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Vivid Pioneer is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified and trained physician or sonographer for ultrasound imaging, measurement, display and analysis of the human body and fluid.

Vivid Pioneer is intended for use in a hospital environment including echo lab, other hospital settings, operating room, Cath lab and EP lab or in private medical offices. The systems support the following clinical applications:

Fetal/Obstetrics, Abdominal (including renal, GYN), Pediatric, Small Organ (breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (adult and pediatric), Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Urology (including prostate), Transesophageal, Transvaginal, Transrectal, Intra-cardiac, Intra-luminal and Interventional Guidance (including Biopsy, Vascular Access), Thoracic/Pleural and Intraoperative (vascular).

Modes of operation include: 3D, Real time (RT) 3D Mode (4D), B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

The proposed Vivid Pioneer is a general purpose, Track 3, diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis but also includes vascular and general radiology applications. It provides digital acquisition, processing, display and analysis capabilities. It consists of a mobile console with a height-adjustable control panel, color LCD touch panel, and a display monitor.

Vivid Pioneer includes a variety of electronic array transducers operating in linear, curved, sector/phased array, matrix array or dual array format, including dedicated CW transducers and real time 3D transducer. The proposed Vivid Pioneer can be used with the stated compatible OEM ICE transducers. The system includes capability to output data to other devices like printing devices.

The user-interface includes an operator control panel, a 23.8" High-Definition Ultrasound LCD type of display monitor (mounted on an arm for rotation and / or adjustment of height), a layout of pre-defined user controls (hard-keys) and a 15.6-inch multi-touch LCD panel with mode-and operation dependent soft-keys.

The operator panel also includes two loudspeakers for audio, shelves for convenient placement of papers or accessories, and 6 holders with cable management for the connected transducers.

The lower console is mounted on 4 rotational wheels with brakes, for ergonomic transport and safe parking. The lower console also includes all electronics for transmit and receive of ultrasound data, ultrasound signal processing, software computing, hardware for image storage, hard copy printing, and network access to the facility through both LAN and wireless (supported by use of a wireless LAN USB-adapter) connection.

This document describes the acceptance criteria and study proving the device meets the criteria for two AI features of the Vivid Pioneer Ultrasound System: AI Cardiac Auto Doppler and AI FlexiViews LAA.

1. Table of Acceptance Criteria and Reported Device Performance

AI Cardiac Auto Doppler

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PIUR tUS inside System is a computer-aided detection device intended to assist and support medical professionals in the diagnostic workflow of thyroid and thyroid nodules acquired from FDA-cleared ultrasound systems, including image documentation, analysis, and reporting. The device supports the physician with additional information during image review, including quantification and visualization of sonographic characteristics of thyroid nodules.

PIUR tUS inside System may be used on any adult patient aged 22 and older, independent of gender, linguistic and cultural background, or health status, unless any of the contraindications apply.

The PIUR tUS inside System acts as part of the diagnostic chain and must not be used as a sole source for treatment decisions, but as an add-on solution to regular 2D ultrasound imaging.

The PIUR tUS inside System is not intended for body contact (including skin, mucosal membrane, breached or compromised surfaces, blood path indirect, tissues, bones, dentin, or circulation blood).

PIUR tUS inside is a medical device which enhances standard ultrasound devices with a three-dimensional (3D) tomographic imaging method for a 3D analysis of ultrasound volumes. With PIUR tUS inside, examining physicians can make diagnostic decisions based on standard 2D as well as 3D image data integrated in an ultrasound device environment. This 3D data provides information which previously could have only been generated using other 3D imaging technologies like CT or MRI.

The PIUR tUS inside runs on a compatible GE Healthcare ultrasound system. The PIUR tUS inside takes as an input a sequence of 2D ultrasound images that are transmitted through a software interface from the ultrasound to the PIUR tUS inside. In addition, the PIUR Sensor must be clipped onto the ultrasound transducer using individually designed PIUR Brackets. For image acquisition, the user moves the 2D ultrasound transducer perpendicular to the structure to be imaged over the region of interest of the patient's body. An inertial measurement unit (IMU), which is built into the PIUR Sensor, tracks the orientation of the transducer during the scan and sends this information to the ultrasound via Bluetooth.

The PIUR tUS inside combines image information and sensor information to generate tomographic 3D ultrasound volumes on which image analysis can be performed. An important property of this method is the unlimited length of the acquired volume. PIUR tUS inside therefore allows recording and analyzing a complete thyroid lobe.

The PIUR tUS inside and the PIUR tUS Infinity Predicate Device share most hardware and software components and algorithms. On the hardware side, both systems use the same PIUR Sensor to track probe movement during a freehand ultrasound acquisition. The data from the PIUR Sensor is transferred wirelessly through a Bluetooth connection to the software where it is being used to generate ultrasound volumes from the freehand sweep. Both systems also share the same volume compounding software algorithms, semi-automatic lobe and nodule segmentation algorithms, and volume calculation algorithms. The performance for image compounding and volume calculations are therefore the same for both systems.

The main difference between the PIUR tUS inside System and the Predicate Device is the interface for image retrieval. While the Predicate Device uses the Infinity Box to transfer digital ultrasound images from a third-party ultrasound system to the software through a Wi-Fi connection, the PIUR tUS inside has direct access to the image stream through a software interface. It runs directly on the compatible ultrasound scanners: GE Healthcare LOGIQ E10 (K231966) and GE Healthcare LOGIQ E10s/Fortis (K231989). This, however, is not performance relevant as the image data remains the same. It only reduces the number of compatible ultrasound systems as a close collaboration with the ultrasound manufacturer is required.

The PIUR tUS inside System acts as part of the diagnostic chain only and must not be used as a sole source for diagnostic or treatment decisions.

The solution is intended to be used on patients aged 22 and older, independent of gender, linguistic and cultural background, or health status, unless any of the contraindications apply, in a non-sterile environment. The solution is not intended to be used on patients with open wounds or irritated skin or during surgery.

The provided FDA 510(k) clearance letter and summary for PIUR tUS inside (K250484) does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study that proves the device meets them.

The document primarily focuses on establishing substantial equivalence to a predicate device (PIUR tUS Infinity, K240036) by demonstrating similar intended use, technological characteristics, and principles of operation, rather than providing a detailed clinical performance study with specific acceptance criteria, sample sizes, expert qualifications, or comparative effectiveness.

However, based on the information available in the document, here's what can be extracted and inferred:

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

The document does not explicitly state acceptance criteria in a quantitative manner as one might find in a clinical study report. Instead, the "Performance Data" section indicates that software performance, verification, and validation testing demonstrated that the PIUR tUS inside System met all design requirements and specifications.

It also states that the device was tested for electrical safety, EMC, and a white-noise test was conducted to verify that the wireless equipment does not induce additional white noise or degrade ultrasound image quality. These are performance aspects, but not specific clinical or diagnostic accuracy acceptance metrics.

2. Sample size used for the test set and the data provenance:

The document mentions "performance validation testing" and "software verification and validation testing," but it does not specify the sample size used for these tests. It also does not provide details on the data provenance (e.g., country of origin, retrospective or prospective nature) for any datasets used in these tests. The only clue is that the device assists in diagnosing thyroid and thyroid nodules acquired from FDA-cleared ultrasound systems.

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):

The document states under "Ground Truth Establishment" in the Substantial Equivalence Comparison Table:
"The ground truth to be established for performance studies of the device are annotated data sets labeled by medical specialists."

However, it does not specify the number of experts used, their qualifications (e.g., specific specialties, years of experience), or their accreditation.

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

The document does not describe any adjudication method used for establishing the ground truth for the test set.

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:

The document does not mention or describe a multi-reader multi-case (MRMC) comparative effectiveness study. The device is described as a "computer-aided detection device intended to assist and support medical professionals" and an "add-on solution to regular 2D ultrasound imaging," implying a human-in-the-loop scenario. However, no study demonstrating the improvement of human readers with AI assistance is detailed.

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

The document states under "Performance Testing Data to Support SE Determination" in the Substantial Equivalence Comparison Table:
"Results from standalone performance testing of machine learning algorithm suggested ROIs of user-selected nodules."

This indicates that some form of standalone performance testing was conducted specifically for the segmentation ("suggested ROIs") of user-selected nodules. However, the details of this standalone performance (e.g., accuracy metrics, specific results) are not provided in this summary.

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

As mentioned above, the ground truth for performance studies is described as "annotated data sets labeled by medical specialists." This suggests an expert consensus or expert labeling approach, rather than pathology or outcomes data specifically.

8. The sample size for the training set:

The document does not specify the sample size used for the training set of the machine learning algorithms.

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

Similar to the test set, the document states generally: "The ground truth to be established for performance studies of the device are annotated data sets labeled by medical specialists." This implies the training set ground truth would also be established through expert labeling, but no further details are provided.

Summary of what is present vs. what is missing:

The provided 510(k) summary focuses heavily on demonstrating substantial equivalence through shared technological characteristics and general compliance with standards. It explicitly states that the device met "all design requirements and specifications" but lacks specific quantitative performance metrics (e.g., sensitivity, specificity, F1-score) or detailed clinical study results often found in AI/CAD device submissions. The information regarding ground truth establishment, sample sizes for training and testing, expert qualifications, and specific study designs (like MRMC or detailed standalone performance) is either very limited or entirely absent from this summary.

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The Versana Premier/Versana Premier Lotus/LOGIQ F is a general-purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid.

Versana Premier/Versana Premier Lotus/LOGIQ F clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Urology, Pediatric, Small Parts (includes breast, testes, thyroid), Cardiac Adult, Cardiac Pediatric, Vascular/Peripheral Vascular, Musculoskeletal Conventional, Musculoskeletal Superficial, Thoracic/Pleural, Transcranial, Transrectal, Transvaginal, Transesophageal, Interventional guidance (includes tissue biopsy, fluid drainage, vascular and nonvascular access).

Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/PWD.

Versana Premier/Versana Premier Lotus/LOGIQ F is intended to be used in a hospital or medical clinic

The Versana Premier, Versana Premier Lotus and LOGIQ F is a general purpose, Track 3, diagnostic ultrasound system for use by qualified and trained healthcare professionals. The system is a mobile console that includes an operator control panel, display monitor and transducers. The console provides digital acquisition, processing, and display capability. The system has an internal battery to allow for acquisition while the system is not plugged into a power source. Acquisition can also be done while the system is connected to an AC power source. The operator control panel includes function keys, trackball, and a touch panel with a digital keyboard (physical keyboard as an option) as input sources of the device. The variety of transducers include convex, linear, sector, Bi-plane probe and mechanical 4D transducers. The access types include trans- body surface, transrectal, transvaginal, transcranial and transesophageal. The Versana Premier, Versana Premier Lotus and LOGIQ F share a common software and hardware platform. There may be different configurations commercially offered, however they are all within the overall design of the product.

The provided text is a 510(k) Summary for a new medical device submission (K242005) for the GE Versana Premier, Versana Premier Lotus, and LOGIQ F ultrasound systems. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study proving that the device meets specific acceptance criteria for performance.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, specifically:

1. A table of acceptance criteria and the reported device performance: Not provided. The document outlines a comparison to predicate devices, but no specific performance metrics with acceptance criteria are listed.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not provided, as no clinical study demonstrating performance against acceptance criteria was conducted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: 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: Not provided. The device is a diagnostic ultrasound system and not an AI-assisted diagnostic tool as described.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided.
8. The sample size for the training set: Not provided.
9. How the ground truth for the training set was established: Not provided.

Summary of what the document does state regarding meeting requirements:

The document states:

• "The subject of this premarket submission, Versana Premier/Versana Premier Lotus/LOGIO F did not require clinical studies to support substantial equivalence." (Page 8)
• It attests to the device's conformance with recognized performance standards and safety standards through non-clinical tests (acoustic output, biocompatibility, cleaning and disinfection effectiveness, thermal, electrical, electromagnetic, and mechanical safety).
• It lists several voluntary standards the device complies with (e.g., AAMI/ANSI ES60601-1, IEC 60601-1-2, ISO 10993-1, ISO 14971, NEMA PS 3.1 - 3.20, IEC 62359).
• It outlines quality assurance measures applied during development, including Risk Analysis, Requirements Reviews, Design Reviews, and various levels of testing (unit, integration, system, performance, safety).

In essence, the submission relies on demonstrating substantial equivalence to previously cleared predicate devices and compliance with recognized safety and performance standards for ultrasound systems, rather than on a new clinical study with specific acceptance criteria met by the device's performance.

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The Venue Fit is a general purpose diagnostic ultrasound system for use by qualified and trained healthcare professionals or practitioners 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. Users may also include medical students working under the supervision or authority of a physician during their education / training. Venue Fit is intended to be used in a hospital or medical clinic. Venue Fit clinical applications include: abdominal (GYN and Urology), thoracic/pleural, ophthalmic, Fetal/OB, Small Organ (including breast, testes, thyroid), Vascular/Peripheral vascular, neonatal and adult cephalic, pediatric, musculoskeletal (conventional and superficial), cardiac (adults and pediatric), Transrectal, Transvaginal, Transesophageal, Intraoperative (vascular) and interventional guidance (includes tissue biopsy, fluid drainage, vascular and non-vascular access). Modes of operation include: B, M, PW Doppler, CW Doppler, Color M Doppler, Color M Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD, B/CWD. B/Color/CWD.

The Venue Fit is a general purpose diagnostic ultrasound system. It is a portable system with a touch screen interface. It can be powered through an electrical wall outlet or an internal battery. It utilizes linear, convex, and phased array transducers and supports standard acquisition modes. Compatible biopsy kits can be used for needle-guidance procedures. The system can display the patient's ECG trace synchronized to the scanned image. A barcode reader and RFID scanner are available as additional input devices. A roller bag is available for transport. It is capable of wired or wireless internet connection and meets DICOM requirements for image storage and archiving.

The provided text describes specific features and functionalities of the GE Venue Fit ultrasound system but does not contain information about acceptance criteria, reported device performance, or a specific study proving it meets acceptance criteria as typically outlined for AI/CADe devices.

The document is a 510(k) Premarket Notification Submission for the Venue Fit ultrasound system. It primarily focuses on demonstrating substantial equivalence to a predicate device (K220848 Venue Fit) regarding general imaging capabilities, technological characteristics, safety, and effectiveness.

Here's what can be extracted and what is explicitly stated as not applicable:

1. A table of acceptance criteria and the reported device performance
Not provided in the document. The document focuses on performance testing in the context of safety and effectiveness, rather than specific diagnostic accuracy metrics.

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 document states, "The subject of this premarket submission, Venue Fit, did not require clinical studies to support substantial equivalence." Therefore, there is no test set in the context of a clinical study for diagnostic performance.

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 clinical studies were required.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical studies were required.

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 document does not describe an AI/CADe device that assists human readers, nor does it present results from an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The Venue Fit is a diagnostic ultrasound system, not a standalone algorithm. Its capabilities, like "Auto Volume Flow (AVF)" or "Bladder Volume Tool", are functionalities of the ultrasound system itself, not standalone AI algorithms with reported diagnostic performance metrics.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable, as no clinical studies requiring ground truth establishment were mentioned.

8. The sample size for the training set
Not applicable. The document does not describe a machine learning algorithm that would have a training set. The "Venue Fit" is a general-purpose diagnostic ultrasound system. While it has "semi-automated tools," the document does not detail their development or any AI-specific training sets.

9. How the ground truth for the training set was established
Not applicable, as there is no mention of a training set for an AI algorithm.

Summary of what is present:

The document establishes substantial equivalence through a comparison to a predicate device (K220848 Venue Fit) and a list of reference devices (K231301 Vscan Air, K161047 LOGIQ P9 and LOGIQ P7, K231989 LOGIQ E10s/LOGIQ Fortis, K180374 Voluson S8/ S10/ S10 Expert, K202035 Vscan Air).

It outlines several non-clinical tests performed to ensure safety and compliance with standards:

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

The system states compliance with various voluntary standards including:

• Marketing Clearance of Diagnostic Ultrasound Systems and Transducers - Guidance for Industry and Food and Drug Administration Staff (February 21, 2023)
• AAMI/ANSI ES60601-1 (Medical Electrical Equipment - Part 1: General Requirements for Safety)
• IEC 60601-1-2 (Electromagnetic Compatibility Requirements and Tests)
• IEC 60601-2-37 (Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment)
• IEC 62359 (Ultrasonics Field characterization Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields)
• ISO 10993-1 (Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing Within a Risk Management Process)
• ISO 14971 (Application of risk management to medical devices)
• NEMA PS 3.1 3.20e (Digital Imaging and Communications in Medicine (DICOM) Set)
• AAMI TIR69 (Technical Information Report Risk management of radio-frequency wireless coexistence for medical devices and systems)

Quality assurance measures applied during development include:

• Risk Analysis
• Requirements Reviews
• Design Reviews
• Testing on unit level (Module verification)
• Integration testing (System verification)
• Performance testing (Verification & Validation)
• Safety testing (Verification)

The conclusion states that based on equipment design similarities, conformance to recognized performance standards, and performance testing, the proposed Venue Fit is considered substantially equivalent in safety, effectiveness, and performance to the predicate device.

Crucially, the document explicitly states: "The subject of this premarket submission, Venue Fit, did not require clinical studies to support substantial equivalence." This means that the information requested regarding acceptance criteria, device performance, sample sizes, ground truth, experts, adjudication, and MRMC/standalone studies in a diagnostic performance context is not available within this document.

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The Venue Go is a general purpose diagnostic ultrasound system for use by qualified and trained healthcare professionals or practitioners 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. Users may also include medical students working under the supervision or authority of a physician during their education / training. Venue Go is intended to be used in a hospital or medical clinic. Venue Go clinical applications include: abdominal (GYN and Urology), thoracic/pleural, ophthalmic, Fetal/OB, Small Organ (including breast, testes, thyroid), Vascular/Peripheral vascular, neonatal and adult cephalic, pediatric, musculoskeletal (conventional and superficial), cardiac (adults and pediatric), Transrectal, Transvaginal, Transesophageal, Intraoperative (vascular) and interventional guidance (includes tissue biopsy, fluid drainage, vascular and non-vascular access). Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD, B/CWD, B/Color/CWD.

Venue Go is a general-purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals to evaluate the body by ultrasound imaging and fluid flow analysis.

The Venue Go is a compact, portable system with a small footprint. The system can be hand carried using an integrated handle, placed on a horizontal surface, attached to a mobile cart or wall mounted. It has a high resolution color LCD monitor, with a simple, multi-touch user interface that makes the system intuitive. The system can be powered through an electrical wall outlet for long term use or from an internal battery for a short time with full functionality and scanning.

The Venue Go utilizes a variety of linear, convex, and phased array transducers which provide high imaging performance and support standard acquisition modes. Compatible biopsy kits can be used for needle-guidance procedures.

The system is capable of displaying the patient's ECG trace synchronized to the scanned image. This allows the user to view an image from a specific time of the ECG signal which is used as an input for gating during scanning. The ECG signal can be input directly from the patient or as an output from an ECG monitoring device. ECG information is not intended for monitoring or diagnosis.

A barcode reader and RFID scanner are available as additional input devices. A roller bag will also be available for the customer to use when transporting the system.
Venue Go is capable of wireless communication through a built-in Wireless LAN device. The system meets DICOM requirements to support image storage and archiving (local PACS or products such as Q-Path) and allows for output to printing devices.

The provided FDA 510(k) summary for the GE Venue Go ultrasound system does not include acceptance criteria for artificial intelligence (AI) performance or the study details to prove the device meets such criteria.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Venue Go K220800) and other reference devices, based on:

• Identical fundamental scientific technology.
• Similar imaging capabilities, technological characteristics, safety, and effectiveness.
• Minor updates to the Indications for Use statement for clarity regarding operator qualifications.
• Addition of new transducers already cleared on other GE devices.
• New features/functionality such as Auto Volume Flow (AVF), Bladder Volume Tool, expanded MSK diagrams, Venue Coach, electronic software delivery, expanded Auto Inferior Vena Cava (IVC), Auto B-Lines, Real-Time ejection fraction (RT-EF), cNerve for Vscan Air CL and SL probes (which are already cleared with these AI features on predicate Vscan Air K231301 and reference LOGIQ E10s/LOGIQ Fortis K231989), and AppAPI functionality.
• Conformity to recognized performance standards for acoustic output, biocompatibility, cleaning/disinfection, thermal, electrical, electromagnetic, and mechanical safety.
• Quality assurance measures like risk analysis, requirements/design reviews, and various levels of testing.

Specifically, the document states: "The subject of this premarket submission, Venue Go, did not require clinical studies to support substantial equivalence." This indicates that any evaluation of "AI performance" as typically understood (e.g., using a test set with ground truth, performance metrics, and acceptance criteria) was not part of this 510(k) submission.

The AI-related features mentioned (Auto IVC, Auto B-Lines, RT-EF, cNerve) are noted as being "expanded" or already "cleared" on predicate/reference devices (K231301 Vscan Air, K231989 LOGIQ E10s/LOGIQ Fortis). This implies their performance was likely evaluated as part of those previous 510(k) submissions, and the current submission is leveraging that prior clearance for their inclusion in the Venue Go system when used with the particular probes.

Therefore, since this 510(k) does not present new AI performance study data for the Venue Go, I cannot extract the requested information. The document focuses on demonstrating that the Venue Go, with its included features, is substantially equivalent to existing cleared devices, rather than proving novel AI algorithm performance.

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The Venue is a general purpose diagnostic ultrasound system for use by qualified and trained healthcare professionals or practitioners 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. Users may also include medical students working under the supervision or authority of a physician during their education / training.

Venue is intended to be used in a hospital or medical clinic. Venue clinical applications include: abdominal (GYN and Urology), thoracic/pleural, ophthalmic. Fetal/OB, Small Organ (including breast, testes, thyroid), Vascular/Peripheral vascular, neonatal and adult cephalic, pediatric, musculoskeletal (conventional and superficial), cardiac (adults and pediatric), Transrectal, Transvaginal, Transesophageal, Intraoperative (vascular) and interventional guidance (includes tissue biopsy, fluid drainage, vascular and non-vascular access). Modes of operation include: B. M. PW Doppler, CW Doppler, Color M Doppler, Color M Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD,B/CWD, B/Color/CWD.

The proposed Venue system is a general-purpose, Track 3, diagnostic ultrasound device, intended for ultrasound imaging, measurement and analysis of the human body and fluid that provides digital acquisition, processing and display capabilities. Venue can be used in offices, clinics and hospitals.

The Venue is a mobile system with a small footprint that easily fits into tight spaces and positioned to accommodate the sometimes-awkward work settings of the point of care user.

The Venue has a high resolution color LCD monitor, with a simple, multi-touch user interface that makes the system intuitive. The single surface screen provides easy cleanability. Articulated monitor arm enables flexible display positions in order to be accessible and clearly visible in both user-standing and sitting positions.

The system is capable of displaying the patient's ECG trace synchronized to the scanned image. This allows the user to view an image from a specific time of the ECG signal which is used as an input for gating during scanning. The ECG signal can be input directly from the patient or as an output from an ECG monitoring device. ECG information is not intended for monitoring or diagnosis.

Barcode reader and RFID scanner are available as additional input devices.

The Venue has a battery that allows for scanning without the need to plug in to an electrical outlet.

System meets DICOM requirements to support users image storage and archiving needs and allows for output to printing devices.

The Venue utilizes a variety of linear, convex, and phased array transducers which provide high imaging capability, supporting all standard acquisition modes. Compatible biopsy kits can be used for needle-guidance procedures.

The system includes several automated tools designed to simplify and shorten the workflow time of the healthcare professional for some common assessments.

The provided document is a 510(k) Summary for a diagnostic ultrasound system (Venue). It does not contain information about acceptance criteria and a study that proves the device meets those criteria for software performance.

The document states:

• "The subject of this premarket submission, Venue, did not require clinical studies to support substantial equivalence." (Page 10)
• The comparison is primarily focused on hardware, transducers, and general features, and states that the Venue system is substantially equivalent to a predicate device regarding "imaging capabilities, technological characteristics and safety and effectiveness." (Page 6)

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, ground truth establishment, or multi-reader multi-case studies because this document does not present such a study. The submission focuses on demonstrating substantial equivalence to a predicate device, which often relies on non-clinical tests and comparisons rather than new clinical performance studies.

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Voluson Signature 18 / Voluson Signature 20 system 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 Signature 18 / Voluson Signature 20 system clinical applications include: Fetal/Obstetrics; Abdominal (including Renal and Gynecology/ 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, Shearwave Elastography, B-Flow, Contrast and Combined modes: B/M, B/Color, B/ PWD, B/Power/PWD. The Voluson Signature 18 / Voluson Signature 20 system 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.

The provided text is a 510(k) summary for the GE Voluson Signature 20 and Signature 18 diagnostic ultrasound systems. This document primarily focuses on demonstrating substantial equivalence to a predicate device, as required for FDA clearance. It does not describe an AI/software-as-a-medical-device (SaMD) study with specific acceptance criteria related to AI performance metrics (e.g., sensitivity, specificity, accuracy).

The document states: "The subject of this premarket submission, Voluson Signature 20/18 did not require clinical studies to support substantial equivalence." This indicates that no specific performance study, clinical or otherwise, was conducted to demonstrate the device meets acceptance criteria using test sets, expert ground truth, or MRMC studies that would be typical for an AI/SaMD product.

Instead, the summary emphasizes that the new device shares fundamental scientific technology with its predicate, has the same clinical intended use (with additional migrated features from other cleared devices like Shearwave Elastography, which is an imaging mode, not an AI algorithm performing diagnostic interpretation), and complies with relevant safety and performance standards for ultrasound systems.

Therefore, I cannot provide the requested information regarding acceptance criteria and performance study details for an AI component from this document because it does not describe such a study. The "acceptance criteria" here are implicitly the regulatory requirements for showing substantial equivalence for an ultrasound system, focusing on safety, fundamental technology, and similar intended use.

In summary, based on the provided text, the device did not undergo the type of study described in your request for AI/SaMD products.

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