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LOGIQ 500 is a general purpose ultrasound imaging system intended for use by, or under the direction of, a qualified physician in the evaluation of soft tissue and vascular disease of the head, neck chest, abdomen pelvis, male and female reproductive organs, limbs and pregnant uterus of the adult, pediatric or neonatal patient. Specific intended uses include Abdominal, Peripheral Vascular, OB/Gyn, Small Parts, Musculoskeletal, Urology, Neonatal, Cardiac, Fetal Doppler, Biopsy, Transrectal/transvaginal, Transesophageal, Intra-operative, and Neurosurgical

The LOGIQ 500 diagnostic ultrasound system with the described modifications is intended for general radiological and cardiac use and consists of a mobile console and assorted transducers. The user interface is an adjustable height keyboard, small A/N display panel and a color video display monitor. Optional image storage or hard-copy devices are integrated into the design.

The provided 510(k) summary for the GE LOGIQ 500 Diagnostic Ultrasound System is a submission intended to demonstrate substantial equivalence to a predicate device, rather than a clinical study establishing new performance criteria.

Therefore, the document does not contain explicit acceptance criteria or a study designed to prove the device meets such criteria. Instead, it relies on the concept of substantial equivalence to already cleared devices.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the context of this 510(k) submission.

This document describes a device seeking clearance based on substantial equivalence, not a device establishing new performance claims that require specific acceptance criteria and a detailed performance study against those criteria. The "performance" reported primarily relates to compliance with safety standards and functional equivalence to predicate devices, rather than quantitative clinical performance metrics.

The "Summary of Studies" section vaguely states: "The device has been evaluated for acoustic output, biocompatibility, and thermal, electrical and mechanical safety, and has been found to conform with applicable medical device safety standards." This implies the acceptance criteria are adherence to these established safety standards, but no specific numerical performance metrics are provided.

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

Not applicable.

There is no mention of a "test set" in the context of clinical performance evaluation. The submission focuses on technical specifications, safety compliance, and comparison to predicate devices, not on a clinical test set for performance evaluation.

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

Not applicable.

As there is no described test set for clinical performance evaluation, there is no mention of experts establishing a ground truth for such a set.

4. Adjudication Method for the Test Set

Not applicable.

Without a test set and ground truth establishment, no adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance

Not applicable.

This submission is for a diagnostic ultrasound system, not an AI-assisted device. Therefore, no MRMC study or AI-related effectiveness is discussed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable.

This submission is for a diagnostic ultrasound system, not an algorithm.

7. The Type of Ground Truth Used

Not applicable (in the sense of clinical performance ground truth).

The "ground truth" implied in this submission relates to:

• Compliance with safety standards: The "truth" is whether the device meets the specified technical requirements of applicable medical device safety standards.
• Substantial equivalence: The "truth" is whether the device is comparable in safety and effectiveness to the identified predicate devices (ATL HDI 3000 and GE Medical Systems LOGIQ 500).

8. The Sample Size for the Training Set

Not applicable.

This submission describes a diagnostic ultrasound system, not a machine learning or AI model that requires a training set.

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

Not applicable.

As there is no training set mentioned, no ground truth establishment for it is described.

In summary, the provided document for the GE LOGIQ 500 Diagnostic Ultrasound System is a 510(k) summary relying on substantial equivalence, and therefore does not include detailed clinical performance studies with acceptance criteria, test sets, or ground truth as would be seen for novel devices making specific diagnostic claims, especially those involving AI/ML components. The primary "study" mentioned is the evaluation against existing safety standards, and the "acceptance criterion" is conformance to those standards, alongside demonstrating equivalence to predicate devices.

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