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TraumaGuard Intra-abdominal Pressure Sensing System is intended for use in the drainage of urine for continuous measuring of intraabdominal pressure (IAP) and core body temperature (CBT). The measured IAP can be used as an aid in the diagnosis of intra-abdominal hypertension (IAH) and abdominal compartment syndrome (ACS).

The TraumaGuard Intra-abdominal Pressure Sensing System is comprised of a catheter and cable used to connect to standard biometric monitors. The catheter is a Foley catheter that provides continuous biometric monitoring of intra-abdominal pressure and core body temperature.

TraumaGuard (TG) is a silicone catheter with two polyurethane pressure sensing balloons used to detect changes in intra-abdominal pressure (IAP), the outer distal balloon and the inner sensing balloon. The outer balloon is filled with 2.0 - 2.5cc of sterile water to ensure contact with the bladder wall. The inner sensing balloon has a column of air that runs the entire length of the catheter from the middle of the outer sensing balloon to a connector on the hub.

Temperature can be displayed in Celsius or Fahrenheit and is accurate within ±1°C over a range of 25°C to 40°C (77°F to 104°F). Pressure displayed is between 0mmHg and 40mmHg.

The inflation, drainage and sensing ports of the catheter are color-coded and can be operated with a Luer Lock syringe tip.
Each TG is sterile and individually pouched. The TG Cables are reusable. TG is a single use catheter intended for short-term use (no more than 30 days).

This document describes a medical device, the TraumaGuard Intra-abdominal Pressure Sensing System, which is a Foley catheter with additional capabilities for continuously measuring intra-abdominal pressure (IAP) and core body temperature (CBT). The document is a 510(k) summary, which is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present acceptance criteria in a quantitative table with corresponding numerical performance results. Instead, it lists functional and safety tests and states that "Representative samples of the TraumaGuard device were tested in accordance with the company's design control procedures to ensure that the functional and performance requirements of the device were met." It further notes that "Finished, sterile devices underwent performance bench testing in simulated conditions."

Implied Acceptance Criteria and Performance (Based on Device Description and Testing):

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

The document states: "Representative samples of the TraumaGuard device were tested in accordance with the company's design control procedures... Finished, sterile devices underwent performance bench testing in simulated conditions."

• Sample Size: The exact sample size used for the test set is not specified. The term "Representative samples" is qualitative.
• Data Provenance: The testing was "performance bench testing in simulated conditions." This indicates laboratory or bench testing, not human clinical data. The country of origin of the data is not explicitly stated, but given the FDA submission, it's presumed to be from the manufacturer's testing facilities, likely within the US or a country with equivalent regulatory standards. The testing is prospective in nature, as it involves newly manufactured devices undergoing specific performance tests.

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

Not applicable. The ground truth for this device's performance is established through direct physical measurements (e.g., temperature readings, pressure readings, flow rates, dimensional measurements) on the device itself during bench testing, not through expert interpretation of clinical data or images.

4. Adjudication Method for the Test Set

Not applicable. As the ground truth is established by direct measurement on the device during bench testing, there is no need for expert adjudication of data.

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

No. This document describes a 510(k) submission for a physical medical device (a catheter) with integrated sensing capabilities. It is not an AI/imaging diagnostic device that would typically involve a multi-reader, multi-case study to assess human reader improvement with or without AI assistance. The focus is on the substantial equivalence of the device's functional performance to a predicate.

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

Yes, in essence. The performance testing described (Static Pressure, Dynamic Pressure, Recharge Pressure, Temperature Measurement, etc.) evaluates the device's sensing capabilities stand-alone, without direct human intervention in the primary sensing and measurement process. The device's internal mechanisms (e.g., dual balloon pressure sensing system) and temperature sensor are evaluated for their inherent accuracy and functionality.

7. The Type of Ground Truth Used

The ground truth used for the performance evaluation of the TraumaGuard system is physical measurement against calibrated standards/references during bench testing. For example:

• Temperature: Comparison against a known temperature source.
• Pressure: Comparison against known pressure values or calibrated pressure gauges.
• Flow Rate: Measurement of fluid volume over time.
• Dimensional: Measurement with calibrated instruments (e.g., calipers).

8. The Sample Size for the Training Set

Not applicable. This device is a hardware product for measurement, not an AI algorithm that requires a training set of data. Its performance is based on its physical design and manufacturing, tested against physical criteria.

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

Not applicable. As there is no AI algorithm being trained, there is no "training set" or ground truth associated with it in this context.

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The Bard® Intra-abdominal Pressure (IAP) Monitoring Device is intended for the monitoring of intra-abdominal pressure via a Foley urinary catheter. The measured pressures can be used as an aid in the diagnosis of intraabdominal hypertension (IAH) and the associated clinical syndrome of abdominal compartment syndrome (ACS).

The Bard® Intra-abdominal Pressure (IAP) Monitoring Device) is composed of a tubing set used for infusing fluid into the urinary bladder through the Foley catheter sampling port. It utilizes a clamping device to occlude the urinary drainage tubing to form a fluid column through which intra-abdominal pressure is measured.

The provided text is a 510(k) summary for the Bard® Intra-abdominal Pressure Monitoring Device. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain the detailed information necessary to fully address all aspects of your request regarding acceptance criteria and a study proving the device meets those criteria.

Specifically, the document states: "The results of bench and biocompatibility testing demonstrated that the functionality, integrity, and safety of the Bard IAP Device is adequate for its intended use and support a determination of substantial equivalence." However, it does not provide specific acceptance criteria values, reported performance metrics, or details about the studies themselves (e.g., sample size, data provenance, ground truth, expert qualifications, adjudication methods, or specific comparative effectiveness results).

Therefore, I can only partially fulfill your request based on the information provided.

Here's an analysis of the provided text in relation to your questions:

1. Table of acceptance criteria and the reported device performance

Based on the provided text, specific numerical acceptance criteria and reported device performance values are not explicitly stated. The general statement is given under "Summary of performance data":

Note: This table reflects the general claims made in the summary. It does not provide quantitative metrics or specific pass/fail thresholds that would typically be found in detailed study reports.

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

Not specified in the provided text. The document only mentions "bench and biocompatibility testing" without detailing the sample sizes (e.g., number of devices tested, number of measurements taken) or the provenance of any data (e.g., country of origin, retrospective/prospective nature).

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

Not applicable/Not specified. The provided summary mentions "bench and biocompatibility testing." This type of testing typically involves engineering or laboratory measurements against established standards, not necessarily human expert-established ground truth in the way it might apply to diagnostic imaging or clinical assessment devices. No experts are mentioned in this context.

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

Not applicable/Not specified. As the testing described is "bench and biocompatibility," an adjudication method for a test set (presumably clinical or image-based) is not relevant or mentioned.

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, an MRMC comparative effectiveness study was not done. This device is a measurement tool (an intra-abdominal pressure monitoring device), not an AI-powered diagnostic or interpretive system that would involve human readers or AI assistance in that context. The summary describes "bench and biocompatibility testing" for the device's physical and functional attributes.

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

Not applicable. This device is not an algorithm or AI system. It is a physical medical device for measuring pressure. The performance evaluated would be the direct measurement capabilities of the device itself.

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

For "bench testing," the ground truth would typically be established by controlled experimental conditions or calibrated reference standards. For example, pressure measurements would be compared against a known, precise pressure source. For "biocompatibility testing," the ground truth would be established by standardized laboratory assays and adherence to relevant ISO standards (e.g., ISO 10993 series) to assess material safety. The document does not provide details on these specific ground truths.

8. The sample size for the training set

Not applicable. This device is not an AI/ML device that requires a training set.

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

Not applicable. This device is not an AI/ML device that requires a training set and established ground truth in that context.

In summary, the provided 510(k) pertains to a physical medical device for pressure monitoring and focuses on establishing substantial equivalence through bench and biocompatibility testing. It lacks the detailed quantitative performance metrics, study designs, and human-expert-related information that would be typical for AI/ML-based diagnostic devices.

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