(86 days)
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; Cardiac (adult & pediatric); Peripheral Vascular; Musculoskeletal Conventional & Superficial; Transvaginal; 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 a separate power supply/charger.
The GE LOGIQ e Diagnostic Ultrasound System is a Class II device intended for ultrasound imaging, measurement and analysis of the human body for multiple clinical applications.
1. Table of Acceptance Criteria and Reported Device Performance:
The document provided does not specify quantitative acceptance criteria or a direct performance study comparing the device against such criteria. Instead, the substantial equivalence determination is based on the device employing the "same fundamental scientific technology as its predicate devices" and being equivalent in "intended use, imaging capabilities, technological characteristics and safety and effectiveness."
The document details the device's intended uses and modes of operation for various clinical applications with different transducers. It indicates whether an indication is "new" (N) or "previously cleared by FDA" (P) with a predicate device. This implies that for "P" indications, the device performance is considered equivalent to the predicate, and for "N" indications, the performance meets established safety and effectiveness standards, likely through non-clinical testing.
2. Sample Size Used for the Test Set and Data Provenance:
The document states, "The subject of this premarket submission, LOGIQ e, did not require clinical studies to support substantial equivalence." This means there was no specific "test set" of patient data used in a clinical study to evaluate the device's performance against pre-defined acceptance criteria, as the assessment was primarily based on non-clinical evaluations and comparison to predicate devices. Therefore, there is no information on sample size or data provenance from a clinical test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Since no clinical studies were conducted to establish performance with a test set, there is no information on the number or qualifications of experts used to establish ground truth in this context.
4. Adjudication Method for the Test Set:
As no clinical studies were conducted, there is no mention of an adjudication method used for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was mentioned or conducted. The submission explicitly states that clinical studies were not required.
6. Standalone Performance:
Standalone performance (algorithm only without human-in-the-loop) in a clinical context was not directly assessed via a clinical study, as the device is an ultrasound system requiring human operation. However, the non-clinical tests assess the inherent performance of the system against various safety and technical standards (e.g., acoustic output, electrical safety).
7. Type of Ground Truth Used:
For the purpose of establishing substantial equivalence, the "ground truth" primarily relied on:
- Comparison to Predicate Devices: The performance and safety characteristics of the GE LOGIQ e were compared against its predicate devices (LOGIQ i/e, Vivide - K113690; LOGIQ S8 - K131527; SonoSite Edge - K113156; Voluson S6/S8 - K120741). The assumption is that if the new device is technologically equivalent and intended for similar uses as a legally marketed device, its performance is also equivalent.
- Compliance with Voluntary Standards: Non-clinical tests were conducted to ensure compliance with a range of safety and performance standards (e.g., AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, NEMA UD 3 & 2, ISO10993-1, ISO14971, DICOM). These standards act as a form of "ground truth" for technical, electrical, acoustic, and biological safety and efficacy.
8. Sample Size for the Training Set:
This information is not applicable as the submission discusses a medical device (ultrasound system), not an AI algorithm that would typically have a "training set" of data in the context of machine learning. The "development of the system" involved quality assurance measures such as risk analysis, requirements reviews, design reviews, unit-level testing, integration testing, performance testing, safety testing, and simulated use testing, but these activities do not involve a "training set" in the sense of machine learning.
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable for the same reason as point 8.
§ 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.