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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 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), Combined (B + Color Doppler) and Harmonic imaging modes with both the curved and linear 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 pediatric, 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, pediatrics, neonatal cephalic, interventional guidance (includes free hand needle/catheter placement, fluid drainage, nerve block, vascular access 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 a probe which uses 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 document indicates that the Vscan Air device did not require clinical studies to support substantial equivalence. Therefore, there is no detailed information regarding acceptance criteria, device performance, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a study proving the device meets acceptance criteria.

The document primarily focuses on non-clinical tests to demonstrate substantial equivalence to predicate devices. These non-clinical tests pertain to acoustic output, biocompatibility, cleaning and disinfection, as well as thermal, electrical, electromagnetic, mechanical safety, and wireless communication. The device was found to conform to applicable medical device safety standards.

Summary of Non-Clinical Tests and Conformance:

Key takeaway regarding clinical studies:

• Clinical Studies: "The subject of this premarket submission, Vscan Air, did not require clinical studies to support substantial equivalence."

Therefore, the requested information regarding a study proving acceptance criteria for clinical performance is not available in the provided text. The submission relied on non-clinical testing and comparison to predicate devices to establish substantial equivalence.

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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), 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.

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 proposed Venue 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 is not intended for monitoring or diagnosis.

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 and a barcode reader is available to be used as an input device. System meets DICOM requirements to support users image storage and archiving needs and allows for output to printing devices. The user documentation is available via electronic media.

The Venue 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 includes several automated tools designed to simplify and shorten the workflow time of the healthcare professional for some common assessments.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided FDA 510(k) summary does not contain specific acceptance criteria or quantitative performance metrics for the device itself. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device by comparing:

• Clinical Indications for Use: Similar, with some additions cleared on reference devices.
• Technological Characteristics: Same fundamental scientific technology.
• Safety and Effectiveness: Assessed through non-clinical tests.
• Imaging Modes and Transducers: Largely identical or similar, with additions cleared on reference devices.
• Features/Functionality: Modifications or additions that are similar to features already cleared on predicate or reference devices.

Therefore, a table of acceptance criteria and reported device performance, as typically understood for AI/ML device performance, cannot be constructed from this document. The "performance" being demonstrated here is the device's adherence to safety standards and its functional equivalence to existing cleared devices.

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

The document explicitly states: "The subject of this premarket submission, Venue, did not require clinical studies to support substantial equivalence."

Therefore, there was no test set as part of a clinical study for this 510(k) submission, and consequently, no sample size or data provenance information.

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

As no clinical study was required and no test set was used, this information is not applicable and not provided in the document.

4. Adjudication Method for the Test Set

As no clinical study was required and no test set was used, this information is not applicable and not provided in the document.

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

The document explicitly states: "The subject of this premarket submission, Venue, did not require clinical studies to support substantial equivalence."

Therefore, no MRMC study was performed, and this information is not applicable and not provided in the document. The device descriptions focus on general ultrasound functionalities without specific mention of AI-assisted diagnostic features that would warrant such a study. While some "automated tools" are mentioned, their performance is established through similarity to pre-cleared features, not through comparative effectiveness studies in this submission.

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

The document states: "The subject of this premarket submission, Venue, did not require clinical studies to support substantial equivalence."

Therefore, no standalone performance study was done for this submission, and this information is not applicable and not provided in the document.

7. The Type of Ground Truth Used

As no clinical study was required and no test set was used, this information is not applicable and not provided in the document. The substantial equivalence argument relies on comparison to predicate and reference devices, not on direct ground truth validation in a clinical setting for this specific submission.

8. The Sample Size for the Training Set

The document explicitly states: "The subject of this premarket submission, Venue, did not require clinical studies to support substantial equivalence."

Since no clinical studies were performed, and the submission does not describe the development or training of new AI/ML algorithms requiring a training set, this information is not applicable and not provided in the document. The "automated tools" mentioned are described as modifications or similar to features already cleared on other devices.

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

As no training set was used for a clinical study in this submission, this information is not applicable and not provided in the document.

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