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The LOGIQ i/e & Vivid e is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Intra-operative (abdominal, thoracic and PV), Musculo-skeletal Conventional & Superficial, Transesophageal, Transrectal and Transvaginal, and Thoracic/Pleural for motion/sliding and fluid detection.

The LOGIQ ife & Vivid e is a full-featured, compact and extremely portable ultrasound system consisting of a main console chassis with integrated keyboard, a color video LCD type display and several interchangeable electronic-array transducers. It has digital acquisition, processing and display capability and operates from an integrated battery or a separate power supply/charger. It is used primarily where portability, size and convenience are essential and is available in three variations: LOGIQ e is for general purpose radiology imaging having a variety of options to tailor it for use by the medical specialist for use in various departments and patient care areas (e.g., OR, ER & outpatient care). Accordingly it has various configurations (Software option/standard and probes supporting) for different packages (Nerve, ED, and GI). LOGIO i is a full-featured premium radiology system suitable for physician rounds in a hospital, nursing home where a broader range of high performance is needed. Vivid e is similar to the LOGIO e with an emphasis on cardiology examinations.

The provided 510(k) Premarket Notification Submission for the GE Healthcare LOGIQ i, LOGIQ e, and Vivid e ultrasound systems does not include acceptance criteria or a study proving that the device meets such criteria in terms of performance metrics like sensitivity, specificity, or image quality statistics.

Instead, this submission is centered on demonstrating substantial equivalence to existing predicate devices (LOGIQ i, LOGIQ e, Vivid e, K102256, and LOGIO E9 K110943). The document explicitly states:

• "The subject of this premarket submission, LOGIQ i/e & Vivid e, did not require clinical studies to support substantial equivalence." (Page 2)
• "GE Healthcare considers the LOGIQ i/e & Vivid e to be as safe, as effective, and performance is substantially equivalent to the predicate device(s)." (Page 2)

The 510(k) summary focuses on non-clinical tests and compliance with voluntary standards to assert equivalence. These include: Risk Analysis, Requirements Reviews, Design Reviews, Testing on unit level (Module verification), Integration testing (System verification), Performance testing (Verification), Safety testing (Verification), and Simulated use testing (Validation).

Therefore, many of the requested categories related to performance studies, sample sizes, expert ground truth, and comparative effectiveness cannot be extracted from this document as these types of studies were not conducted or reported for this submission.

However, I can extract information regarding the intended use and modes of operation for various transducers, which were likely evaluated for functionality and safety, but not for specific performance metrics in comparison to clinical outcomes.

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, no specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy) or corresponding device performance results from clinical studies are stated in this 510(k) for the purpose of demonstrating device performance against specific metrics. The "acceptance criteria" for this submission appear to be based on compliance with voluntary standards and verification/validation testing of the system's functionality and safety, asserting substantial equivalence to predicate devices.

The tables within the document (e.g., Pages 7-21) indicate the intended clinical applications and modes of operation for the main system and each transducer (4C-RS, 8C-RS, E8C-RS, 8L-RS, 9L-RS, 12L-RS, 16L-RS, i12L-RS, i/t739-RS, 3S-RS, 6S-RS, P2D, 6Tc-RS, L8-18i-RS). These tables list whether a particular mode (B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse) is "P" (previously cleared by FDA) or "N" (new indication) for a given anatomical region/clinical application. This indicates the functional scope of the device for which substantial equivalence is claimed, rather than performance against a quantitative criterion.

Example Table Structure (based on the provided information, but without performance data):

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

• Sample Size for Test Set: Not applicable. No clinical test set data is reported as clinical studies were not required for this substantial equivalence submission.
• Data Provenance: Not applicable.

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. No clinical test set or ground truth established by experts is reported.

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

• Not applicable. No clinical test set data is reported.

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 an ultrasound imaging system, not an AI-assisted diagnostic tool as understood in the context of MRMC studies for AI. No MRMC study was performed or reported.

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

• Not applicable. This device is an ultrasound imaging system, not an algorithm being evaluated in a standalone performance study.

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

• Not applicable. No clinical ground truth data is reported. The foundational ground truth for this submission is the established safety and effectiveness of the identified predicate devices.

8. The sample size for the training set

• Not applicable. This premarket notification does not describe an AI/machine learning model where a training set sample size would be relevant.

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

• Not applicable. As above, this submission does not describe an AI/machine learning model.

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