(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 mL | |
| 100 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 mL | |
| 100 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.
§ 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.