Search Results

The Rapid Barostat Bag Pump and Catheter are used together for the inflation of a barostat balloon to measure rectal capacity, as well as rectal volume at points of sensation, urge, and discomfort, to determine hypersensitivity, hyposensitivity, or normal rectal sensations. These determinations aid in the diagnosis of anorectal disorders, such as fecal incontinence and constipation.

The Rapid Barostat Bag system consists of a pump unit and a disposable catheter. The pump uses an air compressor pneumatic system and is operated through a touch screen. It is electrically powered by rechargeable batteries and is wirelessly connected to a peripheral remote control for the patient to input different levels of sensation during the study. The catheter is made up of single-lumen PVC tubing with a plastic non-compliant barostat balloon at the distal end, and a female luer at the proximal end. The balloon end of the catheter is inserted into a patient's rectum, and the luer end is connected to the pump.

The study, also known as RBB Protocol, consists of two or more rounds of inflation and deflation of the catheter. The first round will inflate the balloon to the set internal pressure of 40 mmHg to determine the maximum volume of the rectum. The second round of inflation will be used to determine the volumetric points of sensation, urge, and discomfort associated with the patient's rectum. During the study, the pump will push air through the catheter tubing into the barostat balloon at a constant rate of 2 mL/sec, while displaying the fluctuating pressure within the balloon onto the pump's touch screen display. When the patient begins to feel the sensation of the inflated balloon, they would push the "sensation" button on the remote control to transmit a signal to the pump. The inflation volume and pressure will be recorded at that point of reference. The pump will continue to inflate the balloon for the patient to report the point of the feeling of urge, and then discomfort, and the data points are collected and stored in the systems internal memory. Upon pressing the discomfort indicator button, the system will automatically stop the inflow of air into the balloon and begin to rapidly deflate the balloon at 3 mL/sec. By extrapolating the volume and pressure measurements recorded within the barostat balloon, the pump will be able to provide the healthcare professional with clearer data for a more accurate diagnosis of anorectal functions and rectum disorder.

The provided text describes the Mui Scientific Rapid Barostat Bag (RBB) Pump and Catheter System, detailing its intended use, design, and a comparison to predicate devices to demonstrate substantial equivalence. The document is primarily a 510(k) Summary for regulatory purposes.

Based on the provided information, here's a breakdown of the acceptance criteria and the study that proves the device meets those criteria:

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

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail format typical of a rigorous study. Instead, it describes performance in relation to a predicate device to demonstrate "substantial equivalence." The key performance metrics and their comparison are:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• RBB Pump: A "comparison test was performed to demonstrate that the RBB Pump can measure the same results as the Barostat when both machines are running the same RBB Protocol." The sample size for this test set is not specified. The document does not provide information on the country of origin of the data or whether it was retrospective or prospective, implying it was likely an internal lab-based performance comparison.
• RBB Catheter: Various tests (Balloon Burst/Leak, Tensile Strength, Biocompatibility, Shelf Life) were performed. The sample sizes for these tests are not specified. The data provenance (country, retrospective/prospective) is not provided, suggesting these were internal lab tests for the device itself.

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)

Not applicable. The tests performed are engineering/performance comparison tests against a predicate device, not diagnostic studies requiring clinical ground truth established by experts. The "ground truth" for the pump comparison was the measurements obtained by the predicate device under the same protocol. For the catheter, it was the results of standardized material and safety tests.

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

Not applicable. The studies described are performance comparisons of medical devices, not clinical studies involving expert adjudication of patient data.

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 document describes a medical device (pump and catheter) for physiological measurement, not an AI or imaging diagnostic tool. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is irrelevant to this submission.

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

The primary study mentioned for the RBB Pump is a "comparison test" between the new device and the predicate device, both performing the "same RBB Protocol." This implies a standalone performance test of the new device against the predicate, likely in a controlled environment. The document states: "A comparison test was performed to demonstrate that the RBB Pump can measure the same results as the Barostat when both machines are running the same RBB Protocol." This focuses on the device's inherent measurement capabilities.

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

• RBB Pump: The "ground truth" was a direct comparison of measurements obtained by the proposed RBB Pump against those obtained by the legally marketed predicate device (Distender Series II Barostat) when both were running the "same RBB Protocol." This is a performance equivalence ground truth, not a clinical diagnostic ground truth.
• RBB Catheter: The ground truth for catheter-related tests (burst, leak, tensile, biocompatibility, shelf life) was established by demonstrating equivalence to the predicate's performance or compliance with recognized standards (e.g., biocompatibility standards like those for Cytotoxicity, Irritation, and Sensitization).

8. The sample size for the training set

Not applicable. This device is not an AI/machine learning model, so there is no "training set."

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

Not applicable, as there is no training set for this device.

Ask a specific question about this device

The Pressurized Infusion Pump (Electrically Powered Models #PIP-4-4SS, PIP-4-6SS, PIP-4-8SS, PIP-4-12SS, and Portable Models #PIP-6-4SS, PIP-6-6SS, PIP-6-8SS, PIP-6-12SS, PIP-6-16SS, PIP-6-22SS, PIP-6-24SS, PIP-6-36SS) is intended to provide a regulated and channeled perfusate of water to a motility catheter to perform manometric motility studies along the gastrointestinal tract. The Pressurized Infusion Pump is intended to be used with a separate legally marketed compatible motility catheter and separate computerized gastrointestinal monitoring system.

These pressurized infusion pumps consist of an electrical compartment, a water chamber, a regulator and a set of gauges, and flow restrictors. The electrical compartment unit consists of a compressor motor, a pressure switch, a pressure gauge, and a drying cylinder. When turned on, the motor will compress air into the drying cylinder, which will remove the water byproduct from the compression. The pressure switch will turn the motor off at 42psi (as displayed on the pressure gauge), and will restart it when the pressure drops to 18psi. For the Portable Pressurized Infusion Pump, an air hose connects the electrical unit to the main pump housing to deliver the pressurized air to the pump. The pressurized air will flow through a high pressure gauge (to display the pressure of the supplied compressed air), to a regulator (which will regulate the pressurized air down to 17psi), then a low pressure gauge (to display the pressure of the regulated air), to a water reservoir filled with sterilized irrigation water. The regulated air will push the water out of the water reservoir at a constant rate through resistors that will further reduce the water flow rate to 0.60mL/min before it travels through a pressure transducer to the motility catheter. At the proximal end of the motility catheter are female luers that connect to the top of the pressure transducers on the infusion pump. The water will flow through the entire length of the motility catheter to the distal end where the pressure ports are located. The motility catheter is then inserted into the patient and placed along the specific section of the gastrointestinal system being measured. With the regulated pressurized water flowing through the catheter at a constant rate, when the gut muscles contract, it will constrict the flow of water through the pressure ports, and the pressure change will be transmitted back through the water flow to the pressure transducer on the pressurized infusion pump, where the signal will be displayed onto the computer.

The provided text describes a 510(k) Summary for a Pressurized Infusion Pump. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and expert evaluation of AI. Therefore, much of the requested information regarding AI performance, human readers, and expert-established ground truth is not applicable.

Here's an analysis of the provided text based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated beyond "Bench tests were conducted." The number of devices tested (Electrical and Portable Pressurized Infusion Pumps) isn't specified, nor is the number of "pinch tests" or motility catheters used.
• Data Provenance: The study was a bench test, comparing the new devices against a predicate. There is no information regarding country of origin of data as it's a lab-based test, not human or observational data. It is a prospective test in the sense that newly manufactured devices were tested.

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

• Not Applicable. The study was a bench test verifying physical performance against a predicate device, not involving expert interpretation of medical images or data from human subjects. Ground truth was established by direct physical measurement and comparison to the predicate device's expected performance.

4. Adjudication Method for the Test Set

• Not Applicable. As this was a bench test with objective measurements (pressure, flow rate), there was no need for adjudication by experts as would be the case in subjective or diagnostic assessments. The performance was directly compared to the predicate's known output.

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 is a physical medical device (a pump), not an AI-powered diagnostic or interpretive system. Therefore, no MRMC study or assessment of human reader improvement with AI was conducted.

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

• Not Applicable. This is a physical device, not an algorithm. Its performance is inherent in its mechanical and electrical design.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• The ground truth was established by the performance of the predicate device ("the pressure measured and transmitted on the predicate pump") and the design specifications of the new device (e.g., regulated air pressure, constant water flow rate). For mimicking muscle contraction, the "pinch test" served as a simulated physiological event, with the predicate's response serving as the expected "ground truth" for comparison.

8. The Sample Size for the Training Set

• Not Applicable. This device uses no AI and therefore has no "training set."

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

• Not Applicable. Since there is no training set, there is no ground truth for it.

Ask a specific question about this device

The sphincter of Oddi manometric pump and catheter are used in conjunction with a computerized motility system for motility studies, to measure the Contraction rates along the gastrointestinal system (specifically the sphincter of Oddi); for research or diagnostic purposes within a clinical setting.

This system consists of a water-perfused SOM pump, an air compressor unit, and a Toouli SOM Sleeve catheter. The air compressor unit consists of a compressor motor, a pressure switch, a pressure gauge, and a drying cylinder. When turned on, the motor will compress air into the drying cylinder, which will remove the water by-product from the compression. The pressure switch will turn the motor off at 30psi (as displayed on the pressure gauge), and will restart it when the pressure drops to 10psi. An air hose connects the air compressor unit to the SOM pump to deliver the pressurized air to the SOM pump. The pressurized air will flow through a high pressure gauge (to display the pressure of the supplied compressed air), to a regulator (which will regulate the pressurized air down to 5psi), then a low pressure gauge (to display the pressure of the regulated air), to a water reservoir filled with sterilized irrigation water. The regulated air will push the water reservoir at a constant rate through resistors that will further reduce the water flow rate to 0.18mL/min before it travels through a pressure transducer to the Toouli SOM Sleeve catheter. The proximal end of the Toouli SOM Sleeve catheter has a female luer that connects to the top of the pressure transducer on the SOM pump. The water will flow through the entire length of the Toouli SOM Sleeve catheter to the distal end where a silicone sleeve sensor is located. The Toouli SOM Sleeve catheter is then inserted through the biopsy channel of an endoscope, and then the sleeve sensor is positioned along the Sphincter of Oddi. With the regulated pressurized water flowing through the sleeve sensor at a constant rate, when the sphincter contracts, it will constrict the flow of water through the sleeve sensor, and the pressure change will be transmitted back through the water flow to the pressure transducer on the SOM pump, where the signal will be displayed onto the computer.

The provided text is a 510(k) Summary for the Mui Scientific Sphincter of Oddi Manometric (SOM) System. It describes the device, its intended use, and the basis for substantial equivalence to predicate devices. However, the document does not contain the detailed clinical study results (acceptance criteria table, sample sizes, ground truth establishment, expert qualifications, etc.) that would typically be found in a comprehensive study report proving a device meets specific acceptance criteria.

The document does mention "bench tests" as the primary form of testing conducted.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or provide specific numerical device performance metrics in a table format. It describes the bench testing qualitatively:

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

• Sample Size (Test Set): Not specified. The document refers to "systems" and "catheters" in the plural, but no specific number of devices tested is given.
• Data Provenance: The tests conducted were "bench tests," meaning they were laboratory-based simulations, not involving human subjects. Therefore, there is no country of origin for patient data, nor is it retrospective or prospective clinical data.

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

• Number of Experts: Not applicable. The "ground truth" for the bench tests was the "specific external force" applied to the catheters, which was a physical measurement, not an expert-derived truth.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Since the ground truth was a direct physical measurement ("pressure exerted"), there was no need for expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• MRMC Study: No. This device is a measurement system (pump and catheter), not an AI-assisted diagnostic tool for image or signal interpretation by human readers. Therefore, an MRMC study is not relevant to this submission.

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

• Standalone Performance: Not applicable in the context of an "algorithm." This device is a mechanical/electronic system for physiological measurement. Its "performance" is its ability to accurately measure pressure changes, which was evaluated via the described bench tests. There is no AI algorithm component mentioned. The system transmits signals to a "computerized motility system," but the performance described is for the hardware (pump and catheter) itself.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the bench tests, the ground truth was an "external force" or "pressure exerted" that was known and applied, mimicking a sphincter contraction. This is a physical measurement standard or controlled experimental input, not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

• Sample Size (Training Set): Not applicable. This device is not an AI/ML product developed using a training set. The design of the system relies on established biophysical principles of pressure transmission in fluids.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

Summary of Study Information Provided:

The documentation focuses on demonstrating substantial equivalence through a technical description and bench tests. These bench tests confirmed:

1. The system's ability to accurately transmit measured pressures ("pressure exerted was shown to equal the pressure measured and transmitted").
2. Compatibility and interchangeability with predicate devices.

The information provided is typical for a 510(k) submission for a medical device of this nature, where engineering performance and substantial equivalence to existing devices are demonstrated through bench testing, rather than complex clinical trials or AI model validation studies.

Ask a specific question about this device