(30 days)
Diagnostic ultrasound imaging or motion analysis of the human body as follows: Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal & Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vasculo-skeletal (conventional & superficial); Intraoperative including neurological, Transrectal; and Transvaginal.
The GE LOGIQ A3 is a small, general purpose diagnostic ultrasound system. It consists of a mobile console approximately 42 cm wide, 59 cm deep and 125 cm high that provides digital acquisition, processing and display capability. The user interface consists of a computer keyboard, specialized controls and color video LCD display. The modification provides for a more compact, lighter weight and easily maneuverable system with updated and efficient electronic hardware.
The provided document is a 510(k) premarket notification for the GE LOGIQ A3 Diagnostic Ultrasound System. It describes the device, its intended use, and its substantial equivalence to previously cleared predicate devices.
1. Acceptance Criteria and Reported Device Performance:
The document does not specify quantitative acceptance criteria or a dedicated performance study with numerical results for the GE LOGIQ A3. Instead, it relies on the concept of substantial equivalence to predicate devices (GE LOGIQ 3 and LOGIQ 200MD) and compliance with general safety and medical device standards.
The acceptance criteria are implicitly met by demonstrating that the GE LOGIQ A3:
- Has the same intended uses as the predicate devices.
- Shares comparable technological characteristics.
- Is comparable in key safety and effectiveness features.
- Utilizes similar design, construction, and materials.
- Conforms with applicable medical device safety standards through non-clinical tests (acoustic output, biocompatibility, cleaning/disinfection, thermal, electrical, and mechanical safety).
- Conforms to 21 CFR 820, ISO 9001, and 13485 quality systems.
No specific performance metrics (e.g., sensitivity, specificity, accuracy) are reported for the device as part of newly established acceptance criteria. The "performance" is considered equivalent to that of the predicate devices due to the lack of significant technological changes that would raise new questions of safety or effectiveness.
2. Sample Size Used for the Test Set and Data Provenance:
No clinical test set was used for the GE LOGIQ A3 in this submission. The document explicitly states: "Clinical Tests: None required." This is typical for submissions asserting substantial equivalence to predicate devices where there are no new indications or significant technological changes that would necessitate new clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Since no clinical test set was used, there were no experts establishing ground truth for such a set within the scope of this submission. The determination of device safety and effectiveness relies on the established safety and effectiveness of the predicate ultrasound systems and compliance with recognized standards.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical test set was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was done. The submission for the GE LOGIQ A3 is based on substantial equivalence, not a comparative clinical trial to demonstrate improved human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study:
Not applicable. The GE LOGIQ A3 is a diagnostic ultrasound system intended for direct use by a qualified physician, not an AI algorithm operating in a standalone capacity. No standalone algorithm performance was assessed or reported.
7. Type of Ground Truth Used:
No new ground truth from pathology, outcomes data, or expert consensus was generated specifically for the GE LOGIQ A3 as part of this submission. The ground truth for the device's acceptable safety and effectiveness is implicitly derived from:
- The known safe and effective performance of previously cleared diagnostic ultrasound devices (predicates).
- Compliance with recognized industry standards for acoustic output, biocompatibility, electrical safety, etc.
- General acceptance of diagnostic ultrasound as a safe and effective imaging modality.
8. Sample Size for the Training Set:
Not applicable, as this submission pertains to a diagnostic ultrasound system and not an AI/ML algorithm that requires a training set.
9. How Ground Truth for the Training Set Was Established:
Not applicable, as no training set 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.