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New device: The BladderMass™ BVM 6500 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. The BladderMass BVM 6500 is contraindicated for fetal use and for use on pregnant patients.

The Diagnostic Ultrasound BladderMass BVMTM 6500 Ultrasound System is a hand-held, 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 option for use in a clinical hospital or nursing home setting or for home use under medical supervision.

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

Acceptance Criteria and Device Performance

The document primarily focuses on demonstrating substantial equivalence to a predicate device (BladderScan™ BVI 6100) and proving the accuracy of the new "bladder wall mass" measurement. The core of the acceptance criteria for this new feature is explicitly stated as accuracy when compared to known dimensions of phantoms.

Study Information

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated as a number of phantoms. The study used "different urine volumes and thus different bladder wall thickness measurements" created by filling balloons with varying amounts of urine mimicking material.
   • Data Provenance: The test set data was generated in a controlled laboratory setting using "tissue equivalent phantoms with known dimensions" built by a third-party vendor, Computerized Imaging Reference Systems (CIRS), which is stated to be known for supplying medical imaging phantoms. This is a prospective method using manufactured phantoms, not human data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Number of Experts: Not applicable. The ground truth was established by NIST traceable measurements of the physical phantoms themselves. No human experts were involved in defining the ground truth for this specific test.
   • Qualifications of Experts: Not applicable.

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

   • Not applicable. The ground truth was based on physical measurements of the phantoms, not human interpretations requiring adjudication. The device's measurements were then compared directly to these known physical measurements.

4. 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:

   • No. The study described focuses on the standalone performance of the device's bladder wall mass measurement capability against phantoms. No human readers or AI assistance for human readers are mentioned.

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

   • Yes. The described study is a standalone performance evaluation. The device (BladderMass BVM™ 6500) automatically computes the bladder volume and bladder wall mass. Its measurements are then compared directly to the known "ground truth" of the phantoms.
   • The text explicitly states: "The Diagnostic Ultrasound BladderMass BVM™ 6500 Ultrasound System takes measurements of the bladder wall and calculates the bladder wall mass." This confirms a standalone algorithm performance evaluation.

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

   • The ground truth used was physical measurements of high-precision, NIST-traceable phantoms. These phantoms were designed to mimic the bladder and surrounding tissue, with exact dimensions known from the manufacturing process.

7. The sample size for the training set:

   • Not specified. The document does not provide details about a training set for the algorithm, only the testing methodology. As the device was approved in 2003, it's possible its algorithms were based on more traditional signal processing and image analysis techniques rather than machine learning requiring large, dedicated training datasets as understood today.

8. How the ground truth for the training set was established:

   • Not specified, as no training set details are provided in this summary.

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The intended uses of the BVI 6100 System, as defined by FDA quidance documents, is for Abdominal (Adult and Pediatric) applications.

The BVI 6100 System is intended to project ultrasound energy through the lower abdomen of a nonpregnant patient to obtain an image of the bladder and measure urinary bladder volume non-invasively on an intermittent basis. The indications for use are the same as for Diagnostic Ultrasound's predicate devices. The BladderScan BVI 6100 is contraindicated for fetal use and for use on pregnant patients.

The BladderScan™ BVI 6100 Ultrasound System is a hand-held, batterypowered, 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 option for use in a clinical hospital or nursing home setting or for home use under medical supervision.

The provided text describes the BladderScan™ BVI 6100 Ultrasound System, an ultrasound device for non-invasively monitoring bladder volume. However, the document does not contain information about specific acceptance criteria related to device performance (e.g., accuracy, precision of bladder volume measurement) or a study proving it meets those criteria.

The document primarily focuses on:

• Device Description and Intended Use: The device is a hand-held, battery-powered ultrasound system for acquiring real-time B-mode images of the bladder and measuring urinary bladder volume in non-pregnant patients.
• Compliance with Standards: A list of international and national standards the device is designed to comply with (e.g., EN 60601-1, IEC 61000-4-2, CISPR11). These standards relate to safety, EMC, and acoustic output, not clinical performance metrics.
• Predicate Devices: Identification of similar legally marketed devices (BladderManager™ BVI 5000 System, BladderScan™ BVI 2500 System, and SonoSite™ Hand-Carried Ultrasound System).
• FDA Clearance: Notification of FDA's determination of substantial equivalence (K022153) to predicate devices, allowing it to be marketed. A post-clearance special report for acoustic output measurements based on production line devices was requested.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, or details about a study proving it meets those criteria, as this information is not present in the provided text.

Specifically, the following points from your request cannot be answered based on the provided document:

1. A table of acceptance criteria and the reported device performance: No specific performance metrics (like accuracy or precision for volume measurement) are mentioned along with their acceptance criteria or achieved values.
2. Sample size used for the test set and the data provenance: No performance study is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No performance study is described.
4. Adjudication method for the test set: No performance study is described.
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: No such study is mentioned. This device is a standalone measurement device, not an AI assistance tool for human readers in the context of the document.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: While the device is "standalone" in that it performs the measurement, no specific study evaluating its standalone performance against a ground truth is described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No performance study is described.
8. The sample size for the training set: No information is provided about any training sets for an algorithm.
9. How the ground truth for the training set was established: No information is provided about any training sets for an algorithm.

The only "study" mentioned is the compliance with various standards related to safety and electromagnetic compatibility, and a general statement that the device "meets the FDA's pre-amendment acoustic output limits." These are not performance studies in the sense of clinical accuracy or precision.

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The BladderManager® PC1 5000(+) is intended to project ultrasound energy through r he bladenwanager of the non-pregnant in order to obtain an image of the bladder that is used to determine bladder volume non-invasively. This capability is provided in 2 fundamental modes; 1) hand held probe, aimed by user to obtain reading and 2) Automatically monitor bladder volume via a garment-held probe on non-mobile, supine patient. Patients and/or caregivers are alerted visually and/or audibly when the bladder volume exceeds a pre-programmed threshold.

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.

Here's an analysis of the provided text regarding the BladderManager® Personal Care Instrument PCI 5000:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 40 subjects.
• Data Provenance: The study was conducted at "two sites." The document does not specify the country of origin of the data, but given the US regulatory context (FDA), it's highly probable the study was conducted in the United States.
• Retrospective or Prospective: This was a prospective clinical study, as it "was performed to assess the capability of the BladderManager PCI 5000 to automatically track the bladder filling and emptying." Subjects were enrolled and data was collected specifically for the purpose of this evaluation.

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

The document does not explicitly state the number of experts or their qualifications for establishing ground truth. The "ground truth" for directly comparing bladder volume measurements appears to be derived from the device itself (manual mode readings and voided volume measurement). The post-void residual volume was "manually measured and recorded," implying a clinical measurement rather than an expert consensus on interpreting images.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set in the traditional sense of multiple reviewers resolving discrepancies. The comparison was statistical: "bladder volume measured in autoscan mode was compared to volume measured in the manual mode, and to voided volume." The "post void residual volume was then manually measured and recorded." This suggests direct comparison of objective measurements.

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

No, an MRMC comparative effectiveness study was not explicitly mentioned or described. The study compared different measurement modes of the same device (autoscan vs. manual) and against a physical measurement (voided volume, post-void residual volume). It did not evaluate human readers' improvement with or without AI assistance.

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

Yes, in a way, the evaluation of the "autoscan mode" can be considered a standalone performance assessment of the algorithmic feature. While a human sets the device and observes the alarm, the autoscan function itself is an automated process without continuous human intervention during the measurement cycles. The comparison of autoscan volume to manual mode volume (which is also a device measurement) and voided volume directly assesses the accuracy of the automated function.

7. The Type of Ground Truth Used

The ground truth used was a combination of:

• Reference Device Measurement: Bladder volume measured in "manual mode" of the BladderManager PCI 5000 (which is itself the predicate device and considered reliable).
• Physical Measurement/Outcomes Data: "Voided volume" (measured into a graduated receptacle) and "post void residual volume" (manually measured). These are objective physiological measurements.

8. The Sample Size for the Training Set

The document does not provide any information about a training set size. This device is an ultrasound instrument (hardware) with a minor software update. It's likely that developmental testing and calibration of the algorithms within the device (even for the manual mode) happened internally, but explicit "training set" data, as understood in modern AI/machine learning contexts, is not described in this 1998 submission.

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

As no training set is described, there is no information on how its ground truth was established.

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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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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 describes the BladderManager PCI 5000 and the BladderScan BVI 5000 and their substantial equivalence to a predicate device (BladderScan BVI 2500). However, it does not explicitly state numerical acceptance criteria or detail a specific study proving those criteria are met for the new devices. Instead, it relies on demonstrating substantial equivalence to a previously cleared device.

While the document generally states safety and effectiveness, it doesn't provide the level of detail requested for a comprehensive acceptance criteria and study report.

Here's an attempt to extract and synthesize the information based on the provided text, while also highlighting what is not present:

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

No explicit numerical acceptance criteria are provided in the document. The performance is reported in terms of "substantial equivalence" to the predicate device.

2. Sample size used for the test set and the data provenance

• Preliminary Clinical Testing: "adult ambulatory volunteers."
  • Sample Size: Not specified.
  • Provenance: Not specified (e.g., country of origin). Likely prospective, as it's described as "preliminary clinical testing."
• Clinical Testing (BladderManager PCI 5000): "adult spinal cord diseased patients, as well as healthy volunteers."
  • Sample Size: Not specified.
  • Provenance: Performed at "three independent clinical sites." Geographical location not specified. Likely prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not specified. The document primarily focuses on comparison with a predicate device rather than establishing a new ground truth via expert consensus for this specific submission. The "ground truth" for the test set would effectively be the measurements obtained from the predicate device or a reference method of bladder volume measurement, but this is not explicitly detailed.

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

Not specified.

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 ultrasonic bladder volume instrument, not an AI-assisted diagnostic tool for human readers. There is no mention of "human readers" or "AI assistance" in the context of improving diagnostic effectiveness.

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

The devices (BladderManager PCI 5000 and BladderScan BVI 5000) are standalone ultrasonic instruments designed for direct measurement by a user (patient or clinician). The performance data refers to the accuracy and reliability of these devices compared to a predicate, not an algorithm's performance in isolation from the device operation. So, in a sense, the clinical testing assesses the device's standalone performance in measuring bladder volume.

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

The document implies that the comparison was made against the measurements obtained from the predicate device (BladderScan BVI 2500), which would serve as the de-facto "ground truth" or reference for establishing substantial equivalence in terms of effectiveness/accuracy. There is no mention of other direct ground truth methods like catheterization for volume measurement, which is a common gold standard for bladder volume, but the reliance on substantial equivalence to the BVI 2500 suggests that the BVI 2500's accuracy/validity was previously accepted.

8. The sample size for the training set

Not applicable. These are medical devices, not machine learning algorithms that require a specific "training set" in the computational sense. The "development" or "design" of the device would involve engineering principles and calibration, not AI training data.

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

Not applicable, as there is no training set in the AI sense.

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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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