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Voluson P6 / Voluson P8 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 P6 / Voluson P8 clinical applications include: Fetal/Obstetrics; Abdominal (including renal and GYN/Pelvic); Pediatric; Small Organ (Breast, Testes, Thyroid, etc.); Neonatal Cephalic; Cardiac (Adult and Pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal (including UrologyProstate) (TV),

Mode of operation include: B, M, AMM, PW Doppler, CW Doppler, Color M Doppler, Color M Doppler, HD-Flow, Harmonic Imaging, 3D/4D Imaging mode, Contrast and Combined modes: B/M, B/Color, B/Pwwer/ PWD. The Voluson P6 / Voluson P8 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 display, 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.

This document is an FDA 510(k) summary for the GE Healthcare Voluson P6 and Voluson P8 diagnostic ultrasound systems. It declares the device to be substantially equivalent to a predicate device and states that clinical studies were not required to support substantial equivalence.

Therefore, there is no information in this document regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for a test set or data provenance.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method.
5. Multi-reader multi-case (MRMC) comparative effectiveness study.
6. Standalone (algorithm only without human-in-the-loop) performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document focuses on non-clinical tests and compliance with safety standards to demonstrate substantial equivalence to existing devices.

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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 diagnostic ultrasound system and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.

The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.

It is intended for use by, or by the order of, and under the supervision of, an appropriately trained healthcare professional who is qualified for direct use of medical devices. It can be used in hospitals, clinics and similar care environment for clinical diagnosis of patients.

Modes of Operation: 2D mode, Color Doppler mode, Power Doppler (PD) mode, M mode, Pulsed Wave (PW) Doppler mode, Continuous Wave (CW) Doppler mode, Tissue Doppler Imaging (TDI) mode, Tissue Doppler Wave (TDW) mode, ElastoScan+™ Mode, Combined modes, Multi-Image modes (Dual, Quad), 3D/4D modes.

The HERA W9/ HERA W10 are general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B-mode, M-mode, Pulsed wave (PW) Doppler, Continuous wave (CW) Doppler, Color Doppler, Tissue Doppler Imaging (TDI), Tissue Doppler Wave (TDW), Power Amplitude Doppler, Pulse Inversion Harmonic Imaging (S-Harmonic), Directional Power Doppler (S-Flow), Color M-Mode, 3D Imaging Mode, 4D Imaging Mode, Elastoscan+ Mode, Tissue Harmonic Imaging, MV-Flow Mode or as a combination of these modes.

The HERA W9/HERA W10 also give the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The HERA W10 have real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

Here's a summary of the acceptance criteria and the study details for the SAMSUNG MEDISON CO., LTD. HERA W9/HERA W10 Diagnostic Ultrasound System, specifically focusing on the AI-based features mentioned in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list quantitative acceptance criteria for the AI-based features. Instead, it states that "Performance testing was successfully completed for the new software functions (artificial intelligence based features HeartAssist, ViewAssist and Slice A) to show passing results for predefined testing criteria," and that for BiometryAssist, "measurement accuracy requirements were met."

Therefore, based on the provided text, the table would look like this:

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

The document does not provide details on:

• The specific sample size used for the test set for any of the AI features.
• The data provenance (e.g., country of origin of the data, retrospective or prospective) for the test set.

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

The document does not provide details on:

• The number of experts used to establish the ground truth for the test set.
• The qualifications of those experts.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method used for the test set. It mentions that clinical studies were not required for substantial equivalence and focuses on performance testing.

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

The document does not indicate that an MRMC comparative effectiveness study was done. It focuses on the performance of the AI features themselves rather than comparing human reader performance with and without AI assistance. The text explicitly states: "The subject of this premarket submission, HERA W9/ HERA W10, did not require clinical studies to support substantial equivalence."

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

Yes, the descriptions of HeartAssist, ViewAssist, Slice A, and BiometryAssist (AI version) focus on their automated capabilities ("classification," "proposes caliper placements," "proposes corresponding anatomy annotations," "automatic technology for biometric measurement"). While it mentions user editing, the performance testing appears to validate the algorithm's standalone capabilities against "predefined testing criteria" and "measurement accuracy requirements."

7. The Type of Ground Truth Used

The document states that BiometryAssist's accuracy requirements were met for "biometric measurement," implying that quantitative measurement values (likely manually obtained or from established references) were used as ground truth. For HeartAssist, ViewAssist, and Slice A, the ground truth would likely involve expert-defined "measurement views," "key scanning views," and "anatomy annotations," respectively, but the precise nature (e.g., expert consensus) is not detailed.

8. The Sample Size for the Training Set

The document does not provide details on the sample size used for the training set for any of the AI features.

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

The document does not provide details on how the ground truth for the training set was established. It only generally refers to these features as "deep learning based functions" which implies a training process with labeled data.

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