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The BladderScan® PRIME PLUS system is an ultrasound device intended to be used for measuring urine volume of the bladder non-invasively.

The BladderScan" PRIME PLUS system provides non-invasive measurement of urinary bladder volume. The system calculates the bladder volume using patented neural network technology. Volume measurements made with this technology are based on a more complex, multifaceted image of the bladder.

Bladder volume, directional aiming with real-time feedback, battery status and usage rate indicators are displayed on the LCD display. The system operates using a battery which includes a charging cradle.

The provided text describes the Verathon BladderScan® PRIME PLUS system, an ultrasound device for non-invasive measurement of bladder urine volume. However, the document explicitly states that "The BladderScan® PRIME PLUS System, subject of this submission, did not require clinical studies to support the determination of substantial equivalence." This means that a study proving the device meets acceptance criteria was not conducted or provided in this submission for the purpose of demonstrating substantial equivalence. Instead, the submission relies on the device's technological characteristics being substantially equivalent to a predicate device (BladderScan® PRIME System K153101).

Therefore, I cannot provide details about acceptance criteria and a study that proves the device meets them because such a study was not required for this 510(k) submission and is not described in the provided text.

The closest information available regarding performance is the "Measurement Accuracy" listed under the "Technological Characteristics and Performance" comparison table on page 6, which states:

• Verathon BladderScan® PRIME PLUS System (This submission):
  • 0-100 mL = ±7.5 mL
  • 100-999 mL = ±7.5%
• Predicate Verathon BladderScan® PRIME System (K153101):
  • ±15% ±15mL

This indicates that the new device has improved measurement accuracy compared to its predicate. However, this table is a
comparison of specifications, not a result of a new clinical study.

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The BladderScan® Prime system is an ultrasound device intended to be used for measuring the urine in the bladder non-invasively.

The BladderScan" Prime system instrument provides noninvasive measurement of urinary bladder volume. The instrument calculates the bladder volume using patented NeuralHarmonics technology, which is easy to use and comfortable for the patient. Volume measurements made with NeuralHarmonics are accurate than those from conventional two-dimensional ultrasound as they are based on a more complex, three-dimensional image of the bladder.

Bladder volume, mode (male, female and small child), directional aiming with real-time feedback, battery status and usage rate indicators are displayed on the LCD display. The system also includes a battery charger for custom, user-replaceable lithium-ion batteries included with the system,

The provided text is a 510(k) summary for the BladderScan® Prime System. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device (BladderScan® BVI 9400), rather than outlining a standalone clinical study with detailed acceptance criteria and performance data for a new device's accuracy against a ground truth.

Therefore, the document does not contain the specific information requested regarding acceptance criteria and a study proving the device meets those criteria in the context of an accuracy study (e.g., against a ground truth). It primarily details the technological characteristics, intended use, and safety standards compliance to show equivalence.

However, it does provide one quantitative metric which can be interpreted as an acceptance criterion for measurement accuracy based on the predicate device's performance.

Here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the proposed device (BladderScan® Prime) intends to meet the same accuracy and range specifications as the predicate. It does not provide new, independent study results to prove this for the BladderScan® Prime specifically. It relies on the assertion that "The BladderScan® Prime system and BladderScan® BVI 9400 system are both Track 1 devices that employ the same fundamental technology." implying similar performance.

Missing Information (not found in the provided text):

• 2. Sample size used for the test set and the data provenance: Not mentioned. The document primarily discusses comparisons of technical specifications and safety standards, not a specific clinical test set for accuracy.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as a clinical accuracy study with ground truth establishment is not described.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: 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: Not applicable. This device is an ultrasound system for measuring bladder volume, not an AI-assisted diagnostic imaging device for human reader improvement studies.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device itself is an algorithm for calculating bladder volume from ultrasound data. Its performance is stated to be "± 15% ± 15mL", but no specific study demonstrating this standalone performance for the Prime system is detailed. It is inherited from the predicate.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not detailed. For bladder volume measurement, the gold standard for ground truth often involves catheterization or direct measurement during surgery, but no such method is described for validating the new device. The document implies that the "NeuralHarmonics technology" provides a more complex, three-dimensional image of the bladder, leading to more accurate volume measurements, but it doesn't describe the validation process.
• 8. The sample size for the training set: Not applicable. This is not an AI/ML device in the modern sense that learns from a training set. It's an ultrasound device applying a specific calculation algorithm.
• 9. How the ground truth for the training set was established: Not applicable.

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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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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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The BladderScan® BVI 9400 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 and bladder wall mass noninvasively.

Contraindications:

• The BladderScan® BV19400 is contraindicated for fetal use and for use on pregnant patients.

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application: Other (Bladder) Mode of Operation: N
Clinical Application: Abdominal Mode of Operation: P

The Verathon Inc. BladderScan® BVI 9400 Ultrasound System is a portable, battery powered, software controlled ultrasound system used to acquire and display real time B-mode images of the bladder. The system is intended to non invasively monitor bladder volume on an intermittent basis. The system is an effective, low cost, simple to use option for use in a clinical hospital or nursing home setting or for home use under medical supervision.

The Verathon Inc. BladderScan® BVI 9400 Ultrasound System and its integrated 3.0 MHz mechanical sector transducer operate only in B-mode to locate and automatically measure bladder volume. The same transducer is driven at 1.74 MHz to obtain a second harmonic for enhanced bladder wall detection. Bladder volume, patient gender, non optimal directional aiming, battery status, and usage rate indicators are all displayed on the Verathon Inc. BladderScan® BVI 9400 Ultrasound System scanner. The ultrasonic power transmitted the system is not user adjustable. The portable Verathon Inc. BladderScan® BVI 9400 Ultrasound System is applied to the patient's abdomen with a single patient use Sontac® hydrogel pad, manufactured by Verathon Inc. BladderScan® BVI 9400 Ultrasound System. The transducer collects cross-sectional images of the bladder from twelve (12) scan planes. From this information, the Verathon Inc. BladderScan® BVI 9400 Ultrasound System constructs a finite element model of the bladder and automatically computes the volume of urine via volumetric integration.

Here's an analysis of the acceptance criteria and study proving the device meets them, based on the provided text:

Device: Verathon Inc. BladderScan® BVI 9400 Ultrasound System
Intended Use (from the provided text, specifically page 6 and 7):

• To project ultrasound energy through the lower abdomen of the nonpregnant patient to obtain an image of the bladder.
• To calculate the bladder volume and bladder wall mass noninvasively.

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary focuses primarily on equivalence to a predicate device and safety, rather than explicit numerical acceptance criteria for accuracy against a gold standard in a clinical setting. However, the mention of "accuracy has been demonstrated by comparing CIRS measurements to the measurements of the Verathon Inc. BladderScan® BVI 9400 Ultrasound System" suggests that the implied acceptance criterion is that the device's measurements are consistent with known measurements from a standardized phantom.

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

• Sample Size: Not explicitly stated as a number of phantoms. The text refers to "tissue equivalent phantoms with known dimensions" and "each phantom comes with a certification sheet listing the measurements." It implies the use of one or more BladderScan Phantoms created by CIRS.
• Data Provenance: The 'data' for the test set is derived from phantom measurements. These phantoms were built by Computerized Imaging Reference Systems (CIRS), a vendor known for supplying medical imaging phantoms. The measurements provided by CIRS are NIST traceable. This is a prospective study design as the phantoms were specifically built for testing this device. There is no mention of human subject data for this specific accuracy assessment, rather a phantom study.

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

• Number of Experts: Not applicable. The ground truth for the test set was established by the NIST traceable measurements provided by CIRS when constructing the phantoms.
• Qualifications of Experts: Not applicable. The ground truth relies on physical measurements and established phantom production standards, not human expert consensus.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The "ground truth" (known phantom dimensions/volumes) is inherent in the phantom's construction via NIST traceable measurements. The comparison is between the device's output and these known values, not between human interpretations.

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

• MRMC Study: No, an MRMC study was not done. The study described is a phantom study specifically comparing the device's measurements to known phantom volumes. There is no mention of human readers or AI assistance in this context.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done

• Standalone Study: Yes, effectively. The device is designed to automatically compute bladder volume via volumetric integration from collected cross-sectional images. The assessment described (comparing the device's calculation to known phantom volumes) is a standalone performance evaluation of the device's algorithmic capability without human intervention in the measurement process itself.
  • The statement "The Verathon Inc. BladderScan® BVI 9400 Ultrasound System constructs a finite element model of the bladder and automatically computes the volume of urine via volumetric integration" supports that this is a standalone measurement.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth used is physical measurements from manufactured phantoms with NIST traceability. The phantoms are designed to mimic bladder and tissue, and their internal volumes and dimensions are known and certified.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not explicitly stated in the provided text. The document describes a performance study for the device, not the development or training of an AI model within the device. The device uses "finite element model" and "volumetric integration," suggesting a rule-based or algorithmic approach rather than a machine learning model that would require a distinct "training set."

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

• Ground Truth for Training Set Establishment: Not applicable. As mentioned, the document does not describe the development or training of a machine learning model, but rather the performance evaluation of a device using an algorithmic approach. Therefore, there is no "training set" or corresponding ground truth establishment process described for such a set.

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