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510(k) Data Aggregation
(210 days)
The Versana Premier 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 clinical applications include : Fetal/Obstetrics, Abdominal, Gynecology, Urology, Pediatric, Small Parts (includes breast, testes, thyroid), Cardiac Pediatric, VascularPeripheral Vascular, Musculoskeletal Conventional, Musculosketal Superficial, Thoracic/Pleural, Transrectal, Transvaginal, Interventional guidance (includes tissue biopsy, fluid drainage, vascular access). Modes of operation include : B. M. PW Doppler, CW 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 is intended to be used in a hospital or medical clinic.
The Versana Premier 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. The operator control panel includes function keys, trackball, an alfa-numeric keyboard and a touch panel as input sources of the device. The variety of transducers include convex, linear, sector, dual and mechanical 4D transducers. The access types include trans- body surface, transrectal, transvaginal and transcranial. Data can be imported or exported by DVD, USB, LAN or WiFi if the USB wireless adapter is connected to the system. An external ECG module has been verified to use as input for gating during scanning. The system has a HDMI port, VGA connection port, S-Video port, and a Composite Out port connection. The system has an external AC outlet to allow connection of a printer box of the console and an option for external Printer USB Isolator for other printers to connect. The system supports one way, Bluetooth communication capability from the system to a personal device to allow for sharing of the patient's data/images when the external Bluetooth USB adapter is connected to the system.
The provided text is a 510(k) Premarket Notification Submission for the GE Versana Premier ultrasound system. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than proving that a new AI-powered diagnostic device meets specific performance acceptance criteria through a dedicated clinical study.
Therefore, the information required to populate the fields related to acceptance criteria, ground truth, sample size, expert adjudication, and comparative effectiveness studies is not present in this document. The document explicitly states: "The subject of this premarket submission, Versana Premier, did not require clinical studies to support substantial equivalence."
The only mention of an "Artificial Intelligence (AI) feature" is "Whizz Label," and no performance data or study details are provided for this feature. The document indicates that the Versana Premier employs "the same fundamental scientific technology as its predicate device and reference devices," and that it is "substantially equivalent ... with regard to intended use, imaging capabilities, technological characteristics, imaging modes, hardware, and safety effectiveness."
Here's what can be extracted from the document regarding the AI feature, acknowledging the absence of the requested study details:
- AI Feature Mentioned: Whizz Label is an Artificial Intelligence (AI) feature that is being added.
All other requested information cannot be found in the provided document:
- A table of acceptance criteria and the reported device performance: Not provided.
- Sample sized used for the test set and the data provenance: Not provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided.
- 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: Explicitly stated that clinical studies were not required.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not provided.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not provided.
- The sample size for the training set: Not provided.
- How the ground truth for the training set was established: Not provided.
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(162 days)
The Versana Premier 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 clinical applications include : Fetal/Obstetrics, Abdominal (includes GYN, Urology), Pediatric, Small Organ (includes breast, testes, thyroid), Cardiac (includes Adult and Pediatric), Vascular/Peripheral Vasculoskeletal Conventional, Musculosketal Superficial, Transrectal, Transvaginal, 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, 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 is intended to be used in a hospital or medical clinic.
The Versana Premier is a general purpose, 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. The operator control panel includes function keys, trackball, an alfa-numeric keyboard and a touch panel as input sources of the device. The variety of transducers include convex, linear, sector, dual and mechanical 4D transducers. The access types include trans- body surface, transrectal, transvaginal and transcranial. Data can be imported or exported by DVD, USB, LAN or WiFi if the USB wireless adapter is connected to the system. An external ECG module has been verified to use as input for gating/triggering during scanning. The system has a HDMI port, VGA connection port, Audio out port, S-Video port, and a Composite Out port connection. The system has an external AC outlet to allow connection of a printer and sit in the printer box of the console and an option for external Printer USB Isolator for other printers to connect. The system supports one way, Bluetooth communication capability from the system to a personal device to allow for sharing of the patient's data/images when the Bluetooth USB adapter is connected to the system.
The provided text details a 510(k) premarket notification for the "Versana Premier" diagnostic ultrasound system. However, it explicitly states, "The subject of this premarket submission, Versana Premier, did not require clinical studies to support substantial equivalence."
Therefore, I cannot provide information on acceptance criteria and a study proving the device meets them because such a study was not required or conducted for this specific submission to demonstrate substantial equivalence.
The document focuses on non-clinical tests to demonstrate safety and compliance with standards, and a comparison to predicate devices, rather than a clinical study with acceptance criteria.
If the request is based on the assumption that a clinical study was performed, that assumption is incorrect according to the provided text.
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(56 days)
The Versana Active is a general-purpose diagnostic ultrasound system intended for use by qualified and trained healthicare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid.
Versana Active clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Urology, Pediatric, Small Organ (includes breast, testes, thyroid), Neonatal Cephalic, Cardiac (includes Adult and Pediatric), Vascular Peripheral Vascular, Musculoskeletal Conventional, Musculoskeletal Superficial, Thoracic/ Pleural, Transcranial, Transrectal, Transvaginal, 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, Power Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D, 4D and Combined modes: B/M, B/ Color M, B/PWD or CWD, B/Color/PWD or CWD. B/Power/PWD or CWD.
The device is intended for use in an indoor hospital environment, in medical offices chilities.
The Versana Active is a general purpose, Track 3, diagnostic ultrasound system for use by qualified and trained healthcare professionals. The Versana Active is a compact, portable system, the device includes operator control panel, display monitor and transducers. The system provides digital acquisition, processing and display capability. The system can be powered through an electrical wall outlet for long term use or from internal battery for a short time use. The operator control panel includes function keys, trackball and an alfa-numeric keyboard as input sources of the device. The Versana Active design enables the system to be attached to three kinds of optional mobile carts. The variety of transducers include convex, linear, sector and mechanical 4D. The access tvpes include trans- body surface. transrectal, transvaginal and transcranial. Data can be imported or exported by DVD, USB, LAN or WiFi if the USB wireless adapter is connected to the system. An external ECG module has been verified to use as input for gating/triggering during scanning. The system has a HDMI port connection and with the use of optional Video Output Adapter, the system can have a Composite Out port connection and a S-Video Out port connection. An optional spare battery charger allows the system battery to be charged externally. The system has an option for an external Printer USB Isolator for printers to connect. The system supports one way, Bluetooth communication capability from the system to a personal device to allow for sharing of the patient's data/images when the Bluetooth USB adapter is connected to the system.
The provided text is a 510(k) summary for the GE Healthcare Versana Active ultrasound system. It indicates that no clinical studies were required to support substantial equivalence. Therefore, the document does not contain information regarding acceptance criteria, device performance from a clinical study, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth details.
The information provided focuses on the device's technical specifications, comparison to predicate devices, and a summary of non-clinical tests (acoustic output, biocompatibility, cleaning, electrical safety, etc.) that demonstrate compliance with safety standards.
Since no clinical studies were performed, I cannot provide the requested information about acceptance criteria, device performance, or study details.
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