(55 days)
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics; Abdominal; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic, vascular).
The LOGIQ S8 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 620 mm wide, 880 mm deep and 1720 mm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 9-inch LCD touch screen and color widescreen monitor.
The provided document is a 510(k) Premarket Notification from GE Healthcare for their LOGIQ S8 ultrasound system. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study to prove acceptance criteria for a novel device or AI algorithm.
Therefore, many of the requested details about acceptance criteria metrics, sample sizes, ground truth establishment, and expert involvement are not applicable or explicitly stated in the context provided. The document primarily attests to the device's technical specifications and safety and effectiveness being equivalent to existing cleared devices.
However, I can extract information related to the device's intended use and the non-clinical tests performed to support its substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission demonstrating substantial equivalence, specific quantitative acceptance criteria and performance metrics (e.g., sensitivity, specificity for a diagnostic task) are generally not provided in the same way they would be for a novel device or an AI algorithm proving clinical utility. Instead, performance is established by demonstrating equivalence to a legally marketed predicate device.
The "acceptance criteria" here relate to conforming to recognized safety and performance standards and maintaining the same intended use. The "reported device performance" is implicitly considered equivalent to the predicate device(s) for the listed clinical applications and imaging modes.
| Acceptance Criteria Category | Reported Device Performance (as demonstrated for substantial equivalence) |
|---|---|
| Intended Use | Identical to predicate LOGIQ S8 and other migration predicates. |
| Clinical Applications | Covers Fetal/Obstetrics, Abdominal, Pediatric, Small Organ, Neonatal/Adult Cephalic, Cardiac, Peripheral Vascular, Musculo-skeletal (Conventional & Superficial), Urology, Transrectal, Transvaginal, Transesophageal, Intraoperative. |
| Imaging Modes | Same as predicate LOGIQ S8, including new Shear Wave Elastography (equivalent to LOGIQ E9). Includes B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse, 3D/4D Imaging, Needle Guidance, Elastography, Volume Navigation, Shear Wave Elastography (where applicable per transducer). |
| Safety Standards | Conforms to AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, NEMA UD 3, ISO10993-1, NEMA UD 2, ISO14971, NEMA DICOM. |
| Acoustic Output | Below applicable FDA limits. |
| Biocompatibility | Transducer materials and patient contact materials are biocompatible. |
| Cleaning/Disinfection | Effectiveness evaluated. |
| Thermal/Electrical/Electromagnetic/Mechanical Safety | Evaluated and found to conform to applicable medical device safety standards. |
2. Sample Sizes Used for the Test Set and Data Provenance
The document explicitly states: "The subject of this premarket submission, LOGIQ S8, did not require clinical studies to support substantial equivalence." This means there was no specific clinical "test set" and associated sample size in the traditional sense of a clinical trial for performance evaluation against a defined ground truth. Instead, the equivalence argument is based on technical and performance similarity to existing cleared devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable, as no dedicated clinical test set with independent ground truth establishment was conducted for this 510(k) submission.
4. Adjudication Method for the Test Set
Not applicable, as no dedicated clinical test set with ground truth establishment was conducted.
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 LOGIQ S8 is a diagnostic ultrasound system, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images with and without AI assistance to show an "effect size" of improvement. The document does mention "Shear Wave Elastography" which is an advanced imaging mode, but not an AI-driven interpretation tool in the context of this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as the LOGIQ S8 is a hardware and software system for image acquisition and display, not a standalone AI algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
Not applicable, as no new clinical studies requiring external ground truth were performed for this substantial equivalence submission. The ground truth for proving substantial equivalence to predicate devices typically involves technical specifications, engineering measurements, and adherence to recognized standards.
8. The Sample Size for the Training Set
Not applicable. The document describes a diagnostic ultrasound system, not a device primarily driven by a machine learning or AI algorithm that would require a "training set" for its core function.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there was no training set for an AI algorithm in the context of this 510(k) submission.
§ 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.