(433 days)
SoftVue™ is indicated for use as a B-mode ultrasonic imaging system for imaging of a patient's breast when used with an automatic scanning curvilinear array transducer. The device is not intended to be used as a replacement for screening mammography.
Soft Vue is an automated tomographic B-mode diagnostic ultrasound system to be used as an adjunct to mammography for imaging a patient's breast. SoftVue is comprised of the following subsystems: the Transducer. Table/Housing. Water Control System, Computer Control System, Image Reconstruction System, Power System, and the Data Acquisition System.
SoftVue has a built-in curvilinear transducer that is used to acquire ultrasound images. Images are acquired from a patient lying prone on the table with their breast submerged in an imaging chamber filled with warm (body temperature) water. The breast is positioned in the center of the transducer. A camera, located at the bottom of the imaging chamber provides a live video feed to the system operator to aid in positioning the patient's breast. Once the scan is initiated. the transducer collects data that are processed to produce a series of ultrasound image slices that can be stacked to yield a volumetric ultrasound image of the breast,
The Water Control System is used to de-gas and warm the water that is used as the image acquisition medium. The Computer Control System controls all of the functionality of the other subsystems. The reconstruction engine processes the image data acquired by the transducer ring into B-mode ultrasound images.
The system includes a barcode reader, touchscreen console (user interface), and display monitor. The touchscreen console and monitor allow the clinical user to perform an imaging procedure on a patient. Patient information is entered into the system using either the touchscreen console or the barcode reader. Device errors and warnings are displayed on the console and/or display.
Soft Vue outputs the image Storage Medium that allows the images to be stored until they are reviewed on a workstation or transferred via DICOM to a PACS environment.
The provided document describes the SoftVue device, its intended use, and its substantial equivalence to a predicate device (Sofia™ (ATUS) Imaging Device). However, it does not explicitly detail acceptance criteria or the full results of a study demonstrating the device meets specific performance criteria in a format that lends itself to a direct fill-in-the-blanks response for all requested points.
Based on the available text, here's what can be extracted and inferred regarding the device's acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance:
The document mentions "predetermined specifications and product performance requirements" and "system and performance requirements necessary for its intended use" but does not provide a specific table of these criteria with numerical targets and the SoftVue's reported performance against them. It only gives general statements about meeting requirements.
The only specific performance criteria mentioned are:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Acoustic output | Meets the Global Maximum Output |
| Sub-system Verification | All requirements were met. |
| Resolution and Contrast in breast phantom | Not explicitly stated what was 'met' but the phantom was designed for measuring these. |
2. Sample Size Used for the Test Set and Data Provenance:
The document states, "System Verification and Validation Testing will be performed using an anthropomorphic phantom breast designed for measuring resolution and contrast. The breast phantom was seeded with 18 inclusions located in specific locations within the phantom."
- Sample Size for Test Set: 1 anthropomorphic phantom breast with 18 inclusions.
- Data Provenance: This indicates a prospective experimental design using a phantom, not human subject data. The country of origin for the data is not specified, but the device is submitted in the US for FDA clearance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
For the phantom study, the "ground truth" is inherent in the design of the phantom itself (known locations and characteristics of the 18 inclusions). Therefore, human experts were not used to establish ground truth for this specific test.
4. Adjudication Method for the Test Set:
Not applicable, as ground truth was established by the phantom's design.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study is mentioned in the provided text. The document focuses on performance testing against specifications and substantial equivalence to a predicate device based on technical characteristics and intended use, not on comparing human reader performance with and without AI assistance.
6. Standalone (Algorithm Only) Performance:
The document describes the SoftVue as a "B-mode ultrasonic imaging system" that processes data to produce "a series of ultrasound image slices that can be stacked to yield a volumetric ultrasound image of the breast." This suggests the algorithm's role is in image acquisition and reconstruction. The performance observed in the phantom study is an indicator of the device's standalone imaging capabilities. However, a specific "standalone performance study" in the context of an AI algorithm making diagnostic decisions (without human-in-the-loop) is not detailed. The device is presented as an imaging system, not an AI diagnostic tool.
7. Type of Ground Truth Used:
For the performance evaluation mentioned, the ground truth was phantom-based, meaning the known characteristics and locations of inclusions within the anthropomorphic phantom.
8. Sample Size for the Training Set:
No information is provided about a training set. This document describes a traditional 510(k) submission for an imaging device, not a machine learning or AI-driven device that typically requires a distinctive training set for model development. The "reconstruction engine processes the image data" (Page 1) but the methodology for its development and any associated training data are not discussed.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as no training set is mentioned or described.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.