(219 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.
SoftVue™ 3.0 is indicated for use as a B-mode ultrasonic imaging system for imaging of a patient's breast using a curvilinear array transducer that completely surrounds the breast. The SoftVue™ System is comprised of the following subsystems: Transducer, Table/Housing Assembly, Water Conditioning System, Computer Control System, Image Reconstruction System, Power System, and the Data Acquisition System.
The SoftVue™ System has a built-in curvilinear transducer that is used to acquire ultrasound data. Data 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 Breast Interface Assembly connects to the distal end of the breast using a gentle vacuum, drawing the breast downward to center, shape, and stabilize the breast for optimal imaging. Cameras located at the bottom of the imaging chamber provide 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 B-mode ultrasound image slices that can be stacked to yield a volumetric ultrasound image of the breast. SoftVue™ also outputs colorized and grayscale relative stiffness image stacks that provide the radiologist with additional reference information.
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 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 touchscreen display (user interface). The touchscreen display allows the user to control the system and perform an imaging procedure. Patient information is entered into the system using the QWERTY keyboard on the touchscreen display, or the user can import the patient information from a DICOM modality worklist on an externally networked RIS server. Device errors and warnings are displayed on the touchscreen display.
SoftVue™ outputs the images to an externally networked PACS server which allows the images to be stored until they are reviewed on a workstation.
The provided text describes the Delphinus Medical Technologies SoftVue device (K172256).
Here's an analysis of the acceptance criteria and the study conducted:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" for clinical performance in a table format. Instead, it refers to "non-clinical design verification and validation testing" and "phantom imaging analysis" to demonstrate that the device "successfully meets the requirements of its intended use."
The intended use is: "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."
Therefore, the implicit acceptance criteria from the non-clinical testing are that the device effectively performs B-mode ultrasonic imaging of the breast and adheres to safety standards.
| Acceptance Criteria (Inferred from intended use and non-clinical testing) | Reported Device Performance |
|---|---|
| Imaging Capability: Effective B-mode ultrasonic imaging of a patient's breast using an automatic scanning curvilinear array transducer. | The results of the evaluation tests demonstrate that the modified SoftVue device successfully meets the requirements of its intended use, including system performance and image quality tests. The system acquires and processes B-mode grayscale images of a patient's breast. |
| Safety - Acoustic Output: Acoustic output within industry-accepted limits. | The SoftVue system has undergone acoustic output testing and was found to be well within industry-accepted limits. |
| Safety - Electrical/General: Compliance with applicable industry safety standards (AAMI/IEC 60601-1, IEC 60601-1-2, IEC 62304, IEC 60601-2-37). | The SoftVue system has been tested to applicable industry safety standards listed in Table 3 (reproduced above). |
2. Sample size used for the test set and the data provenance
- Sample Size: The document mentions a "phantom imaging analysis." Phantoms are模拟 objects used for testing and calibration, not human subjects. Therefore, there is no sample size of patients/images in the traditional sense for a clinical test set.
- Data Provenance: Not applicable as the testing was performed on a phantom, not human data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Phantom studies do not typically involve human experts establishing ground truth in the same way clinical studies do. The "ground truth" for a phantom would be its known physical properties and the expected image output from an ideal system.
4. Adjudication method for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for human expert consensus on clinical cases. This study involved a phantom imaging analysis.
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. The document explicitly states: "No clinical testing is required to be performed to assess the changes to the SoftVue System." This indicates that no MRMC study, or any clinical study involving human readers, was conducted. The device is referred to as an "imaging system," and there is no mention of AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in a way. The "phantom imaging analysis" assesses the performance of the device itself (the "algorithm only" or system performance) against established requirements. The B-mode imaging and other outputs (colorized and grayscale relative stiffness image stacks) are generated by the system without human intervention in the generation process.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the "phantom imaging analysis" would be the known properties of the phantom itself. This could include:
- Known size, shape, and location of simulated lesions or structures within the phantom.
- Known acoustic properties (e.g., speed of sound, attenuation) of the phantom materials.
- Expected image quality metrics (e.g., resolution, contrast, artifact levels) when imaging the known phantom structures.
8. The sample size for the training set
Not applicable. The document describes a "phantom imaging analysis" for verification and validation of a medical imaging device. It does not mention machine learning or AI components that would require a "training set" in the context of algorithm development. The system functions as an imaging device, not a diagnostic AI algorithm.
9. How the ground truth for the training set was established
Not applicable, as no training set is mentioned or implied for this device.
§ 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.