(127 days)
General Indication for Use:
An ultrasound pulsed echo imaging system is intended to project a pulsed sound beam into body tissue to determine the depth of 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.
Specific Indications for Use:
The device is indicated for use as an adjunct to mammography for B-mode ultrasonic imaging of a patient's breast when used with an automatic scanning linear array transducer or a handheld transducer. The device is not intended to be used as a replacement for screening mammography.
The ABUS system with automated ultrasound imaging of the breast, gives the radiologist a cost-effective solution for reviewing the ultrasound images with the corresponding mammogram.
The modification to the sponsor's predicate device consists of the addition of the accessory of a conventional handheld ultrasound transducer, and modification to the software to control the new transducer.
This 510(k) premarket notification for the Automated Breast Ultrasound System (ABUS) does not contain information about specific acceptance criteria or an analytical study comparing the device's performance against predefined metrics.
The document details a modification to an existing device, primarily the addition of a handheld ultrasound transducer and associated software changes. The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than providing new performance data against acceptance criteria.
Here's a breakdown of why the requested information is largely absent, based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Absent. The document states: "The ABUS System will successfully complete integration testing, beta testing, and verification and validation prior to market release." This indicates future testing, not performance data from a completed study against specific acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Absent. No test set is described or referenced in terms of sample size or data provenance.
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)
- Absent. As no test set is described, no information on ground truth experts is provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Absent. No test set or adjudication method is described.
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
- Absent. The device is an ultrasound imaging system, not an AI-powered diagnostic tool, and no MRMC study or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Absent. This device is a hardware and software system for image acquisition and display, not an algorithm in the sense of a standalone diagnostic AI. Performance is inherently "human-in-the-loop" as it requires a clinician to operate and interpret.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Absent. No ground truth is mentioned.
8. The sample size for the training set
- Absent. This submission does not describe any machine learning or AI components that would require a "training set." It focuses on a hardware and software modification to an existing medical imaging system.
9. How the ground truth for the training set was established
- Absent. See point 8.
Explanation of the Submission Type:
This is a 510(k) submission, specifically for a modification to an existing device. For device modifications, the primary goal is often to demonstrate "substantial equivalence" to a predicate device, meaning it's as safe and effective as a device already on the market. This typically involves showing that the new features or changes do not raise new questions of safety or effectiveness and that the technological characteristics are comparable.
In this case, U-Systems Inc. is adding a conventional handheld ultrasound transducer and modifying the software to control the new transducer. This type of change often relies on existing performance data for the predicate device and the general understanding that conventional ultrasound transducers are well-established technology. Therefore, extensive new clinical performance studies or specific acceptance criteria for a new "device performance" (beyond ensuring the system functions as intended and meets technical specifications for ultrasound imaging) are not typically required for this type of modification. The "Performance data" section explicitly states these tests "will successfully complete" prior to market release, indicating these are internal verification and validation activities rather than formal clinical studies for regulatory clearance.
§ 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.