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

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

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

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

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

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

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

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

Summary of what the document does state regarding meeting requirements:

The document states:

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

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

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Vscan Air is a battery-operated software-based general-purpose ultrasound imaging 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. 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 device is enabling visualization and measurement of anatomical structures and fluid including blood flow.
Vscan Air's pocket-sized portability and simplified user interface enables integration into training sessions and examinations in professional healthcare facilities (ex. Hospital, clinic, medical office), home environment, road/air ambulance and other environments as described in the user manual. The information can be used for basic/focused assessments and adjunctively with other medical data for clinical diagnosis purposes during routine, periodic follow-up, and triage.
Vscan Air supports black/white (B-mode), color flow (Color Doppler mode, M-mode, M-mode, combined (B + Color Doppler) and Harmonic Imaging modes with curved, linear and sector array transducers.
With the curved array transducer of the dual headed probe solution, the specific clinical applications and exam types include: abdominal, fetal/obstetrics, gynecological, urology, thoracic/lung, cardiac (adult and pediatio, 40 kg and above), vascular/peripheral vascular, musculoskeletal (conventional guidance (includes free hand needle/catheter placement, fluid drainage, nerve block and biopsy).
With the linear array transducer of the dual headed probe solution, the specific clinical applications and exam types include: vascular/peripheral vascular, musculoskeletal (conventional and superficial), small organs, thoraciclung, ophthalmic, pediatics, neonatal cephalic, interventional guidance (includes free hand needle/catheter placement, fluid drainage, nerve block, vascular access and biopsy).
With the sector array transducer of the dual headed probe solution, the specific clinical applications and exam types include: cardiac (adult and pediatic, 40 kg and above), abdominal, fetal/obstetnes, gynecological, urology, thoracic/ lung, pediatics, adult cephalic, interventional guidance (includes free hand needle/catheter placement, fluid drainage, nerve block and biopsy).

Vscan Air™ is a battery-operated general-purpose diagnostic ultrasound imaging system for use by qualified and trained healthcare professionals. It enables ultrasound imaging guidance, visualization and measurement of anatomical structures and fluid.
Vscan Air consists of an app which can be installed on Android™ or iOS devices, and 2 probes which use wireless technology for communication.
Its pocket-sized portability and simplified user interface enable integration into training sessions and examinations in professional healthcare facilities (ex. Hospital, clinic, medical office), home environment, road/air ambulance and in other environments. The information can be used for basic/focused assessments and adjunctively with other medical data for clinical diagnosis purposes during routine, periodic follow-up, and triage assessments for adult, pediatric and neonatal patients. Vscan Air can also be useful for interventional guidance.

The provided text is a 510(k) Summary for the GE Medical Systems Ultrasound and Primary Care Diagnostics Vscan Air, outlining its substantial equivalence to predicate devices. It does not contain information on specific acceptance criteria and the detailed study results that prove the device meets these criteria in terms of clinical performance (e.g., accuracy, sensitivity, specificity) for a particular AI function.

The document primarily focuses on:

• Regulatory information: Device name, regulation, product codes, predicate devices.
• Intended Use/Indications for Use: Describes the general applications of the ultrasound system.
• Technological comparison: Explains how the Vscan Air is similar to its predicate and reference devices in terms of technology, modes, transducers, and software features.
• Non-Clinical Tests: Mentions evaluation for acoustic output, biocompatibility, cleaning/disinfection, and electrical/electromagnetic/mechanical safety, and adherence to various safety standards.
• Absence of Clinical Studies: Explicitly states, "The subject of this premarket submission, Vscan Air, did not require clinical studies to support substantial equivalence."

Therefore, based on the provided input, I cannot fulfill the request for:

1. A table of acceptance criteria and reported device performance (for clinical/AI performance).
2. Sample size used for the test set and data provenance.
3. Number of experts and their qualifications for ground truth.
4. Adjudication method for the test set.
5. MRMC study details or effect size.
6. Standalone performance details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document confirms that this particular submission for Vscan Air did not require clinical studies, implying that the performance evaluation relied on non-clinical testing and comparison to predicate devices, rather than a prospective clinical trial with a defined test set and established ground truth for an AI algorithm.

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