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

The LOGIQ P9 and LOGIQ P7 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 53 cm wide, 69 cm deep and 157 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 10.4-inch LCD touch screen and color 21.5-inch LCD image display.

The provided text does not contain detailed acceptance criteria and a study proving the device meets those criteria in the traditional sense of a clinical performance study for an AI/ML device.

Instead, the document is a 510(k) premarket notification for a diagnostic ultrasound system (GE LOGIQ P9 and LOGIQ P7) and its various transducers. The "study" described is a non-clinical comparison to predicate devices to establish substantial equivalence, rather than a clinical trial demonstrating performance against specific metrics.

Here's a breakdown of the information that can be extracted, and where limitations exist based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a table of specific quantitative acceptance criteria or reported performance metrics in terms of accuracy, sensitivity, specificity, or other performance measures typically associated with AI/ML devices.

Instead, the "acceptance criteria" are implied by the comparison to legally marketed predicate devices and compliance with voluntary safety and performance standards. The "reported device performance" is framed as its "substantial equivalence" to these predicates.

Implied Acceptance Criteria (based on comparison to predicate and standards):

• Intended Use Equivalence: Same clinical intended uses as predicate devices.
• Imaging Capabilities Equivalence: Same imaging modes and similar capabilities (measurements, digital image capture, reviewing/reporting).
• Technological Equivalence: Employs the same fundamental scientific technology as predicate devices.
• Safety Standards Compliance: Acoustic output below FDA limits, compliance with AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, NEMA UD 3, NEMA UD 2, ISO10993-1, ISO14971, and NEMA PS 3.1 3.20 (DICOM).
• Biocompatibility: Transducer materials and other patient contact materials are biocompatible.
• Quality Assurance: Adherence to risk analysis, requirements reviews, design reviews, unit testing, integration testing, performance testing, and safety testing.

Reported Device Performance (as stated in the document):

The LOGIQ P9 and P7 systems are "substantially equivalent to the predicate devices with regard to intended use, imaging capabilities, technological characteristics and safety and effectiveness."

Specific new features or transducers are noted to be "previously cleared by FDA" on other GE Healthcare devices, implicitly demonstrating their performance was already deemed acceptable.

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

The document explicitly states: "The subject of this premarket submission, LOGIO P9 and LOGIO P7, did not require clinical studies to support substantial equivalence."

Therefore, there is no test set of patient data of a specific sample size used for performance evaluation in the context of an AI/ML study, nor is there information on data provenance (country of origin, retrospective/prospective). The substantiation is primarily based on engineering and performance testing against standards, and comparison to already cleared predicate devices.

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

Since no clinical studies or test sets with patient data were required for this submission, there is no mention of experts used to establish ground truth for such a test set.

4. Adjudication Method for the Test Set

As no clinical test set was required, there is no adjudication method described.

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 or reported in this document. The device is a diagnostic ultrasound system, not explicitly an AI-assisted diagnostic tool, and the submission focuses on substantial equivalence to existing ultrasound devices.

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

Not applicable. This submission is for an ultrasound imaging system. While it includes "software features" like STIC and OmniView, and a "general measurement tool" called Cardiac AFI, these are presented as capabilities of the ultrasound system itself, not as standalone AI algorithms whose performance is evaluated independently. The primary focus is the imaging hardware and its integrated software relative to predicate ultrasound devices.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the new features or specific transducers mentioned as "previously cleared," their original submissions would have involved appropriate ground truth methods relevant to specific clinical applications (e.g., phantom studies for image quality, clinical data for specific measurements). However, for this specific 510(k) submission, since no new clinical studies were required, there is no ground truth established using patient data for the purpose of demonstrating performance of the LOGIQ P9/P7 as a complete system. The ground truth for proving safety and effectiveness here relies on compliance with engineering standards and demonstrated performance of predicate devices.

8. The Sample Size for the Training Set

Not applicable. This document describes a diagnostic ultrasound system, not an AI/ML algorithm that would undergo specific training on a data set.

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

Not applicable. As there is no AI/ML training set explicitly discussed, the establishment of ground truth for such a set is not detailed.

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