(102 days)
The LOGIQ E10s and LOGIQ Fortis are general-purpose diagnostic ultrasound systems intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. LOGIQ E10s and LOGIQ Fortis clinical applications include: Fetal / Obstetrics; Abdominal (including Renal, Gynecology/Pelvic); Pediatric; Small Organ (Breast, Testes, Thyroid); Neonatal Cephalic; Cardiac (Adult and Pediatric); Peripheral Vascular; Musculo- skeletal Conventional and Superficial; Urology (including Prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (Vascular). Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, Shear Wave Elastography, Attenuation Imaging and Combined modes: B/M, B/Color, B/ PWD, B/Color/PWD, B/Power/PWD. The LOGIQ E10s and LOGIQ Fortis are intended to be used in a hospital or medical clinic.
The LOGIQ E10s is a full featured, Track 3, general purpose diagnostic ultrasound system which consists of a mobile console approximately 585 mm wide (keyboard), 991 mm deep and 1300 mm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 12-inch high- resolution color touch screen and 23.8-inch High Contrast LED LCD monitor (or an optional 22-inch color OLED widescreen monitor).
The LOGIQ Fortis is a full featured, Track 3, general purpose diagnostic ultrasound system which consists of a mobile console approximately 575 mm wide (keyboard), 925 mm deep and 1300 mm high that provides digital acquisition, processing and display capability. The user interface includes a digital keyboard (physical keyboard as an option), specialized controls, 12-inch high-resolution color touch screen and 23.8-inch High Contrast LED LCD monitor (or 23.8-inch High Resolution LED LCD monitor as an option).
The provided text is a 510(k) Premarket Notification from the FDA for GE Healthcare's LOGIQ E10s and LOGIQ Fortis diagnostic ultrasound systems. This document primarily focuses on establishing substantial equivalence to a predicate device and does not contain detailed information about specific clinical studies with acceptance criteria, sample sizes, or ground truth establishment in the way typically found for AI/ML-driven medical devices that require such studies for de novo or PMA applications.
Therefore, most of the requested information cannot be extracted from this document as it explicitly states: "The subject of this premarket submission, LOGIQ E10s, LOGIQ Fortis, did not require clinical studies to support substantial equivalence."
However, I can provide available information:
1. Table of acceptance criteria and the reported device performance:
This document does not specify quantitative acceptance criteria or reported device performance in terms of diagnostic accuracy metrics (e.g., sensitivity, specificity, AUC) for clinical applications. Instead, it relies on demonstrating substantial equivalence to a predicate device by comparing intended use, technology, imaging modes, safety, and functionality.
2. Sample size used for the test set and the data provenance:
Not applicable. The document states that clinical studies were not required.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The document states that clinical studies were not required.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. The document states that clinical studies were not required.
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 states that clinical studies were not required, and this device is primarily a diagnostic ultrasound system, not explicitly an AI-assisted diagnostic tool as described in the context of improving human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The document states that clinical studies were not required. This device is a diagnostic ultrasound system operated by a human.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. The document states that clinical studies were not required.
8. The sample size for the training set:
Not applicable. The document states that clinical studies were not required. This is for a general-purpose ultrasound system, not an AI/ML algorithm requiring a specific training set with ground truth in the context described.
9. How the ground truth for the training set was established:
Not applicable. The document states that clinical studies were not required.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.