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The Fluent Pro Fluid Management System is intended to provide liquid distension of the uterus during diagnostic and operative hysteroscopy, and to monitor the volume differential between the irrigation liquid flowing into and out of the uterus while providing drive, control and suction for hysteroscopic morcellators.

The Fluent Pro Fluid Management System is a hysteroscopic fluid management system and drive console for hysteroscopic morcellators. The Fluent Pro Fluid Management System consists of a console and single-use procedure kit. The single-use procedure kit consists of sterile inflow (In-FloPak) and outflow (Out-FloPak) tube sets, and a non-sterile waste bag. The FloPaks and waste bag connect for use in hysteroscopic procedures. The console includes motors that control fluid inflow and outflow for hysteroscopic insufflation, as well as a pressure sensor monitoring system and graphical user interface. In addition, the console includes a connection for MyoSure Tissue Removal Devices and a pneumatic foot pedal to perform tissue removal procedures. The Fluent Pro Fluid Management System is compatible with currently marketed MyoSure Tissue Removal Devices.

This FDA 510(k) summary describes a medical device, the Fluent Pro Fluid Management System, for which substantial equivalence is claimed against a predicate device. The document focuses on regulatory compliance and device characteristics rather than a clinical study evaluating diagnostic or treatment efficacy.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, multi-reader multi-case studies, and standalone algorithm performance cannot be fully extracted or accurately described from the provided text. These types of details are typically found in clinical study reports, which are not included here.

However, based on the provided text, I can infer and extract some information related to performance testing and acceptance criteria as described in the context of device safety and functional equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are functional and safety performance, demonstrated through various engineering and bench tests, rather than clinical efficacy metrics.

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

The document does not specify exact sample sizes for the various performance tests (e.g., number of units tested for electrical safety, number of sterility tests etc.). The provenance of the "data" is from internal company testing and validation activities as part of the 510(k) submission process. These are all prospective tests conducted on the device.

3. 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) submission. The "ground truth" for these engineering and performance tests is defined by adherence to international standards and design specifications, not expert consensus on medical images or patient outcomes.

4. Adjudication method

Not applicable. Testing involves engineering verification and validation against objective standards and specifications, not subjective expert adjudication.

5. Multi-reader multi-case (MRMC) comparative effectiveness study

No, an MRMC comparative effectiveness study was not done or reported in this 510(k) summary. This type of study is relevant for diagnostic devices where human readers interpret medical data (e.g., images) with and without AI assistance to assess improved accuracy or efficiency. The Fluent Pro Fluid Management System is a hysteroscopic insufflator and morcellator control system; its functions are mechanical and fluidic control, not diagnostic interpretation.

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

This refers to an AI algorithm's performance without human interaction. This is not applicable to the Fluent Pro Fluid Management System, as it is a physical medical device with software components that control mechanical actions, not an AI-driven image analysis or diagnostic algorithm. Its "performance" is its functional operation in conjunction with a human operator during a hysteroscopic procedure.

7. The type of ground truth used

For the performance testing mentioned, the "ground truth" is defined by:

• International Standards: e.g., ISO 10993 for biocompatibility, ISO 11135 for sterilization, IEC 60601-1/1-2 for electrical safety/EMC, IEC 62366-1 for usability.
• Device Design Specifications: For metrics like Intrauterine Pressure Control, Fluid Deficit Accuracy (± 50 mL), Maximum Inflow Rate, etc. These are objective engineering parameters.

8. The sample size for the training set

Not applicable. The Fluent Pro Fluid Management System is not an AI/ML device that requires a "training set" in the conventional sense for learning and model development. The software within the device undergoes testing (unit, integration, system testing) to ensure it performs according to its predefined logical and control functions, not to train a learning algorithm.

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

Not applicable, as there is no "training set" for an AI/ML algorithm.

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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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Endomat Select is intended to:
· provide the infusion of the sterile irrigant solutions into the ureter and upper urinary tract, as well as to suction off the irrigation fluids, bodily fluids, secretions, tissue and gas during diagnostic and operative endoscopic urological procedures
· provide the infusion of the sterile irrigant solutions into the uterus, as well as to suction off the irrigation fluids, bodily fluids, secretions, tissue and gas during diagnostic and operative endoscopic hysteroscopic procedures
· provide the infusion of the sterile irrigant solutions into organs and operating diagnostic and operative procedures in laparoscopic and open general surgery
· provide sustained liquid irrigation of joint or intra-articular spaces during all phases of arthroscopic surgery
· provide the infusion of the sterile irrigant solutions in order to enable the Lens Cleaning during endoscopically assisted Functional Endoscopic Sinus Surgery and endoscopically assisted transnasal pituitary gland surgery

The Endomat Select is a multi-functional, pressure-controlled, combined irrigation and suction pump. It can be used for irrigation and, where appropriate dilation, during Hysteroscopic (HYS), Arthroscopic (ART), Urological (URO) and General Surgical or Laparoscopic (SURG) interventions. The device can be used for suction during Urological (URO) and Hysteroscopic (IBS) interventions. In addition, the device can function in an oscillatory mode (ENT/Neuro) providing a fluid means to maintain lens clarity during use in Transnasal procedures. The device has a modern LCD display with touch screen user interface. The tubing sets are encoded so that they can be identified by the device, which selects the appropriate operating modes based on the tubing set connected. The device can also be connected to other Karl Storz devices using the proprietary Storz Control Bus (SCB) [K994348].

The device protects the patient from overpressure via software means. The software-controlled pressure measurement system can stop the actuator (roller pump) should the pressure rise beyond the pre-determined limit and will immediately reverse the pump roller direction to depressurize the fluid system if required. Additionally, the device has high pressure alarms to alert the operating room staff of a high-pressure situation. The device also requires positive action from the user to increase pressures above 100mmHg; the user is prompted to confirm their choice on the user interface.

The accessories for this device are provided separately. All of the accessories for use with this device are already marketed in the U.S. and are either Class I, Class II 510(k) exempt or Class II previously cleared devices. The generic tubing sets for use with this device are single use, sterile Class I accessories.

The provided text describes a 510(k) submission for the "Endomat Select" device and its substantial equivalence to predicate devices, but it does not contain the detailed acceptance criteria for a specific study, nor does it present the results of a study designed to prove the device meets such criteria.

The document primarily focuses on establishing substantial equivalence through a comparison of the Endomat Select's indications for use, technological characteristics, and non-clinical performance data against two predicate devices (KARL STORZ Endomat Select (K180735) and KARL STORZ HAMOU Endomat (K936231)).

However, I can extract information related to the performance data and "acceptance criteria" in a general sense, as implied by the "Pass" status for various verification tests.

Here's the information based on the provided document, addressing your numbered points where possible, and indicating where information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide explicit numeric acceptance criteria. Instead, it lists "Verification Tests" and indicates they "Pass," implying that the device met pre-defined internal specifications.

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

• Sample Size: Not specified. The tests are described as "bench testing," which implies laboratory or engineering testing, but the number of units or test runs is not mentioned.
• Data Provenance: Not specified, but generally, bench testing would originate from the manufacturer's R&D or testing facilities (Germany, given the applicant's address). The data is retrospective (i.e., conducted before the 510(k) submission).

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

• Not Applicable. This type of information (experts establishing ground truth) is typically relevant for studies involving subjective human interpretation, such as image analysis for diagnostic accuracy. The reported tests are objective performance verification tests for a medical device (a pump).

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert interpretations, again, relevant to subjective assessments rather than objective device performance tests.

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

• No. The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence to the predicate devices." MRMC studies are clinical studies involving human readers.

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

• Not Applicable/Not a software algorithm device. The Endomat Select is a hardware device (a pump) with software control for pressure measurement and operation modes. The performance tests are for the physical device's function, not a standalone diagnostic algorithm.

7. The Type of Ground Truth Used

• Objective Device Specifications/Design Requirements. For performance tests like flow rate and pressure, the "ground truth" would be the pre-defined target values and tolerances specified in the device's design and engineering documents. For safety and usability, it would involve adherence to relevant standards and risk analyses.

8. The Sample Size for the Training Set

• Not Applicable. This concept is relevant for machine learning algorithms. The Endomat Select is a electromechanical medical device; it does not "train" on a dataset in the way an AI algorithm does. Its software logic is programmed based on engineering principles and design specifications.

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

• Not Applicable. As noted above, there is no "training set" for this type of device. The functional specifications and safety parameters are established through engineering design, risk assessment, and compliance with medical device standards.

Summary of Device and Study:

The Endomat Select is a multi-functional, pressure-controlled, combined irrigation and suction pump intended for various endoscopic surgical procedures. The substantial equivalence documentation highlights its expanded hysteroscopy suction mode compared to a primary predicate, while maintaining similarity to a secondary predicate's features.

The "study" to prove the device meets acceptance criteria was a series of non-clinical bench tests. These tests verified and validated that the Endomat Select met its design specifications for operating mode activation, software installation, flow rate performance, pressure performance, accessory compatibility, error detection, and usability. The results showed that all these tests passed, leading to the conclusion that the device is as safe and effective as its predicate devices, rendering clinical testing unnecessary for this 510(k) submission.

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Endomat Select is intended to:
• provide the infusion of the sterile irrigant solutions into the ureter and upper urinary tract, as well as to suction off the irrigations fluids, bodily fluids, secretions, tissue and gas during diagnostic and operative endoscopic urological procedures
• provide liquid distention of the uterus for diagnostic and operative hysteroscopy
• provide the infusion of the sterile irrigant solutions into organs and operating fields during diagnostic and operative procedures in laparoscopic and open general surgery
• provide sustained liquid irrigation and distention of joint or intra-articular spaces during all phases of arthroscopic surgery
• provide the infusion of the sterile irrigant solutions in order to enable the Lens Cleaning during endoscopically assisted Functional Endoscopic Sinus Surgery and endoscopically assisted transnasal pituitary gland surgery

The Endomat Select is a multi-functional, pressure- controlled, combined irrigation and suction pump. It can be used for irrigation and, where appropriate dilation, during Hysteroscopic (HYS), Arthroscopic (ART), Urological (URO) and General Surgical or Laparoscopic (SURG) interventions. The device can be used for suction during Urological (URO) interventions. In addition the device can function in an oscillatory mode (ENT/Neuro) providing a fluid means to maintain lens clarity during use in Transnasal procedures. The device has a modern LCD display with touch screen user interface. The tubing sets are encoded so that they can be identified by the device, which selects the appropriate operating modes based on the tubing set connected. The device can also be connected to other Karl Storz devices using the proprietary Storz Control Bus (SCB) [K994348]. The device protects the patient from overpressure via software means. The software controlled pressure measurement system can stop the actuator (roller pump) should the pressure rise beyond the pre-determined limit and will immediately reverse the pump roller direction to depressurize the fluid system if required. Additionally the device has high pressure alarms to alert the operating room staff of a high pressure situation. The device also requires positive action from the user to increase pressures above 100mmHg; the user is prompted to confirm their choice on the user interface.

The Endomat Select (Model Number: UP210) is a multi-functional pressure-controlled irrigation and suction pump. The device received FDA clearance K180735 on October 31, 2018.

Acceptance Criteria and Device Performance:

The device's performance was evaluated through a series of bench tests. The detailed acceptance criteria are implied by the "Pass" status for each performance and safety test. The reported device performance is that it Passed all these tests.

Study Details:

1. Sample size used for the test set and data provenance:
   The document states that "Additional bench testing was performed to ensure the device met its design specifications." and "The bench testing performed verified and validated that the Endomat Select has met all its design specification and is substantially equivalent to its predicate devices." However, specific sample sizes for these bench tests are not provided in this document. The data provenance is also not explicitly stated beyond being "bench testing." It is implied to be from the manufacturer, Karl Storz SE & Co. KG, located in Germany.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This information is not provided as the evaluation was based on non-clinical bench testing against design specifications and established standards, rather than expert-derived ground truth from a test set involving human interpretation.

3. Adjudication method for the test set:
   This information is not applicable as the evaluation was based on objective bench tests against pre-defined engineering and safety standards, rather than subjective interpretation requiring adjudication.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size:
   No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to assess safety and effectiveness and to establish the substantial equivalence." Therefore, no effect size of human readers improving with AI vs. without AI assistance is reported.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
   This device is a medical pump, not an algorithm or AI-powered system designed for diagnostic aid or similar tasks that would have standalone algorithm-only performance. Its performance is inherent in its mechanical and software functions. The "Performance" and "Safety" tests listed above can be considered standalone performance evaluations of the device's functional capabilities.

6. The type of ground truth used:
   The ground truth for the verification of the Endomat Select was based on design specifications and compliance with FDA recognized consensus standards and FDA Guidances. These include:

   • Electrical Safety and EMC (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8)
   • Software Verification and Validation Testing (Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11, 2005)
   • Summative Usability Testing (IEC 62366)
   • Performance Testing for Hysteroscopic and Laparoscopic Insufflators (Submission Guidance For A 510(K), August 1, 1995 for Product Code HIG)
   • Additional bench testing against design specifications.

7. The sample size for the training set:
   This information is not applicable as the device is not an AI/ML product developed using a training set in the conventional sense. Its development involved engineering design, software development, and testing against specifications.

8. How the ground truth for the training set was established:
   This information is not applicable for the same reason as above.

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The Fluent Fluid Management System is intended to provide liquid distension of the uterus during diagnostic and operative hysteroscopy, and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus while providing drive, control and suction for hysteroscopic morcellators.

The Fluent Fluid Management System is a hysteroscopic fluid management system and drive console for hysteroscopic morcellators. The Fluent Fluid Management System consists of a console and single-use procedure kit. The single use procedure kit consists of a sterile Inflow Tube Set (In-FloPak) and Outflow Tube Set (Out-FloPak) with a nonsterile Waste Bag. The two FloPaks and Waste Bag connect to the Console for performing hysteroscopic procedures. The console includes motors that control inflow and outflow of fluid for hysteroscopic insufflation, as well as a pressure sensor monitoring system and graphical user interface touchscreen. In addition, the console includes a connection for MyoSure Tissue Removal Devices and a pneumatic foot pedal to perform tissue removal procedures. The Fluent Fluid Management System is compatible with currently marketed MyoSure Tissue Removal Devices. The primary functions of the subject device are fluid distension, fluid deficit tracking, and morcellator drive control. The subject device includes a deficit alert feature as well as an overpressure protection mechanism.

Here's an analysis of the provided text to extract information about acceptance criteria and the study that proves the device meets them:

Disclaimer: The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a comprehensive clinical study report with detailed acceptance criteria and performance data in a structured format. Therefore, I will extract relevant information where available, and note when specific details (like numerical acceptance criteria or clinical study specifics) are not explicitly stated.

Acceptance Criteria and Device Performance

The 510(k) summary does not explicitly present a table of acceptance criteria with corresponding reported device performance values in a quantifiable manner that is typical for a clinical study. Instead, it relies on demonstrating that the new device's performance is "substantially equivalent" to the predicate devices. The performance testing section describes categories of tests conducted, implying that the device successfully met internal specifications and standards relevant to those tests.

However, based on the "Comparison of Technological Characteristics" Table 5-1 and the "Performance Testing" section, we can infer some operational parameters and functional aspects that would have associated acceptance criteria internally.

Study Details:

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

   • The document describes non-clinical performance testing (design verification, fluid management validation, intrauterine pressure control, system performance, system cutting performance).
   • It does not specify sample sizes for these tests (e.g., how many units were tested, how many trials were conducted for each metric).
   • The data provenance is internal to Hologic, Inc. (the manufacturer), as these are manufacturing and engineering validation tests. There's no mention of external data or specific countries of origin beyond the company's location in Marlborough, MA, USA.
   • These tests are inherently prospective in nature, as they involve testing the manufactured device against pre-defined specifications.

2. 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):

   • This question is not applicable in the context of the provided 510(k) summary. The summary describes engineering and performance validation tests for a medical device (hysteroscopic insufflator/morcellator drive), not a diagnostic algorithm or a clinical study requiring expert assessment of medical images or patient outcomes to establish ground truth. The "ground truth" for these tests would be the established engineering specifications and regulatory standards.

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

   • This question is not applicable as the tests described are technical performance validations, not clinical assessments requiring adjudication by multiple experts. The results of the engineering tests would be pass/fail against predetermined specifications.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI devices, where the AI assists human readers (e.g., radiologists). The Fluent Fluid Management System is a surgical assist device, not a diagnostic imaging device with an AI component for human reader assistance.

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

   • This device is a hardware system with integrated software for fluid management and morcellator control. Its "performance" is inherently standalone in the sense that the system itself performs its functions (e.g., maintaining pressure, tracking deficit, driving the morcellator) without direct human-in-the-loop influence on those specific operations. However, the device is used by a human surgeon. There is no "algorithm only" performance study in the typical AI sense. The performance tests (fluid management, cutting performance) were done on the device itself.

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

   • For the non-clinical performance testing, the "ground truth" refers to the engineering specifications, design requirements, and applicable industry standards (e.g., ISO, ASTM, IEC standards for sterilization, biocompatibility, electrical safety, and performance metrics as defined by the manufacturer). There is no "expert consensus," "pathology," or "outcomes data" ground truth discussed for these particular non-clinical studies.

7. The sample size for the training set:

   • This question is not applicable as this is not an AI/machine learning device that requires a "training set" in the conventional sense. The device's software is built on established algorithms for control, not on learning from a large dataset.

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

   • This question is not applicable for the same reasons as point 7.

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The GYN-Pump PH304 is a combined suction and irrigation pump for use in hysteroscopic and laparoscopic interventions. During diagnostic and operative hysteroscopy, the GYN-Pump PH304 is intended to provide liquid distension of the uterus and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus. During diagnostic and therapeutic laparoscopic procedures, the GYN-Pump PH304 is intended to irrigate fluid into and remove fluid from the abdominal cavity.

The GYN-Pump PH304 is a microprocessor controlled single roller pump that functions according to the peristaltic principle. It transports sterile irrigation fluid to distend the uterus and provides fluid deficit monitoring during operative hysteroscopy. It is also used to irrigate the abdominal cavity during laparoscopy and provides fluid aspiration. The pump consists of the following main components: a power supply, a power switch, a touch display, a connection for the suction function, a roller wheel, a pump head and a casing. The proposed pump is designed to be used with the Fluid Monitoring Unit PS304 in order to assist with fluid deficit monitoring. The Fluid Monitoring Unit PS304 is a component of the GYN-Pump PH304 and together they are a medical electrical system. The pump must be used with the following tube sets: Standard Irrigation Tube Set (also referred to as "ST261"), Suction Tube Set (one connection, "I"-shape; also referred to as "ST287"), Suction Tube Set (two connections, "Y"-shape; also referred to as "ST282"), Vacuum Tube Set (also referred to as "ST291").

The medical device in question is the GYN-Pump PH304, a combined suction and irrigation pump for hysteroscopic and laparoscopic interventions.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document focuses on comparing the GYN-Pump PH304 to its predicate devices, rather than explicitly stating acceptance criteria in a standalone table within the performance section. However, the comparative table on page 7 and the subsequent discussion implicitly define the performance targets for the GYN-Pump PH304 by referencing the predicate devices' specifications and emphasizing improvements or equivalency.

2. Sample Sizes Used for the Test Set and Data Provenance:

The document describes bench tests for performance.

• Comparative Bench Test – Fluid Deficit Measurement: This test compared the GYN-Pump PH304 to the Aquilex Fluid Control System H112. The sample size for fluid deficit measurement is not explicitly stated in terms of number of procedures or specific data points. It mentions "fluid was dispensed through the system," implying a controlled experimental setup.
• Pressure Regulation Bench Test: This test involved connecting the GYN-Pump PH304 to a model system and cycling it through a range of flow rates and pressures. The sample size is not explicitly stated.
• Data Provenance: The studies were bench tests, conducted in a controlled laboratory environment by the manufacturer (W.O.M. World of Medicine GmbH). The country of origin for the studies would be Germany, where the manufacturer is located. The studies are prospective in nature, as they were conducted to evaluate the performance of the newly developed GYN-Pump PH304.

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

The document does not mention the involvement of experts (e.g., clinicians, radiologists) to establish ground truth for the bench tests. Ground truth for these performance tests was established through manual measurement (for fluid deficit) and continuous monitoring and recording (for pressure regulation) within the experimental setup, likely using calibrated instruments. The expertise would lie in the engineers and technicians conducting the validation tests according to established protocols and standards.

4. Adjudication Method for the Test Set:

No adjudication method (like 2+1 or 3+1) is mentioned as these were bench tests of a physical device's performance against predefined quantifiable metrics, not assessments of qualitative outputs or interpretations that would require expert consensus.

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

No MRMC comparative effectiveness study was done. The studies described are bench tests comparing device performance to predicate devices and predefined specifications, not human reader performance with or without AI assistance. Therefore, no effect size of human readers improving with AI vs without AI assistance is reported.

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

The device (GYN-Pump PH304) is a physical pump with embedded software, not an AI algorithm for diagnostic interpretation. The performance data presented is for the standalone device operating according to its design specifications in a test environment. Thus, a "standalone" performance study in the context of an AI algorithm is not applicable here, but the described bench tests effectively serve as standalone performance evaluations of the device.

7. The Type of Ground Truth Used:

• Bench Tests (Fluid Deficit Measurement): Ground truth was established through manual measurement of the fluid deficit. This involved a direct and objective physical measurement to compare against the device's computed deficit.
• Bench Tests (Pressure Regulation): Ground truth was established through continuously monitored and recorded pressure data from the model system, likely using highly accurate pressure transducers or sensors.

8. The Sample Size for the Training Set:

The GYN-Pump PH304 is a hardware device with embedded software logic, not an AI/machine learning system that requires a "training set" of data in the conventional sense. The software development, testing, and verification followed standards like IEC 62304, which involves rigorous development and testing phases, but not a "training set" of patient data as understood in AI/ML.

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

As there is no "training set" in the context of an AI/ML algorithm for this device, this question is not applicable. The software's "ground truth" or correct functioning is established through comprehensive software verification and validation activities (unit testing, integration testing, system testing) against its design specifications and requirements, as per IEC 62304.

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The Aquilex® Fluid Control System AQL-100S is intended to provide fluid distension of the uterus during diagnostic and operative hysteroscopy and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus.

The Aquilex® Fluid Control System AQL-100S is a modified version of the primary predicate device, Aquilex Fluid Control System H112 (K112642). The proposed device is a microprocessor-controlled device that consists of the following two main components: (1) an irrigation pump unit including suction pumps (AQL-110P) and (2) and fluid monitoring unit (AQL-100CBS) that are to be placed on a roller stand. The irrigation pump unit (AQL-110P) of the Aquilex® Fluid Control System AQL-100S is a microprocessor-controlled device that functions according to the peristaltic principle and consists of the following components: (1) a casing. (2) a power switch, (3) a power supply, (4) mains cable, (5) a roller wheel, (6) a pump head, (7) suction pumps, (8) various setting keys and (9) display elements. The irrigation pump unit (AQL-110P) is to be used with specially designed single use irrigation and outflow tube sets that are delivered sterile (AQL-110 and AQL-111). In addition, the suction pumps of the irrigation pump unit are to be used with specially designed non-sterile vacuum tube sets (AQL-114). The fluid monitoring unit (AQL-100CBS) consists of the following main components: (1) two scale units, (2), a bag holder, (4) a bag deflector, (5) a container holder, and (6) a roller wheel base. The irrigation pump unit of the proposed device is only operational in conjunction with the fluid monitoring unit.

The provided document in the prompt relates to a 510(k) premarket notification for a medical device called the "Aquilex® Fluid Control System AQL-100S." This document describes the device, its intended use, comparison to predicate devices, and a summary of performance data collected to demonstrate substantial equivalence.

However, the document does not contain specific acceptance criteria tables nor detailed results from a clinical study proving the device meets those criteria. Instead, it provides a summary of various bench tests and compliance with standards (electrical safety, EMC, software, biocompatibility, sterilization, shelf life) to support its substantial equivalence claim, rather than a clinical study with acceptance criteria for device performance in a real-world or simulated clinical setting.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth cannot be extracted directly from this document in the manner typically associated with studies demonstrating performance against specific clinical or diagnostic metrics.

Based on the available information, here's what can be inferred and what cannot:

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

The document mentions "Bench testing was performed to demonstrate that the fluid deficit determination...is substantially equivalent...in terms of accuracy." However, it does not provide a specific table of acceptance criteria for this accuracy or the reported numerical performance values (e.g., mean accuracy, standard deviation, or specific thresholds).

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

• Test Set Sample Size: Not specified for any of the performance tests. The bench testing refers to "fluid deficit determination" but doesn't quantify the number of measurements or conditions.
• Data Provenance: The tests (electrical safety, EMC, software verification/validation, biocompatibility, sterilization, shelf life, bench testing) are described as performed by "independent laboratories" or internally. No information on country of origin of data or whether it was retrospective or prospective is given, as these are typically laboratory/bench tests, not clinical studies.

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 performance tests described are laboratory-based and do not involve human interpretation or subjective assessment that would require "experts to establish ground truth" in the clinical sense.

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

Not applicable. There's no human adjudication involved in the described bench and standard compliance tests.

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 device is a fluid control system, not an AI or imaging diagnostic device that would involve human readers or MRMC studies.

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

The performance tests are essentially standalone for the device, as they assess its functional capabilities (e.g., electrical safety, fluid deficit accuracy) without human intervention in the primary measurement. However, this is not an "algorithm only" study in the context of AI, but rather a functional characterization of hardware and software.

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

For the bench testing related to "fluid deficit determination," the ground truth would likely be established by highly accurate reference measurement systems (e.g., precise scales or flow meters) that are calibrated and traceable to known standards. This is inherent in laboratory bench testing. The document doesn't explicitly state the specifics of this ground truth.

8. The sample size for the training set:

Not applicable. This is not an AI-driven device requiring a training set in the typical machine learning sense. The software development and testing, while mentioned (IEC 62304), refers to traditional software verification and validation, not machine learning model training.

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

Not applicable, as there is no training set for an AI model.

Summary of available information:

Reported Performance: No specific numerical performance values (e.g., accuracy percentages, error ranges) are reported for the fluid deficit determination. The conclusion is that the device "is substantially equivalent" to the predicate for this function. |
| Test Set Sample Size | Not specified for any of the performance tests. |
| Data Provenance | Tests performed by "independent laboratories" or internally. No details on country of origin or retrospective/prospective nature. |
| Number & Qualifications of Experts for Ground Truth | Not applicable; tests are laboratory-based, not reliant on expert clinical interpretation for ground truth. |
| Adjudication Method for Test Set | Not applicable; no human adjudication involved in these functional tests. |
| MRMC Comparative Effectiveness Study | No. This is a fluid control system, not an imaging/AI diagnostic device. |
| Standalone Performance Study | Yes, the various bench, electrical safety, EMC, software, biocompatibility, sterilization, and shelf-life tests assess the device's performance in a standalone context against relevant standards and predicate device functions. |
| Type of Ground Truth Used | For "fluid deficit determination," ground truth would be established by precise, calibrated reference measurement systems in a laboratory setting. Not explicitly detailed in the document. |
| Training Set Sample Size | Not applicable; this device does not use machine learning that requires a training set. Software verification and validation followed IEC 62304. |
| How Training Set Ground Truth was Established | Not applicable; no training set for AI. |

The document primarily relies on demonstrating compliance with recognized standards (IEC 60601-1, IEC 60601-1-2, IEC 62304, ISO 10993 series, ISO 11135, ISO 14937, ISO 11607-1, ASTM-F1980) and bench testing indicating functional equivalence to a predicate device for its 510(k) clearance, rather than reporting detailed clinical study results with explicit acceptance criteria often found for diagnostic or treatment efficacy devices.

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Intended for irrigation and fluid warming in laparoscopic procedures, and distention, fluid warming, and volume/deficit measurements in endoscopic procedures within gynecology, and orthopedic disciplines.

FluidSmart® is intended for irrigation, distention, fluid warming, and fluid volume/deficit measurements in endoscopic procedures within gynecology, urology, and orthopedic disciplines. Fluids commonly used include 0.9% saline, lactated ringer's solution, 5% mannitol, 1.5% glycine, and sterile water.

The main unit is mounted on a rolling stand which houses the technology used to warm the fluids and the peristaltic pump used to pressurize the fluids. A touch-screen operated processor provides closed loop controls for fluid warming and pumping. The processor monitors temperature and pressure sensors to adjust warming power and pump speed as required. Load cells attached to the fluid bag hooks and suction canister ring allow the processor to monitor fluid levels pumped to and suctioned from the surgical site.

This document is a 510(k) summary for the FluidSmart device, which is a hysteroscopic insufflator. Such summaries typically focus on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and study results in the manner requested for AI/ML devices. Therefore, much of the requested information, which is common in regulatory submissions for AI/ML or novel devices, is not present here.

Here's a breakdown of the available information and what is not present:

1. Table of acceptance criteria and the reported device performance

The document provides a comparative table of technological characteristics to predicate devices, but it does not specify quantitative acceptance criteria for performance benchmarks, nor does it present device performance against such criteria directly in a table format as might be expected for software performance metrics.

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

Not applicable. This device is a hardware device (insufflator, fluid warmer) with associated software for control. The testing involved non-clinical design verification, not analysis of a "test set" of patient data in the context of an AI/ML device.

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

Not applicable, as this is not an AI/ML device requiring expert ground truth for a test set.

4. Adjudication method for the test set

Not applicable, as this is not an AI/ML device requiring expert adjudication of a test set.

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. This is not an AI/ML device and thus an MRMC study is not relevant.

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

Not applicable, as this is not an AI/ML algorithm. The device itself (FluidSmart®) is a standalone system.

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

Not applicable, as this is not an AI/ML device. The "ground truth" for a device like this would involve engineering specifications, safety standards, and functional performance benchmarks (e.g., temperature accuracy, pressure regulation accuracy, leak tests), which are evaluated through non-clinical testing.

8. The sample size for the training set

Not applicable, as this is not an AI/ML device with a training set.

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

Not applicable, as this is not an AI/ML device with a training set.

Summary of the Study Mentioned (Non-Clinical Testing):

The document states:

• Non-clinical testing performed including the following design verification testing:
  1. Software verification testing.
  2. Tubing set verification testing.

This indicates that Thermedx conducted internal testing to ensure the software functions as designed and the disposable tubing sets meet their specifications (e.g., integrity, pressure relief valve operation, biocompatibility, and expiration dating, as mentioned elsewhere). No clinical testing was conducted or submitted. The "study" here is essentially internal design verification and validation against engineering specifications and regulatory standards for safety and effectiveness for a medical device.

Key takeaway: This 510(k) submission primarily focuses on demonstrating substantial equivalence to existing predicate devices by comparing technological characteristics and asserting that the minor proposed changes (specifically, increasing maximum pressure for ureteroscopy procedures from 200 mmHg to 300 mmHg) do not raise new questions of safety or effectiveness. It is not an AI/ML device, and therefore, the typical AI/ML study parameters are not applicable or provided.

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The Thermedx Fluid Management System is intended for irrigation and fluid warming in laparoscopic procedures, and distention, fluid warming, and volume/deficit measurements in endoscopic procedures within gynecology, urology, and orthopedic disciplines.

The Thermedx device is a fluid management system intended for surgical applications. The device consists of a main unit and disposable tubing sets. A rolling stand-mounted device houses infrared fluid heating technology and a peristaltic fluid pump with closed-loop controls. The Thermedx monopolar electrocautery probes are an optional accessory for electrosurgical cutting and coagulation.

This document is a 510(k) summary for the Thermedx Fluid Management System. It outlines the device's intended use, description, and non-clinical testing performed. However, it does not contain any information about acceptance criteria or specific studies that prove the device meets said acceptance criteria. The document primarily focuses on establishing substantial equivalence to a previously cleared device (Thermedx 37-5, K091939) based on identical technology and unchanged packaging/sterilization. The changes relate to individual procedure settings and the addition of a high-pressure disposable tubing set.

Therefore, I cannot provide the requested information. The document explicitly states:

• No acceptance criteria or device performance table.
• No specific study proving device meets acceptance criteria.
• No sample sizes for test sets or training sets.
• No information on data provenance.
• No mention of experts for ground truth or adjudication methods.
• No Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
• No standalone algorithm performance study.
• No type of ground truth used.
• No details on how ground truth for training set was established.

The "Non Clinical Tests" section lists biological testing of tube-sets and software verification testing. These are general tests for safety and functionality, not performance studies against specific acceptance criteria. For example, "Verify crack pressures of valve for HLL003 is within 240-360mmHg range" is a functional verification, not a performance study proving a clinical outcome or meeting specific efficacy criteria within a clinical context.

The document refers to "numerous journal articles, practical guidelines, hospital guidelines" in support of changes to procedures and settings, implying reliance on existing knowledge and practices rather than new clinical trials for this specific device version.

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The Hysteroscopy Pump HM6 is intended to provide liquid distension of the uterus during diagnostic and operative hysteroscopy, and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus.

The Hysteroscopy Pump HM6 is a microprocessor controlled device that consists of the following two main components: (1) an irrigation pump unit and (2) and fluid monitoring unit that are to be placed on a cart. The irrigation pump unit is a single roller pump that functions according to the peristaltic system and includes a manmachine interface (MMI) and a touch-screen display. The Hysteroscopy Pump HM6 is to be used with specially designed single use irrigation and outflow tube sets that are supplied sterile. The fluid monitoring unit of the Hysteroscopy Pump HM6 is a microprocessor controlled device, which monitors the amount of delivered irrigation solution and compares it with the volume of the secretions returned to the container. The monitoring enables the surgeon to observe the quantity of fluids left in the patient. The irrigation pump unit of the proposed device indicates any fluid deficit that exceeds the fluid deficit level pre-set by the surgeon. The Hysteroscopy Pump HM6 determines both the inflow and outflow volume by means of two separate scales.

This document describes a 510(k) premarket notification for the Hysteroscopy Pump HM6. The focus of the submission is to demonstrate substantial equivalence to predicate devices, rather than establishing de novo safety and effectiveness through extensive clinical studies with acceptance criteria. Therefore, the information provided is primarily focused on demonstrating the similarity of the new device to existing devices on the market, relying on bench testing for performance.

Here's an analysis of the provided information concerning acceptance criteria and studies:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance data in the traditional sense of a clinical trial proving a specific efficacy or accuracy metric. Instead, the "performance testing" section refers to bench tests and compliance with standards. The key "acceptance criterion" for this 510(k) submission is showing that the device is substantially equivalent to predicate devices and that the modifications do not raise new questions of safety and effectiveness.

The document highlights the following performance aspects and their comparison to the predicate Aquilex System:

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