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510(k) Data Aggregation
(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.
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(284 days)
The Bladder Scanner (Models: M3, M4, M4-HD) is B-mode pulsed-echo ultrasound device. It intended as a handheld battery-operated device. The M3, M3-HD, M4, M4-HD 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 M3, M3-HD, M4, M4-HD Bladder Scanner is intended to be used only by qualified medical professionals.
The M Series Bladder Scanner is a handheld battery-operated device, which is developed by SUZHOU PEAKSONIC MEDICAL TECHNOLOGY CO., LTD., and manufactured by Suzhou Lischka Medtech Co., Ltd., it provides non-invasive bladder volume measurement utilizing real-time ultrasound imaging. The device consists of the main unit, 3D probe (M4, M4-HD)/2D probe (M3, M3-HD), Data processing and storage modules, APP software, battery and Charger.
Here's a breakdown of the acceptance criteria and the study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in an "acceptance criteria" section. However, it does list the "Volume measurement accuracy" and implicitly sets the predicate device's performance as the benchmark for substantial equivalence.
| Metric / Parameter | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Subject Device) |
|---|---|---|
| Bladder Volume Measurement Accuracy (M4/M4-HD) | Under 100 mL: ± 7 mL100 to 999 mL: ± 7% | Under 100 mL: ± 7 mL 100 to 999 mL: ± 7% |
| Bladder Volume Measurement Accuracy (M3/M3-HD) | Under 100 mL: ± 14 mL100 to 999 mL: ± 14% | Under 100 mL: ± 14 mL 100 to 999 mL: ± 14% |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "Clinical testing is not required." This implies that no clinical test set with human patients was used to prove the device meets these specific performance metrics. The performance metrics are likely derived from non-clinical phantom studies or internal validation processes that are not detailed in this summary. Therefore, there is no information on sample size or data provenance (country of origin, retrospective/prospective) for a clinical test set.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Since clinical testing was not required, there is no mention of experts being used to establish ground truth for a test set in the context of human patient data.
4. Adjudication Method
Not applicable, as no clinical test set with human data was used requiring expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document clearly states that clinical testing was not required. Therefore, no MRMC study comparing human readers with and without AI assistance was performed.
6. Standalone (Algorithm Only) Performance Study
The document focuses on the device performance and states that "The M3,M3-HD,M4,M4-HD Bladder Scanner was evaluated with safety, EMC and Acoustic Output." It provides performance accuracy figures for volume measurement. This suggests that the algorithm's performance, as integrated into the device, was evaluated to achieve these accuracy figures. While the term "standalone study" in the context of an algorithm might imply a specific type of evaluation (e.g., using a separate dataset to test the algorithm's output without the full device), the volume measurement accuracy directly reflects the algorithm's capability.
7. Type of Ground Truth Used
Based on the lack of clinical testing, the ground truth for the stated performance accuracy (bladder volume measurement) was likely established through:
- Phantom studies: Using calibrated phantoms with known volumes. This is a common method for validating ultrasound device accuracy.
- Engineering measurements: Direct measurements of physical models.
The document does not specify the exact method for establishing ground truth for the performance metrics, but it is implied to be non-clinical.
8. Sample Size for the Training Set
The document does not provide any information regarding the training set size for the device's algorithms.
9. How the Ground Truth for the Training Set Was Established
The document does not provide any information regarding how the ground truth for the training set (if any, as it could be rule-based or trained on phantom data) was established.
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