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The Accuryn Monitoring System is intended for use in the drainage and/or collection of urine, and in the monitoring of urine output and core body temperature, in degrees Fahrenheit and degrees Celsius. The Accuryn Monitoring System with the Accuryn Sensing Urinary Catheter (SmartFoley®) - IAP UO Temp is also intended for use in the monitoring of intra-abdominal pressure. The measured pressures can be used as an aid in the diagnosis of intra-abdominal hypertension (IAH) and the associated clinical syndrome of abdominal compartment syndrome (ACS). The Accuryn Sensing Urinary Catheter is a single use device intended for short term use (less than 30 days).

The Accuryn Monitoring System consists of three components, the Accuryn Sensing Urinary Catheter, Accuryn Urine Collection Set or Accuryn SmartFoley Adapter, and the Accuryn Monitor.

The Accuryn Sensing Urinary Catheter is a single use, sterile, MR conditional, disposable (12F, 14F, and 16 F), two-way silicone urinary bladder catheter with two opposing drainage eyes and four lumens. The first lumen is for urine drainage, the second lumen for the retention balloon, the third lumen embedded with a thermistor, and the fourth lumen to measure intra-abdominal pressure (IAP).

The Accuryn SmartFoley® comes in three configurations:

• IAP, U/O, Temp (intra-abdominal pressure, urine output, and core temperature)
• U/O. Temp (urine output and core temperature) ●
• Adapter (that is compatible with commercially available Foley catheters between 6-24Fr)

The Accuryn Urine Collection Set is provided permanently pre-connected to the Accuryn Sensing Urinary Catheter's drainage lumen conveys urine to a urine measurement cassette. which connects to the Accuryn Monitor. The cassette feeds the urine collection bag. Potrero Medical also provides a configuration of the Accuryn Urine Collection Set that is not provided pre-connected to the catheter/foley. It is known as Accuryn SmartFoley Adapter and enables the user to connect a Foley catheter of their choice to the Accuryn Urine Collection Set. The Accuryn Urine Collection Set and Accuryn SmartFoley Adapter function in conjunction with the Accuryn Monitor to measure and display urine output is considered a 510(k) exempt device per 21 CFR 876.1800 (urine flow or volume measuring system, product code EXY).

The Accuryn Monitor is a portable electronic device which maintains urine flow from the foley through the Accuryn Urine Collection Set or Accuryn SmartFoley Adapter, measures the urine output volume in the measurement cassette, and displays the urine output. The Accuryn Monitor also measures and displays the temperature from the thermistor and intra-abdominal pressure (IAP) from the pressure lumen. The monitor contains software.

The provided text is a 510(k) summary for the Accuryn Monitoring System. This document focuses on demonstrating substantial equivalence to a predicate device rather than outright proving device performance against pre-defined acceptance criteria in the manner of a novel device. Therefore, the information typically found in a study proving acceptance criteria for a new AI/ML medical device (like MRMC studies, detailed ground truth establishment, training set provenance, etc.) is largely not present in this type of submission.

The "acceptance criteria" here are essentially that the new device configurations (smaller catheter sizes) perform comparably to the predicate device and don't introduce new safety or effectiveness concerns. The "study" proving this is a series of non-clinical performance tests designed to validate and verify the device's adherence to relevant standards and its functional characteristics.

Here's an attempt to answer your questions based on the provided text, highlighting where information is absent due to the nature of a 510(k) submission for substantial equivalence:

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

The document does not provide a specific table of quantitative acceptance criteria with corresponding performance values in the way one might expect for a novel AI/ML device. Instead, it summarily states that the device "met all acceptance criteria" and "Performance testing data has demonstrated that the Accuryn Monitoring System is safe and effective for its intended use."

The closest a comparison table comes to "acceptance criteria" is the "Comments" column in the Comparison of Technological Characteristics and Device Use with Predicate Device section, where "Same" indicates meeting the implicit criterion of being equivalent to the predicate.

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The Accuryn Monitoring System is intended for use in the drainage and/or collection of urine, and in the monitoring of urine output and core body temperature, in degrees Fahrenheit and degrees Celsius. The Accuryn Monitoring System is also intended for use in the monitoring of intra-abdominal pressure. The measured pressures can be used as an aid in the diagnosis of intra-abdominal hypertension (IAH) and the associated clinical syndrome of abdominal compartment syndrome (ACS). The Accuryn Sensing Urinary Catheter is a single use device intended for short-term use (less than 30 days).

The Accuryn Monitoring System consists of the three components, the Accuryn Sensing Urinary Catheter, Accuryn Urine Collection Set, and the Accuryn Monitor.

The Accuryn Sensing Urinary Catheter is a single use, sterile, MR conditional, disposable 16 French, twoway silicone urinary bladder catheter with two opposing drainage eyes and 4 lumens.

The first lumen of the Urinary Catheter is for urine drainage and is packaged pre-connected to the Accuryn Urine Collection Set. The Accuryn Urine Collection Set function with the Accuryn Monitor to measure and display urine output and is considered a 510(k) exempt device per 21 CFR 876.1800 (urine flow or volume measuring system, product code EXY).

The second lumen is for the 5cc retention balloon, which serves to keep the catheter in place. Inflation of the retention balloon is provided by connecting a barrel tip syringe filled with sterile water to the catheter by means of a two-way valve. Sterile water is conveyed through the retention balloon lumen to inflate the retention balloon; water is contained within the balloon to maintain retention; the water is removed by reopening the valve to deflate the balloon prior to removing the catheter from the bladder.

The third lumen contains a thermistor wire for monitoring a patient's core body temperature in degrees Fahrenheit and degrees Celsius when connected to the Accuryn Monitor.

The fourth lumen consists of a closed air column that connects to a pressure transducer inside the Accuryn Monitor. Intra-abdominal pressure is measured via this lumen and displayed on the Monitor screen.

This 510(k) summary provides information on the Accuryn Monitoring System. However, it does not contain the details required to fully address all the requested points, especially concerning a traditional "study" in the sense of clinical trials or multi-reader, multi-case evaluations for AI. This is because the device appears to be a physical monitoring system, not an AI or imaging diagnostic tool.

Therefore, many of the requested fields cannot be directly answered from the provided text. I will address what can be inferred and explicitly state where information is missing.

Acceptance Criteria and Device Performance (Inferred from general claims and predicate device equivalence)

The document states that "Results from the bench tests for design verification and validation have proven acceptable performance on all tests to indicate that the device is suitable for its intended use and is as safe and effective as the predicate devices to support a determination of substantial equivalence."

While specific numerical acceptance criteria and performance data are not provided in this summary, the FDA's clearance implies that the device met internal criteria based on the testing performed. The "reported device performance" is implicitly that it functions as intended for urine drainage/collection, urine output monitoring, core body temperature monitoring, and intra-abdominal pressure monitoring, with accuracy considered comparable to predicate devices.

Study Details:

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

   • Sample Size: Not specified. The performance evaluation primarily involved bench testing (e.g., biocompatibility, catheter performance, MR compatibility, electrical safety) rather than human clinical trials.
   • Data Provenance: Not specified, but given it's bench testing, the "data provenance" would relate to laboratory conditions and test setups, not patient data from specific countries. It is implicitly retrospective as the testing was completed prior to submission.

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

   • Not applicable in the context of this 510(k) summary. This device is a physical monitoring system and does not involve interpretation of images or data by human experts for ground truth establishment in the way AI/imaging devices might. Ground truth for its measurements would be established by reference standards in a lab setting.

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

   • Not applicable as this summary describes bench testing of a physical device, not a human reader study or AI algorithm evaluation requiring adjudication of expert opinions.

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. This is a physical monitoring system, not an AI or imaging device that would typically undergo an MRMC study.

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

   • The "software-related documentation" was provided for a "Moderate Level of Concern device" (per FDA Guidance 2005). However, this refers to the embedded software in the monitor, not a standalone AI algorithm for diagnostic interpretation in the sense typically asked for in these questions. The performance evaluation was of the system (catheter + monitor) as a whole for its intended physiological measurements.

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

   • Bench Testing Standards: For the physical characteristics and measurement capabilities, ground truth was implicitly established against established scientific and engineering standards (e.g., ASTM, IEC, ISO) and reference methods/equipment used in the bench tests. For example, temperature measurements would be validated against calibrated thermometers, and pressure measurements against calibrated pressure transducers.

7. The sample size for the training set:

   • Not applicable. This device is not an AI algorithm that undergoes "training" on a dataset in the conventional sense. Its design and validation rely on engineering principles, material science, and performance testing against established standards.

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

   • Not applicable for the same reason as above.

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