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The Verathon Inc. BladderScan® BVI 9600 with AortaScan® Mode is a user selectable, dual-function ultrasound device that projects ultrasound energy either into the lower abdomen to obtain an image of the bladder for measuring bladder volume, or into the mid-abdomen to obtain an image of the abdominal aorfa for aorlic diameter measurement.

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application: General (Track I only), Specific (Tracks I & III)
Specific: Abdominal, Other (Abdominal Aorta Measurement), Other (Bladder)
Mode of Operation: B (for Abdominal), N (for Abdominal Aorta Measurement), P (for Bladder)

The BVI9600, with AortaScan®, is a B-mode ultrasonic instrument that is portable and battery operated. The BVI 9600 has two user controlled modes of operation; (1) - Bladder Volume Measurement and (2)- Abdominal Aortic Measurement, both noninvasive. Either bladder volume or aortic diameter measurement functions can be chosen by a button press. When the scan button is pressed the BVI9600 uses patented Vmode® technology to measure ultrasonic reflections on multiple planes inside the body to produce a 3dimensional image. Based on these images and the mode of operation chosen, the BV19600 either calculates and displays the bladder volume (BladderScan® mode) or calculates and displays the abdominal aortic diameter (AortaScan® mode). The 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. Bladder volume (in BladderScan® mode), aortic diameter (in AortaScan® mode), mode selection, directional aiming, battery status, and usage rate indicators are all displayed on the BV19600 LCD display. The instrument contains a thermal printer that allows the user to print exams with a single button click.

New device: The Verathon Inc. BladderScan® BVI 9600 with AortaScan® is a user selectable dual function ultrasound device that projects ultrasound energy either into the lower abdomen to obtain an image of the bladder for measuring bladder volume or the mid abdomen to obtain an image of the abdominal aorta for aortic diameter measurement.

The Verathon Inc. BladderScan® BVI 9600, with AortaScan®, and its integrated 3.0 MHz mechanical sector transducer operate only in B-mode to locate and automatically measure bladder volume (in BladderScan® Mode) or abdominal aortic diameter (in AortaScan® Mode). The same transducer is driven at 1.74 MHz to obtain a second harmonic for enhanced bladder wall detection. Bladder volume (in BladderScan® Mode), aortic diameter (in AortaScan® Mode), patient gender, non optimal directional aiming, battery status, and usage rate indicators are all displayed on the Verathon Inc. BladderScan® BVI 9600 Ultrasound System scanner. The ultrasonic power transmitted from the system is not user adjustable.

The portable Verathon Inc. BladderScan® BVI 9600 Ultrasound System with AortaScan® is applied to the patient's abdomen along with Sontac Ultrasound Coupling Gel to obtain aortic measurement. The BladderScan® BVI 9600 Ultrasound System transducer collects cross- sectional images of the bladder or aorta from twelve (12) scan planes. From this information, the Verathon Inc. BladderScan® BVI 9600 Ultrasound System constructs a finite element model of the bladder (in BladderScan® Mode) or aorta (in AortaScan® Mode) and automatically computes the volume of urine via volumetric integration (for the bladder measurement) or the diameter of the aorta (for aortic measurement), depending on the mode of operation chosen (AortaScan® or BladderScan®).

The provided document describes the Verathon Inc. BladderScan® BVI 9600 Ultrasound System with AortaScan®. The system has two main functions: BladderScan® for bladder volume measurement and AortaScan® for abdominal aortic diameter measurement.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the comparison to existing, already cleared devices and the use of phantoms with known dimensions. The document does not provide specific numerical acceptance criteria (e.g., "accuracy must be within X%"). Instead, it states that the device's performance is demonstrated by comparing its measurements to the known values of the phantoms and to measurements from predicate devices.

"In addition to these measurements, additional measurements are taken by standard ultrasound systems, such as the Sonosite 180, to compare bladder volume measurements..." |
| | Accuracy demonstrated by comparing measurements to a bladder phantom with known volumes. | "The BladderScan® Phantom is essentially a balloon which gets filled with urine mimicking material ... This balloon is a known volume and can be compared to the BladderScan® measurements from the BVI 9600."

"These results obtained through the Verathon Inc. BladderScan® BVI 9600 Ultrasound System are compared to the expected results derived from the NIST traceable measurements." |
| AortaScan® Mode | Equivalence to the Sonosite MicroMaxx Ultrasound System (K053069) for aorta scan measurements. | "Summary and Conclusion of Non Clinical and Clinical Testing... equivalent to the Sonosite MicroMaxx Ultrasound System (K053069)for aorta scan measurements."

"In addition to these measurements, additional measurements are taken by standard ultrasound systems, such as the Sonosite 180, to compare ... aortic measurements." |
| | Accuracy demonstrated by comparing measurements to an aortic phantom with known diameters (including an aneurism). | "The AortaScan® phantom is essentially a tube roughly the length of an adult aorta, with a bulge in the length of the tube that represents an aortic aneurism, filled with blood mimicking material that is surrounded by tissue mimicking material. Known diameters of the tube can then be compared to the AortaScan® measurements from the BVI 9600."

"AortaScan® accuracy has been demonstrated by comparing the AortaScan® Phantom measurements to the measurements of the Verathon Inc. BladderScan® BVI 9600 Ultrasound System." |
| Acoustic Output | Within Pre-amendment limits. | "All acoustic output measurements for the BladderScan® BVI 9600 Ultrasound System with AortaScan® are not changed from the BladderScan® BVI 9400 Ultrasound System and remain within Pre-amendment limits." |

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

The document does not specify a "test set" in terms of human subjects or a dataset of clinical images. The testing was conducted using physical phantoms.

• Aortic Phantom: Designed to represent an adult aorta with a bulge for an aneurism, filled with blood-mimicking material.
• Bladder Phantom: A balloon filled with urine-mimicking material, surrounded by tissue-mimicking material.

The data provenance is from phantom measurements, which are controlled laboratory environments, not human data or real-world clinical data. The phantoms themselves were sourced from "third-party vendors": Blue Phantom (aortic) and Computer Imaging Reference Systems (CIRS) (bladder).

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

The ground truth for the test set (the phantoms) was established by the manufacturers of the phantoms (Blue Phantom and CIRS).

• "During the manufacturing processes, both Blue Phantom and CIRS measure key parameters of the physical parts as the parts are constructed."
• "These measurements are all NIST traceable and each phantom comes with a certification sheet listing the measurements."

No "experts" in the sense of medical professionals were used to establish the ground truth for these phantom measurements. The ground truth relies on NIST traceable engineering measurements by the phantom manufacturers.

4. Adjudication Method for the Test Set

No adjudication method (like 2+1, 3+1 consensus) was used, as the "test set" consisted of physical phantoms with established, NIST-traceable dimensions. The comparison was directly between the device's measurements and these known dimensions.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was mentioned. The study described focuses on device performance against known phantom values and comparison to predicate devices, not on human reader performance with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, the described study is a standalone performance evaluation. The device (algorithm and hardware) automatically measures bladder volume or aortic diameter. The evaluations against the phantoms and predicate devices directly assess this standalone measurement capability.

7. Type of Ground Truth Used

The ground truth for both the BladderScan® and AortaScan® modes was based on engineering measurements of physical phantoms. These measurements were "NIST traceable" and documented on a "certification sheet."

8. Sample Size for the Training Set

The document does not specify a training set sample size. This is common for this type of 510(k) submission, especially for a device primarily relying on known principles of ultrasound measurement and comparison to predicate devices rather than a new machine learning algorithm trained on a large dataset. The device leverages "patented Vmode® technology" and is described as "identical" to a previous cleared device in hardware, software, and calibration for the bladder function.

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

Since no specific training set or associated ground truth establishment method is mentioned, this information is not available in the provided text. The device's underlying technology and calibration are likely based on established ultrasound physics and engineering principles, and potentially on internal development and testing data that are not explicitly detailed as a "training set" in this summary.

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