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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; Peripheral Vascular; Transvaginal (including GYN); Transrectal

The systems are full-featured Track 3 ultrasound systems, primarily for general radiology use and specialized for OB/GYN with particular features for realtime 3D/4D acquisition. They consist of a mobile console with keyboard control panel; color LCD/TFT touch panel, color video display and optional image storage and printing devices. They provide high performance ultrasound imaging and analysis and have comprehensive networking and DICOM capability. They utilize 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 document describes the GE Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound Systems, which are general purpose ultrasound systems with specific applications primarily for OB/GYN. The submission is a 510(k) premarket notification, indicating that the device aims to demonstrate substantial equivalence to legally marketed predicate devices.

The information provided does not include details of specific clinical studies with acceptance criteria or performance metrics for new or altered indications. Instead, it focuses on demonstrating that the new Voluson E Series systems are substantially equivalent to their predicate devices based on technological characteristics, safety, and existing cleared indications for use.

Here's the breakdown of the information requested, based on the provided document:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria or reported device performance in terms of clinical accuracy or diagnostic performance for the new system. The basis for clearance is "substantial equivalence" to predicate devices, meaning the device performs as intended and is as safe and effective as a legally marketed device. The performance is implied to be equivalent to the predicate devices. The document states:

• "The Voluson E Series (Voluson E6 / Voluson E8 / Voluson E10) is substantially equivalent to the predicate devices with regards to intended use, imaging capabilities, technological characteristics and safety and effectiveness."
• "The Voluson E Series and predicate Voluson E Series systems have the same clinical intended use."
• "The Voluson E Series and predicate Voluson E Series systems have the same imaging modes."
• "The Voluson E Series and predicate Voluson E Series systems transducers are identical except for the removal of three old transducers; no change to the indications for use."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not provided in the document. The submission is for a general purpose diagnostic ultrasound system; specific clinical studies with defined test sets, sample sizes, or data provenance are typically not included in these types of 510(k) summary documents when demonstrating substantial equivalence for existing indications. The focus is on technical conformity and safety standards.

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)

This information is not provided. As no specific clinical performance study for a new indication is detailed, there's no mention of experts establishing ground truth for a test set.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not provided.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done and is not mentioned. The device is an ultrasound system and not explicitly described as having AI assistance in the provided summary. The submission focuses on the system's fundamental operational capabilities and safety, not on augmented diagnostic performance with AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

A standalone algorithm performance study was not done and is not mentioned. The device is an ultrasound system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not provided. No specific clinical performance evaluations requiring ground truth are detailed in the document.

8. The sample size for the training set

This information is not provided. The document describes an ultrasound system undergoing substantial equivalence review, not an AI/ML algorithm development process that typically involves training sets.

9. How the ground truth for the training set was established

This information is not provided.

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