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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: 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.

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.

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The device is a general purpose ultrasound system. Specific Intended Use: 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 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 document is a 510(k) Premarket Notification Submission for the GE Voluson E-Series diagnostic ultrasound systems. It focuses on establishing substantial equivalence to previously cleared predicate devices rather than presenting a performance study against specific acceptance criteria for a new clinical claim. Therefore, much of the requested information regarding acceptance criteria, study design parameters, and outcomes is not present in this type of regulatory submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not contain a table of acceptance criteria and reported device performance in the context of a new clinical study. Instead, it asserts substantial equivalence to predicate devices based on:

• The device being a general-purpose ultrasound system with clinical applications remaining the same as previously cleared.
• Minor hardware (new Power Supply, new Beamformer, new ECG-Module) and software (features like STIC, HDLive, SonoRenderstart, Cine Loop) improvements.
• The system employing the same fundamental scientific technology as its predicate devices.
• Conformity with applicable medical device safety standards.

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

No test set sample size or data provenience (country of origin, retrospective/prospective) is mentioned in this document for a clinical performance study. The submission explicitly states: "The subject of this premarket submission, Voluson E Series, did not require clinical studies to support substantial equivalence."

3. Number of Experts Used to Establish Ground Truth and Qualifications:

No information regarding experts used to establish ground truth or their qualifications is provided, as no clinical studies were performed.

4. Adjudication Method:

No adjudication method is mentioned, as no clinical studies were conducted to establish new ground truth.

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

No MRMC comparative effectiveness study was done, nor is there any mention of human readers improving with or without AI assistance. This device is an ultrasound system, not an AI diagnostic tool in the sense of the query.

6. Standalone Performance Study:

No standalone (algorithm-only) performance study was conducted or reported.

7. Type of Ground Truth Used:

No specific type of ground truth (e.g., expert consensus, pathology, outcomes data) is mentioned as being used for a clinical performance study since none was required. The "ground truth" for this submission is implicitly the established performance and safety of its predicate devices and compliance with recognized standards.

8. Sample Size for the Training Set:

No training set sample size is indicated, as this submission is not about an AI/ML algorithm requiring a training set in the typical sense for a new clinical claim.

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

This information is not applicable as no training set, in the context of a new AI/ML algorithm, was described.

Summary of Device and Evidence Presented:

The GE Voluson E-Series (including models E6/E8/E8Expert/E8Expert Limited Edition/E10) is a diagnostic ultrasound system intended for general radiology use, particularly specialized for OB/GYN with features for real-time 3D/4D acquisition.

The submission focuses on modifications to a previously cleared device (K122327 Voluson E6/E8/E8Expert/E10 Diagnostic Ultrasound System) and predicate device (K120741 Voluson S6/S8 Diagnostic Ultrasound System). The modifications include a new power supply, new beamformer, and new ECG-module, along with minor software improvements to existing features (STIC, HDLive, SonoRenderstart, Cine Loop).

The argument for substantial equivalence is based on:

• The intended use and clinical applications remaining the same as previously cleared.
• The fundamental scientific technology remaining the same.
• Non-clinical testing demonstrating conformity with safety standards (acoustic output, biocompatibility, cleaning/disinfection, thermal, electrical, electromagnetic, mechanical safety) and voluntary standards (e.g., AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, NEMA UD 3, ISO10993-1, NEMA UD 2, ISO14971, DICOM).
• Quality assurance measures applied during development (Risk Analysis, Requirements Reviews, Design Reviews, Testing on unit level, Integration testing, Final Acceptance Testing, Performance testing, Safety testing).
• The assertion that clinical studies were not required to support substantial equivalence.

In essence, this 510(k) submission is a declaration that the modified device is as safe and effective as its legally marketed predicate devices, and therefore does not require new or updated clinical performance data.

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