(24 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Specific clinical uses include cardiac (adult & pediatric); peripheral vascular; transesophageal; abdominal including GYN and urology; fetal; pediatric; small organ including breast, testes, thyroid; adult and neonatal cephalic; intraoperative (abdominal, thoracic, and vascular); musculo-skeletal (conventional and superficial); transvaginal and transrectal.
The GE Vivid 3 Pro and Expert are minor variations of the Vivid 3 suited for slightly different market segments. The Expert version provides more features as standard equipment while the Pro version, having fewer base options, allows features to be added if desired. Both systems consists of a mobile console with digital beam former and assorted electronic array transducers. Their user interface consists of a keyboard control panel and color video display monitor. They are network accessible and have integrated on-board image storage and hard-copy devices.
The provided FDA 510(k) summary for the GE Vivid 3 Expert/Pro Diagnostic Ultrasound System does not contain typical acceptance criteria or a study demonstrating device performance in the way a clinical trial or algorithm validation study would.
This document is a premarket notification submission (510(k)) for substantial equivalence, not a detailed performance study report. The key assertion is that the new device (GE Vivid 3 Expert/Pro) is substantially equivalent to a previously cleared predicate device (GE Vivid 3 system, K000695). Therefore, the "acceptance criteria" and "device performance" are primarily focused on matching the predicate device's characteristics and adhering to safety standards.
Here's an analysis based on the provided text, addressing your points as much as possible:
1. Table of Acceptance Criteria and Reported Device Performance
As mentioned, there isn't a direct "acceptance criteria vs. reported performance" table in the sense of accuracy, sensitivity, or specificity for diagnostic tasks. Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to the predicate device and compliance with applicable safety standards.
| Acceptance Criteria Category | Description/Standard Met | Reported Device Performance |
|---|---|---|
| Technological Characteristics | "Same technological characteristics" as predicate device. | The GE Vivid 3 Expert/Pro systems have a mobile console with digital beam former and assorted electronic array transducers, a keyboard control panel, and a color video display monitor. They are network accessible and have integrated on-board image storage and hard-copy devices, consistent with the predicate. |
| Safety and Effectiveness Features | "Compare in key safety and effectiveness features" to predicate. | Demonstrated to be safe and effective due to substantial equivalence and adherence to safety standards. |
| Design, Construction, Materials | "Use same design, construction, and materials" as predicate. | Confirmed to be the same as the predicate device. |
| Intended Uses and Clinical Applications | "Similar intended uses, clinical applications" as predicate. | General purpose ultrasound systems specialized for cardiac imaging, with a broad range of specific clinical uses matching those of the predicate device (Cardiac, Peripheral Vascular, Abdominal, Fetal, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Intraoperative, Musculo-skeletal, Transesophageal, Transvaginal, Transrectal, Urology). Many new indications (N) are added for specific transducers, but these are for the same overarching clinical applications. |
| Operating Modes | "Similar operating modes" as predicate. | Supports B, M, PW Doppler, CW Doppler (for some transducers), Color Doppler, Color M Doppler, Power Doppler, Combined Modes (B/M, B/PWD, B/Color/PWD, B/Amplitude/PWD), and Harmonic Imaging. Some transducers also support Coded Pulse. |
| Acoustic Output | Conformity with applicable medical device safety standards for acoustic output. | Evaluated, found to conform. (Note: A post-clearance special report for production units was requested to ensure continued compliance.) |
| Biocompatibility | Conformity with applicable medical device safety standards for biocompatibility. | Evaluated, found to conform. |
| Thermal, Electrical, Mechanical Safety | Conformity with applicable medical device safety standards. | Evaluated, found to conform. |
| Quality System Regulation | Compliance with 21 CFR 820 Quality System Regulation. | Manufacturer's design and development process conforms to 21 CFR 820, ISO 9001, & EN 46001. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable (N/A). This submission explicitly states "Clinical Tests: None required." The substantial equivalence determination relies on comparisons to the predicate device and adherence to recognized safety standards, not on a new clinical test set for performance evaluation in the usual sense (e.g., diagnostic accuracy).
- Data Provenance: N/A for clinical performance data. The data provenance discussed is related to non-clinical tests (acoustic output, biocompatibility, safety) which would be lab-based testing conducted by the manufacturer (GE Medical Systems).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- N/A. No clinical test set requiring ground truth established by experts was performed or reported in this 510(k) summary.
4. Adjudication Method for the Test Set
- N/A. No clinical test set requiring adjudication was performed or reported.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No. This type of study would compare human readers with and without AI assistance to measure a change in diagnostic effectiveness. This 510(k) does not involve AI, nor does it present an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- N/A. This device is a diagnostic ultrasound system, a medical imaging hardware and software system, not an AI algorithm intended for standalone interpretation. Performance evaluation here refers to the system's ability to produce images and perform measurements, and its safety, in comparison to an existing device.
7. The Type of Ground Truth Used
- N/A for clinical performance in a diagnostic sense. For the non-clinical tests (acoustic output, safety, etc.), the "ground truth" would be established by physical measurements against established industry standards and regulatory limits.
8. The Sample Size for the Training Set
- N/A. This submission is for an ultrasound system, not an AI/ML algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
- N/A. As there is no AI/ML algorithm involved requiring a training set, the concept of establishing ground truth for a training set does not apply here.
In summary: This 510(k) submission for the GE Vivid 3 Expert/Pro Diagnostic Ultrasound System is a demonstration of substantial equivalence to a predicate device, focusing on similar technological characteristics, intended uses, safety, and compliance with general device regulations and standards. It is not an AI/ML device, and therefore does not include detailed clinical performance studies in the way you might expect for an algorithm seeking FDA clearance, nor does it involve test sets, training sets, or expert ground truthing for AI performance metrics.
§ 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.