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The Diaqnostic Ultrasound Systems Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800, Aplio i700 Model TUS-AI700 and Aplio i600 Model TUS-AI600 are indicated for the visualization of structures, and dynamic processes with the human body usinq ultrasound and to provide image information for diaqnosis in the followinq 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 i900 Model TUS-AI900, Aplio i800 Model TUS-AI800, Aplio i700 Model TUS-AI700 and Aplio i600 Model TUS-A1600, V2.4 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.

This document describes the Toshiba Medical Systems Corporation Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4, a modified device, and compares it to a predicate device (Aplio i900/i800/i700, V2.1, K163702).

Here's a breakdown of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The device is substantially equivalent to its predicate device and offers several new features and improvements. Acceptance criteria are typically defined by demonstrating substantial equivalence to a legally marketed predicate device and meeting performance specifications through testing.

Specific performance assessments for new and improved features include:

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

• 3D Wall Motion Tracking (RV Analysis): n=11 for the correlation coefficient for volume measurement.
• Mitral Valve Analysis (MVA): Seventy (70) patients were included in a side-by-side comparison study. A cardiac phantom was also used.
• Auto-EF: A group of three volunteers for workflow improvement assessment. A clinical evaluation was also conducted (sample size not specified).
• Z-Score Measurement: Previously acquired fetal ultrasound data. (Sample size not specified)
• 4D Imaging for 2D Array transducers: Phantom studies and volunteer studies (number of volunteers not specified).
• Improvements to existing features: Phantom and volunteer studies (sample sizes not specified).

The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective" for most studies. However, the mention of "previously acquired fetal ultrasound data" for Z-Score implies retrospective data for that specific test. The mention of "volunteers" and "patients" suggests prospective data for other tests.

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

This information is not provided in the given text.

4. Adjudication Method for the Test Set

This information is not provided in the given text.

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

The document does not explicitly describe an MRMC comparative effectiveness study where human readers improve with AI assistance. The testing focuses on the device's performance against predicate devices or pre-defined performance metrics, but not on human-AI collaboration.

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

The studies conducted for Auto-EF, 3D ACM, Z-Score Measurement, and MPI Measurement appear to be standalone tests of the algorithm's performance against defined criteria or phantoms. While Auto-EF also involved an assessment of workflow improvement with volunteers, the core performance checks for these features seem to be standalone.

7. The Type of Ground Truth Used

• 3D Wall Motion Tracking (RV Analysis): Comparison to the predicate function (Vivid E9, K131514 with GE EchoPAC, K120221).
• Auto-EF: "Appropriate clinical measurements" as expected.
• 3D ACM: Performance specifications for flow volume measurement using a pulsating flow phantom.
• Z-Score Measurement: Pre-obtained values of femur length (FL), biparietal diameter (BPD), or gestational age (GA) using fetal echocardiography.
• MPI Measurement: Correct measurement of velocity and time durations in a Doppler phantom, and correct MPI calculation according to predefined methods.
• Mitral Valve Analysis (MVA):
  • In vivo evaluation: "Basic function and performance" in visualization, measurements, workflow improvement, and interoperator variability using 70 patients.
  • Phantom study: Comparison of MVA software output measurements to equivalent parameters obtained from a Computed Tomography (CT) system.
• 4D Imaging for 2D Array transducers: Correct depiction of shapes and flow in a phantom, and performance "as intended" in clinical images on volunteers.

8. The Sample Size for the Training Set

This information is not provided in the given text. The document describes verification and validation testing, but not details about model training.

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

This information is not provided in the given text, as training set details are absent.

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The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic and vascular).

The LOGIQ E9 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 58 cm wide, 87cm deep and 130 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 10-inch LCD touch screen and color wide screen image display.

The provided text is a 510(k) Premarket Notification Submission for the GE LOGIQ E9, LOGIQ E9 XDclear 2.0 Diagnostic Ultrasound System. This document focuses on establishing substantial equivalence to previously cleared devices rather than presenting a new clinical study with acceptance criteria and device performance. Therefore, much of the requested information regarding acceptance criteria and performance studies in the traditional sense of a clinical trial for a novel device is not directly available in this document.

However, I can extract information related to the device's intended use, comparison to predicates, and the non-clinical tests performed.

Important Note: The acceptance criteria and performance data requested in the prompt typically refer to a clinical study demonstrating the efficacy and safety of a novel device. As this submission is for substantial equivalence to existing devices (K142160 GE LOGIQ E9, K131527 GE LOGIQ S8, K131514 GE Vivid E9), the "acceptance criteria" here are met by demonstrating that the new device shares the same intended use, imaging capabilities, technological characteristics, and safety and effectiveness as the predicate devices, and complies with applicable safety standards. There is no new clinical study presented that would define novel acceptance criteria and then report performance against them.

Here's the information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a substantial equivalence submission, the "acceptance criteria" are implied by the features and performance of the predicate devices and compliance with relevant standards. The "reported device performance" is the demonstration that the LOGIQ E9, LOGIQ E9 XDclear 2.0 system performs equivalently to the predicates for its intended uses and complies with safety standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document explicitly states: "The subject of this premarket submission, LOGIQ E9, did not require clinical studies to support substantial equivalence." Therefore, there is no test set, sample size, or data provenance from a new clinical study provided in this submission for device performance evaluation. The substantial equivalence relies on demonstrating that the new device operates similarly and safely as the predicate devices, which were previously cleared.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as no new clinical study (and thus no "test set" and "ground truth" to establish) was required for this substantial equivalence submission.

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

Not applicable, as no new clinical study was conducted.

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. This device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool in the sense of image interpretation. The "AutoEF and AFI" mentioned are software features but there's no MRMC study detailed here to show improved human reader performance.

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

Not applicable, as this is a diagnostic ultrasound imaging system, not a standalone algorithm.

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

Not applicable, as no new clinical study was required for this substantial equivalence submission. The "ground truth" for the predicate devices' clearance would have been established through methods appropriate for diagnostic ultrasound systems at the time of their original clearance (e.g., comparison to other imaging modalities, clinical correlation).

8. The sample size for the training set

Not applicable. This document describes a medical device, not a machine learning algorithm that requires a training set.

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

Not applicable, as there is no training set for an algorithm described in this submission.

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The device is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified physician for ultrasound imaging and analysis of Fetal/Obstetrics; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional; Urology (including prostate); Transesophagea1; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).

GE Vivid E80 / E90 / E95 is a Track 3 diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis, but which also includes vascular and general radiology applications. The Vivid E80 / E90 / E95 incorporates a variety of electronic array transducers operating in linear, curved linear, sector/phased array or matrix array format, including two dedicated CW transducers and several real time 3D transducers. It consists of a mobile console with keyboard control panel; color LCD/TFT touch panel, Alternative OLED or LCD color video display and optional image storage and printing devices. It provides high performance ultrasound imaging and analysis and has comprehensive networking and DICOM capability.

The provided document is a 510(k) Premarket Notification for the GE Vivid E80/E90/E95 Diagnostic Ultrasound System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance criteria through new clinical studies. Therefore, much of the requested information regarding acceptance criteria, specific study design details, and ground truth establishment is not explicitly available in this document.

However, I can extract the following information based on the document's content:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the GE Vivid E80/E90/E95 system is substantially equivalent to its predicate devices concerning indications for use, imaging capabilities, technological characteristics, safety, and effectiveness. This "substantial equivalence" acts as the acceptance criterion. The reported device performance is that it meets this criterion by being comparable to the predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily relies on comparisons to predicate devices and adherence to recognized standards. It explicitly states: "The subject of this premarket submission, Vivid E80 / E90 / E95, did not require clinical studies to support substantial equivalence."
Therefore, there is no specific test set or data provenance details relating to clinical performance provided in this document as new clinical studies were not deemed necessary for this 510(k) submission. The evidence is based on demonstrating the new device performs equivalently to existing cleared devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Since new clinical studies were not required, there is no information on experts establishing ground truth for a test set. The predicate devices would have undergone their own validation for their initial clearance.

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

Not applicable, as no new clinical test set was required.

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. This is a diagnostic ultrasound system, and the submission is for showing substantial equivalence to predicate ultrasound systems, not for evaluating AI assistance or human reader improvement with AI.

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

Not applicable. This device is a diagnostic ultrasound system that functions with a human operator for image acquisition and interpretation.

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

Not applicable, as no new clinical studies requiring external ground truth were conducted for this 510(k). The "ground truth" for demonstrating substantial equivalence is the established performance and safety profiles of the predicate devices.

8. The sample size for the training set

Not applicable, as this is related to a new clinical study or AI development, neither of which were required for this 510(k) submission.

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

Not applicable, for the same reasons as above. The submission focuses on demonstrating the device's technical and functional equivalence to already cleared devices.

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