(242 days)
The Bladder Scanner (Model Name:MS) is intended to project ultrasound energy through the lower abdomen of the nonpregnant patient to obtain an image of the bladder and uses that image to calculate the bladder volume non-invasively. It is contraindicated for fetal use and for use on pregnant patients. And it should not be used by those who are allergic to coupling agent and who have abdomen wound and skin disease.
Mode of operation: B-mode.
Intended user population: Trained and qualified healthcare professionals.
Intended use environment:Professional health care facilities.
The Bladder Scanner (model:M5) designed and manufactured by SUZHOU PEAKSONIC MEDICAL TECHNOLOGY CO., LTD. is a kind of B mode noninvasive bladder volume measurement and bladder wall thickness measurement based on ultrasonic imaging and measurement principle. The Bladder Scanner (model:M5) is composed of main device, probe, trolley and upper computer software. The main device and probe measure bladder wall thickness, and thickness, and they can transmit the patient information and measurement result to upper computer running upper computer software by WIFI or USB to manage and process patient's data, and the main device include print function.
The provided 510(k) summary for the Bladder Scanner (Model Name: M5) by Suzhou Peaksonic Medical Technology Co., Ltd. does not include a specific study detailing acceptance criteria and reported device performance in the format requested.
The document focuses on demonstrating substantial equivalence to a predicate device (Wireless Probe Type Ultrasound Scanner, Model: BProbe, K172750) through a comparison of technological characteristics and compliance with various international standards for safety, EMC, biocompatibility, and software.
While there is a mention of "Performance verification" with an "Internal verification protocol," the details of this protocol, including specific acceptance criteria and the results of the performance are not explicitly provided in the summary. The summary states that there are "slight difference in measurement range, measurement accuracy, and acoustic output, the subject device has wider measurement range and more accurate measurement accuracy, the measurement range and accuracy were verified." However, the actual acceptance criteria and the verified performance values are not tabulated.
Therefore, many parts of your request for specific details of the acceptance criteria and the study that proves the device meets them cannot be fully answered from the provided text.
Based on the available information, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table with "acceptance criteria" and "reported device performance" in the typical sense of a clinical or performance study with quantified metrics and thresholds. Instead, it refers to the device having a "wider measurement range" and "more accurate measurement accuracy" than the predicate, and states that these were "verified."
Measurement Accuracy (Compared to Predicate):
| Criterion (Implicit) | Reported Device Performance (M5) | Predicate Device Performance (K172750) |
|---|---|---|
| Bladder Volume Measurement Accuracy (for 10-999ml) | ±7%, ±7ml | ±10% |
Measurement Range (Compared to Predicate):
| Criterion (Implicit) | Reported Device Performance (M5) | Predicate Device Performance (K172750) |
|---|---|---|
| Volume Measurement Range | 10-999ml | 10-999ml (No difference stated, but "wider measurement range" is claimed in "Note 3") |
Other Performance-Related Characteristics (not explicit acceptance criteria, but comparisons):
| Characteristic | Proposed Device (Bladder Scanner, M5) | Predicate Device (Wireless Probe Type Ultrasound Scanner, BProbe) |
|---|---|---|
| Transducer Frequency | 2.5 MHz | 3.5MHz |
| Penetration Depth | 190mm | ≥150mm |
| Maximum MI | 0.8 | 0.47 |
| Maximum TIS | 0.06 | 0.037 |
2. Sample Size for the Test Set and Data Provenance
The document states: "Clinical testing is not required" and mentions "Internal verification protocol 1" for performance verification. This implies that the performance data for the "more accurate measurement accuracy" was likely derived from internal testing, possibly using phantoms or simulated data, rather than a clinical human test set.
- Sample Size for Test Set: Not specified.
- Data Provenance: Likely internal verification, not specified as human clinical data. No country of origin is mentioned for specific test data, apart from the manufacturer being in China.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Given the statement "Clinical testing is not required," there is no indication of experts being used to establish ground truth for a clinical test set. If the performance verification involved phantoms or other non-clinical methods, the "ground truth" would be the known properties of those phantoms.
4. Adjudication Method
Not applicable, as no clinical test set with expert adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was conducted or presented. The submission focuses on substantial equivalence based on technical specifications and international standard compliance, not a comparative effectiveness study with human readers.
6. Standalone Performance
The claimed "measurement accuracy" of ±7%, ±7ml refers to the standalone performance of the device's volume calculation algorithm. Details of the study or verification that quantified this accuracy are not provided beyond the mention of an "Internal verification protocol."
7. Type of Ground Truth Used
For the accuracy claim, the ground truth would likely be the known volumes of phantoms or carefully measured fluid volumes if internal verification protocols were used. The document does not specify the exact nature of the ground truth used for this verification.
8. Sample Size for the Training Set
The document does not mention any machine learning or AI components that would require a dedicated training set. The device is described as operating based on "ultrasonic imaging and measurement principle" and "complex algorithm is used to calculate the bladder volume." If these algorithms involve learning, the training set size is not disclosed.
9. How Ground Truth for the Training Set Was Established
Not applicable, as no training set is explicitly mentioned for algorithm development.
§ 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.