(15 days)
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.
U-Systems FFBU Diagnostic Ultrasound System is intended for diagnostic breast examinations.
U-Systems L. 9-5 X W MI-12 Transducer is intended for diagnostic breast examinations.
The FFBU Diagnostic Ultrasound system represents hardware and software changes to the predicate device and changes it to a Track 3 system.
The provided text for K032640 does not contain sufficiently detailed information regarding quantitative acceptance criteria and a study that proves the device meets those criteria. The submission states: "The FFBU System performance has been verified according to the FFBU System Test Plan. The FFBU Test Plan and the summary of test results to date are included in this submission." However, the actual test plan, acceptance criteria, and specific results are not included in the provided snippets. The document focuses on regulatory approval based on substantial equivalence.
Therefore, I cannot populate the table or answer most of the questions as the specific performance data, study design, and ground truth establishment methods are not present in the provided text.
Based on the limited information, here's what can be inferred:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Quantitative) | Reported Device Performance |
|---|---|
| Not specified in provided text. | Not specified in provided text. |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not specified.
4. Adjudication method
- Not specified (e.g., 2+1, 3+1, none).
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- Not specified. The document focuses on substantial equivalence to a predicate device, USI-2000 Horizon, rather than a comparative effectiveness study involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not specified. This device is an ultrasound system and transducer, not an AI algorithm.
7. The type of ground truth used
- Not specified.
8. The sample size for the training set
- Not applicable/Not specified. This is a hardware/software modification of an ultrasound system, not an AI model that undergoes a training phase for image analysis.
9. How the ground truth for the training set was established
- Not applicable/Not specified. As it's not an AI model, there isn't a training set with established ground truth in the context of machine learning.
§ 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.