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The device is intended for use by a qualified physician for ultrasound evaluation of 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, Transrectal and Transvaginal.

Device Description

The GE Compact Ultrasound is a very compact and portable diagnostic ultrasound system having three variations: LOGIQ-i, LOGIQ-e and Vivid-e, each with options and features suited for its market niche. It has an integrated keyboard, LCD display and several interchangeable electronic-array transducers with an approximate size of 34 cm wide, 29 cm deep and 6 cm high in transport configuration and provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, an intuitive layout of specialized controls, color GUI display and Doppler audio.

AI/ML Overview

The provided Special 510(k) Premarket Notification for the GE LOGIQ-i/e & Vivid-e Compact Ultrasound system explicitly states that no clinical tests were required for this submission. The rationale given is: "Diagnostic ultrasound has accumulated a long history of safe and effective performance."

Therefore, the document does not contain acceptance criteria in the context of clinical performance metrics (like sensitivity, specificity, accuracy) derived from a study validating the device's diagnostic capabilities, nor does it describe a study to prove those criteria are met. The acceptance criteria and "reported device performance" in this context relate to demonstrating substantial equivalence to a predicate device through non-clinical testing and verification of intended use without introducing new safety or effectiveness concerns.

Here's a breakdown of the requested information based on the provided text, while acknowledging the absence of clinical performance data:

1. Table of Acceptance Criteria and Reported Device Performance

Since no clinical outcome-based acceptance criteria are presented or met via clinical study, the acceptance criteria here are derived from the regulatory requirements for establishing substantial equivalence for an ultrasound device.

Acceptance Criteria (Non-Clinical/Regulatory)	Reported Device Performance
Device Description & Intended Use Equivalence: The modified device is "virtually identical having the same design, construction, materials, brand names and intended uses" as the predicate device (K050126), with additional transducers, enhanced imaging (for invasive needles), and electrical docking carts. It must maintain traditional clinical practice, FDA guidelines, and established methods of patient examination.	The device, including all listed transducers (4C-RS, 8C-RS, E8C-RS, 8L-RS, 9L-RS, 12L-RS, i12L-RS, i/t739-RS, 3S-RS, 6S-RS, P2D), successfully indicated its intended use for various clinical applications (Fetal/OB, Abdominal, Pediatric, Small Organ, Neonatal/Adult Cephalic, Cardiac, Peripheral Vascular, Musculo-skeletal Conventional, Transrectal, Transvaginal, Intra-operative) across multiple modes of operation (B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse), where applicable. The expanded indications (marked "E") and new harmonics ("N") for specific transducers were deemed equivalent based on this submission.
Safety Standards Conformance: Evaluation for acoustic output, biocompatibility, cleaning and disinfection effectiveness, thermal, electrical, and mechanical safety. Compliance with applicable medical device safety standards.	The device "has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety, and has been found to conform with applicable medical device safety standards." Compliance is "verified through independent evaluation by a Nationally Recognized Testing Lab. (NRTL) with ongoing factory surveillance."
Quality Systems Conformance: Design and development process conforms with 21 CFR 820, ISO 9001, and 13485 quality systems.	The "design and development process of the manufacturer conforms with 21 CFR 820, ISO 9001 and 13485 quality systems."

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

Test Set Sample Size: Not applicable. No clinical test set.
Data Provenance: Not applicable. No clinical data was used for testing against acceptance criteria in this submission. The submission relies on non-clinical evaluations and the substantial equivalence to a previously cleared predicate device.

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 ground truth was established for a test set. The determination of "substantial equivalence" was a regulatory decision based on documented non-clinical tests and comparison to a predicate device.

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

Not applicable. No clinical test set requiring adjudication was performed.

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 a diagnostic ultrasound system, not an AI-assisted diagnostic tool.

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

No standalone algorithm performance study was done. This submission is for a diagnostic ultrasound system.

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

Not applicable. No clinical ground truth was used. The basis for clearance was a demonstration of substantial equivalence to a predicate device through non-clinical testing and design documentation.

8. The sample size for the training set

Not applicable. This is not an AI/algorithm-based device requiring a training set.

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

Not applicable. This is not an AI/algorithm-based device requiring a training set.

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