(234 days)
The BVT02 Bladder Scanner is B-mode pulsed-echo ultrasound device. It is intended as a portable device. The BVT02 Bladder Scanner projects ultrasound energy through the lower abdomen of the patient to obtain images of the bladder which is used to calculate bladder volume noninvasively. The BVT02 Bladder Scanner is intended to be used only by qualified medical professionals. Intended use environment: Professional health care facilities.
The BVT02 Bladder Scanner manufactured by Xuzhou Kaixin Electronic Instrument Co., Ltd. provides real - time ultrasound imaging and measuring, and also provides non invasive volume measurement of the bladder. During image scanning, multiple 2D plane ultrasonic images are acquired in several seconds. It features: Expert operating mode and Lite operating mode. Portable. Combined power supply with AC adapter and a battery.
Here's an analysis of the acceptance criteria and study information for the BVT02 Bladder Scanner, based on the provided FDA 510(k) summary:
1. Acceptance Criteria and Reported Device Performance
The primary performance criterion mentioned is the bladder volume accuracy.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy: ±15%, ±15ml (for volumes 20-999ml) | Complies with pre-set acceptability criterion (which is stated to be the same as the predicate device, implying ±15%, ±15ml) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not explicitly state the specific sample size used for the volume accuracy test set. It mentions that "All the test results comply with the pre-set acceptability criterion," but not the number of measurements or subjects involved.
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It only states that the testing was done per the FDA Guidance document "Marketing Clearance of Diagnostic Ultrasound Systems and Transducers."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The volume accuracy testing appears to be a bench test involving physical measurements rather than human interpretation of images, so expert consensus on bladder volume images might not have been directly applicable.
4. Adjudication Method for the Test Set
This information is not provided. Given that the volume accuracy test appears to be a bench test, an adjudication method in the context of human interpretation is unlikely and not described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not mentioned or performed. The device is a bladder scanner that automatically calculates volume, not an AI diagnostic aid for image interpretation by clinicians.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
Yes, a standalone performance test for volume accuracy was conducted. The "Performance-Bench Testing" section explicitly states: "The BVT02 Bladder Scanner had been tested volume accuracy per the FDA Guidance document 'Marketing Clearance of Diagnostic Ultrasound Systems and Transducers' issued in June 27, 2019. All the test results comply with the pre-set acceptability criterion..." This indicates the algorithm's performance was evaluated independently on a test setup.
7. Type of Ground Truth Used
The type of ground truth used for the volume accuracy test would likely be precise physical measurements of known volumes (e.g., water in a phantom) or a highly accurate clinical measurement method against which the device's calculated volume is compared. While not explicitly stated, the context of "volume accuracy" in bench testing for medical devices typically relies on such objective physical ground truth.
8. Sample Size for the Training Set
This information is not applicable and not provided. As a medical device for non-invasive volume measurement using pulsed-echo ultrasound, it is a hardware-software system rather than a machine learning/AI algorithm that requires a "training set" in the conventional sense for deep learning. Its accuracy is based on the underlying physical principles of ultrasound and algorithms for volume calculation, which are validated through bench testing rather than trained on data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided since there's no mention of a "training set" for an AI or machine learning model. The device's performance is established through validation against known values in bench testing.
§ 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.