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

The device may include EchoPilot reporting software which provides guidance to support the quality of the echocardiography examination and report. It compares patient data, user entered clinical data and measurements to generally accepted guidelines and studies, and helps to identify mismatches, inconsistencies and unusual or missing data. It can generate a preliminary data analysis that can be used as basis for the examination report.

The Vivid i and Vivid q are mobile ultrasound consoles having a wide assortment of electronic array transducers intended primarily for echocardiography with additional capability in vascular and general ultrasound imaging. Its intuitive user interface, high level of auto-optimization along with significantly reduced size and weight make it readily maneuverable, efficient and easy to use.

The information provided pertains to the GE Healthcare Vivid i and Vivid q Diagnostic Ultrasound Systems (K121062). This submission is a 510(k) for a modified device, primarily claiming substantial equivalence to predicate devices (Vivid i and Vivid q Diagnostic Ultrasound Systems, K102388; Vivid E9 Diagnostic Ultrasound System, K101149).

Crucially, no new clinical studies were conducted or required to support the substantial equivalence of the modified device. The submission focuses on non-clinical tests to demonstrate safety and performance. Therefore, the device does not have explicit acceptance criteria based on performance metrics from clinical trials, nor a study proving it meets such criteria in the context of this 510(k) submission.

The "acceptance criteria" for this 510(k) are the various safety and performance standards the device conforms to, and the "study" demonstrating this is the summary of non-clinical tests.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for a modified device relying on substantial equivalence to predicates, the "acceptance criteria" are implied by conformity to standards and safety reviews. There are no specific quantitative performance metrics reported in this document from a clinical test.

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

• Sample Size for Test Set: Not applicable. No clinical tests were conducted for this 510(k) submission. Non-clinical tests typically refer to engineering, laboratory, and bench testing, not patient-based data.
• Data Provenance: Not applicable for patient data. The provenance of the non-clinical test data (e.g., conducted internally by GE Healthcare or by external labs) is not specified beyond "GE Healthcare considers..." and "The device has been evaluated for...".

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

• Number of Experts: Not applicable. No clinical test set with ground truth established by experts was used, as clinical studies were not required.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No clinical test set with expert adjudication was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• MRMC Study: No. The document explicitly states: "The subject of this premarket submission, the modified Vivid i/q, did not require clinical studies to support substantial equivalence." Therefore, no MRMC study was performed.
• Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: Not applicable, as no MRMC study or AI assistance feature is discussed in the context of clinical performance evaluation for this 510(k). The "EchoPilot reporting software" is mentioned as providing guidance for quality and generating preliminary data analysis, but its clinical effectiveness or impact on human reader performance through a comparative study is not assessed in this submission.

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

• Standalone Performance Study: No. This submission is for an ultrasound system and its transducers, not a standalone algorithm. Any software components (like EchoPilot) are part of the overall device functionality, but their isolated "standalone" performance in a clinical context is not evaluated as part of this 510(k).

7. The Type of Ground Truth Used

• Type of Ground Truth: Not applicable for clinical performance. The ground truth for non-clinical tests would involve engineering specifications, recognized standards, and established testing methodologies (e.g., using phantoms for acoustic output, material standards for biocompatibility).

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This 510(k) is not for an AI/ML algorithm that requires a training set of clinical data.

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

• Ground Truth for Training Set: Not applicable. This 510(k) is not for an AI/ML algorithm that requires a training set.

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