(105 days)
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.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.