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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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