(340 days)
LOGIQ 700 with 3D 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.
Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Fetal and other (includes urological), Abdominal, Cardiac Adult, Cardiac Pediatric, Pediatric, Small Organ (includes breast, testes, thyroid), Neonatal Cephalic, Peripheral vessel, Trans-rectal, Trans-vaginal. Combined modes are B/M, B/Color, B/PWD, B/Color/PWD.
The LOGIQ 700 diagnostic ultrasound system with 3D is the same in all other aspects as the currently marketed LOGIQ 700, consisting of a mobile console approximately 70 cm wide, 120 cm deep and 120 cm high that provides full 128 channel capability, 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 text is a 510(k) summary for the GE LOGIQ 700 3D Cine diagnostic ultrasound system, submitted in 1996. This document evaluates the device for substantial equivalence to a predicate device, focusing on safety and effectiveness.
Here's an analysis of the requested information based only on the provided text, recognizing that some modern AI/ML device study criteria may not apply to a 1996 submission for an ultrasound system.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of quantitative acceptance criteria or specific performance metrics in the way a modern AI/ML device submission would. Instead, the acceptance criteria are implicitly tied to demonstrating "substantial equivalence" to a predicate device. The performance is reported in a qualitative manner, confirming adherence to safety standards.
| Acceptance Criteria (Stated/Implied) | Reported Device Performance |
|---|---|
| Safety: Conformity with applicable medical device safety standards. | "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." |
| Effectiveness: Comparable key features, design, construction, materials, intended uses, and operating modes to the predicate device. | "The GE LOGIQ 700 with 3D is comparable in key safety and effectiveness features, uses the same design, construction, and materials, and has the same intended uses and operating modes as the predicate device." |
| GMP Compliance: Conformance with Good Manufacturing Practices. | "The design and development process of the manufacturer conforms with GMP standards." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide information regarding a specific "test set" in the context of an AI/ML algorithm. The evaluation described refers to acoustic output, biocompatibility, and thermal, electrical, and mechanical safety, which typically involve testing of the physical device components rather than a dataset of clinical cases. Therefore, there is no mention of sample size or data provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable or not provided in the document. The submission is for a diagnostic ultrasound system and its transducers, not an AI/ML algorithm that requires expert-annotated ground truth for a test set of clinical images. The "ground truth" in this context would likely be physical measurements, engineering specifications, and established medical device safety limits.
4. Adjudication Method for the Test Set
This information is not applicable or not provided in the document. As there is no described test set requiring human interpretation for ground truth, no adjudication method is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Improvement with AI vs. Without AI Assistance
This information is not applicable or not provided in the document. The device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool. Therefore, a MRMC comparative effectiveness study comparing human readers with and without AI assistance was not performed or mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable or not provided in the document. The device is a diagnostic ultrasound system, which inherently involves human operation and interpretation. It is not a standalone AI algorithm.
7. The Type of Ground Truth Used
The ground truth used for this type of medical device submission (a diagnostic ultrasound system in 1996) centers around:
- Engineering Specifications and Safety Standards: The device's acoustic output, electrical safety, thermal safety, mechanical safety, and biocompatibility are measured against established industry and regulatory standards.
- Predicate Device Comparison: The "ground truth" for demonstrating effectiveness is the substantial equivalence to a legally marketed predicate device (GE Medical Systems LOGIQ 700, K930768) with a known history of safe and effective performance. This implies that the predicate device's established performance serves as the benchmark.
8. The Sample Size for the Training Set
This information is not applicable or not provided in the document. The GE LOGIQ 700 is a hardware and software system for image acquisition and display, not an AI/ML algorithm that is "trained" on a dataset in the modern sense.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable or not provided in the document, as there is no "training set" for an AI/ML algorithm associated with this device submission.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.