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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." This statement of intended use is unchanged with the DxU Gel Pad.

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. For both instruments, the scanhead is applied to the patient's abdomen with a hydrogel pad providing ultrasound transmission coupling between the scanhead and the patient's body. Standard ultrasound gel can also be used by itself or in addition to the hydrogel pad, depending on patient preference. The hydrogel pad used in the original 510(k) submission, the Koolgel gel pad, is composed of water and polyethylene oxide, manufactured with the identical formulation as a previously cleared device (Ad-Heal wound dressing, K881731). The object of this submission, the DxU Gel Pad, is composed of distilled water, glycerol, gracillaria agar, carrageenan, methyl paraben, and propyl paraben.

This document describes the DxU Gel Pad, an accessory for the BladderScan™ BVI 5000 and BladderManager™ PCI 5000 ultrasonic bladder volume instruments. The submission is a 510(k) summary, aiming to demonstrate substantial equivalence to a predicate device, the Koolgel wound dressing.

It's important to note that this is a medical device accessory submission focusing on the gel pad itself, not the core ultrasonic imaging device. Therefore, the "device performance" in this context refers to the performance of the gel pad in enabling the ultrasonic instruments to function effectively, rather than the performance of an AI algorithm making diagnoses or measurements. Because it is a medical device, AI is not a relevant consideration and thus cannot be included in the response.

Here's a breakdown of the requested information based on the provided text, focusing on the gel pad's performance:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" for the gel pad's performance in terms of specific numerical thresholds for accuracy, sensitivity, or specificity. Instead, the acceptance is based on demonstrating "substantial equivalence" to the predicate device in terms of safety, effectiveness, and performance.

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

• Test Set Sample Size: The document mentions clinical testing was "performed on healthy volunteers, as well as actual spinal cord injured subjects." However, it does not specify the sample size (number of volunteers or subjects) used for this clinical testing.
• Data Provenance: The document does not explicitly state the country of origin for the data. The submission is from Diagnostic Ultrasound Corporation, located in Redmond, WA, USA, suggesting the clinical testing likely occurred in the USA. The study design (retrospective or prospective) is also not explicitly stated, but clinical testing on "volunteers" and "subjects" usually implies a prospective study.

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

Given that this is a 510(k) submission for a gel pad accessory, and the "performance" relates to enabling an ultrasonic instrument, the concept of "ground truth" as established by experts (e.g., radiologists interpreting images) for diagnostic accuracy is not directly applicable in the same way it would be for an AI-driven diagnostic device.

The "ground truth" in this context would likely be the accurate bladder volume measurements obtained by the BladderScan/BladderManager instruments when used with the gel pad, validated against established methods (which are not detailed here for the predicate device either, as it's an accessory submission). The document does not mention the use of experts to establish a "ground truth" for the gel pad's performance in a diagnostic sense.

4. Adjudication Method for the Test Set

As the "ground truth" by expert consensus (e.g., 2+1, 3+1) is not explicitly established for this accessory, an adjudication method is not applicable and therefore not described in the document.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study, typically used to evaluate the impact of an AI algorithm on human reader performance, is not relevant for this submission. This document describes an accessory (gel pad) for an ultrasonic device, not an AI-powered diagnostic tool. Therefore, no such study was performed or reported.

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

This submission is for a gel pad, which is a passive accessory and does not involve an algorithm or AI. Therefore, a standalone performance study (algorithm only) is not applicable and was not performed.

7. Type of Ground Truth Used

The "ground truth" in the context of this submission (gel pad facilitating ultrasonic measurement) would be the accurate bladder volume measurements obtained by the ultrasonic instrument, likely verified by the instrument itself when functioning correctly. The specifics of how this "ground truth" was established for the fundamental bladder volume measurement (e.g., catheterization, other imaging modalities) are outside the scope of this accessory submission and are not detailed here. The submission uses the term "effectiveness" which implies that the gel pad allowed the BVI/PCI 5000 to function as intended, determining bladder volume non-invasively.

8. Sample Size for the Training Set

Since this is a submission for a physical accessory (gel pad) and not an AI algorithm, there is no concept of a "training set" as would be used to train a machine learning model. Therefore, no training set sample size is reported.

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

As there is no training set for an AI algorithm, the question of how its ground truth was established is not applicable to this submission.

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