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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:

1. A table of acceptance criteria and the reported device performance: Not provided.
2. Sample sized used for the test set and the data provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Explicitly stated that clinical studies were not required.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not provided.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not provided.
8. The sample size for the training set: Not provided.
9. How the ground truth for the training set was established: Not provided.

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

The Vivid S5 and Vivid S6 are mobile ultrasound consoles having a wide assortment of electronic array transducers intended primarily for echocardiography with additional capability in vascular and general ultrasound imaging. Its intuitive user interface, high level of auto-optimization along with significantly reduced size and weight make it readily maneuverable, efficient and easy to use.

The GE Healthcare Vivid S5/S6 Ultrasound System is a diagnostic ultrasound device intended for various clinical applications. The submission K121063 does not contain acceptance criteria or study data that proves the device meets specific performance metrics. Instead, it is a 510(k) Premarket Notification Submission asserting substantial equivalence to predicate devices. This type of submission relies on demonstrating that the modified device is as safe and effective as a legally marketed device that does not require premarket approval.

Key points from the submission regarding performance:

• No new clinical studies were conducted or required. The submission explicitly states: "The subject of this premarket submission, the modified Vivid S5/S6, did not require clinical studies to support substantial equivalence." (Page 2)
• The device's performance is asserted to be "substantially equivalent to the predicate device(s)." (Page 2)
• The submission outlines non-clinical tests performed to ensure safety and effectiveness, including acoustic output, biocompatibility, cleaning and disinfection effectiveness, thermal, electrical, electromagnetic, and mechanical safety, and conformity with applicable medical device safety standards. These are general safety and performance checks, not specific clinical performance metrics.

Therefore, the requested information elements related to acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance are not present in this 510(k) submission.

The tables provided (pages 6-26) list the "Indications for Use" for the Vivid S5/S6 system and its various transducers. These tables specify for each clinical application (e.g., Fetal/Obstetrics, Abdominal, Cardiac) and mode of operation (e.g., B-mode, PW Doppler, Color Doppler) whether that combination was:

• "P" - previously cleared by FDA
• "N" - a new indication in this submission
• "E" - added under Appendix E of the Ultrasound Guidance

These tables clarify the intended uses allowed for the device and its transducers, but they do not contain any quantitative acceptance criteria or reported device performance data. They merely state the cleared usage.

In summary, the provided document does not contain the specific information requested about acceptance criteria and a study proving those criteria are met for the following reasons:

1. No Acceptance Criteria and Reported Performance Table: The document explicitly states that no clinical studies were required to support substantial equivalence, focusing instead on non-clinical safety and performance aspects. Therefore, there are no reported performance metrics against specific acceptance criteria.
2. No Test Set Sample Size and Data Provenance: Since no clinical studies were conducted, there are no test sets or associated provenance information.
3. No Number of Experts and Qualifications: There is no mention of experts establishing ground truth for test sets, as clinical studies were not performed.
4. No Adjudication Method: Not applicable as no clinical test set was used requiring adjudication.
5. No MRMC Comparative Effectiveness Study: No such study was performed or reported.
6. No Standalone Performance: While the device functions as an algorithm (ultrasound imaging), the submission does not present standalone performance metrics in the context of a study demonstrating its diagnostic effectiveness. It relies on the equivalence to previously cleared devices.
7. No Type of Ground Truth Used: Not applicable, as there were no clinical studies generating ground truth.
8. No Sample Size for Training Set: Since this is a hardware device modification and a substantial equivalence claim, it does not involve an AI algorithm with a training set in the conventional sense described for machine learning.
9. No Ground Truth for Training Set Establishment: Not applicable as there is no mention of a training set for an AI algorithm.

The submission focuses entirely on demonstrating the safety and effectiveness of the modified device by comparing its technical characteristics and intended uses to those of legally marketed predicate devices, along with adherence to general safety standards.

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Ultrasound imaging, measurement and analysis of the human body as follows: Abdominal/GYN; Urology; Fetal/OB; Small Organ (breast, testes, thyroid); Pediatric; Neonatal & Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Musculo-skeletal (conventional & superficial); Transesophageal; Intraoperative (abdominal, thoracic and PV); Transvaginal and Transrectal, Intra-cardiac and intra-luminal applications.

The Vivid-i and Vivid-q are compact and portable diagnostic ultrasound systems with integrated keyboard, fold-up LCD type display and interchangeable electronic-array transducers. They have an overall size approximately 36 cm wide, 31.5 cm deep and 6 cm high in transport configuration and provide digital acquisition, processing and display capability. The user interface includes a computer keyboard, an intuitive layout of specialized controls, color GUI display and Doppler audio.

The provided text is a 510(k) Summary for the GE Healthcare Vivid i/q Diagnostic Ultrasound System. It is primarily focused on demonstrating substantial equivalence to predicate devices rather than presenting detailed performance criteria and a study to prove those criteria.

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" is largely not present in the provided document. The 510(k) summary explicitly states:

"The subject of this premarket submission, the modified Vivid i/q, did not require clinical studies to support substantial equivalence." (Page 3)

However, I can extract the following relevant details from the document:

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

Since no clinical studies were performed to establish new acceptance criteria and performance metrics for the modified Vivid i/q, a table of specific clinical performance acceptance criteria and reported device performance cannot be generated from this document. The document instead relies on substantial equivalence to predicate devices, implying that their performance characteristics are maintained.

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

No clinical test sets were used for this 510(k) submission, as explicitly stated above. Therefore, details regarding sample size and data provenance are not applicable.

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 test sets requiring expert-established ground truth were used.

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

Not applicable, as no clinical test sets requiring adjudication were used.

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 submission is for an ultrasound system, not an AI-assisted diagnostic tool. No MRMC studies were conducted.

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

Not applicable. This submission is for an ultrasound system, which inherently involves human operation and interpretation.

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

Not applicable, as no clinical studies requiring new ground truth establishment were performed for this submission. The ground truth for the predicate devices would have been established through clinical validation relevant to diagnostic ultrasound.

8. The sample size for the training set:

Not applicable, as this submission is for a medical device (ultrasound system), not a machine learning algorithm that requires a training set.

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

Not applicable, as this submission is for a medical device (ultrasound system), not a machine learning algorithm.

Summary of Non-Clinical Tests (from Page 3 of the document for completeness, as this is the closest to "performance"):

The document highlights the following non-clinical evaluations to ensure safety and effectiveness:

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

These tests comply with applicable medical device safety standards and voluntary standards. The following quality assurance measures were applied to the development of the system:

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

The biocompatibility of transducer materials and other patient contact materials was also confirmed.

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The GE EchoPAC BT10 workstation is indicated for diagnostic review and analysis of ultrasound images acquired under various modes of operation including B, M, Color M modes, Color, Power, Pulsed & CW Doppler modes, Coded Pulse, Harmonic and Realtime 3D. Clinical applications include: Fetal; Abdominal; Urology (including prostate); Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalio; Cardiac (adult and pediatric); Peripheral Vascular; Transesophageal (TEE); Musculo-Conventional; Transrectal (TR); Transvaginal (TV); and Intraoperative skeletal (abdominal, thoracic, & vascular).

GE EchoPAC provides image processing, annotation, analysis, measurement, report generation, communication, storage and retrieval of ultrasound images that are acquired via GE Vivid family of ultrasound scanners, primarily for cardiology ultrasound applications but also for general imaging. The EchoPAC software is an integral component of each Vivid system, providing the post acquisition image management and reporting functions of the scanner. Sold as a stand-alone software only product it can be installation on the customer's PC hardware, or as a plug-in to third party PACS. EchoPAC is DICOM compliant, transferring images and data via LAN between scanners, hard copy devices, file servers and other workstations. The modified or added software features for GE EchoPAC BT10 are substantially equivalent to the unmodified device and functionality cleared on GE Vivid E9 and GE Vivid S5/S6.

This document, K101324, describes a 510(k) Premarket Notification for the GE EchoPAC BT10 Review station. It's important to note that this is a submission for a review station software and not a diagnostic AI device in the modern sense. Therefore, many of the performance metrics and study designs typically associated with AI/ML diagnostic tools (like sensitivity, specificity, MRMC studies, training set details) are not applicable here. The submission focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical testing and verification of design specifications.

Here's an analysis based on the provided text, addressing your questions to the extent possible:

Acceptance Criteria and Device Performance:

Since this is not a diagnostic AI device, the "acceptance criteria" are not framed in terms of clinical performance metrics like sensitivity or specificity. Instead, they are focused on design specifications, compliance with standards, and functional equivalence to predicate devices.

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

• Not applicable / Not explicitly stated. This submission focuses on non-clinical testing and verification. There is no mention of a "test set" in the context of clinical data or patient samples being analyzed for performance metrics. The testing would have involved software validation and verification against functional requirements, not clinical diagnostic accuracy.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. As there was no clinical "test set" in the diagnostic sense, there was no need for experts to establish ground truth for such a set.

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

• Not applicable. No clinical test set requiring adjudication was used.

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. An MRMC study was not conducted. This device is a review station, not an AI-powered diagnostic tool, and its purpose is not to assist human readers in a diagnostic capacity that would be measured by an MRMC study.

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

• Not applicable. The GE EchoPAC BT10 is workstation software for image review, analysis, and reporting, which by its nature is a human-in-the-loop system. It is not an algorithm that operates standalone to produce diagnostic outputs.

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

• Not applicable / System Functionality, Compliance, and Equivalence. For this type of device, "ground truth" would relate to the correct functioning of the software, its adherence to design specifications, and its ability to process and display images as intended, consistent with DICOM standards and the functionality of predicate devices. There wouldn't be a clinical "ground truth" in the sense of a disease state.

8. The sample size for the training set:

• Not applicable. As the GE EchoPAC BT10 is not an AI/ML device that requires a "training set" in the machine learning context, this information is not relevant.

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

• Not applicable. There was no training set for a machine learning model.

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