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• Abdomen, B-Mode, per Indications for Use Ultrasound Form .
• The BladderScan® BVM 9500 is intended to project ultrasound energy through . the lower abdomen to obtain an image of the bladder and measure urinary bladder volume and mass non-invasively.
• Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal, Other (Bladder)

The BladderScan® BVM 9500 is a B-mode ultrasonic instrument, portable and battery operated, intended for the noninvasive measurement of urinary bladder volume and bladder mass. The BladderScan® BVM 9500 calculates the bladder volume and mass using patented Vmode® technology. Vmode ultrasound is easy to use and comfortable for the patient. When you release the scan button, within seconds, the Vmode technology measures ultrasonic reflections on multiple planes inside the body and produces a 3-dimensional image. Based on this image, the BladderScan® calculates and displays the bladder volume and bladder mass. Volume measurements made with Vmode ultrasound are more accurate than those from conventional 2-dimensional ultrasound, as they are based on a more complex, 3-D image of the bladder. Bladder volume and mass, mode (uterus detection or standard BladderScan), directional aiming with real-time feedback, battery status, and usage rate indicators are all displayed on the BladderScan® BVM 9500 LCD display. The instrument contains a thermal printer that will allow the user to print exams with a single button click.

Here's a breakdown of the acceptance criteria and study information for the Verathon Inc. BladderScan® BVM 9500 Ultrasound System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to previously cleared devices. The study compares the performance of the BVM 9500 against known volumes and wall thicknesses of phantoms.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated, but the study used "tissue equivalent phantoms with known dimensions." The text implies multiple phantoms were used to demonstrate accuracy for both volume and mass.
• Data Provenance: The testing was conducted using synthetic phantoms manufactured by CIRS. This is a controlled, laboratory-based environment, not real-world patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Number of Experts: Not applicable.
• Qualifications of Experts: Not applicable.
• Method of Ground Truth Establishment: The ground truth was established by the known dimensions of the tissue-equivalent phantoms provided by CIRS. These phantoms are designed to have quantifiable and precise characteristics (known volume and wall thickness).

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The "ground truth" was the known physical properties of the phantoms, not subjective expert assessment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• MRMC Study: No, an MRMC comparative effectiveness study was not conducted or reported in the provided text. This study focused on the standalone performance of the device against phantoms.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

• Standalone Study: Yes, the described study is a standalone performance evaluation. The BladderScan® BVM 9500's ability to measure bladder volume and mass was assessed directly against the known values of the phantoms, without involving human readers or human-in-the-loop performance.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth used was phantom-based known dimensions. Specifically, the phantoms had "known volume and wall thickness."

8. The Sample Size for the Training Set

• Sample Size: The document does not provide information about a separate "training set" or its size. The device calculates volume and mass using "patented Vmode® technology" and algorithms, but the development and training process for these algorithms are not detailed in this section. The focus is on the validation of the finalized device.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth for Training Set: Not discussed in the provided text. The document describes the validation of the final product against phantoms, not the internal development or training of its underlying algorithms.

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