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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal / Obstetrics, Abdominal (including renal and GYN), Pediatric, Small Organ (breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (adult and pediatric), Peripheral Vascular (PV), Musculo-skeletal Conventional, Urology (including prostate), Transesophageal, Transvaginal (TV), and Intraoperative (abdominal, thoracic, & vascular).

The GE Vivid E9 Ultrasound is a full featured echocardiography imaging and analysis system. It consists of a mobile console with multiple electronic array transducers that provides digital acquisition, processing and display capability. The user interface includes a floating and variable height user control panel with specialized controls, high resolution LCD display and separate LCD touch panel. This modification offers improved performance and productivity for users in a smaller and lighter weight package.

This document describes the Summary of Safety and Effectiveness for the GE Vivid E9 Ultrasound system, prepared in accordance with 21 CFR Part 807.92(c).

Acceptance Criteria and Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device (GE Vivid 7 Diagnostic Ultrasound) rather than establishing specific quantitative acceptance criteria for device performance. The "acceptance criteria" are implied to be adherence to medical device safety standards and comparable performance to the predicate.

The table below summarizes the claimed performance characteristics and indications for use, noting that these are "previously cleared by FDA" (P) or "new indication" (N) for specific transducers. The core acceptance criterion for the device itself is its safety and effective performance, which is stated to be consistent with traditional clinical practice and FDA guidelines.

Study Details:

A formal clinical study to prove the device meets acceptance criteria was not required or performed for this 510(k) submission.

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

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

  • No clinical test set was used, as clinical tests were stated as "None required."
  • Therefore, no sample size, data provenance, or retrospective/prospective nature of the data is reported.

• 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 clinical test set was utilized and no ground truth was formally established for direct comparison of the new device's performance against clinical outcomes. The equivalence relies on the established safety and efficacy of diagnostic ultrasound and its predicate.

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

  • Not applicable, as no clinical test set was utilized.

• 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:

  • No MRMC comparative effectiveness study was done. This submission is for an ultrasound imaging system, not an AI-powered diagnostic aid. The device is a diagnostic ultrasound system, and the submission emphasizes its substantial equivalence to a predicate device and adherence to safety standards, not an improvement in human reader performance through AI assistance.

• 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 requires human operation, not a standalone AI algorithm.

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

  • Not applicable. No new ground truth for performance evaluation was established for this submission, as clinical tests were not required. The "ground truth" for the device's acceptable safety and effectiveness is implied through its adherence to established medical device safety standards and the long history of safe and effective performance of diagnostic ultrasound as a modality.

• 8. The sample size for the training set:

  • Not applicable. This device is a hardware/software system, not a machine learning model requiring a training set in the typical sense.

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

  • Not applicable, as no training set for a machine learning model was used.

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