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The Wireless Probe Type Ultrasound Scanner (Model: UProbe-C) (frequency: 3.5Hz, module: convex) is intended for diagnostic ultrasound echo imaging, measurement, and analysis of the human body for general clinical applications including obstetrics (OB), gynecology (GY) and general (abdominal) imaging.

The Wireless Probe Type Ultrasound Scanner (Model: UProbe-L) (frequency: 7.5Hz, module: linear) is intended for diagnostic ultrasound echo imaging, measurement, and analysis of the human body for general clinical applications including small organ and peripheral vessel imaging.

The Wireless Probe Type Ultrasound Scanner (Model: BProbe) 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.

The Wireless Probe Type Ultrasound Scanner (Model: UProbe-C; UProbe-L; BProbe) is a wireless ultrasound system that uses pulsed-echo technology to transmit ultrasound images via wireless communication to a mobile device that utilizes the iOS operating system.

The mobile device for use with the Wireless Probe Type Ultrasound Scanner (Model: UProbe-C; UProbe-L; BProbe) are those that utilizes the iOS operating system, i.e. all series of iPad or iPhone from Apple Inc.

The Wireless Probe Type Ultrasound Scanner is a portable, general-purpose, software-controlled, hand-held diagnostic ultrasound system that consists of (i) a commercial off-the-shelf iOS mobile device, (ii) the Wireless Probe Type Ultrasound Scanner software that runs as an app on the mobile device, (iii) the battery-operated, hand-held Wireless Probe Type Ultrasound Scanner transducer that communicates wirelessly with iOS mobile devices, and (iv) the instructions for use manual, USB Cable for Charging, wrist wrap.

The Wireless Probe Type Ultrasound Scanner utilizes pulsed-echo technology to determine the depth and location of tissue interfaces, and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. Ultrasound waves are emitted from the transducer, propagate through tissues, and return to the transducer as reflected echoes. The returned echoes are then converted into electrical impulses by transducer crystals and further processed in order to form the ultrasound image presented on the screen.

The device components are not supplied sterile and do not require sterilization prior to use.

The provided document is a 510(k) summary for the Wireless Probe Type Ultrasound Scanner (Models: UProbe-C, UProbe-L, BProbe). It establishes substantial equivalence to predicate devices rather than providing a study proving performance against acceptance criteria for an AI/ML device.

Therefore, most of the requested information regarding acceptance criteria, reported performance, sample sizes, ground truth, experts, adjudication, and MRMC studies for an AI/ML device is not available in the provided text. The document describes a traditional medical device (ultrasound scanner) and its non-clinical testing for safety and effectiveness to demonstrate equivalence to existing devices.

Here's what can be extracted from the document:

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

This information is not directly provided in the context of device performance metrics against specific acceptance criteria. Instead, the document focuses on demonstrating that the device meets general safety and effectiveness standards comparable to predicate devices. The "reported device performance" is implicitly that it meets the requirements of the standards listed below.

For the BProbe model, specific accuracy for bladder volume measurement is mentioned:

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified. The document states non-clinical tests were performed according to standards. There is no mention of a "test set" in the context of diagnostic performance evaluation with patient data.
• Data Provenance: Not applicable, as no clinical data or test sets from patients are described for performance evaluation. The "tests performed" section indicates non-clinical (engineering and safety) tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. There is no mention of expert-established ground truth for a test set, as no clinical performance study involving diagnostic interpretation is described.

4. Adjudication method for the test set

• Not applicable. No test set requiring adjudication is described.

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, and the device is an ultrasound scanner, not an AI/ML diagnostic aid for human readers.

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

• Not applicable. This is a medical imaging device, not an algorithm.

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

• Not applicable. As described in this document, the device itself is an ultrasound imaging system and not an AI/ML algorithm requiring diagnostic ground truth for performance evaluation of its interpretations. The ground truth for the non-clinical tests would be defined by the specifications and protocols of the listed ISO/IEC standards (e.g., electrical parameters, acoustic output measurements, material properties).

8. The sample size for the training set

• Not applicable. This document describes an ultrasound scanner, not an AI/ML algorithm that requires a training set.

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

• Not applicable. This document describes an ultrasound scanner, not an AI/ML algorithm requiring a training set.

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