(31 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).
The GE LOGIQ Twin is a compact and portable diagnostic utrasound system with integrated keyboard, fold-up LCD type display and interchangeable electronic-array transducers. It has an overall size approximately 34 cm wide, 29 cm deep and 6 cm high in transport configuration and provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, an intuitive layout of specialized controls, color GUI display and Doppler audio.
The provided text is a 510(k) premarket notification for the GE Vivid-i Diagnostic Ultrasound System. This type of regulatory submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, meaning it is as safe and effective. It does not typically require extensive clinical studies with specific acceptance criteria in the same way a Premarket Approval (PMA) application would for a novel device.
Based on the provided document, the following can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present a table of quantitative acceptance criteria for device performance or corresponding reported performance metrics. The submission focuses on demonstrating substantial equivalence to a predicate device (GE Vivid-i Ultrasound System, K033139) by highlighting comparable design, construction, materials, safety, effectiveness features, and intended uses.
The "device performance" in this context refers to the device's ability to function safely and effectively for its intended uses, which are the same as the predicate device. The performance is implied to be equivalent to the predicate.
2. Sample Size Used for the Test Set and Data Provenance
No specific test set or associated sample size is mentioned for clinical performance evaluation. The document states: "2. Clinical Tests: None required." This indicates that no new clinical study was conducted to demonstrate performance in a test set. This is typical for a 510(k) submission where substantial equivalence to an already approved device is being leveraged.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
As no clinical tests were required or performed, there is no mention of experts establishing a ground truth for a test set.
4. Adjudication Method for the Test Set
Since no clinical tests were required or performed, there is no adjudication method mentioned for a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
No such study was performed or mentioned in this document. The device is a diagnostic ultrasound system and not an AI-assisted diagnostic tool in the sense of providing automated readings or interpretations.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable to the device described. The GE Vivid-i is a diagnostic ultrasound system that produces images and data for interpretation by a qualified physician (human-in-the-loop). It is not an algorithm designed for standalone diagnostic performance.
7. The Type of Ground Truth Used
No explicit ground truth is mentioned in the context of a new clinical study for this 510(k) submission. The basis for safety and effectiveness relies on the substantial equivalence to the predicate device, which would have been established through traditional clinical practice and established methods of patient examination.
The indications for use (e.g., Fetal, Abdominal, Cardiac, etc.) are listed as "P = previously cleared by FDA" for the overall system and "E = added under Appendix E" for certain transducers, meaning their performance for those indications was previously evaluated and deemed acceptable.
8. The Sample Size for the Training Set
No training set is mentioned as this is not an AI/machine learning device that requires a training set in the typical sense for performance evaluation.
9. How the Ground Truth for the Training Set was Established
Not applicable, as no training set is mentioned.
Summary of the Study (or lack thereof) Proving the Device Meets Acceptance Criteria:
The document states that "Clinical Tests: None required." and "Diagnostic ultrasound has accumulated a long history of safe and effective performance."
Instead of a new study with specific acceptance criteria, GE Healthcare demonstrated that the modified GE Vivid-i ultrasound system is substantially equivalent to a currently marketed predicate device (GE Vivid-i Ultrasound System, K033139). This equivalence is based on:
- Comparable Design, Construction, and Materials: The new device shares these fundamental aspects with the predicate.
- Comparable Key Safety and Effectiveness Features: Implies that the new device performs at a similar level regarding safety and clinical effectiveness as the predicate.
- Same Intended Uses: The device is intended for the same clinical applications as the predicate.
- Additional Software Features: These features are stated to be identical to those of other cleared GE Ultrasound systems, suggesting prior regulatory review and approval.
- Non-Clinical Tests: The device underwent evaluations for acoustic output, biocompatibility, cleaning and disinfection effectiveness, and thermal, electrical, and mechanical safety, conforming to applicable medical device safety standards.
- Quality Systems: The manufacturer's design and development process conforms to 21 CFR 820, ISO 9001, and ISO 13485 quality systems.
The FDA's decision to clear the device (K061525) is based on the determination of substantial equivalence to the predicate device, which implies that the device meets "acceptance criteria" effectively inherited from the predicate's established safety and effectiveness.
§ 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.