and improved features and transducer models rather than a specific AI algorithm. As such, the document does not provide information on the sample size of a training set as it is not discussing the development of an AI model.

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

As no training set is discussed or implied to exist for a specific AI algorithm in this Preamarket Notification summary, no information on how ground truth for a training set was established is provided.

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