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510(k) Data Aggregation
(15 days)
GE LOGIQ A100 MP, MODEL 2272413
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 Cephalic; Cardiac (adult & pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional; Transrectal (TR); and Transvaginal (TV) applications.
The GE LOGIQ 100 PRO is a portable general purpose diagnostic ultrasound system. It consists of a small hand-carried console, weighing approximately 22 lbs., providing real-time B and M-mode images with a variety of linear and curved-linear array type transducers. The user interface includes a fold down keyboard, specialized controls and a B&W video CRT display.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Safety | Compliance with applicable medical device safety standards (thermal, electrical, mechanical safety, acoustic output, biocompatibility, cleaning and disinfection effectiveness). | Device found to conform with applicable medical device safety standards through non-clinical tests and independent evaluation. |
| Effectiveness/Performance | Comparable type, technological characteristics, key safety and effectiveness features, design, construction, materials, intended uses, and basic operating modes to the predicate device (GE LOGIQ x100). | The GE LOGIQ 100 PRO is stated to be of a "comparable type" and "substantially equivalent" to the current GE LOGIQ x100, having "the same technological characteristics" and being "comparable in key safety and effectiveness features," and utilizing "similar design, construction, and materials," with "the same intended uses and basic operating modes." |
| Clinical Tests | None required for this device, based on established safety and effectiveness history of diagnostic ultrasound and substantial equivalence to predicate. | "None required." |
2. Sample Size Used for the Test Set and Data Provenance:
No explicit test set or clinical data is mentioned for the GE LOGIQ 100 PRO Diagnostic Ultrasound System. The submission states "Clinical Tests: None required." The device's safety and effectiveness were primarily evaluated through non-clinical tests and a comparison of its features and intended uses to an existing predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
Not applicable, as no clinical test set requiring expert-established ground truth was performed or reported in this document.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical test set requiring adjudication was performed or reported in this document.
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. This document pertains to a diagnostic ultrasound system, not an AI-assisted diagnostic tool, and no MRMC study was conducted or reported.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a diagnostic ultrasound system (hardware), not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable, as no clinical test required specific ground truth data for the GE LOGIQ 100 PRO. The evaluation was based on non-clinical testing and substantial equivalence to a predicate device.
8. The Sample Size for the Training Set:
Not applicable. This device is a hardware system, not an artificial intelligence or machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as no training set was used for this device.
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