(52 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
The Voluson E-Series system is a full-featured Track 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 and electronic scanning transducers, which provide highly accurate realtime three dimensional imaging supporting all standard acquisition modes.
The GE Voluson E Series Diagnostic Ultrasound Systems did not require a clinical study to support substantial equivalence. The submission states: "The subject of this premarket submission. Voluson E Series, did not require clinical studies to support substantial equivalence." (Page 3).
Therefore, there are no specific acceptance criteria or a study proving the device meets them in the provided document, as no clinical studies were performed. The device's substantial equivalence refers to its similarity to predicate devices already on the market.
However, the submission does include several non-clinical tests and quality assurance measures applied to the development of the system to ensure its safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance:
Since no clinical studies were conducted, there are no reported device performance metrics from human or in-vitro tests against specific acceptance criteria for diagnostic accuracy, sensitivity, or specificity. The acceptance criteria essentially rely on conformance to established safety and performance standards for ultrasound equipment.
| Acceptance Criterion (Type) | Reported Device Performance |
|---|---|
| Acoustic output (Conformance to NEMA UD 3 & NEMA UD 2) | Conforms with applicable medical device safety standards. |
| Biocompatibility (Conformance to ISO 10993-1) | Conforms with applicable medical device safety standards. |
| Cleaning and disinfection effectiveness | Conforms with applicable medical device safety standards. |
| Thermal, electrical, electromagnetic, and mechanical safety (Conformance to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37) | Conforms with applicable medical device safety standards. |
| Risk Analysis (Quality Assurance Measure) | Applied to the development of the system. |
| Requirements Reviews (Quality Assurance Measure) | Applied to the development of the system. |
| Design Reviews (Quality Assurance Measure) | Applied to the development of the system. |
| Testing on unit level (Module verification) (QA Measure) | Applied to the development of the system. |
| Integration testing (System verification) (QA Measure) | Applied to the development of the system. |
| Final Acceptance Testing (Validation) (QA Measure) | Applied to the development of the system. |
| Performance testing (Verification) (QA Measure) | Applied to the development of the system. |
| Safety testing (Verification) (QA Measure) | Applied to the development of the system. |
| DICOM Set Conformance (Conformance to NEMA) | Complies with voluntary standards. |
| Transducer materials biocompatibility | Biocompatible. |
2. Sample size used for the test set and the data provenance: Not applicable, as no clinical test set was used.
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 test set was used.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as 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: Not applicable. The device is an ultrasound system, not an AI-assisted diagnostic tool in the sense of image interpretation assistance for humans. No MRMC study was mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. The Voluson E Series is a diagnostic ultrasound system whose operation inherently involves a human operator to acquire and interpret images. There's no "algorithm only" performance reported.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no clinical studies requiring ground truth were performed. The "ground truth" for the non-clinical tests would be the established specifications and regulatory standards that the device was tested against.
8. The sample size for the training set: Not applicable, as this is related to clinical studies or machine learning model development, neither of which are described in the context of this submission. The device is a traditional ultrasound system.
9. How the ground truth for the training set was established: Not applicable, as no training set for a clinical study or machine learning model is mentioned.
§ 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.