(173 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional; Urology (including prostate), Transesophageal; Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).
The GE Vivid E9 Diagnostic Ultrasound is a full-featured echocardiography imaging and analysis system with additional capability in vascular and general ultrasound imaging. It consists of a mobile console with multiple electronic array transducers that provide digital acquisition, processing and display capability. The user interface includes a floating and variable height user control panel with specialized controls, high-resolution LCD display and separate LCD touch panel. This modification offers improved performance and productivity for users.
The provided document is a 510(k) Premarket Notification for the GE Vivid E9 BT10 Ultrasound System. It is a submission to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. As such, it does not detail specific acceptance criteria or performance studies in the way a clinical trial report for an AI device might. Instead, it relies on established safety and effectiveness for diagnostic ultrasound systems and the equivalence to predicate devices.
Therefore, the requested information elements related to specific performance metrics, sample sizes for test sets, expert adjudication, MRMC studies, standalone performance studies, ground truth establishment for training and test sets, and effect sizes of AI assistance are generally not applicable or not provided in this type of regulatory document for an ultrasound system.
However, I can extract the relevant information regarding safety and equivalence.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
This document does not provide a table of explicit performance-based acceptance criteria for a new AI feature or image analysis algorithm, nor does it present detailed quantitative performance metrics for the device. The "acceptance criteria" in this context are related to demonstrating substantial equivalence to a predicate device and adherence to general safety standards.
The reported device performance is primarily framed as improved performance and productivity compared to the predicate device, especially regarding new transducers and software features comparable to other cleared GE ultrasound systems.
Key statements on performance:
- "This modification offers improved performance and productivity for users." (Section a): Device Description)
- "The GE Vivid E9 BT10 is of a comparable type and substantially equivalent to the current GE Vivid E9 with enhanced performance and added transducers..." (Section a): Comparison with Predicate Device)
2. Sample Size Used for the Test Set and Data Provenance:
- Not applicable / Not provided. This 510(k) submission does not describe a clinical test set or data provenance for evaluating a new algorithm's performance. The review focuses on the device as a whole and its equivalence to predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable / Not provided. Ground truth establishment for a specific AI algorithm's performance is not part of this type of submission for a general diagnostic ultrasound system.
4. Adjudication Method for the Test Set:
- Not applicable / Not provided.
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:
- Not applicable / Not provided. This document does not describe an MRMC study or AI assistance. The device is a diagnostic ultrasound system, not an AI-powered image analysis tool in the sense of comparing human readers with and without AI.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- Not applicable / Not provided. This relates to an AI algorithm's performance, which is not the focus of this submission.
7. The Type of Ground Truth Used:
- Not applicable / Not provided.
8. The Sample Size for the Training Set:
- Not applicable / Not provided.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable / Not provided.
Summary of the Study that Proves the Device Meets "Acceptance Criteria" (Substantial Equivalence):
The "study" demonstrating the device meets its "acceptance criteria" (which, in this context, means showing substantial equivalence for regulatory clearance) is summarized in Section b: Non-clinical Tests and Clinical Tests.
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Non-clinical Tests:
- The device was evaluated for:
- Acoustic output
- Biocompatibility
- Cleaning and disinfection effectiveness
- Electromagnetic compatibility
- Thermal, electrical, and mechanical safety
- It was found to conform with applicable and harmonized medical device safety standards.
- The device was evaluated for:
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Clinical Tests:
- "None required." This indicates that for this type of device modification and the established predicate, new clinical trials to demonstrate safety and effectiveness were not deemed necessary by the manufacturer or the FDA (as per the clearance letter). The long history of safe and effective performance of diagnostic ultrasound, combined with the substantial equivalence argument, negated the need for new clinical data.
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Conclusion:
- The manufacturer stated that intended uses and other key features are consistent with traditional clinical practice, FDA guidelines, and established methods of patient examination.
- The design and development process conforms with 21 CFR 820, ISO 9001:2008, and ISO13485:2003 quality systems.
- Compliance with applicable medical device safety standards is verified through 3rd party product certifications and regular production monitoring.
- GE Healthcare's opinion is that the device is substantially equivalent in safety and effectiveness to devices already cleared for market.
The FDA's decision letter (starting on page 3 of the document) confirms that they reviewed the 510(k) premarket notification and determined the device is substantially equivalent to legally marketed predicate devices, subject to general controls. This means the FDA agreed with GE Healthcare's assessment that the non-clinical tests and the comparison to predicate devices were sufficient to support clearance without a new clinical study.
§ 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.