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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.

The provided FDA 510(k) summary for the GE Healthcare Voluson E6, Voluson E8, and Voluson E10 Diagnostic Ultrasound Systems does not contain details about acceptance criteria or a specific study that proves the device meets acceptance criteria in the context of an AI/algorithm-driven device with performance metrics like sensitivity, specificity, etc.

This submission is for a general-purpose ultrasound system, and the "study" described is a non-clinical evaluation to ensure the device's safety and effectiveness compared to a predicate device. The information provided heavily emphasizes substantial equivalence to a previously cleared ultrasound system (K142472).

Therefore, I cannot extract information to fill in most of the requested fields related to acceptance criteria and device performance based on the input text. However, I can provide what is present, highlighting the absence of AI-specific performance criteria.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not provide a table of performance acceptance criteria (e.g., sensitivity, specificity, accuracy) for an AI/algorithm feature, nor does it report such performance. The "acceptance criteria" here are framed around compliance with safety standards and equivalence to a predicate device.

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

Not applicable in the context of AI performance studies. The non-clinical tests would have involved various hardware and software validation tests, but not a "test set" of clinical cases for AI performance.

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

Not applicable for an AI performance study. Ground truth in this context would refer to engineering and safety standards compliance.

4. Adjudication Method for the Test Set

Not applicable for an AI performance study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. The document explicitly states: "The subject of this premarket submission, Voluson E Series (Voluson E6 / Voluson E8 / Voluson E10), did not require clinical studies to support substantial equivalence." This indicates no MRMC study or any clinical study was performed for this 510(k) submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not applicable for a standalone AI performance. The document describes an "improved version of an existing software feature SonoAVC called SonoAVC Antral (Antral follicle count)" which "The algorithm has more sensitivity to detect antral (small) follicles." However, no standalone performance study results or acceptance criteria for this improved sensitivity are provided. The claim is made, but no supporting data in the form of a performance study is included in this summary.

7. The Type of Ground Truth Used

For the general ultrasound system and its components (including the SonoAVC Antral feature), the "ground truth" for demonstrating substantial equivalence primarily relies on:

• Engineering measurements and tests against established medical device safety standards (e.g., acoustic output, electrical safety).
• Comparison to the performance and specifications of the predicate device (K142472 Voluson E6_E8_E10 Diagnostic Ultrasound System).
• The improved SonoAVC Antral feature claims "more sensitivity to detect antral (small) follicles," implying that some form of internal validation was done against either expert assessment or another reliable method to establish "ground truth" for follicle detection. However, details of such validation are not provided in this summary.

8. The Sample Size for the Training Set

Not applicable. This document does not describe the development or training of an AI/ML model for which a training set size would be relevant. While the SonoAVC Antral is an algorithm, details on its development or training data are not present.

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

Not applicable. (See #8)

Summary of what is available from the document regarding "acceptance criteria" and "performance":

The acceptance criteria for this ultrasound system are based on demonstrating substantial equivalence to a predicate device (K142472 Voluson E6_E8_E10 Diagnostic Ultrasound System) regarding:

• Intended Use: The systems are for diagnostic ultrasound imaging and fluid flow analysis, with specific clinical applications (Fetal/OB, Abdominal, Pediatric, Small Organ, Neonatal/Adult Cephalic, Cardiac, Musculo-skeletal, Peripheral Vascular, Transvaginal, Transrectal) remaining the same as previously cleared.
• Technological Characteristics: Employing the same fundamental scientific technology and imaging modes as predicate devices.
• Safety and Effectiveness:
  • Manufactured with materials assessed as safe.
  • Acoustic power levels below FDA limits.
  • Compliance with various safety standards (AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, NEMA UD 3, ISO10993-1, NEMA UD 2, ISO14971, NEMA DICOM).
  • Similar capability in measurements, digital image capture, reviewing, and reporting.
  • Designed in compliance with approved electrical and physical safety standards.
  • Transducers are equivalent to the predicate (with some removals and additions of new transducers (IC9-D and eM6C G2) whose applications are within the predicate's indications for use).
  • Addition of an improved SonoAVC Antral feature ("The algorithm has more sensitivity to detect antral (small) follicles"). No specific quantitative performance metric or acceptance criteria are given for this sensitivity improvement in this document.
  • Addition of a Fetal Cardio preset (already cleared in the predicate).
  • Addition of a card reader/bar code scanner.

Reported Device Performance:

The document primarily reports that the device conforms to applicable medical device safety standards and that its performance and features are substantially equivalent to the predicate device. The only specific performance claim related to an algorithm is that SonoAVC Antral has "more sensitivity to detect antral (small) follicles," but no quantifiable performance metrics, specific acceptance criteria, or a study detailing this improvement are provided in this summary. The non-clinical tests evaluated the device for safety (acoustic output, biocompatibility, cleaning/disinfection, thermal, electrical, electromagnetic, mechanical safety) and confirmed compliance with voluntary standards. No clinical studies were required or performed.

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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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