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The X-FLO Fluid Management System is intended to:

· Warm and pump fluid, via intravenous (IV) bags or fluid bottles, to provide fluid distention and flushing of the uterus for gynecology procedures. The device can also measure fluid deficit of the surgical procedure.

· Warm and pump fluid, via IV bags or fluid bottles, to provide fluid distention and flushing of the bladder and kidneys, or general distention and flushing, for urological procedures. The device can also measure fluid deficit of the surgical procedure.

· Warm and pump fluid, via IV bags or fluid bottles, to provide fluid distention and flushing of the shoulder, knee, or other small joints for orthopedic procedures. The device can also measure fluid deficit of the surgical procedure.

The X-FLO Fluid Management System ("X-FLO") (P/N 01910), with an optional deficit module (P/N 01601) is intended for fluid distention, fluid warming, and fluid volume/deficit measurements, as well as external suction regulation pertaining to deficit measurements for diagnostic and/or operative endoscopic procedures within gynecology, urology, and orthopedic disciplines.

The X-FLO utilizes a touchscreen user interface and performs fluid pressurization, warming, and volume/deficit monitoring functions. More specifically, the device employs a peristaltic pump to pressurize and deliver fluid to the surgical site for distending and continually flushing the surgical site for visualization purposes, utilizes infrared lamps to optionally warm the fluid to body temperature, and uses fluid bag weight to monitor fluid inflow.

Regarding the optional deficit monitoring function, the device utilizes external suction to return fluid from the surgical site. The X-FLO monitors and adjusts the vacuum level to the operator selected setpoint by opening the suction line to atmosphere if necessary. Once the fluid is returned from the surgical site, the single-use deficit cartridge measures the fluid volume collected, prior to transfer to fluid collection equipment and/or the hospital's waste disposal system.

The X-FLO is controlled via a Graphical User Interface (GUI), wherein the user is guided to select a surgical discipline and a procedure type. Once selected, the user can input the desired setpoint within the established minimum and maximum parameters for that procedure type. As set forth below, the X-FLO can operate in Pressure Control (the default control, or X-Control. Each control view has defaults and adjustment ranges for fluid pressure, flow, temperature, deficit alarm, and external suction regulation.

In addition to adjusting the fluid pressure setpoint via the GUI, the user may optionally utilize a foot pedal included with the X-FLO to temporarily increase the fluid pressure. By pressing the foot pedal, the user initiates an increase in fluid pressure. The increase is user configurable but can never exceed the maximum allowable fluid pressure for the procedure. When the user desires to have the fluid pressure return to the setpoint, the foot pedal is released.

The provided text details the 510(k) submission for the Thermedx X-FLO Fluid Management System, which is a medical device intended for fluid distention, warming, and volume/deficit measurements during various endoscopic procedures.

Here's an analysis of the acceptance criteria and study data based on the provided document:

Acceptance Criteria and Reported Device Performance

The document presents a comparison table between the subject device (X-FLO Fluid Management System) and its predicate device (FluidSmart), which implicitly defines the performance criteria. The relevant criteria mainly relate to fluid warming, fluid delivery (pressure/flow), and deficit monitoring.

Table of Acceptance Criteria and Reported Device Performance:

Study Proving Device Meets Acceptance Criteria:

The document describes non-clinical performance testing conducted to support the substantial equivalence determination.

1. Sample Size Used for Test Set and Data Provenance:

   • The document implies that testing was performed on representative units of the device and its accessories (tubing sets, deficit cartridge, etc.).
   • Sample Size: Not explicitly stated as a number of devices or data points for each bench test. For example, "Fluid compatibility with sterile water, lactated ringers solution, 5 % mannitol solution, 1.5 % glycine solution, 0.9% saline solution, and sorbitol solution" implies multiple tests, but the quantity of tests, runs, or devices tested for each parameter is not specified. Similarly, "Irrigation pressure controls with three different hysteroscope models" specifies the models but not the number of runs or devices.
   • Data Provenance: The document does not specify the country of origin of the data. It is a 510(k) submission to the US FDA, so the testing was presumably conducted in a manner acceptable for US regulatory submission. The studies are bench/laboratory studies focused on device performance, not patient data studies, so "retrospective or prospective" is not an applicable distinction in the sense of patient data collection.

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

   • This is a technical performance study of a medical device, not a study involving human interpretation of clinical data (like AI for imaging). Therefore, the concept of "experts establishing ground truth" in the clinical sense (e.g., radiologists) is not applicable. The "ground truth" for these tests is the physical measurement of device performance against engineering specifications using calibrated equipment and standard test methods.

3. Adjudication Method for the Test Set:

   • Not Applicable. As this involves objective bench testing, there is no "adjudication" in the sense of reconciling subjective expert opinions. Device performance measurements are compared directly against pre-defined engineering and regulatory specifications.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

   • No. This is not an AI/imaging device or a device whose performance is dependent on human reader interpretation. Therefore, an MRMC study is not relevant.

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

   • Not Applicable. While the device has software ("Software controlled"), its performance is measured as an integrated system (hardware and software) in bench testing, not as a standalone algorithm evaluating clinical data. The "stand-alone" performance is implicitly the results of the bench testing.

6. The Type of Ground Truth Used:

   • The "ground truth" for the performance studies is the pre-defined engineering specifications and internationally recognized standards (e.g., IEC 60601 series for electrical safety, ISO 10993 for biocompatibility) that the device must meet. Performance metrics (e.g., temperature, pressure, flow rate, deficit volume) are objectively measured using calibrated instruments during bench testing.

7. The Sample Size for the Training Set:

   • Not Applicable. This is a hardware medical device with embedded software; it does not involve machine learning or AI models that require "training sets" in the conventional sense of data-driven model training. The software is developed and verified via traditional software engineering principles.

8. How the Ground Truth for the Training Set Was Established:

   • Not Applicable. (As explained above, no traditional training set exists for this type of device.) The "ground truth" for software functionality testing (verification and validation) would be the software requirements specifications derived from the device's intended use and design.

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