(281 days)
The device is a general purpose ultrasound system. Specific clinical applications remain the same as previously cleared: Fetal/OB; Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Musculo-skeletal Conventional and Superficial; Peripheral Vascular: Transvaginal; Transrectal; and Intraoperative (abdominal, PV and neurological).
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Anatomy/Region of Interest: Fetal / Obstetrics, Abdominal, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac, Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Transrectal, Transvaginal, Intraoperative, Intraoperative Neurological.
The Voluson E6/E8/E8Expert BT10 system is a full-featured Track 3 ultrasound system, primarily for general radiology use and specialized for OB/GYN with particular features for realtime 3D/4D acquisition. It consists of a mobile console with keyboard control panel; color LCD/TFT touch panel, color video display and optional image storage and printing devices. It provides high performance ultrasound imaging and analysis and has comprehensive networking and DICOM capability. It utilizes a variety of linear, curved linear, matrix phased array transducers including mechanical scanning transducers, which provide highly accurate realtime three dimensional imaging supporting all standard acquisition modes.
The provided 510(k) summary for the GE Healthcare Voluson E6/E8/E8 Expert Diagnostic Ultrasound System (K101236) indicates that no clinical studies were required to support substantial equivalence (page 3). Therefore, there is no specific study data or acceptance criteria related to device performance in a clinical setting provided in this document.
The document focuses on the device being substantially equivalent to a predicate device (K061682 Voluson E8 Diagnostic Ultrasound System) and outlines non-clinical tests to ensure safety and performance based on applicable medical device safety standards.
Here's a breakdown of the requested information based on the provided text, heavily inferring where no direct information is given due to the lack of clinical studies:
1. A table of acceptance criteria and the reported device performance
Since no clinical studies were performed, there are no specific performance metrics (like sensitivity, specificity, accuracy) provided in a table for clinical acceptance criteria. The acceptance criteria implied for this submission are related to safety and equivalent performance to the predicate device.
| Acceptance Criteria Category | Reported Device Performance (Summary of Non-Clinical Tests) |
|---|---|
| Acoustic Output Safety | Device evaluated and conforms to applicable medical device safety standards. |
| Biocompatibility | Transducer materials and other patient contact materials are biocompatible. |
| Cleaning and Disinfection Effectiveness | Device evaluated and conforms to applicable medical device safety standards. |
| Thermal Safety | Device evaluated and conforms to applicable medical device safety standards. |
| Electrical Safety | Device evaluated and conforms to applicable medical device safety standards. |
| Electromagnetic Safety | Device evaluated and conforms to applicable medical device safety standards. |
| Mechanical Safety | Device evaluated and conforms to applicable medical device safety standards. |
| Compliance with Voluntary Standards | Complies with voluntary standards as detailed in Sections 9, 11, and 17 of the submission. |
| Quality Assurance Measures | Risk Analysis, Requirements Reviews, Design Reviews, Unit-level Testing (Module verification), Integration testing (System verification), Final Acceptance Testing (Validation), Performance testing (Verification), Safety testing (Verification) were applied. |
| Substantial Equivalence | Considered "as safe, as effective, and performance is substantially equivalent to the predicate device(s)." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable, as no clinical studies were conducted for this 510(k) submission. Non-clinical tests were performed on the device itself.
- Data Provenance: Not applicable for clinical studies. For non-clinical tests, the provenance would be internal GE Healthcare testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts & Qualifications: Not applicable, as no clinical studies requiring expert ground truth were conducted for this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable, as no clinical studies were conducted for this 510(k) submission.
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
- MRMC Study: No, a multi-reader multi-case comparative effectiveness study was not performed. The device is a general-purpose diagnostic ultrasound system and not an AI-assisted diagnostic tool as described in these types of studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: Not applicable in the context of an AI algorithm, as this device is a general-purpose ultrasound system. The non-clinical tests evaluate the system's inherent performance and safety.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not applicable for clinical ground truth. For the non-clinical tests, the "ground truth" would be established by engineering specifications, regulatory standards, and validated testing protocols.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable, as this device is a diagnostic ultrasound system, not an AI or machine learning model that undergoes a training phase with a specific dataset.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable, as this device is a diagnostic ultrasound system, not an AI or machine learning model that undergoes a training phase with a specific dataset.
In summary, the K101236 submission is for a general-purpose ultrasound system (Voluson E6/E8/E8 Expert) and relies on demonstrating substantial equivalence to a previously cleared predicate device (K061682 Voluson E8). This type of submission typically focuses on non-clinical performance and safety data, rather than new clinical studies with AI-specific 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.