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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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The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics; Abdominal; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic, vascular).

The LOGIQ S8 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 520 mm wide (keyboard), 865 mm deep and 1760 mm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 10.1-inch LCD touch screen and color widescreen monitor.

The provided text describes a 510(k) premarket notification for the GE LOGIQ S8 ultrasound system. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel claims or establishing new acceptance criteria through extensive clinical studies.

Therefore, the document does not provide specific acceptance criteria in terms of analytical or clinical performance metrics (e.g., sensitivity, specificity, accuracy for a particular disease or measurement), nor does it detail a study performed to prove such metrics against acceptance criteria. Instead, it demonstrates substantial equivalence based on technological characteristics, intended use, and compliance with recognized safety and performance standards.

Here's an breakdown of the information that can be extracted based on your request, as well as indications of what is not present in this type of regulatory filing:

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

This information is not provided in the document as it is a 510(k) summary for showing substantial equivalence, not a clinical trial report establishing new performance criteria. The "performance" described relates primarily to equivalence with predicate devices and compliance with general safety and performance standards.

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

This information is not provided. The document explicitly states: "The subject of this premarket submission, LOGIQ S8, did not require clinical studies to support substantial equivalence." The testing mentioned is for acoustic output, biocompatibility, cleaning/disinfection, and safety standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided as no clinical studies are reported to have been conducted for this submission.

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

This information is not provided as no clinical studies are reported to have been conducted for this submission.

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

This information is not provided. The device is an ultrasound imaging system, and there's no mention of AI assistance or MRMC studies in this document.

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

This information is not provided. The device is a diagnostic ultrasound imaging system, not an AI algorithm for standalone interpretation.

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

This information is not provided as no clinical studies are reported to have been conducted for this submission. The "ground truth" for the device's claims are the safety and performance characteristics of its predicate devices and compliance with recognized standards.

8. The sample size for the training set

This information is not provided as no machine learning or AI training is mentioned as being part of this submission's substantial equivalence argument.

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

This information is not provided as no machine learning or AI training is mentioned.

Summary of what the document does provide regarding device performance and compliance:

The document focuses on demonstrating that the GE LOGIQ S8 is substantially equivalent to legally marketed predicate devices. This is achieved by:

• Intended Use Equivalence: Stating that the LOGIQ S8 has the same clinical intended use as the predicate LOGIQ S8 (K152195).
• Technological Equivalence: Declaring that it employs the same fundamental scientific technology as its predicate device(s).
• Imaging Modes: Noting that it has the same imaging modes as the predicate LOGIQ S8, with additions of Fibroscan elastography and CAP (Controlled Attenuation Parameter), which are equivalent to features found on the reference predicate FibroScan (K160524).
• Safety and Standards Compliance:
  • Manufactured with materials evaluated and found safe.
  • Acoustic power levels are below applicable FDA limits.
  • Designed in compliance with approved electrical and physical safety standards.
  • Compliance with voluntary standards:
    • AAMI/ANSI ES60601-1 (Medical Electrical Equipment - General Requirements for Safety)
    • IEC60601-1-2 (Electromagnetic Compatibility)
    • IEC60601-2-37 (Ultrasonic Medical Diagnostic and Monitoring Equipment Safety)
    • ISO10993-1 (Biological Evaluation of Medical Devices)
    • ISO14971 (Application of risk management to medical devices)
    • NEMA UD 2 (Acoustic Output Measurement Standard)
    • NEMA UD 3 (Real Time Display of Thermal and Mechanical Acoustic Output Indices)
    • NEMA, Digital Imaging and Communications in Medicine (DICOM) Set.
  • Quality assurance measures applied to development (Risk analysis, Requirements Reviews, Design Reviews, Testing on unit level, Integration testing, Final Acceptance Testing, Performance testing, Safety testing).
  • Transducer and patient contact materials are biocompatible.

The document lists various transducers cleared with the system and for which clinical applications and modes of operation they are "previously cleared" (P), "new" (N), or "added under Appendix E" (E), primarily based on equivalence to other GE Ultrasound systems (e.g., LOGIQ E9, VIVID E90/E95).

In conclusion, for this specific 510(k) submission, the "acceptance criteria" are compliance with established medical device safety and performance standards and demonstration of substantial equivalence to predicate devices, rather than predefined performance thresholds from new clinical trials.

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