(51 days)
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics; Abdominal (Including Renal & Gyn); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Cardiac (adult and pediatrics); Peripheral Vascular (PV); Musculo-skeletal Conventional; Urology (including prostate) and Transesophageal.
The Vivid S60/S70 is a Track 3 diagnostic ultrasound system, which is primarily intended for echocardiography imaging and analysis, with additional capability in vascular and general ultrasound imaging. The Vivid S60/S70 incorporates a variety of electronic array transducers that provide digital acquisition, processing and display capabilities, and operate in linear, curved linear, sector/ phased array format or matrix array format, including CW transducer and a real time 3D transducer. Vivid S60/S70 consists of a mobile console approximately 56 cm wide 77 cm deep and 120 cm high, and includes multiple electronic array transducers that provide digital acquisition, processing and display capabilities. The user interface includes a variable height rotatable, user control panel with specialized controls, a 19-inch wide screen LCD display and a separate 12.1-inch touch panel with a resolution of 1280x800 with multi-touch capabilities.
The provided text describes a 510(k) premarket notification for the GE Vivid S60/S70 Diagnostic Ultrasound System. This type of submission relies on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing de novo safety and effectiveness through extensive clinical trials. Therefore, the information typically requested regarding acceptance criteria and a study proving the device meets those criteria will not be present in the same way as for a novel device.
Here's an analysis based on the provided document, addressing the requested information where applicable:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) submission for substantial equivalence, the "acceptance criteria" are implicitly that the new device performs as safely and effectively as the predicate devices and shares similar technological characteristics and indications for use. There are no specific quantitative performance metrics provided as "acceptance criteria" in the sense of a novel device proving its effectiveness against a particular target. Instead, the performance is assessed by comparison to predicates.
The "reported device performance" is the statement of substantial equivalence to the predicate devices across various features and clinical applications.
| Feature/Criterion | Predicate Device Performance (Implicitly Met) | Proposed Device Performance (Reported) |
|---|---|---|
| Intended Use | Diagnosis of specific anatomical regions and clinical applications. | Same as predicate devices, with some minor differences (e.g., Transrectal, Transvaginal, Intraoperative not listed for the new system, but many are "new" indications on the general form, implying expansion from a single predicate). |
| Imaging Capabilities | B, M, Color M, Color/Power Doppler, Pulsed & CW Doppler, Combined modes, Harmonic, Coded Pulse, Realtime 3D, Multi-plane. | Same as predicate devices. |
| Technological Characteristics | Fundamental scientific technology, probe array types. | Same fundamental scientific technology and probe array types. |
| Safety and Effectiveness | Electrical safety, EMC, biocompatibility, acoustic output, cleaning and disinfection. | Conforms with applicable safety standards (AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, NEMA UD 3, ISO10993-1, NEMA UD 2, ISO14971, NEMA DICOM Set). |
| Track Level (FDA limits) | Track 3 | Track 3 (within FDA limits) |
Note: The tables in the document listing "N" for new indications, "P" for previously cleared, and "E" for added under appendix E show expansion of indications for different transducers compared to specific predicate clearances. The overall summary (Page 14) states the Vivid S60/S70 intended use is consistent with a range of applications, indicating a broad equivalence to multiple predicate devices.
2. Sample size used for the test set and the data provenance
No clinical test set was used for this 510(k) submission. The document explicitly states: "The subject of this premarket submission, Vivid S60/S70, did not require clinical studies to support substantial equivalence." (Page 17)
Data provenance for non-clinical tests would refer to the standards and engineering tests mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As no clinical studies were required, no ground truth was established by experts for a test set in this submission. The "ground truth" for a 510(k) is effectively the established performance and safety of the predicate devices.
4. Adjudication method for the test set
Not applicable. No clinical test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a hardware diagnostic ultrasound system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this 510(k) submission, the "ground truth" is the performance of the predicate devices, which have already been deemed safe and effective by the FDA. The submission demonstrates that the new device performs equivalently based on non-clinical engineering tests and comparison of technical specifications.
8. The sample size for the training set
Not applicable. This device is a standard diagnostic ultrasound system, not an AI/machine learning device that would require a training set.
9. How the ground truth for the training set was established
Not applicable. This device is a standard diagnostic ultrasound system, not an AI/machine learning device.
§ 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.