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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. TG Cables are reusable. TG is a single use catheter intended for short-term use (no more than 30 days).

This document is a 510(k) Premarket Notification from the FDA regarding the "TraumaGuard Intra-abdominal Pressure Sensing System." It describes the device, its intended use, and its substantial equivalence to a previously cleared predicate device.

Based on the provided text, the acceptance criteria and study proving the device meets those criteria are primarily focused on bench testing and laboratory studies demonstrating functional and safety performance, particularly regarding MR compatibility, rather than a clinical study evaluating AI assistance or human reader improvement. The submission is for a new version of an existing device (K210570) with the primary modification being the addition of MR conditional labeling.

Here's a breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a neat table of acceptance criteria with corresponding performance values for all aspects. However, it lists the standards followed and the outcome of the testing. The core "acceptance criteria" here relate to demonstrating that the new device (with MR conditional labeling) performs equivalently to the predicate device for its original functions, and meets MR safety standards.

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

The document explicitly states that "Representative samples of the TraumaGuard device were tested." It does not specify the exact sample size for the functional, performance, or MRI safety testing.

• Data Provenance: The studies were laboratory and bench tests ("laboratory tests," "bench testing") rather than clinical studies with patient data. The origin would be the testing facility, likely in the US, as Sentinel Medical Technologies is based in Jacksonville, FL. The studies appear to be prospective as they were conducted to gather data for this submission.

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

This type of information is not applicable to the evidence provided in this 510(k) summary. The submission relies on physical and engineering bench testing, as well as computational modeling, against established international and ASTM standards for medical device performance and safety (e.g., MRI safety, biocompatibility, sterilization). There is no mention of "experts" establishing ground truth in the context of clinical interpretation or diagnosis, as there would be for an AI-based diagnostic device.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies, especially those involving human interpretation of medical images or data, to resolve discrepancies or determine a definitive ground truth. As this submission focuses on bench testing and device performance against physical standards, there is no human interpretation or adjudication process described.

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

No, an MRMC comparative effectiveness study was not done. This submission is for a device that directly measures physical parameters (IAP and CBT) and is a catheter, not an AI or imaging diagnostic software that assists human readers. Therefore, the concept of human readers improving with AI assistance is not relevant to this device.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone algorithm-only performance study was not done in the context of AI. The device itself is the "algorithm" in a sense, as it provides direct measurements. The performance testing focuses on the accuracy and safety of these direct measurements and the device's physical properties. There is no AI component described in the device functionality.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

• Physical measurement standards: Ensured by calibrated equipment and methods defined in the listed ASTM and ISO standards for properties like temperature accuracy, pressure range, and MRI safety parameters (displacement, torque, heating, artifact).
• Biocompatibility standards: ISO 10993 series and associated GLP reports for non-pyrogenicity.
• Sterilization standards: Achieving a specified SAL.

Essentially, the "ground truth" is adherence to pre-defined, measurable engineering, physical, chemical, and biological safety standards for medical devices, rather than a clinical ground truth like pathology, expert consensus on images, or outcomes data.

8. The Sample Size for the Training Set

This is not applicable. This is a physical medical device that measures IAP and CBT; it does not involve machine learning or AI models that require training sets. The "training" for this device would be its manufacturing process and design, not data-driven algorithm training.

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

This is not applicable for the same reason as point 8.

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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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