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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; Vascular; Transvaginal; Transrectal: and Peripheral Intraoperative (abdominal, PV and neurological).

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application: Fetal / Obstetrics, Abdominal, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac, Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Transrectal, Transvaginal, Intraoperative, Intraoperative Neurological.
Mode of Operation: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse, Other [Notes].

The Voluson E6/E8/E8Expert/E10 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 and electronic scanning transducers, which provide highly accurate realtime three dimensional imaging supporting all standard acquisition modes.

The provided 510(k) Premarket Notification Submission for the GE Voluson E6/E8/E8Expert/E10 Diagnostic Ultrasound System states that clinical studies were not required to support substantial equivalence (page 2).

Therefore, there is no information in this document regarding acceptance criteria, reported device performance from a clinical study, sample sizes, data provenance, number of experts for ground truth, adjudication methods, MRMC comparative effectiveness studies, standalone performance studies, training set size, or how ground truth for the training set was established.

The substantial equivalence determination was based on non-clinical tests (acoustic output, biocompatibility, cleaning and disinfection effectiveness, thermal, electrical, electromagnetic, and mechanical safety) and compliance with applicable medical device safety standards (page 1). The device was found to conform with the following voluntary standards:

• IEC60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety
• IEC60601-1-2, Medical Electrical Equipment -Part 1-2:General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests
• IEC60601-2-37, Medical Electrical Equipment -Part 2-37:Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment
• NEMA UD 3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
• ISO10993-1, Biological Evaluation of Medical Devices- Part 1: Evaluation and Testing- Third Edition
• NEMA UD 2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
• ISO14971, Application of risk management to medical devices
• NEMA, Digital Imaging and Communications in Medicine (DICOM) Set (Radiology)

Additionally, the development process included quality assurance measures such as Risk Analysis, Requirements Reviews, Design Reviews, Testing on unit level (Module verification), Integration testing (System verification), Final Acceptance Testing (Validation), Performance testing (Verification), and Safety testing (Verification). Transducer materials and other patient contact materials were also evaluated for biocompatibility.

The acceptance criteria for the device are therefore implicit to its compliance with these non-clinical standards and internal quality assurance measures, as no separate clinical performance metrics are provided.

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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); Musculoskeletal Conventional and Superficial; Peripheral Vascular; Transvaginal; Transrectal; and Intraoperative (abdominal, PV and neurological).

The Voluson E6/E8/E8Expert/E10 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 and electronic scanning transducers, which provide highly accurate realtime three dimensional imaging supporting all standard acquisition modes.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the GE Voluson E6/E8/E8Expert/E10 Diagnostic Ultrasound System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific quantitative acceptance criteria (e.g., minimum sensitivity, fidelity, or error rates) for the ultrasound system's performance. Instead, the "acceptance criteria" are implied by the process of demonstrating substantial equivalence to a predicate device (K112213 Voluson E6/E8/E8Expert/E10 Diagnostic Ultrasound System).

The summary states: "GE Healthcare considers the Voluson E6/E8/E8 Expert/E10 to be as safe, as effective, and performance is substantially equivalent to the predicate device(s)."

Therefore, the "acceptance criteria" are implicitly that the new device performs within the same safety and effectiveness parameters as the predicate device across all its intended uses and modalities.

2. Sample Size Used for the Test Set and Data Provenance

The summary explicitly states: "The subject of this premarket submission, Voluson E6/E8/E8/ Expert/E10, did not require clinical studies to support substantial equivalence."

Therefore, there is no specific test set or clinical data provenance mentioned in this submission for proving the device's performance in a clinical setting. The evaluation relies on non-clinical tests and comparison to the predicate device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Since no clinical studies were performed or reported in this submission to establish a "ground truth" for a test set, this information is not applicable and therefore not provided.

4. Adjudication Method for the Test Set

As no clinical test set was used to assess new performance, an adjudication method for a test set is not applicable and therefore not provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done, as clinical studies were not required for this submission. The submission is focused on demonstrating substantial equivalence to a previously cleared device through non-clinical testing and technological similarity.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

Since this is an ultrasound imaging system and not a standalone AI algorithm designed for interpretation, the concept of "standalone performance" in the context of an algorithm's diagnostic output is not directly applicable in the way it might be for a CAD system. The device's performance is inherently tied to its imaging capabilities, which are assessed through non-clinical means (acoustic output, safety, electrical, mechanical, etc.) to ensure it performs comparably to the predicate. No separate "standalone" algorithm performance study is mentioned.

7. Type of Ground Truth Used

Given that clinical studies were not required, there is no explicit ground truth (e.g., pathology, outcomes data, expert consensus on clinical cases) used to establish the device's diagnostic accuracy in this submission. The "ground truth" for demonstrating substantial equivalence rests on:

• Conformity to safety and performance standards.
• The fact that it employs the same fundamental scientific technology as the predicate device, K112213. This implies that if the predicate was deemed safe and effective, and the new device uses the same technology and passes the non-clinical checks, it too is safe and effective.

8. Sample Size for the Training Set

This device is an ultrasound imaging system, not an AI/ML algorithm that requires a "training set" in the conventional sense of machine learning. Therefore, a training set sample size is not applicable to this submission.

9. How the Ground Truth for the Training Set Was Established

As this is not an AI/ML algorithm requiring a training set, the establishment of ground truth for a training set is not applicable.

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