(115 days)
The Bladder Scanner(model: PadScan HD2) is B-mode pulsed-echo ultrasound device. It intended as a handheld batteryoperated device. The PadScan HD2 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 PadScan HD2 Bladder Scanner is intended to be used only by qualified medical professionals.
The PadScan HD2 Bladder Scanner manufactured by Caresono Technology provides real-time ultrasound imaging and measuring, and also provides non-invasive volume measurement of the bladder. It is a handheld bladder scanner, the main unit and the probe are all-in-one.
It features:
- · Expert operating mode and Easy operating mode
- · Non-invasive, comfortable, correct, reliable, fast and simple operation
- SD card storage
- Voice recording function
- Urine volume setting and alarm setting
- Multi-language selection
- · Injection molded shell, the main unit and the probe are all-in-one, 2.5-inch LCD screen(240x320pixels)
- Power supply with built-in battery.
The provided document is a 510(k) summary for the Caresono Technology Co., Ltd. PadScan HD2 Bladder Scanner. It details the device's indications for use, its comparison to a predicate device, and the non-clinical testing performed to establish substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (PadScan HD2 Bladder Scanner) |
|---|---|
| Bladder volume range: 0-999ml | Bladder volume range: 0-999ml |
| Accuracy: ±15%, ±15ml | Accuracy: ±15%, ±15ml |
Study Proving Acceptance Criteria:
The document states: "The PadScan HD2 Bladder Scanner had been tested volume accuracy per the FDA Guidance document 'Information for Manufactures Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers' issued in September 2008. All the test results comply with the pre-set acceptability criterion, which is the same as predicate device."
Additional Information:
Since this is a 510(k) summary focused on establishing substantial equivalence through non-clinical testing, it primarily details engineering and performance benchmarks against an existing predicate device rather than comprehensive clinical study data. Many of the requested details related to human reader studies, ground truth establishment, and sample sizes for clinical trials are not typically found in this type of submission for a device like a bladder scanner, which primarily relies on established physical principles and performance accuracy.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided document for volume accuracy testing. The testing mentioned is "Bench Testing."
- Data Provenance: Not specified, but given it's bench testing, it's likely conducted in a controlled lab environment by the manufacturer in China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/not specified. The volume accuracy testing described is mechanical or phantom-based bench testing, not reliant on expert interpretation of clinical data in the same way an AI diagnostic algorithm might be.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/not specified. This term typically refers to the resolution of discrepancies among human readers in clinical studies, which is not described for this bench testing.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study is not mentioned. This type of study would be more relevant for an AI-powered diagnostic imaging interpretation tool, not a bladder volume measurement device based on pulsed-echo ultrasound. The device calculates bladder volume non-invasively, not assisting human readers in interpreting complex images to improve diagnostic accuracy.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, the performance testing for volume accuracy described (
10.3 Performance-Bench Testing) appears to be a standalone evaluation of the device's ability to measure volume against a known standard. The device "projects ultrasound energy...to calculate bladder Volume noninvasively," implying an algorithmic calculation of volume based on the ultrasound data, without human interpretation of the final volume number.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the volume accuracy testing, the ground truth would likely be a precisely measured phantom or known volume of fluid, as typically used in bench testing for such devices. The document does not explicitly state the specific ground truth, but refers to "pre-set acceptability criterion."
8. The sample size for the training set:
- Not applicable/not specified. The document does not describe an AI or machine learning component that would require a distinct training set in the context of diagnostic performance testing. The device is described as a "B-mode pulsed-echo ultrasound device" that calculates volume, implying traditional signal processing and measurement algorithms rather than machine learning models that are "trained."
9. How the ground truth for the training set was established:
- Not applicable/not specified, as no training set for an AI/ML algorithm is described.
§ 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.