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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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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 Smith & Nephew DYONICS 25 Fluid Management System is indicated for use during arthroscopic joint surgery to regulate flow of irrigation fluids in the knee, shoulder, hip, and small joints to maintain intra-articular pressure for uniform distension and clear visualization of the surgical site.

The Smith & Nephew DYONICS 25 Fluid Management System is a centrifugal fluid management pump used in arthroscopic surgery to regulate the flow of irrigation fluids through the joint to maintain intra-articular pressure for distension and visualization of the surgical site. This is accomplished using an electronic pressure control feedback loop between the control unit and the tube set cassettes.

The Smith & Nephew DYONICS 25 Fluid Management System includes -

• . control unit
• . inflow tube set
• . inflow /outflow tube set
• inflow/outflow tube set with forked suction lines
• . day-tube set
• . patient tube set
• . wired/wireless (IR) remote control (optional)
• . Luer to colder Connector (optional)

Additionally, the Smith & Nephew LEVELERT II Fluid Level Sensors (K060123) as well as a shaver system interface cable, U.S. and international power cords can be used with the Smith & Nephew DYONICS 25 Fluid Management System (DYONICS 25).

Here's an analysis of the provided text regarding the acceptance criteria and study for the Smith & Nephew DYONICS 25 Fluid Management System:

This document is a 510(k) Summary of Safety and Effectiveness Information for a medical device. It's important to understand that a 510(k) submission generally aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving absolute safety and effectiveness through extensive clinical trials as might be required for a novel device. The "acceptance criteria" here refer to meeting performance specifications and relevant standards to demonstrate equivalence, not necessarily clinical outcome measures.

Description of Acceptance Criteria and Study to Prove Device Meets Them

The Smith & Nephew DYONICS 25 Fluid Management System is a centrifugal fluid management pump used in arthroscopic surgery. The current submission (K171794) is for a modified version of a previously cleared device (K051326). The "acceptance criteria" for this submission are primarily that the modified device performs comparably to the predicate device and meets relevant performance specifications and recognized consensus standards, without raising new questions of safety or effectiveness due to the design changes.

The study proving the device meets these criteria is a series of bench and engineering tests and software verification and validation.

1. Table of Acceptance Criteria and Reported Device Performance

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

This document does not specify a "sample size" in the context of patient data or a test set of clinical images. The testing described (Package/Performance, Environmental, Fluids, EMC, Safety, Software V&V) are bench and engineering tests, performed on the device itself or its components. Therefore, terms like "test set," "data provenance," or "country of origin for data" are not applicable in the typical sense of a clinical study or AI model evaluation.

• Sample size: Not applicable as it's not a clinical or image-based study. The "sample" would be the device units or components tested.
• Data provenance: Not applicable. The data is from internal engineering and bench testing.
• Retrospective/Prospective: Not applicable.

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

Not applicable. This is not a study requiring expert readers or consensus to establish ground truth. The "ground truth" for the engineering and performance tests is defined by the technical specifications, international standards (e.g., IEC), and the functional requirements of the device.

4. Adjudication Method for the Test Set

Not applicable. There is no expert adjudication process for bench and engineering tests. The results are typically pass/fail based on predefined technical criteria and standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is common for evaluating diagnostic imaging devices or AI systems, especially when comparing human performance with and without AI assistance. This device is a fluid management pump, not a diagnostic or AI-powered imaging device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device does not feature an "algorithm only" component in the sense of an AI/ML system that would operate autonomously. While it has software and a feedback loop for pressure control, its operation is an integral part of an arthroscopic surgical procedure that always involves a human surgeon. The "software verification & validation" conducted is the closest equivalent to testing the "standalone" performance of its control logic.

7. Type of Ground Truth Used

The "ground truth" for this submission is based on:

• Technical specifications derived from the intended function of the device (e.g., maintaining pressure, regulating flow).
• International consensus standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 62304) which define safety and performance requirements.
• Comparison to the predicate device's established performance.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a "training set" of data in the common sense. The software development process involves coding, verification, and validation, but not training on a dataset to learn patterns.

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

Not applicable. As noted in point 8, there is no "training set" for this device.

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The DOLPHIN® 3 Fluid Management System provides low viscosity liquid distension of the uterus for hysteroscopy, and monitors intrauterine pressure, fluid use and fluid deficit.

The DOLPHIN® 3 will be used during Hysteroscopic procedures where physicians need to monitor fluid pressure and fluid loss. The system will provide delivery of low viscosity distension fluid through a disposable tubing set that includes an integrated pressure transducer. The system will calculate and display fluid pressure and fluid deficit while providing distension of the uterus for visualization and flow. The DOLPHIN® 3 provides both audible and visual alarms if pressure levels are too high or if the user-set fluid deficit alarm levels are exceeded. The DOLPHIN® 3 incorporates a two-bag distension fluid system that utilizes a bladder bag to provide steady pressure on (each) the fluid bags. The two bladder bags are essentially pneumatic "bag squeezers" set within a rigid housing that contains the fluid bags. The DOLPHIN® 3 fluid pump adjusts the pressure applied to the distension fluid bags by inflating or deflating the pneumatic bladder. The infusion pressure can be set by the user between 40-140 mm Hg (40 mmHg is the factory default setting at power up) The system can accommodate 1, 2 or 3 liter fluid bags, The sterile/disposable tubing set with integrated pressure transducer is used to deliver fluid from the DOLPHIN® 3 to the inflow port on the hysteroscope. The device weighs the fluid in order to calculate the deficit. Any fluid dispensed but not returned to the collection canisters is considered part of the deficit.

The provided text describes a 510(k) summary for the DOLPHIN® 3 Fluid Management System. It outlines the device's intended use, product description, and a summary of nonclinical/bench testing performed to verify its performance. However, it does not include specific acceptance criteria for performance metrics in a tabular format, nor does it detail a study that directly proves the device meets such criteria with numerical results. The document primarily focuses on verifying functionality and safety rather than quantifying performance against pre-defined acceptance thresholds in a clinical or comparative study with human readers.

Therefore, much of the requested information cannot be extracted from the provided text. I will provide what is available and note what is missing.

1. Table of Acceptance Criteria and Reported Device Performance

The provided summary lists multiple performance/functional tests conducted but does not specify numerical acceptance criteria for these tests or quantitatively report the device's performance against such criteria. The document generally states that tests were conducted "to verify that the subject device met specified requirements" or "to determine the ability" or "to verify functionality," without providing the actual values or thresholds.

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

This information is not provided in the document. The tests described are bench/nonclinical tests, not human subject studies or data-driven clinical trials. There is no mention of a "test set" in the context of clinical data.

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

This information is not applicable and not provided in the document. As this is a bench/nonclinical study for a hardware system, there is no "ground truth" derived from expert review or clinical data. The tests focus on the device's physical and functional performance.

4. Adjudication Method for the Test Set

This information is not applicable and not provided in the document for the reasons stated above.

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

This information is not applicable and not provided in the document. The DOLPHIN® 3 is a fluid management system, not an AI-powered diagnostic device, and the studies described are bench tests, not MRMC studies involving human readers.

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

This information is not applicable and not provided in the document. The device is a physical system with sensors and controls, not a standalone algorithm. The tests described assess the device's physical and functional performance, not algorithm-only performance.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)

This information is not applicable and not provided. The "ground truth" for the nonclinical tests would be the established engineering specifications and physical principles against which the device's performance is measured. For example, for "Pressure Accuracy vs Flow Rate," the ground truth would be accepted physics and engineering standards for pressure and flow.

8. The Sample Size for the Training Set

This information is not applicable and not provided in the document. As this is not an AI/machine learning device, there is no "training set."

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

This information is not applicable and not provided in the document for the reasons stated above.

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The 37-5 is a multi-purpose fluid management system indicated for the following:

• Laparoscopy: warming fluids for irrigation and aspiration .
• Hysteroscopy: uterine distention during diagnostic and operative procedures .
• Cystoscopy: distention of the bladder during diagnostic and operative procedures (with optional . fluid warming)
• Arthroscopy: distention and irrigation of the knee, shoulder, and small joints, during diagnostic . and operative procedures

During hysteroscopic, cystoscopic and arthroscopic procedures, the 37~5 can be used to monitor fluid deficit.

The Thermedx 37-5 is a general purpose fluid management system intended for standard surgical fluid management applications. The device consists of a Base Unit and Disposable Tubing Sets. A rolling standmounted device houses infrared fluid heating technology and a peristaltic fluid pump with closed-loop controls. The unit operates in 2 primary modes with fluid heating; flow control and pressure control. The Disposable Tubing Sets include IV bag spike, heating cartridge, and trumpet valve or luck connectors for endoscopes or other devices.

Here's a breakdown of the acceptance criteria and study information for the Thermedx 37-5 Fluid Management System, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not provide a table with specific numerical acceptance criteria (e.g., target temperature ranges, flow rates with specific tolerances, pressure ranges with specific accuracies) or detailed numerical performance results for the Thermedx 37-5. Instead, it makes a general statement about meeting specifications.

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

• Sample Size for Test Set: Not specified. The document mentions "non-clinical performance testing" which typically involves a series of tests, but not a "sample size" in the statistical sense of a patient cohort. The tests are simulated, indicating no human or animal subjects were used.
• Data Provenance: Not applicable, as the testing was "non-clinical" and "simulated." This would imply in-house laboratory testing rather than data from a country of origin or retrospective/prospective studies on patients.

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

There is no mention of experts being used to establish a "ground truth" in the context of this 510(k) summary. The testing conducted was non-clinical and simulated, implying engineering and technical validation against pre-defined specifications rather than expert clinical judgment.

4. Adjudication Method for the Test Set

Not applicable. As no expert ground truth or clinical data requiring adjudication is mentioned, no adjudication method was used.

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

No. An MRMC study is not relevant for this type of medical device (fluid management system) which does not involve image interpretation or diagnostic performance that would require human readers. The document details performance testing of the device's physical functions.

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

This question is not directly applicable in its typical sense for an AI/algorithm-based diagnostic device. However, the "non-clinical performance testing" described (simulated laparoscopy, uterine distension, over-temperature, etc.) is standalone device performance testing, as it assesses the device's functions without direct human intervention in its operation for the purpose of the test. The device itself is designed to be used with human operators in a clinical setting.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to the defined performance specifications and safety standards. For instance:

• Temperature accuracy (e.g., maintaining fluid at approximately body temperature).
• Pressure limits (e.g., maintaining pressure within safe ranges).
• Flow rates (e.g., meeting specified flow capabilities).
• Electrical safety standards (IEC 60601-1).

The device was tested against these pre-defined engineering and safety specifications.

8. The Sample Size for the Training Set

Not applicable. This device is a mechanical/electronic fluid management system, not an AI/machine learning algorithm that requires a "training set" of data.

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

Not applicable, as there is no training set for this device.

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The BioDrain STREAMWAY™ Fluid Management System (FMS) is intended to be used in areas such as Operating Rooms, Intensive Care Units, Pathology Suites, Emergency Rooms, Surgical Centers and Doctors' Offices to collect and dispose of fluid waste.

The BioDrain STREAMWAY™ FMS system has been designed to safely remove surgical fluid waste during a surgical procedure. The device is wall mounted in the room in which the procedure is being conducted. It is connected to the hospital/clinic vacuum line system, the hospital/clinic drain system, and electrical power. The device removes waste via a disposable suction tube (not provided with system) from the patient and surrounding area, measures the volume of fluid collected, and disposes of the waste into the hospital drainage system. The device has a self cleaning cycle to clean the internal mechanism of the device. The cleaning solution container and the suction tube to the operative field are disposable. The cleaning solution adapter is reusable.

The provided text describes the BioDrain STREAMWAY™ Fluid Management System (FMS) and its substantial equivalence to predicate devices, but it does not contain information about specific acceptance criteria or a study proving that the device meets such criteria.

The document is a 510(k) summary for a medical device (a fluid management system, essentially a powered suction pump). The FDA's 510(k) pathway is for devices that are "substantially equivalent" to already legally marketed devices (predicates), meaning they have the same intended use and technological characteristics as the predicate, or have different technological characteristics but do not raise new questions of safety and effectiveness.

Here's what can be inferred from the document based on the request:

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

• Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for the device. The "acceptance criteria" in a 510(k) context generally revolve around demonstrating substantial equivalence to a predicate device.
• Reported Device Performance: The document states "Bench testing was performed to support a determination of substantial equivalence and consisted of packaging, electrical safety testing and all testing identified in the FDA's Guidance for Powered Suction Pumps, September 30, 1998 and Premarket Submissions for Software Contained in Medical Devices."
  • Specific performance results (e.g., flow rate, vacuum strength, volume measurement accuracy) are NOT provided in this summary. It only states that testing was performed and results provide assurance of conformance.

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

• Sample Size: Not specified. The document only mentions "bench testing."
• Data Provenance: Not specified. Bench testing typically occurs in a lab setting rather than using patient data from a specific country or being retrospective/prospective.

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

• Not applicable. This information is typically relevant for studies involving human interpretation (e.g., imaging studies, AI diagnostics). The study described here is bench testing of a physical device.

4. Adjudication method for the test set:

• Not applicable. Adjudication methods are relevant for studies where human expert consensus is needed to establish ground truth.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No. This type of study (MRMC) is for assessing the impact of a device (often AI) on human reader performance, typically in diagnostic imaging. The BioDrain STREAMWAY™ FMS is a fluid management system, and no such study is mentioned or relevant here.

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

• Not applicable in the typical sense of AI algorithms. While the device itself operates "standalone" in its function, "standalone performance" usually refers to the performance of an AI algorithm independent of human intervention in a diagnostic context. The FMS is a physical piece of medical equipment. The "software" mentioned in the testing implies some control logic, but no "algorithm-only" performance metrics are provided.

7. The type of ground truth used:

• For physical performance aspects (e.g., vacuum, flow, electrical safety), the "ground truth" would be established by engineering specifications, industry standards, and regulatory guidance documents. The device's performance is measured against these established parameters.
• The document implies that testing was done to assure conformance to the requirements of its intended use, based on FDA guidance and internal design specifications.

8. The sample size for the training set:

• Not applicable. This device is hardware with some embedded software, not a machine learning model that requires a "training set" of data in the AI sense.

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

• Not applicable. (See point 8).

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The Smith & Nephew 25 Fluid Management System is indicated for use during arthroscopic joint surgery to regulate flow of irrigation fluids in the knee, shoulder, hip and small joints to maintain intra-articular pressure for uniform distension and clear visualization of the surgical site.

The Smith & Nephew 25 Fluid Management System is a microprocessor controlled arthroscopic fluid management system that is designed for controlled delivery of irrigation fluids during intra-articular surgery. The system controls joint pressure independently of aspiration rate over a wide range of flow rates. The system will maintain control of intra-articular pressure regardless of varying outflow rates and may be used with any arthroscopic inflow cannula.

The provided text describes a 510(k) premarket notification for the "Smith & Nephew 25 Fluid Management System." It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria, study details, expert involvement, and ground truth cannot be extracted from this document.

Here's an analysis of what can and cannot be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as quantifiable metrics. The document implies the acceptance criterion is "substantial equivalence" to predicate devices without introducing new issues of safety or efficacy.
• Reported Device Performance: The document states that "performance testing and the software verification and validation conducted on the Smith & Nephew 25 Fluid Management System demonstrates substantial equivalence." However, it does not provide specific performance data (e.g., accuracy, precision, reliability figures) in a quantifiable manner against predefined acceptance criteria.

Therefore, a table cannot be fully constructed with specific acceptance criteria and performance numbers from this document.

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

• The document mentions "performance testing" but does not specify any sample size for a test set (e.g., number of cases, images, or test runs), nor does it provide data provenance (country of origin, retrospective/prospective). This is typically a preclinical engineering test, not a clinical study with a "test set" in the sense of patient data.

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

• Since a clinical "test set" with ground truth established by experts is not described, this information is not applicable and not present in the document.

4. Adjudication method for the test set:

• As no expert-established ground truth for a test set is described, an adjudication method is not applicable and not present.

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:

• This device is a fluid management system, not an AI-powered diagnostic tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and not mentioned.

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

• The document implies that "performance testing and the software verification and validation" were conducted on the device itself. This would be considered "standalone" performance for the device, but it's not an "algorithm only" in the sense of a diagnostic AI. No specific performance metrics for this standalone testing are provided.

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

• For this type of device (fluid management system), "ground truth" would likely be established through engineering specifications and measurements (e.g., fluid pressure accuracy, flow rate stability, software functionality against requirements). The document doesn't explicitly state the methodology for establishing this "ground truth."

8. The sample size for the training set:

• Training sets typically refer to data used for machine learning models. This device is described as a "microprocessor controlled arthroscopic fluid management system," not an AI/ML device in the modern sense. Therefore, a "training set" with a specified sample size is not applicable and not mentioned.

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

• As there is no described training set, this information is not applicable and not present.

Summary of what is available from the document:

• Device: Smith & Nephew 25 Fluid Management System
• Purpose of the study/testing: To demonstrate substantial equivalence to predicate devices (Smith & Nephew InteliJET™ HERMES-Ready (K031605) and Smith & Nephew InteliJET™ Fluid Management Systems (K050580)).
• Method of demonstrating equivalence: "Performance testing and the software verification and validation."
• Conclusion: The testing "demonstrates substantial equivalence" and that "the differences in the new device and the predicate device do not raise any new issues of safety and efficacy."

This document is a regulatory submission focused on comparing a new device to existing legally marketed predicate devices, not on proving de novo performance against a set of clinical acceptance criteria using a typical clinical study design with human readers or AI algorithms.

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