(12 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal / Obstetrics; Abdominal (includes renal, GYN/Pelvic); Pediatric; Small Organ (breast, testes, thyroid); Neonatal & Adult Cephalic; Cardiac (Adult and Pediatric); Peripheral Vascular (conventional & superficial); Intraoperative; Transrectal; and Transvaginal. Other use includes Urology/Prostate.
The GE LOGIQ 3 is a small, general purpose diagnostic ultrasound system. It is a mobile console approximately 49 cm wide, 85 cm deep and 135 cm high that provides digital acquisition, processing and display capability. The user interface consists of a computer keyboard, trackball and color video CRT display. The modification provides a system with numerous high end features on a product intended for diagnostic ultrasound users in a value market segment.
The GE LOGIQ 3 Diagnostic Ultrasound System is a general-purpose ultrasound system for a variety of clinical applications. Its acceptance for market clearance is primarily based on substantial equivalence to a predicate device (GE LOGIQ 5) and adherence to safety standards, rather than specific performance metrics from a dedicated clinical study.
Here's an analysis based on the provided documents:
Acceptance Criteria and Reported Device Performance
The core acceptance criterion for the GE LOGIQ 3 Diagnostic Ultrasound System is substantial equivalence to a previously cleared predicate device, the GE LOGIQ 5. This means the device must demonstrate comparable technological characteristics, intended uses, and safety/effectiveness profiles.
The provided documents do not specify quantitative performance metrics (e.g., sensitivity, specificity, accuracy) that would typically be found in a study proving the device meets numerical acceptance criteria. Instead, the "performance" accepted is its ability to function as a diagnostic ultrasound system for its stated indications, with safety and technological characteristics comparable to its predicate.
| Acceptance Criteria (Inferred) | Reported Device Performance | Study Type to Demonstrate Performance |
|---|---|---|
| Substantial Equivalence to Predicate Device (GE LOGIQ 5) in: | The device has the same technological characteristics, is similar in its operating modes and features, utilizes similar design, construction, and materials, and has the same intended uses and basic operating modes as the predicate device. | Comparison with Predicate Device (Section b), Clinical Tests: None required.) |
| Safety and Effectiveness for Stated Indications: Uses are consistent with traditional clinical practice, FDA guidelines, and established patient examination methods. | The device conforms to applicable medical device safety standards and compliance is verified through independent evaluation and ongoing factory surveillance. Diagnostic ultrasound has a long history of safe and effective use. | Non-clinical Tests (Section b), Historical Safety of Ultrasound (Section b)) |
| Conformance to Applicable Medical Device Safety Standards: Includes acoustic output, biocompatibility, cleaning/disinfection effectiveness, thermal, electrical, and mechanical safety. | The device has been evaluated and found to conform with applicable medical device safety standards. | Non-clinical Tests (Section b)) |
Study Information
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable. No dedicated clinical test set with patient data was used to establish performance metrics.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. As no clinical test set was used to establish performance, no ground truth experts were involved for that purpose. The indications for use were compared against established clinical practice and FDA guidelines, which are implicitly derived from expert consensus over time.
4. Adjudication method for the test set:
- Not applicable. No test set requiring expert adjudication 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. This device is a diagnostic ultrasound system itself, not an AI-assisted diagnostic tool. No MRMC study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware diagnostic device, not a standalone algorithm.
7. The type of ground truth used:
- For the purpose of clearance, the "ground truth" relied upon is the established safety and effectiveness of Diagnostic Ultrasound technology generally, and the specific performance characteristics of the predicate device (GE LOGIQ 5). This is a historical and regulatory "ground truth" based on prior clearances and medical consensus rather than new, primary clinical data for this specific device.
8. The sample size for the training set:
- Not applicable. As a diagnostic ultrasound system cleared via substantial equivalence, there is no mention of a "training set" in the context of an algorithm. The development of the device likely involved engineering design and testing, but not machine learning training on patient data.
9. How the ground truth for the training set was established:
- Not applicable. No training set as typically understood in the context of algorithm development was used.
§ 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.