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The LOGIQ V5 Expert / LOGIQ V5 / LOGIQ V3 are general purposed ultrasound imaging and analysis systems providing digital acquisition, processing and display capability and clinical applications including: Abdominal, Obstetrical, Gynecological, Small parts, Vascular, Adult Cephalic, Pediatric, Musculoskeletal, Transcranial, Neonatal Cephalic, Transvaginal, Cardiac, Transrectal, and Tissue Biopsy/Fluid Drainage,

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

The LOGIQ V5 Expert / LOGIQ V5 / LOGIQ V3 are entry level ultrasound scanners from the LOGIQ family for private clinics focusing on OB/GYN. The systems are for general purpose imaging and analysis providing real-time digital acquisition, processing and display capability intended for general radiology imaging, evaluation with some cardiology and vascular applications, and providing guidance during tissue biopsy and fluid drainage procedures. The track 3 systems consist of a mobile console with keyboard control panel; color display and optional image storage, wireless capability, and printing devices. They utilize a variety of linear, curved linear and matrix phased array transducers. The systems have the same hardware and software but may have different options available.

The document is a 510(k) premarket notification for the GE Medical Systems Ultrasound and Primary Care Diagnostics LLC LOGIQ V5 Expert, LOGIQ V5, and LOGIQ V3 ultrasound systems.

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the LOGIQ V5 Expert / LOGIQ V5 / LOGIQ V3 systems comply with several voluntary standards for safety and performance. These standards serve as the acceptance criteria for the device. The reported device performance is that the systems meet these standards.

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

The document explicitly states: "The subject of this premarket submission, LOGIQ V5 Expert / LOGIQ V5 / LOGIQ V3, did not require clinical studies to support substantial equivalence." This indicates that there was no specific clinical "test set" in the traditional sense, and therefore no associated sample size or data provenance from clinical testing for this specific submission. The majority of the comparisons are based on predicate devices and compliance with recognized standards.

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

As no clinical studies were required, there were no experts used to establish ground truth for a clinical test set in this submission. The "ground truth" for demonstrating substantial equivalence relied on compliance with engineering and safety standards, and comparison to already cleared predicate devices.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set was used for this submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. The document explicitly states that clinical studies were not required. The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices through technical comparisons and compliance with standards, not comparative effectiveness with human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:

This device is an ultrasound imaging system, which inherently involves a human operator (sonographer/clinician) to acquire and interpret the images. Therefore, the concept of "standalone performance" for an algorithm without human-in-the-loop is not applicable in the context of this device. The performance is tied to the integrated system and its ability to produce diagnostic quality images for human interpretation.

7. Type of Ground Truth Used:

The "ground truth" for demonstrating substantial equivalence in this submission is primarily based on:

• Compliance with recognized industry standards: (e.g., AAMI/ANSI ES 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 3, ISO 10993-1, NEMA UD 2, ISO 14971, NEMA, PS 3.1 3.20).
• Technical comparison to predicate devices: Proving that the new device has the same or similar intended use, technology, probes, and performance as devices already cleared by the FDA.

8. Sample Size for the Training Set:

Not applicable. This is a medical imaging device, not an AI/ML algorithm that requires a "training set" in the context of data-driven learning. The development process involved traditional engineering design, testing, and verification against specifications and standards.

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

Not applicable, as there is no "training set" for this type of device. The verification and validation process involved:

• Risk Analysis
• Requirements Reviews
• Design Reviews
• Testing on unit level (Module verification)
• Integration testing (System verification)
• Performance testing (Verification)
• Safety testing (Verification)
• Simulated use Testing (Validation)

These measures aim to ensure the device performs according to its specifications and meets safety and efficacy requirements, derived from established engineering principles and regulatory standards.

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The LOGIQ V5/LOGIQ V3 is general purposed ultrasound imaging and analysis systems providing digital acquisition, processing and display capability and clinical applications including: Abdominal, Obstetrical, Gynecological, Small parts, Vascular/Peripheral Vascular, Adult Cephalic, Pediatric, Musculoskeletal, Transcranial, Neonatal Cephalic, Transvaginal, Urological and Cardiac.

LOGIQ V5/LOGIQ V3 is a general-purpose ultrasound system used for acquiring and storing ultrasound images for applications such as: Obstetrics; Abdominal, Obstetrical, Gynecological, Small parts, Vascular/Peripheral Vascular, Adult Cephalic, Pediatric, Musculoskeletal, Transcranial, Neonatal Cephalic, Urological and Cardiac. The system used for performing measurements, annotating, printing/reporting on the acquired/stored images.

The LOGIQ V5/LOGIQ V3 is a general-purpose entry level ultrasound scanner from LOGIQ family for private clinics focusing on OB/GYN. The device is a general-purpose imaging and analysis system providing real-time digital acquisition, processing and display capability intended for general radiology imaging and evaluation with some cardiology and vascular applications.

The provided document is a 510(k) premarket notification for the GE Healthcare LOGIQ V5/LOGIQ V3 Diagnostic Ultrasound System. It details the device's indications for use and compares it to predicate devices to establish substantial equivalence.

Based on the provided text, the following information can be extracted regarding acceptance criteria and the study:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of quantitative acceptance criteria for device performance. Instead, the "acceptance criteria" are implied through the comparison with predicate devices and compliance with relevant standards to demonstrate substantial equivalence. The reported "performance" is based on functional capabilities and adherence to safety and regulatory benchmarks rather than specific diagnostic accuracy metrics.

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 explicitly states: "The subject of this premarket submission, LOGIQ V5/LOGIQ V5, did not require clinical studies to support substantial equivalence."

Therefore, there is no clinical test set, no sample size, and no data provenance information for a clinical study to report. The evaluation relies on non-clinical tests and comparison to existing predicate 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 no clinical studies were required to support substantial equivalence, there was no test set requiring expert-established ground truth.

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

Not applicable, as no clinical test set was used.

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. The document describes an ultrasound system, not an AI or computer-assisted diagnostic device, and no clinical comparative effectiveness study was performed.

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

Not applicable. This is not an algorithm-only device; it is a general-purpose ultrasound imaging system.

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

Not applicable, as no clinical test set requiring ground truth was used. The substantial equivalence relies on comparison of technical specifications, safety standards compliance, and functional capabilities with predicate devices, rather than diagnostic accuracy against a definitive ground truth.

8. The sample size for the training set

Not applicable. The device is an ultrasound imaging system. The document does not describe the use of machine learning or AI models with training sets. Its development involved standard quality assurance measures such as risk analysis, requirements reviews, design reviews, and various levels of testing (unit, integration, performance, safety, simulated use).

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

Not applicable, as there is no training set described.

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