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The Venue, Venue Go, Venue Fit and Venue Sprint are general purpose diagnostic ultrasound systems 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, Venue Go and Venue Fit are intended to be used in a hospital or medical clinic. Venue, Venue Go and 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 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.

The Venue Sprint is intended to be used in a hospital, medical clinic, home environment and road/air ambulance. Venue Sprint 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, 40 kg and above) and interventional guidance (includes free hand tissue biopsy, fluid drainage, vascular and non-vascular access). Modes of operation include: B, M, PW Doppler, Color Doppler and Harmonic Imaging.

Venue, Venue Go, Venue Fit and Venue Sprint are general-purpose diagnostic ultrasound systems intended for use by qualified and trained healthcare professionals to evaluate the body by ultrasound imaging and fluid flow analysis.

The systems utilize a variety of linear, convex, and phased array transducers which provide high imaging capability, supporting all standard acquisition modes.

The systems have 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 is a mobile system, the Venue Go and Venue Fit are compact, portable systems that can be hand carried using an integrated handle, placed on a horizontal surface, attached to a mobile cart or mounted on the wall. Venue, Venue Go and Venue Fit have a high-resolution color LCD monitor, with a simple, multi-touch user interface that makes the systems intuitive.

The Venue Sprint is used together with the Vscan Air probes and provides the user interface for control of the probes and the needed software functionality for analysis of the ultrasound images and saving/storage of the related images and videos.

The Venue, Venue Go, Venue Fit and Venue Sprint systems 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. A barcode reader and RFID scanner are available as additional input devices. The systems meet DICOM requirements to support users image storage and archiving needs and allows for output to printing devices.

The Venue, Venue Go and Venue Fit systems are 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. Compatible biopsy kits can be used for needle-guidance procedures.

The provided document, a 510(k) Clearance Letter and Submission Summary, primarily focuses on the substantial equivalence of the GE Healthcare Venue series of diagnostic ultrasound systems to previously cleared predicate devices. It specifically details the "Auto Bladder Volume (ABV)" feature as an AI-powered component and provides a summary of its testing.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance (for Auto Bladder Volume - ABV)

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

• Test Set (Verification Dataset) Sample Size: 1874 images from 101 individuals.
• Data Provenance:
  • Country of Origin: USA and Israel.
  • Retrospective or Prospective: Not explicitly stated as either retrospective or prospective. However, the description of "data collected from several different Console variants" for training and verification suggests pre-existing data, which often leans towards a retrospective collection.

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

• Number of Experts: Not explicitly stated. The document refers to "annotators" who performed manual annotation.
• Qualifications of Experts: Not explicitly stated. The annotators are described as performing "manual annotation," implying they are skilled in this task, but specific qualifications (e.g., radiologists, sonographers, years of experience) are not provided.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly stated. The document mentions "annotators performed manual annotation," but does not detail if multiple annotators were used for each case or any specific adjudication process (e.g., 2+1, 3+1 consensus).

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

• Was an MRMC study done? No. The document states: "The subjects of this premarket submission, Venue, Venue Go, Venue Fit and Venue Sprint, did not require clinical studies to support substantial equivalence." The testing described for ABV is a standalone algorithm performance validation against established ground truth, not a comparative human-AI study.
• Effect Size of Human Readers Improvement: Not applicable, as no MRMC study was performed.

6. Standalone (Algorithm Only) Performance Study

• Was a standalone study done? Yes. The "AI Summary of Testing" section describes a study for the Auto Bladder Volume (ABV) feature, which assesses the algorithm's "automatic caliper placement success rate" against manually established ground truth. This is a standalone performance evaluation of the algorithm.

7. Type of Ground Truth Used (for ABV Test Set)

• Ground Truth Type: Expert consensus/manual annotation. The document states: "Ground truth annotations of the verification dataset were obtained as follows: In all Training/Validation and Verification datasets, annotators performed manual annotation on images converted from DICOM files." They identified "landmarks, which represent the bladder edges," corresponding to standard measurement locations.

8. Sample Size for the Training Set (for ABV)

• Training Set Sample Size: Total dataset included 8,392 images from 496 individuals. Of these, 1,874 were used for the verification dataset, and "the rest" were used for training/validation. This implies the training/validation set would be 8392 - 1874 = 6518 images from the remaining individuals not included in the verification set.

9. How the Ground Truth for the Training Set Was Established (for ABV)

• Ground Truth Establishment: Similar to the verification dataset, "annotators performed manual annotation on images converted from DICOM files" for both Training/Validation and Verification datasets. They chose "4-6 images that represent different bladder volume status" for each individual and annotated "4 different landmarks" per view (transverse and longitudinal) representing bladder edges.

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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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Venue Sprint 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.

The Venue Sprint is intended to be used in a hospital, medical clinic, home environment and road/air ambulance.

Venue Sprint 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, 40 kg and above) and interventional guidance (includes free hand tissue biopsy, fluid drainage, vascular access). Modes of operation include: B. M. PW Doppler, Color Doppler and Harmonic Imaging.

Venue Sprint 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 Sprint is used together with the Vscan Air probes and provides the user interface for control of the probes and the needed software functionality for analysis of the ultrasound images and saving/storage of the related images and videos.

This document describes the Venue Sprint diagnostic ultrasound system (K240206). Based on the provided text, the device is an ultrasound system and does not appear to have AI/ML functionality that requires specific performance metrics beyond general safety and effectiveness. The document explicitly states that clinical studies were not required to support substantial equivalence.

Therefore, most of the requested information regarding acceptance criteria, specific performance tables, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance is not present in this 510(k) summary for the Venue Sprint.

Here's an attempt to answer the questions based only on the provided text:

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

The provided document does not contain a specific table of acceptance criteria or performance metrics for an AI/ML component. The "acceptance criteria" for this device appear to be compliance with various safety and performance standards for diagnostic ultrasound systems.

• Marketing Clearance of Diagnostic Ultrasound Systems and Transducers - Guidance
• AAMI/ANSI ES60601-1
• IEC 60601-1-2
• IEC 60601-2-37
• IEC 62359
• ISO 10993-1
• ISO 14971
• NEMA PS 3.1-3.20e (DICOM)
• AAMI TIR69
• IEC 60601-1-11
• IEC 60601-1-12 |
  | Quality Assurance Measures | Risk Analysis, Requirements Reviews, Design Reviews, Testing (unit, integration, performance, safety) |

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

The document explicitly states: "The subject of this premarket submission, Venue Sprint, did not require clinical studies to support substantial equivalence." Therefore, there is no mention of a test set, its sample size, or data provenance from clinical studies within this submission.

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 requiring ground truth establishment for a test set were conducted or described.

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

Not applicable, as no clinical studies requiring ground truth establishment for a test set were conducted or described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The document does not describe any AI-assisted features or MRMC studies. The device is described as a "general-purpose diagnostic ultrasound system." The phrase "expanding cleared Auto Inferior Vena Cava (IVC), Auto B-Lines, Real Time ejection fraction (RT-EF) and cNerve" refers to features already cleared on other predicate devices and their expansion to new probes on this system; it does not constitute a new AI feature with its own performance study described here.

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

Not applicable, as no standalone algorithm performance study is described.

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

Not applicable, as no clinical studies requiring ground truth were conducted or described.

8. The sample size for the training set

Not applicable, as no machine learning model training is described in this submission.

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

Not applicable, as no machine learning model training is described in this submission.

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The Venue Fit is a general purpose diagnostic ultrasound system for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. Venue Fit is intended to be used in a hospital or medical clinical applications include: abdominal (GYN and Urology), thoracic pleural, ophthalmic. Fetal/OB. Small Organ (including breast, testes, thyroid), VascularPeripheral vascular, neonatal and adult cephalic, pediatric, musculoskeletal (conventional and superficial), cardiac (adults and pediatic), Transrectal, Transvaginal, Transesophageal, Intraoperative (vascular) and interventional guidance (includes tissue biopsy, fluid dramage, 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: BM, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD, B/CWD, B/Color/CWD.

Venue Fit 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 analvsis. The Venue Fit is a compact, portable system with a small footprint. The system can be hand carried using the integrated handle, placed on a horizontal surface (if kickstand is attached), attached to a mobile cart or mounted on the wall. 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 Fit 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 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 Fit is capable of wired or wireless internet connection. The system meets DICOM requirements to support users image storage and archiving needs (local PACS or products such as Q-Path) and allows for output to printing devices. The user documentation is available electronically.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance (cNerve feature)

Note: The document does not provide specific performance percentages against the 70% and 80% thresholds. It states that success criteria were based on conformance to ground truth and that preliminary surveys identified appropriate thresholds for pixel and frame accuracy for the intended use.

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

• Sample Size:
  • Sequences: 124 sequences
  • Frames: 3776 frames
  • Individuals: 44 individuals
• Data Provenance: USA, Japan, Israel (Retrospective, as it was a pre-existing dataset used for verification)

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

• Number of Experts: A single clinical expert.
• Qualifications of Experts: "clinical expert" - further specific qualifications (e.g., years of experience, specialty) are not provided in the document.

4. Adjudication Method for the Test Set

• Adjudication Method: None explicitly stated. Ground truth annotations were performed by a single clinical expert.

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

• No MRMC comparative effectiveness study was done to evaluate human reader improvement with AI assistance. The testing focused on the standalone performance of the cNerve feature.

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

• Yes, a standalone study was performed. The "AI Summary of Testing" directly addresses the performance of the cNerve algorithm against ground truth annotations.

7. The Type of Ground Truth Used

• Type of Ground Truth: Expert consensus (from a single clinical expert) on anatomical areas of nerve bundles within individual frames.

8. The Sample Size for the Training Set

• The document does not specify the sample size for the training set. It only states that the data used for verification is "completely distinct" from the training data.

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

• The document does not specify how the ground truth for the training set was established. It only ensures that the verification data was distinct from the training data.

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The Venue is a general purpose diagnostic ultrasound system for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. 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 pediatic), 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, Color Doppler, Color M Doppler, Power Doppler, Harnonic 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. 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. The Venue has a battery that allows for scanning without the need to plug in to an electrical outlet. The system is capable of wireless communication. 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 provided document describes the FDA 510(k) premarket notification for the GE Medical Systems Venue diagnostic ultrasound system. While the primary focus of the document is on establishing substantial equivalence to a predicate device, it also includes an "AI Summary of Testing" specifically for a feature called "cNerve." This summary provides some details about the cNerve feature's acceptance criteria and performance evaluation.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text, focusing on the cNerve feature.

Acceptance Criteria and Study for cNerve Feature

The cNerve feature is designed to "detect and track nerves during the scouting stage of a nerve block procedure, prior to inserting the needle to inject the anesthetic material."

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size:
  • Individuals: A total of 44 individuals.
  • Sequences: 124 sequences. Each individual contributed up to 2 sequences per view location, often from both laterals (left and right).
  • Frames: 3776 frames.
• Data Provenance: Retrospective, collected from "USA, Japan, Israel."

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

• Number of Experts: A single clinical expert.
• Qualifications: "A single clinical expert" - specific qualifications (e.g., years of experience, specialty) are not detailed in the provided text.

4. Adjudication Method for the Test Set

• Adjudication Method: "None" explicitly mentioned. Ground truth annotations were "obtained as follows: Frames from scouting sequences were annotated by a single clinical expert, where the anatomical area of the nerves was marked in each frame." This indicates a single-expert annotation without a specified adjudication process.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not explicitly mentioned or performed for the cNerve feature in this summary. The AI testing described focuses on standalone algorithm performance against a single expert's ground truth.

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

• Standalone Performance: Yes. The "AI Summary of Testing" describes the evaluation of the cNerve feature's "accuracy" based on its detections conforming to ground truth annotations. The acceptance criteria heavily focus on the algorithm's ability to meaningfully and successfully detect nerves in sequences and frames, suggesting a standalone performance evaluation.

7. The Type of Ground Truth Used

• Type of Ground Truth: Expert consensus (from a single expert). The ground truth was established by "a single clinical expert, where the anatomical area of the nerves was marked in each frame."

8. The Sample Size for the Training Set

• Training Set Sample Size: Not specified in the provided document. The summary only mentions that the "data used for verification is completely distinct from that used during training process and there is no overlap between the two."

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

• Training Set Ground Truth Establishment: Not specified in the provided document. The summary only states that the training data and verification data are distinct.

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The Venue Go is a general purpose diagnostic ultuse by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. 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, thyroid), Vascular/Peripheral vascular, neonatal and adult cephalic, pediatric, musculoskeletal (conventional and superficial), cardiac (adults and pediatic), 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 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. The Venue Go utilizes a varietv 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 builtin 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 user documentation is available electronically.

The provided document is a 510(k) Premarket Notification Submission for the GE Venue Go ultrasound system. It includes a specific section detailing the AI feature cNerve. Based on this information, here's a description of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance (cNerve AI Feature)

Important Note: The document outlines the acceptance criteria for cNerve but does not explicitly provide the measured numerical performance results of the device against these criteria. It states that the "cNerve performance requirements" are listed but does not follow up with a section detailing the actual tested performance numbers.

2. Sample Size and Data Provenance for the Test Set

• Sample Size (Individuals): A total of 44 individuals contributed to the verification dataset.
• Sample Size (Sequences/Frames): The test dataset included 124 sequences and 3776 frames.
• Relationship between Samples: Each individual contributed up to 2 sequences per view location (often both left and right laterals were scanned).
• Demographic Distribution:
  • Gender: Male and Female
  • Age: 18-82 years
  • Ethnicity/Country: USA, Japan, Israel
• Subgroups Tested: The algorithm performance was verified via frame accuracy on all demographic subgroups: Gender (M/F), Age (=60), BMI (25). It was also tested for all supported nerve block locations and supported probe types.
• Data Provenance: The document implies the data was collected from a mix of clinical settings (implied by "USA, Japan, Israel" for ethnicity/country) and clinical scenarios ("all supported nerve block locations and all supported probe types"). The study type (retrospective or prospective) is not explicitly stated, but the process of collecting and annotating an existing dataset suggests a retrospective approach for the dataset creation for validation.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: A single clinical expert annotated the frames from scouting sequences.
• Qualifications of Experts: The specific qualifications (e.g., years of experience, specific specialty like "radiologist") of the "single clinical expert" are not detailed in the provided text.

4. Adjudication Method for the Test Set

• The ground truth was established by a single clinical expert. Therefore, there was no adjudication method described (e.g., 2+1, 3+1 concensus), as only one expert was involved in marking the ground truth.

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

• The document does not indicate that an MRMC comparative effectiveness study was done to evaluate how much human readers improve with AI vs without AI assistance. The study focuses solely on the standalone performance measurement of the cNerve algorithm against defined ground truth.

6. Standalone (Algorithm Only) Performance Study

• Yes, a standalone performance study was done. The "AI Summary of Testing" section describes the evaluation of the cNerve algorithm's accuracy, focusing on its ability to detect and track nerve bundles independently. The acceptance criteria ("Sequence accuracy requirement - for testing overall cNerve performance") explicitly relate to the algorithm's performance.

7. Type of Ground Truth Used

• The ground truth used was expert annotation/consensus (from a single expert). The frames were "annotated by a single clinical expert, where the anatomical area of the nerves was marked in each frame."

8. Sample Size for the Training Set

• The sample size for the training set is not provided in the document. The document explicitly states: "The data used for verification is completely distinct from that used during training process and there is no overlap between the two." However, it does not disclose details about the training data itself.

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

• The document does not describe how the ground truth for the training set was established. It only mentions that the test data was distinct from the training data.

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The Venue Fit is a general purpose diagnostic ultrasound system for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. 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, thyroid), VascularPeripheral 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, 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 Fit 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 Fit is a compact, portable system with a small footprint. The system can be hand carried using the integrated handle, placed on a horizontal surface (if kickstand is attached), attached to a mobile cart or mounted on the wall. 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 Fit utilizes a variety of linear, convex, and phased array transducers which provide high imaging capability. supporting all standard acquisition modes. Some transducers are compatible with OEM biopsy kits to support needle-guidance procedures.

The system has the capability for 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. The ECG signal can be input directly from the patient leads or as an output from an ECG monitoring device. ECG information is not intended for monitoring or diagnosis.

Venue Fit is capable of wired or wireless internet connection and a barcode reader is available to be used as an input device. The system meets DICOM requirements to support users image storage and archiving needs (local PACS or products such as O-Path) and allows for output to printing devices. The user documentation is available electronically. An additional accessory available for the customer is a roller bag.

I am sorry, but the provided text does not contain the information required to answer your request. The document is a 510(k) premarket notification submission for a medical device (Venue Fit ultrasound system).

It primarily focuses on:

• Regulatory information: FDA letter, indications for use, and a 510(k) summary.
• Device description: Explaining the Venue Fit's features, intended use, and technical specifications.
• Comparison to predicate devices: Highlighting similarities and differences with previously cleared GE ultrasound systems.
• Non-clinical tests: Listing the safety and performance standards the device complies with (e.g., acoustic output, biocompatibility, electrical safety).
• A statement explicitly saying: "The subject of this premarket submission, Venue Fit, did not require clinical studies to support substantial equivalence."

Therefore, there is no information regarding:

• Acceptance criteria for AI/algorithm performance.
• Results of a study proving the device meets acceptance criteria (as no clinical studies were required).
• Sample sizes for test or training sets.
• Data provenance.
• Number of experts, their qualifications, or adjudication methods for ground truth.
• MRMC studies or effect sizes.
• Standalone algorithm performance.
• Type of ground truth used.
• How ground truth for training was established.

This document indicates that the device's substantial equivalence was demonstrated through non-clinical testing and comparison to predicate devices, rather than a clinical study involving AI performance metrics.

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The Venue Go is a general purpose diagnostic ultrasound system for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. 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, thyroid), VascularPeripheral 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, 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.

The Venue Go utilizes a variety of linear, convex, and phased array transducers which provide high imaging capability, supporting all standard acquisition modes. Some transducers are compatible with OEM biopsy kits to support needle-guidance procedures.

The system has the capability for 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. The ECG signal can be input directly from the patient leads or as an output from an ECG monitoring device. ECG information is not intended for monitoring or diagnosis.

A barcode reader is available to be used as an input device. Venue Go is capable of wireless communication through a builtin Wireless LAN device. The system meets DICOM requirements to support users image storage and archiving needs (local PACS or products such as O-Path) and allows for output to printing devices. The user documentation is available electronically. An additional accessory that will also be available for the customer will be a roller bag.

The provided text describes the GE Medical Systems Ultrasound and Primary Care Diagnostics' Venue Go device and its 510(k) premarket notification. However, it does not include information about acceptance criteria or a study proving the device meets those criteria, as typically understood in the context of diagnostic performance (e.g., sensitivity, specificity, accuracy).

Instead, the document details the device's technical specifications, intended use, comparison to predicate devices, and compliance with non-clinical safety standards (acoustic output, biocompatibility, electrical safety, etc.). The "Summary of Non-Clinical Tests" section outlines various standards the device complies with, but these are safety and engineering standards, not performance criteria for a diagnostic algorithm.

Specifically, the "Summary of Clinical Tests" section explicitly states: "The subject of this premarket submission, Venue Go, did not require clinical studies to support substantial equivalence." This means that no clinical performance study was conducted to establish diagnostic accuracy metrics for the device itself. The substantial equivalence argument is based on its similarity to existing, legally marketed ultrasound systems.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving their fulfillment, as it is not present in the provided text.

If you have a document that describes the diagnostic performance claims and supporting studies for the Venue Go or a similar medical device, please provide that text, and I will be able to answer your questions.

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