(30 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).
The Voluson E6/E8/E8Expert/E10 system is a full-featured 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.
This is a summary of the clinical evidence for the GE Voluson E6/E8/E8Expert/E10 Diagnostic Ultrasound System.
The provided document is a 510(k) Premarket Notification Submission for the GE Voluson E6/E8/E8Expert/E10 Diagnostic Ultrasound System. It states that clinical studies were not required to support substantial equivalence for this device. Therefore, it does not contain specific acceptance criteria, study data, or performance metrics in the way a clinical trial report would.
Instead, the document asserts substantial equivalence to a predicate device (K101236 Voluson E6/E8/E8Expert Diagnostic Ultrasound System and K101149 Vivid E9 Diagnostic Ultrasound System) based on:
- The device employing the same fundamental scientific technology.
- Evaluation for acoustic output, biocompatibility, cleaning and disinfection effectiveness, and thermal, electrical, electromagnetic, and mechanical safety, conforming with applicable medical device safety standards.
- Compliance with voluntary standards detailed in sections 9, 11, and 17 of the premarket submission (not provided in this excerpt).
- Quality assurance measures applied to development, including risk analysis, requirements reviews, design reviews, unit-level testing, integration testing, final acceptance testing (validation), performance testing (verification), and safety testing (verification).
The "acceptance criteria" for this type of submission are implicitly that the device demonstrates it is as safe and as effective as the predicate device(s) and performs its intended functions according to established standards. The tables provided list the various transducers and their cleared "modes of operation" for different clinical applications. The "P" in these tables denotes "previously cleared by FDA," indicating that these functionalities are already accepted based on the predicate device. "N" indicates new indications, and "E" indicates additions under Appendix E.
Given that no clinical study was conducted for this 510(k) submission, the following information cannot be extracted from the provided text:
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Table of Acceptance Criteria and Reported Device Performance: No specific performance metrics or acceptance criteria from a clinical study are provided, as no clinical study was performed. The "performance" is considered substantially equivalent to the predicate.
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Sample Size for Test Set and Data Provenance: Not applicable, as no clinical test set was used.
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Number of Experts and Qualifications for Ground Truth: Not applicable, as no ground truth from human experts for a test set was established in a clinical study context.
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Adjudication Method: Not applicable.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No MRMC study was done, as stated that clinical studies were not required.
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Standalone (Algorithm Only) Performance Study: Not applicable, as this is an ultrasound system, not an AI algorithm.
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Type of Ground Truth Used: Not applicable. The basis for clearance relies on substantial equivalence to existing devices and verification of technical and safety standards.
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Sample Size for Training Set: Not applicable, as this device does not appear to be an AI/ML algorithm that would require a training set.
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How Ground Truth for 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.