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The LOGIQ e is intended for ultrasound imaging, measurement and analysis of the human body for multiple clinical applications including: ophthalmic: fetal/ob; abdominal (gyn & urology); pediatric; small organ (breast, testes, thyroid); neonatal and adult cephalic; cardiatric); peripheral vascular; musculosketal conventional & superficial; transrectal; transvaginal; transesophageal; intraoperative (abdominal, thoracic and peripheral); thoracic/pleural for motion and fluid detection and imaging guidance of interventional procedures (e.g. Nerve block; vascular access).

The LOGIQ e device is a laptop ultrasound console approximately 70mm in height, 295mm in width and 346mm in length 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 separate power supply/charger.

The provided document is a 510(k) Premarket Notification Submission for the GE LOGIQ e ultrasound system. This type of submission is for demonstrating "substantial equivalence" to a predicate device, rather than proving the device meets specific acceptance criteria in the manner of a new device approval or efficacy study for a novel AI/software function.

Therefore, the document does not contain the information requested regarding acceptance criteria met by a proven device performance, sample size for test sets, data provenance, number or qualifications of experts, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or ground truth establishment relevant to an AI/software as a medical device (SaMD) study.

The closest information available that might be interpreted in a similar vein would be the "Determination of Substantial Equivalence," which details how the LOGIQ e compares to its predicate devices. However, this is focused on technological characteristics and intended use, not on quantitative performance metrics derived from a study designed to meet specific clinical acceptance criteria.

Here's why the document doesn't fit the request's framework:

• Device Type: The LOGIQ e is an ultrasound imaging system, an established medical device. The submission focuses on its equivalence to existing ultrasound systems, not on a novel AI or software component requiring clinical validation against specific performance targets.
• Regulatory Pathway: A 510(k) submission primarily demonstrates that a new device is "substantially equivalent" to a legally marketed predicate device. This is different from a PMTA (Premarket Approval) or De Novo submission, which might require extensive clinical data demonstrating safety and effectiveness against predefined performance endpoints.
• "Acceptance Criteria" in this context: The "acceptance criteria" here are implicitly the regulatory requirements for showing substantial equivalence (e.g., similar intended use, technological characteristics, safety, and effectiveness). The "reported device performance" is not a set of quantitative metrics from a clinical study, but rather a qualitative comparison to the predicate device, stating it performs in the same manner.
• Absence of Clinical Studies: The document explicitly states: "The subject of this premarket submission, LOGIQ e, did not require clinical studies to support substantial equivalence." This immediately negates the possibility of finding the detailed information requested about test sets, ground truth, experts, and statistical studies.

In summary, the provided document relates to a 510(k) clearance for a general-purpose ultrasound system based on substantial equivalence, not a performance study for a medical device that would have specific acceptance criteria and detailed study designs for its performance metrics.

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