(37 days)
The device is intended for use by a qualified physician for ultrasound evaluation of 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; Transrectal; Transvaginal; Intraoperative (abdominal, thoracic, and vascular), Intra-cardiac and Intra-luminal.
The GE Vivid-i and Vivid-q is compact and portable diagnostic ultrasound system with integrated keyboard, fold-up LCD type display and interchangeable electronic-array transducers. It has an overall size approximately 36 cm wide, 31.5 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 GE Vivid-i and Vivid-q Diagnostic Ultrasound System is a compact and portable diagnostic ultrasound system.
Here's an analysis of the provided information, addressing your requested criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document is a 510(k) summary for a premarket notification, seeking substantial equivalence to a predicate device. It primarily focuses on demonstrating that the modified device (GE Vivid-i and Vivid-q BT10) is as safe and effective as the previously cleared version (GE Vivid-i and Vivid-q BT09) and other cleared GE Ultrasound systems, and also to clear new transducers for specific indications. As such, it does not present a table of specific acceptance criteria (e.g., performance metrics like sensitivity, specificity, accuracy) that were met by the device itself in a typical clinical study, nor does it report numerical device performance against such criteria.
Instead, the acceptance criteria are implicitly related to:
- Safety and Effectiveness: The device being "substantially equivalent" to predicate devices in terms of safety and effectiveness.
- Conformance to Standards: Adherence to applicable medical device safety standards.
- Intended Uses: The modified device performing its stated indications for use reliably.
The document asserts that these criteria have been met through non-clinical tests and a comparison with the predicate.
2. Sample Size Used for the Test Set and Data Provenance
No specific test set or clinical data (sample size, data provenance) is mentioned for evaluating the performance of the GE Vivid-i and Vivid-q BT10 system itself beyond the non-clinical tests. The submission states "Clinical Tests: None required."
For the new transducers (8C-RS, 4C-RS, SoundStar 3D 10F, AcuNav™ 8F), the document lists new indications for use that are "N = new indication (previously cleared by FDA...)" on other existing and cleared devices (GE LOGIQ Book K032477, Vivid 7 K051449, stand-alone devices K070242 by Biosense Webster, Inc., and K071234 by Siemens Medical Solutions). This implies that the safety and effectiveness for these indications with these transducers have been established in previous clearance processes and are being leveraged for this new comprehensive system. However, specific test set sizes or data provenance for these previous clearances are not detailed in this document.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable, as no dedicated clinical test set with ground truth establishment is described for this submission. The "Clinical Tests: None required" statement implies that existing knowledge and previous clearances were sufficient.
4. Adjudication Method for the Test Set
Not applicable, as no dedicated clinical test set with adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The submission relies on substantial equivalence and "Clinical Tests: None required."
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
The device is a diagnostic ultrasound system, not an algorithm-only device. Therefore, a standalone performance study in the context of an AI algorithm is not applicable. The device's performance is intrinsically linked to its use by a qualified physician.
7. Type of Ground Truth Used
Not explicitly stated for this particular submission, as "Clinical Tests: None required." For the previously cleared devices supporting the new indications for the transducers, ground truth would have been established through standard medical practices (e.g., expert clinical diagnosis, other imaging modalities, pathology, or surgical findings).
8. Sample Size for the Training Set
Not applicable. This document pertains to the clearance of a medical device (ultrasound system) and not the submission of an AI/ML algorithm that would typically involve a separate training set. The device's functionality is based on established ultrasound physics and signal processing, not a trained AI model in the modern sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of an AI/ML training set.
§ 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.