(157 days)
The device is indicated for use as a B-mode ultrasonic imaging of a patient's breast when used with an automatic scanning linear array transducer. The device is not intended to be used as a replacement for screening mammography.
Operator: Trained Healthcare Professional
Patient Population: Ages 18 and above
Environment of use: Facilities where healthcare is provided - e.g. hospitals, clinics, physician offices, mobile care units.
The ATUSA™ Automated 3D Breast Ultrasound System is a battery operated Track 3 diagnostic ultrasound system intended for imaging of the breast. The device utilizes B-mode grayscale ultrasound via an automated linear transducer and consists of the following components:
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- Automated ultrasound scanner that integrates all hardware components including the transducer, electronics, and mechanical parts in a compact form factor. The scanner connects to a laptop via USB cable and automatically captures ultrasound images of the breast volume;
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- Positioning accessory that includes a pair of expandable cups, disposable straps, drain bags and mesh. The expandable cups are assembled as a wearable accessory with disposable straps to form the breast tissue conveniently in the field of view of the scanner and facilitate reproducible positioning of the scanner on the breast. The expandable cups come in different sizes to accommodate a range of breast sizes;
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- Charger base for wirelessly charging the scanner battery;
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- Software application to control the scanner operation, to acquire and display the images in realtime, and to perform advanced image processing, 3D reconstruction and visualization in various image planes.
The provided text describes the ATUSA™ Automated 3D Breast Ultrasound System and its 510(k) submission (K213620) to the FDA. While it details safety and performance testing in general terms, it does not provide specific acceptance criteria or quantitative performance data in a format that allows for a direct comparison table of acceptance criteria vs. reported device performance. It also lacks detailed information regarding the study design concerning a test set, ground truth establishment with expert involvement, and MRMC studies.
Therefore, I will extract and synthesize the information that is present and explicitly state what information is not available based on the provided text.
Device: ATUSA™ Automated 3D Breast Ultrasound System
Indications for Use: The device is indicated for use as a B-mode ultrasonic imaging of a patient's breast when used with an automatic scanning linear array transducer. The device is not intended to be used as a replacement for screening mammography.
1. A table of acceptance criteria and the reported device performance
The provided document does not contain a specific table of quantitative acceptance criteria and the corresponding reported device performance for image quality or diagnostic accuracy. It mentions "Performance Testing - ATUSA™ Scanner Imaging Performance Test Report" and that "Sample clinical images were reviewed by board-certified radiologists who validated that the gray scale B-mode images have adequate image quality for visualizing breast tissue structures." However, it does not provide the numerical criteria or results of this validation.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The text does not specify the sample size for any test set or provide details on the data provenance (e.g., country of origin, retrospective or prospective nature) for clinical image validation. It only mentions "Sample clinical images" were reviewed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
The text states that "Sample clinical images were reviewed by board-certified radiologists who validated that the gray scale B-mode images have adequate image quality for visualizing breast tissue structures."
- Number of experts: Not specified (refers to "board-certified radiologists" in plural, but not a specific count).
- Qualifications of experts: "board-certified radiologists." No detail on years of experience or sub-specialty.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
The text does not describe any specific adjudication method for the image review or ground truth establishment.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned or described in the provided document. The device is for B-mode ultrasonic imaging and does not appear to incorporate AI for interpretation assistance based on this text. The focus is on demonstrating adequate image quality for human interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device is described as an "Automated 3D Breast Ultrasound System" for generating B-mode images intended for review by a "Trained Healthcare Professional." There is no mention of a standalone algorithm for automated interpretation or diagnostic performance without human-in-the-loop. Therefore, a standalone interpretation algorithm performance study was not conducted or reported. The "standalone" aspect refers to the device's ability to acquire and reconstruct images, not interpret them diagnostically.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for image quality validation was based on the assessment by board-certified radiologists that images had "adequate image quality for visualizing breast tissue structures." This can be inferred as a form of expert consensus/review rather than pathological confirmation or long-term outcomes data, as the validation was for image quality, not disease detection accuracy specifically.
8. The sample size for the training set
The provided text does not mention or specify a training set sample size. The document focuses on regulatory compliance and performance validation rather than model training details.
9. How the ground truth for the training set was established
Since a training set and its use were not discussed in this document, there is no information on how its ground truth might have been established.
§ 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.