(14 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal / Obstetrics, Abdominal (including Renal and GYN/Pelvic), Pediatric, Small Organ (including breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (adult and pediatric), Peripheral Vascular, Musculo-skeletal Conventional, Other (including Urology/Prostate), Transesophageal, Transrectal, Transvaginal, and Intraoperative (abdominal, thoracic, & vascular).
The GE Vivid 7 Diagnostic Ultrasound is a full featured echocardiography imaging and analysis system. It consists of a mobile cart or a large console with Service, 96 cm deep and 139 cm deep and 139 cm and analysis system. The user interface includes and high that provides digital acquisition, processing and display. This modification will provide users with for improved performance and productivity.
The provided document is a 510(k) Premarket Notification for the GE Vivid 7 Diagnostic Ultrasound System with EchoPAC BT05. This submission focuses on comparing the new device to a predicate device and demonstrating substantial equivalence, rather than establishing new performance criteria or efficacy beyond what is already accepted for diagnostic ultrasound systems.
Thus, the document explicitly states: "Clinical Tests: None required." This means no specific acceptance criteria or dedicated study proving the device meets those criteria were conducted beyond non-clinical tests. The submission relies on the existing substantial equivalence to predicate devices and established safety standards for diagnostic ultrasound.
Therefore, many of the requested details about acceptance criteria and clinical study design cannot be extracted from this document, as such a study was not deemed necessary for this type of submission.
Here's a breakdown of what can be inferred or explicitly stated based on the provided text, and where information is not available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Effectiveness | The device's "key safety and effectiveness information" is comparable and substantially equivalent to the currently marketed GE Vivid 7, which is already in commercial distribution and deemed safe and effective. |
| Predicate Device Equivalence | The GE Vivid 7 BT05 is described as "of a comparable type and substantially equivalent to the current GE Vivid 7." It has the "same basic intended use and overali characteristics, key safety and effectiveness information and operating modes as the predicate device." This includes enhanced measurement capability, upgraded beamformer, and improved patient exam reporting. |
| Compliance with Non-Clinical Standards | "The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, electromagnetic compatibility, as well as thermal, electrical and mechanical safety standards." The manufacturer conforms with 21 CFR 820, ISO 9001:2000 and ISO 13485 quality systems. |
| Intended Uses consistency with traditional clinical practice | The "Intended uses and other key features are consistent with traditional clinical practice, FDA guidance documents and development process of the development process of the device manufacturer..." |
| Specific Performance Metrics | Not applicable/Not provided. This is a 510(k) for an incremental update (BT05) to an existing device (GE Vivid 7), demonstrating equivalence, not establishing new performance benchmarks. |
2. Sample sized used for the test set and the data provenance
- Sample Size: Not applicable. No clinical test set was used, as clinical tests were "None required."
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No clinical test set was used.
4. Adjudication method for the test set
- Not applicable. No clinical test set was used.
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
- No MRMC comparative effectiveness study was done. The document states "Clinical Tests: None required."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is a diagnostic ultrasound system, not an AI-only algorithm. No standalone performance study was conducted or required.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. No specific ground truth was established for "clinical tests" as they were not required. The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate GE Vivid 7 device.
8. The sample size for the training set
- Not applicable. This is not a submission for an AI/ML algorithm that would undergo a training phase.
9. How the ground truth for the training set was established
- Not applicable.
§ 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.