(66 days)
The device is intended for use by a qualified physician for ultrasound evaluation of Cardiac (adult and pediatric), Peripheral Vascular. Fetal/Obstetrics. Abdominal (including GYN), Pediatric, Small Organ (including breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Intra operative (abdominal, thoracic and peripheral), Musculo-skeletal Conventional, Urology (including prostate). Transrectal and Transvaginal.
The VividTM P3 is a high performance, mobile Color Doppler Ultrasound Imaging system. This system is designed for cardiovascular applications and including abdominal neonatal/pediatrics & intra-operative. It is integrated with keyboard control panel, LCD type video display and interchangeable electronic-array transducers.
The provided text is a 510(k) Premarket Notification Submission for the GE VIVID P3 ultrasound system. It outlines the device's technical specifications and intended uses, primarily to demonstrate substantial equivalence to previously cleared predicate devices.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance metrics for the VIVID P3. Instead, it focuses on demonstrating that the VIVID P3 is substantially equivalent to its predicate devices by sharing the same fundamental scientific technology and conforming to applicable medical device safety standards. The "performance" reported is primarily the list of clinical applications and operating modes for which the device and its various transducers ("4C", "E8Cs", "8L", "8C", "5Cs", "3S", "11L", "T739", "6S") are intended and "previously cleared by FDA".
The device performance is implied through compliance with and application of:
- Acoustic output evaluation (Summary of Non-Clinical Tests)
- Biocompatibility evaluation (Summary of Non-Clinical Tests)
- Cleaning and disinfection effectiveness evaluation (Summary of Non-Clinical Tests)
- Thermal, electrical, electromagnetic, and mechanical safety standards (Summary of Non-Clinical Tests)
- Voluntary standards as detailed in Sections 9, 11, 15, and 17 of the premarket submission (Summary of Non-Clinical Tests) - These specific standards are not detailed in the provided excerpt.
- Application of quality assurance measures: Risk Management, Requirement Reviews, Design reviews, Unit level testing (Module Verification), Integration Testing (System level verification), Final acceptance testing (Validation), Performance testing (Verification), and Safety testing (Verification).
2. Sample Sizes Used for the Test Set and Data Provenance:
The document explicitly states: "The subject of this premarket submission, VIVID P3, did not require clinical studies to support substantial equivalence."
Therefore, there is no test set or associated sample size for clinical performance evaluation mentioned. The provenance of any data used for non-clinical tests (acoustic output, biocompatibility, etc.) is not specified, nor is whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
Since no clinical studies were required or performed to establish substantial equivalence based on clinical performance, there is no mention of experts establishing ground truth for a test set in clinical scenarios.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical studies with a test set requiring expert adjudication are mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not conducted or mentioned. The submission states that clinical studies were not required to support substantial equivalence. Therefore, there is no effect size reported for human readers improving with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. The VIVID P3 is an ultrasound imaging system with various transducers, not a standalone algorithm. Its performance is demonstrated through its hardware and software capabilities as a whole system, benchmarked against predicate devices in terms of safety and technical specifications, not typically through standalone algorithmic metrics.
7. Type of Ground Truth Used:
For the purpose of this 510(k) submission, the "ground truth" for the device's acceptability is its substantial equivalence to existing, legally marketed predicate devices (GE Logiq e/i & Vivid e - K072797, GE Logiq P5/A5 K060993, GE Logiq P6 K073297, GE Vivid S5/S6 K092079) and its conformity to recognized medical device safety standards. This is established through non-clinical testing and internal quality assurance measures rather than clinical outcome data or pathology. The "ground truth" for its intended uses is that these uses were "previously cleared by FDA" for the predicate devices or previous iterations of GE's ultrasound systems.
8. Sample Size for the Training Set:
Not applicable. This document describes a medical device submission based on substantial equivalence, not an AI or machine learning model that would typically involve training sets for performance evaluation.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set mentioned in this context.
§ 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.