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The BladderManager PCI 5000 and BladderScan BVI 5000 "project ultrasound energy through the lower abdomen of the non-pregnant patient to obtain an image of the bladder that is used to determine bladder volume non-invasively."

The BladderManager PCI 5000 is a portable, battery-powered ultrasound instrument designed for a patient to non-invasively monitor his or her bladder volume on an intermittent basis. The BladderScan BVI 5000 is similar, except that it is designed for use by the clinician with the added feature of a "docking cradle" containing an onboard computer that provides a hard copy printout of the scan images and the bladder volume.

The provided text does not contain detailed acceptance criteria or a comprehensive study report with the specific information requested in your bullet points (e.g., specific performance metrics, sample sizes for test and training sets, expert qualifications, or adjudication methods).

The document describes the submission of a 510(k) summary for the BladderManager PCI 5000 and BladderScan BVI 5000 devices, asserting their substantial equivalence to a predicate device (BladderScan BVI 2500). It mentions clinical testing but provides only a high-level summary.

Here's what can be inferred from the provided text, and where information is missing:

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

The document states that "clinical accuracy testing demonstrated that the subject devices are substantially equivalent to the predicate device in terms of effectiveness." It also mentions "All non-clinical testing demonstrated that the subject devices are substantially equivalent to the predicate device in terms of safety, effectiveness, and performance." However, specific quantitative acceptance criteria or reported performance metrics (e.g., accuracy percentages, sensitivity, specificity, or specific error ranges for bladder volume measurement) are not provided.

2. Sample sized 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:
  • "Preliminary clinical testing of the BladderManager PCI 5000 and the BladderScan BVI 5000 was performed on adult ambulatory volunteers." (Specific number of volunteers not provided).
  • "Clinical testing of the BladderManager PCI 5000 was performed at three independent clinical sites using adult spinal cord diseased patients, as well as healthy volunters." (Specific number of patients/volunteers not provided).
• Data Provenance: The location of the "three independent clinical sites" is not specified, though the company has offices in the USA, Canada, and The Netherlands. It's unclear if the participants were from the US or international, and whether the data was retrospective or prospective is not explicitly stated, although "preliminary clinical testing" and "clinical testing" generally imply prospective data collection in the context of device approval.

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 in the text. The document refers to "clinical accuracy testing" but does not detail how the "ground truth" for bladder volume was established (e.g., catheterization, MRI, or another method) or who performed these measurements and their qualifications.

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

This information is not provided.

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

This is not applicable as the device is an "Ultrasonic Bladder Volume Instrument" which directly measures volume, not an AI-assisted diagnostic tool interpreted by human readers. It's a standalone measurement device.

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

Yes, the device itself is a "standalone" instrument designed to measure bladder volume. The clinical testing mentioned assessed the performance of the device itself (the "algorithm" or measurement capability) against some implied standard of effectiveness.

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

The specific type of ground truth used for bladder volume measurement is not explicitly stated. For bladder volume measuring devices, a common "ground truth" method in clinical studies is catheterization, or using another validated imaging modality (e.g., MRI) as a reference. The document only mentions "clinical accuracy testing."

8. The sample size for the training set

This information is not provided. The text focuses on clinical testing for substantial equivalence, not on the development or training of an algorithm for the device. If the device uses an algorithm, details on its training set are not included here.

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

This information is not provided, as details about a "training set" are absent.

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