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The Bladder Scanner is B-mode pulsed-echo ultrasound device adopts a 3D mechanical fan scanning probe for the ultrasonic scanning for bladder and measures the bladder volume from the abdominal surface of ultrasonic imaging. The Bladder Scanner is intended to be used only in hospital and by qualified medical professionals.

The Bladder Scanner (Model: AS-2) is a hand-held battery-operated device, it provides non-invasive bladder volume measurement utilizing real-time ultrasound imaging. The proposed device consists of the main unit (include 3D probe), battery power adapter and USB charging cable.

This FDA 510(k) summary provides information for a device called "Bladder Scanner" (Model: AS-2) by Avantsonic Technology Co., Ltd. The document primarily focuses on establishing substantial equivalence to a predicate device (K201316 Bladder Scanner by Suzhou Peaksonic Medical Technology Co., Ltd.) rather than detailing an independent study against acceptance criteria. However, it does state the acceptance criteria for volume measurement accuracy and reports whether the device met these criteria through non-clinical testing.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Sample Size for Test Set: The document states that the "Bladder Scanner volume measurement accuracy test" was conducted for the measurement range of 0 ml ~ 999 ml, implying a range of volumes were tested to verify accuracy across this spectrum. However, a specific number of samples (e.g., number of measurements, number of phantoms/models used) is not provided.
• Data Provenance: The document does not specify the country of origin for the data or whether the tests were retrospective or prospective. Given that it's a non-clinical test, it likely refers to laboratory testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• This information is not provided. The document mentions non-clinical tests were conducted, which typically involve measuring known volumes using standard metrology rather than expert judgment on images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• This information is not provided. As it refers to non-clinical testing of volume measurement accuracy, an adjudication method in the context of expert review is not applicable.

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 MRMC comparative effectiveness study was done. The document explicitly states: "No clinical study is included in this submission." The device's primary function is to measure bladder volume using ultrasound, not to assist human readers in interpreting complex images or diagnoses.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Yes, in essence, a standalone evaluation was performed in terms of the device's ability to measure volume. The "Bladder Scanner volume measurement accuracy test" assesses the device's algorithmic and hardware performance in calculating volume against known standards, independent of human interpretation or assistance during the measurement process itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• The ground truth for the "Bladder Scanner volume measurement accuracy test" would have been known, precisely measured volumes. These are typically established using phantoms or controlled liquid volumes where the true volume is known and verifiable through other metrological means.

8. The sample size for the training set:

• This information is not provided. The document describes a "Bladder Scanner" which is a hardware device that utilizes ultrasound principles. While it inherently relies on algorithms for volume calculation, the document does not detail any specific "training set" in the context of machine learning or AI. It's more likely based on established physics and signal processing principles rather than a trained AI model in the modern sense.

9. How the ground truth for the training set was established:

• This information is not provided and is likely not applicable in the context of the information given. As mentioned above, the device's mechanism is described in terms of "B-mode pulsed-echo ultrasound" and "3D mechanical fan scanning probe," suggesting a more traditional ultrasound technology rooted in physics rather than a deep learning model requiring a distinct training set with established ground truth labels.

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