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Voluson S6 / Voluson S8 / Voluson S8t / Voluson S10 / Voluson S10 Expert are a general-purpose diagnostic ultrasound system intended for use by a qualified and trained healthcare professional that are legally authorized or licensed by law in the country, state or other local municipality in which he or she practices for ultrasound imaging, measurement, display and analysis of the human body and fluid. The users may or may not be working under supervision or authority of a physician. Voluson S6 / Voluson S8 / Voluson S8t / Voluson S10 / Voluson S10 Expert clinical applications include: Fetal/Obstetrics; Abdominal (including renal and GYN/Pelvic); Pediatric; Small Organ (Breast, Testes, Thyroid, etc.); Neonatal Cephalic; Adult Cephalic; Cardiac (Adult and Pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal (including Urology/Prostate) (TR); Transvaginal (TV).

Mode of operation include: B, M, AMM, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Tissue Doppler, HD-Flow, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, B-Flow, Contrast and Combined modes: B/M, B/Color, B/PWD, B/Power/PWD. The Voluson S6 / Voluson S8 / Voluson S8t / Voluson S10 / Voluson S10 Expert are intended to be used in a hospital or medical clinic.

The systems are full-featured Track 3 ultrasound systems, primarily for general radiology use and specialized for OB/GYN with particular features for real-time 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 accurate real-time three-dimensional imaging supporting all standard acquisition modes. All probes on the subject device have been previously cleared on the predicate K180374 with the exception of the IC9b-RS which was previously cleared on predicate K201828. All probes available as accessories for the subject systems Voluson are used unchanged from the cleared predicates. They are made of the same materials and their shape is unchanged The primary differences between the difference models are the Voluson S10 Expert/S10 and S8t have a touch panel in the user interface and the S8 and S6 do not. Additionally, the Voluson S10 Expert is the highest configuration offering all the features and probes available on the S Series and the other models offer a subset of them.

The provided document is a 510(k) premarket notification for the GE Healthcare Voluson S series diagnostic ultrasound system. It details the device's characteristics, intended use, and comparison to predicate devices to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria or quantify device performance in terms of metrics like sensitivity, specificity, or AUC for any specific diagnostic task. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device, K180374 Voluson S series Diagnostic Ultrasound System, and reference device K201828 Voluson SWIFT, Voluson SWIFT+ Diagnostic Ultrasound System.

The "reported device performance" is implicitly that the device is as safe and effective as its predicate, adhering to the same performance standards of diagnostic ultrasound systems. The summary states:

Acceptance Criteria (Implicit - Substantial Equivalence Basis):

• Acoustic power levels below applicable FDA limits.
• Similar capability in performing measurements, capturing digital images, reviewing, and reporting studies as predicate devices.
• Designed in compliance with approved electrical and physical safety standards.
• Same clinical intended use and imaging modes as predicate devices.
• Manufactured with materials found to be safe for intended use.
• Transducer materials and patient contact materials are biocompatible.
• Compliance with voluntary standards (AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, ISO 14971, NEMA PS 3.1 3.20, IEC 62359).

Reported Device Performance (Implicit - Demonstrated Equivalence):
The document asserts that the Voluson S Series meets these implicit criteria by being substantially equivalent to the predicate devices. It explicitly mentions:

• "The systems have acoustic power levels which are below the applicable FDA limits."
• "The proposed Voluson S Series and predicate Voluson S series systems have similar capability in terms of performing measurements, capturing digital images, reviewing and reporting studies."
• "The proposed Voluson S Series and predicate Voluson S series systems have been designed in compliance with approved electrical and physical safety standards."
• "Transducer materials and other patient contact materials are biocompatible."
• The system complies with a list of voluntary standards related to safety, electromagnetic compatibility, and medical diagnostic ultrasonic fields.

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

The document explicitly states: "The subject of this premarket submission, Voluson S Series did not require clinical studies to support substantial equivalence."

Therefore, there is no test set in the context of clinical performance evaluation mentioned in this document, as no clinical studies were performed for this submission.

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

As no clinical studies were conducted for this submission, there was no test set requiring ground truth established by experts.

4. Adjudication Method for the Test Set

Not applicable, as no clinical studies were conducted.

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

No, an MRMC comparative effectiveness study was not done, as explicitly stated that "The subject of this premarket submission, Voluson S Series did not require clinical studies to support substantial equivalence."

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone performance study was not mentioned or performed, as the submission relies on substantial equivalence to predicate devices, not on proving new diagnostic performance.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

Not applicable, as no clinical studies were conducted. The "ground truth" for this submission is the established safety and effectiveness of the legally marketed predicate devices, which the new device is claimed to be substantially equivalent to, based on technical and performance similarity.

8. The Sample Size for the Training Set

Not applicable. This submission is for a diagnostic ultrasound system (hardware and associated software for image acquisition and display), not an AI/Machine Learning algorithm that requires a training set in the conventional sense for a diagnostic task. The document lists "Risk Analysis," "Requirements Reviews," "Design Reviews," "Testing on unit level," "Integration testing," "Performance testing," and "Safety testing" as quality assurance measures for the development of the system. These refer to engineering and system validation, not machine learning model training.

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

Not applicable, as there was no training set for an AI/Machine Learning algorithm described in this submission.

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The device is a general-purpose ultrasound system. Specific clinical applications and exam types include: Fetal (Obsterics); Abdominal (including renal and GYN/pelvic); Pediatic; Small Organ (breast, testes, thyroid, salvary gland, lymph nodes, pediatic and neonatal patients); Neonatal Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal (TR); Transvaginal (TV).

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application/Anatomy/Region of Interest: Fetal / Obstetrics; Abdominal (includes renal, GYN/Pelvic); Pediatric; Small Organ (includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients); Neonatal Cephalic; Adult Cephalic; Cardiac (Adult and Pediatric); Peripheral Vascular; Musculo-skeletal Conventional; Musculo-skeletal Superficial; Transrectal (includes urology/prostate); Transvaginal.

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 accurate realtime three dimensional imaging supporting all standard acquisition modes.

The provided text is a 510(k) Pre-Market Notification submission for the GE Healthcare Voluson S6, Voluson S8, and Voluson S10 ultrasound systems. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices ([K141639](https://510k.innolitics.com/search/K141639), [K152567](https://510k.innolitics.com/search/K152567), and [K142472](https://510k.innolitics.com/search/K142472)) and does not contain detailed information about acceptance criteria and a study proving the device meets those criteria, as one would expect from a de novo submission or a more comprehensive performance study report.

Instead, the submission states that "The subject of this premarket submission, Voluson S6 / Voluson S8 / Voluson S10, did not require clinical studies to support substantial equivalence." This indicates that the device's performance was deemed substantially equivalent to a predicate device based on non-clinical tests and technological comparisons, rather than new clinical trials with specific acceptance criteria.

Therefore, many of the requested details about acceptance criteria, sample sizes, expert ground truth, adjudication methods, and comparative effectiveness studies are not present in this document. The document argues for equivalence based on:

• Intended Use, Imaging Capabilities, and Technological Characteristics: Stating they are the same as or similar to the predicate devices.
• Compliance with Safety Standards: Listing various ISO, IEC, AAMI/ANSI, and NEMA standards.
• Quality Assurance Measures: Mentioning risk analysis, requirements reviews, design reviews, and various levels of testing.
• Biocompatibility: Stating that patient contact materials are biocompatible.

Given this, I will answer the questions based on the information available in the document, explicitly stating when details are not provided.

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

Since this is a 510(k) submission for substantial equivalence based on a predicate device, specific performance acceptance criteria for new clinical studies are not explicitly stated. The device is deemed to meet acceptance criteria by demonstrating substantial equivalence to predicate devices. The "performance" reported is therefore equivalence, rather than reaching specific quantitative thresholds.

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

Not applicable. The submission explicitly states, "The subject of this premarket submission, Voluson S6 / Voluson S8 / Voluson S10, did not require clinical studies to support substantial equivalence." Therefore, there was no separate test set with human subject data for a new clinical study. The evaluation focused on non-clinical tests and comparison to predicate devices.

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)

Not applicable, as no new clinical studies requiring expert ground truth were conducted for this 510(k) submission.

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

Not applicable, as no new clinical studies requiring expert adjudication were conducted for this 510(k) submission.

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. This device is an ultrasound system with imaging modes and software features; it is not an AI-assisted diagnostic tool for which an MRMC study on human reader performance improvement would typically be conducted. The submission focuses on the safety and technological equivalence of the ultrasound system itself.

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

Not applicable. This is a medical imaging device (ultrasound system), not a standalone algorithm.

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

For the non-clinical tests and comparisons, the "ground truth" would be the established safety standards and the performance specifications of the predicate devices. For instance, acoustic output levels were compared against applicable FDA limits (NEMA UD 3, NEMA UD 2), and material biocompatibility was evaluated against ISO10993-1. These are objective engineering and regulatory standards rather than clinical ground truth derived from expert consensus, pathology, or outcomes data in the context of a new clinical study.

8. The sample size for the training set

Not applicable. The document describes a medical imaging device (ultrasound system), not an AI/ML algorithm that would typically have a training set. The "development" mentioned refers to engineering and quality assurance processes, not machine learning model training.

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

Not applicable, as there was no training set for an AI/ML algorithm in this context.

Ask a specific question about this device

The device is a general-purpose ultrasound system. Specific clinical applications and exam types include: Fetal (Obstetrics); Abdominal (including renal and GYN/pelvic): Pediatric: Small Organ (breast, testes, thyroid, salivary gland. lymph nodes, pediatric and neonatal patients); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial: Transrectal (TR); Transvaginal (TV).

The subject device consists of a mobile console with keyboard, specialized controls, a color video LCD display with electronicarray transducers. It has the same general appearance, dimensions and weight as the unmodified device, it is a Track 3 generalpurpose imaging and analysis system providing real-time digital acquisition, processing and display capability intended for general radiology imaging and evaluation with some cardiology and vascular applications.

The study discussed is a 510(k) Premarket Notification Submission for the GE Healthcare Voluson S6, Voluson S8 Ultrasound System. This submission asserts substantial equivalence to predicate devices, rather than presenting a de novo clinical study with specific acceptance criteria and performance metrics.

Therefore, this specific document does not contain the information requested in points 1-7, and 9 because no new clinical studies were conducted for this submission. The device's safety and effectiveness are established through comparison to legally marketed predicate devices.

However, based on the provided text, the following information can be extracted:

8. The Sample Size for the Training Set: Not applicable. This submission is for an ultrasound system, not an AI/ML device that requires a training set in the conventional sense. The "training" for such a device is implicitly in its design and manufacturing process to meet established standards.

No other information regarding acceptance criteria, reported device performance, sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, multi-reader multi-case studies, or standalone performance is present because the submission explicitly states:

"The subject of this premarket submission, Voluson S6, Voluson S8, did not require clinical studies to support substantial equivalence." (Page 3)

The "study" used to demonstrate substantial equivalence relies on non-clinical tests and comparison to predicate devices, which already have established safety and effectiveness. The non-clinical tests involved:

• Acoustic output
• Biocompatibility
• Cleaning and disinfection effectiveness
• Thermal, electrical, electromagnetic, and mechanical safety

The device was found to conform to applicable medical device safety standards and voluntary standards such as: AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, NEMA UD 3, ISO10993-1, NEMA UD 2, ISO14971, and NEMA DICOM Set.

Ask a specific question about this device

The device is a general-purpose ultrasound system. Specific clinical applications and exam types include: Fetal (Obstetrics); Abdominal (including renal and GYN/pelvic); Pediatric; Small Organ (breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal (TR); Transvaginal (TV).

The subject device consists of a mobile console with keyboard, specialized controls, a color video LCD display with electronicarray transducers. It has the same general appearance, dimensions and weight as the unmodified device, it is a Track 3 generalpurpose imaging and analysis system providing real-time digital acquisition, processing and display capability intended for general radiology imaging and evaluation with some cardiology and vascular applications.

The GE Voluson S6/S8 Ultrasound System is a general-purpose imaging and analysis system. The provided document is a 510(k) Premarket Notification Summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study results for novel acceptance criteria.

Therefore, this document does not contain explicit acceptance criteria tables with reported device performance metrics like sensitivity or specificity, nor does it detail a clinical study designed to "prove the device meets acceptance criteria" in terms of algorithm performance for specific medical tasks. Instead, it describes non-clinical tests and affirms the device's technical equivalence and safety to its predicates.

Based on the provided text, here's a breakdown of what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

Not applicable. The document focuses on demonstrating substantial equivalence through non-clinical testing and comparison to predicate devices, not on setting and meeting specific performance acceptance criteria from a clinical study. The device is a diagnostic ultrasound system, whose performance is generally assessed through imaging quality, safety, and functionality, rather than specific diagnostic accuracy metrics, which would typically be evaluated in a clinical study if new diagnostic indications or automated analysis features were being introduced.

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

Not applicable to a clinical study demonstrating performance against acceptance criteria. The document explicitly states: "The subject of this premarket submission, Voluson S6, Voluson S8, did not require clinical studies to support substantial equivalence." (Page 1)

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

Not applicable. No clinical study data for ground truth establishment is presented.

4. Adjudication Method for the Test Set:

Not applicable. No clinical study data for ground truth establishment is presented.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a general diagnostic ultrasound system, not explicitly an AI-assisted diagnostic tool. No MRMC study is mentioned.

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

Not applicable. The device is a diagnostic ultrasound system that requires a human operator for image acquisition and interpretation. It is not an algorithm-only device.

7. The Type of Ground Truth Used:

Not applicable, as no dedicated clinical study assessing diagnostic performance against a ground truth is described. The "ground truth" for this type of submission relies on the established safety and performance of its predicate devices and compliance with regulatory standards.

8. The Sample Size for the Training Set:

Not applicable. As this device is not an AI/algorithm-based diagnostic product with a training set in the conventional sense, no training data or sample size is relevant for this submission.

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

Not applicable. See point 8.

Summary of Device Evaluation (from the provided text):

The GE Voluson S6, Voluson S8 Ultrasound System underwent non-clinical tests to demonstrate substantial equivalence to its predicate devices, covering:

• Acoustic output
• Biocompatibility
• Cleaning and disinfection effectiveness
• Thermal, electrical, electromagnetic, and mechanical safety

The development process also included standard 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)
• Safety testing (Verification)

The conclusion states that GE Healthcare considers the Voluson S6, Voluson S8 to be as safe, as effective, and its performance substantially equivalent to the predicate device(s). The FDA concurred with this finding of substantial equivalence based on the provided information, without requiring clinical studies.

The tables in pages 6-19 list the various clinical applications and modes of operation for the Voluson S6/S8 system with different transducers. "P" indicates applications and modes previously cleared by FDA, while "N" indicates new indications. These tables specify the intended uses and capabilities of the device and its transducers, rather than presenting acceptance criteria for a performance study.

Ask a specific question about this device

The device is a general-purpose ultrasound system. Specific clinical applications and exam types include: Fetal (Obstetrics); Abdominal (including renal and GYN/pelvic); Pediatric; Small Organ (breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal (TR); Transvaginal (TV).

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application: Ophthalmic, Fetal / Obstetrics, Abdominal, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac, Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Other.
Exam Type, Means of Access: Transesophageal, Transrectal, Transvaginal, Transuretheral, Intraoperative, Intraoperative Neurological, Intravascular, Laparoscopic.

The subject device consists of a mobile console with keyboard. specialized controls, a color video LCD display with electronicarray transducers. It has the same general appearance, dimensions and weight as the unmodified device, it is a Track 3 generalpurpose imaging and analysis system providing real-time digital acquisition, processing and display capability intended for general radiology imaging and evaluation with some cardiology and vascular applications. The device is a general-purpose ultrasound system.

The GE Healthcare Voluson S6, Voluson S8 Ultrasound System did not require a clinical study to support its substantial equivalence. The device was evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, as well as thermal, electrical, electromagnetic, and mechanical safety, and found to conform to applicable medical device safety standards. The manufacturer asserts that its performance is substantially equivalent to predicate devices.

Summary of Non-Clinical Tests and Quality Assurance Measures:

• Non-Clinical Tests: Acoustic output, biocompatibility, cleaning and disinfection effectiveness, thermal, electrical, electromagnetic, and mechanical safety.
• Voluntary Standards Conformance: The device and its applications comply with voluntary standards detailed in Sections 9, 11, and 17 of the premarket submission.
• Quality Assurance Measures:
  • Risk Analysis
  • Requirements Reviews
  • Design Reviews
  • Unit level testing (Module verification)
  • Integration testing (System verification)
  • Final Acceptance Testing (Validation)
  • Performance testing (Verification)
  • Safety testing (Verification)
• Biocompatibility: Transducer materials and other patient contact materials are biocompatible.

Information Not Available in the Provided Text:

• A table of acceptance criteria and reported device performance (beyond the summary that it conforms to standards).
• Sample size used for the test set or data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect size for human readers with AI assistance.
• Whether a standalone (algorithm only) performance study was done.
• The type of ground truth used (e.g., expert consensus, pathology, outcomes data).
• Sample size for the training set.
• How the ground truth for the training set was established.

Ask a specific question about this device