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The LIBERTY® Endovascular Robotic System is intended for use in the remote delivery and manipulation of guidewires and catheters, and remote manipulation of guide catheters, to facilitate navigation to anatomical targets in the peripheral vasculature.

The LIBERTY® Endovascular Robotic System is not intended for coronary or neurointerventional procedures.

The LIBERTY® Endovascular Robotic System (LIBERTY System) is a single-use, sterile, disposable device designed to help physicians navigate guidewires and catheters in peripheral endovascular procedures. It allows physicians to control the devices remotely using a handheld controller while enabling a physician to remain seated and away from the X-ray radiation source, thus reducing radiation exposure.

Key components:

• Bedside Robotic Drive: This motorized unit grips and maneuvers the interventional devices.
• Handheld Remote Control: This wireless controller allows the physician to remotely advance, retract, and rotate the guidewire and microcatheter by communicating with the Robotic Drive.
• Mounting Arm: This arm securely attaches the Robotic Drive to the patient's bed near the insertion point.
• Accessories: These include hemostatic valves and an extension tube for managing fluids during the procedure.

The system is intended to be used in peripheral endovascular procedures. Following manual insertion of an introducer sheath and guide catheter, the system is utilized via the handheld remote control that operates the robotic drive from a distance and enables remote positioning of guidewire and catheter (microcatheter) devices at a desired point inside the peripheral vasculature. Once the interventional devices are placed at the target site using the LIBERTY Robotic System, the devices are used manually consistent with their cleared indications for use for the interventional procedure.

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HemoSphere Alta™ Advanced Monitor with Swan-Ganz Technology
The HemoSphere Alta monitor when used with the HemoSphere Alta Swan-Ganz patient cable and Edwards Swan-Ganz catheters is indicated for use in adult and petical care patients requiring monitoring of cardiac output (continuous [CO] and intermittent [iCO]) and derived hemodynamic parameters in a hospital environment. Pulmonary artery blood temperature monitoring is used to compute continuous and intermittent CO with thermodilution technologies. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed in a hospital environment. Refer to the Edwards Swan-Ganz Ir catheter indications for use statement for information on target patient population specific to the catheter being used.

The Global Hypoperfusion Index (GHI) algorithm provides the clinician with physiological insight into a patient's likelihood of future hemodynamic instability. The GHI algorithm is intended for use in surgical or non-surgical patients receiving advanced hemodynamic monitoring with the Swan-Ganz catheter. The GHI algorithm is considered to provide additional information regarding the patient's predicted future risk for clinical deterioration, as well as identifying patients at low risk for deterioration. The product predictions are for reference only and no therapeutic decisions should be made based solely on the GHI algorithm predictions.

When used in combination with a Swan-Ganz catheter connected to a pressure transducer, the Edwards Lifesciences Smart Wedge algorithm measures and provides pulmonary artery occlusion pressure and assesses the quality of the pulmonary artery occlusion pressurement. The Smart Wedge algorithm is indicated for use in critical care patients over 18 years of age receiving advanced hemodynamic monitoring. The Smart Wedge algorithm is considered to be additional quantitative information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the Smart Wedge algorithm parameters.

HemoSphere Alta Advanced Monitor with HemoSphere Oximetry Cable
The HemoSphere Alta monitor when used with the HemoSphere oximetry cable and Edwards oximetry catheters is indicated for use in adult and pediatric critical care patients requiring of venous oxygen saturation (SvO2 and ScvO2) and derived hemodynamic parameters in a hospital environment. Refer to the Edwards oximetry catheter indications for use statement for information on target patient population specific to the catheter being used.

HemoSphere Alta Advanced Monitor with HemoSphere Pressure Cable or HemoSphere Alta Monitor Pressure Cable
The HemoSphere Alta monitor when used with the HemoSphere Pressure Cable or HemoSphere Alta monitor Pressure cable is indicated for use in adult and pediatric critical care patients in which the balance between cardiac fluid status, vascular resistance and pressure needs continuous assessment. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards FloTrac, FloTrac Jr, Acumen IQ, and TruWave DPT sensor indications for use statement for information on target patient population specific to the sensor being used.

The Edwards Lifesciences Acumen Hypotension Prediction Index software feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events and the associated hemodynamics. The Acumen HPI feature is intended for use in surgical patients receiving advanced hemodynamic monitoring. The Acumen HPI feature is considered to be additional quantitative information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the Hypotension Prediction Index (HPI) parameter.

When used in combination with the Swan-Ganz technology connected to a compatible Swan-Ganz catheter, the Edward Lifesciences Right Ventricular Pressure (RVP) algorithm provides the clinician with physiological insight into the hemodynamic status of the right ventricle of the heart. The RVP algorithm is indicated for critically ill patients over 18 years of age receiving advanced hemodynamic monitoring in the operating room (OR) and intensive care unit (ICU). The RVP algorithm is considered to be additional quantitative information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the Right Ventricular Pressure (RVP) parameters.

When used in combination with the HemoSphere Pressure Cable connected to a compatible Swan-Ganz catheter, the Right Ventricular Cardiac Output (RVCO) feature provides the clinician with physiological insight into the hemodynamic status of the right ventricle of the heart. The RVCO algorithm is intended for use in surgical patients over 18 years of age that require advanced hemodynamic monitoring. The Right Ventricular Cardiac a continuous cardiac output and derived parameters.

The Cerebral Adaptive Index (CAI) Algorithm is an informational index to help assess the level of coherence or lack thereof between Mean Arterial Pressure (MAP) and the Absolute Levels of Blood Oxygenation Saturation (StO2) in patient's cerebral tissue. MAP is acquired by the HemoSphere pressure cable or HemoSphere Alta Pressure Cable and StO2 is acquired by the ForeSight oximeter cable. CAI is intended for use in patients over 18 years of age receiving advanced hemodynamic monitoring. CAI is not indicated to be used for treatment of any disease or condition and no therapeutic decisions should be made based solely on the Cerebral Adaptive Index (CAI) Algorithm.

HemoSphere Alta Advanced Monitor with Acumen Assisted Fluid Management Feature and Acumen IQ Sensor
The Acumen assisted fluid management (AFM) software feature provides the clinician with physiological insight into a patient's estimated response to fluid therapy and the associated hemodynamics. The Acumen AFM software feature is intended for use in surgical patients ≥18 years of age, that require advanced hemodynamic monitoring. The Acumen AFM software feature offers suggestions regarding the patient's physiological condition and estimated response to fluid therapy.

Acumen AFM fluid administration suggestions are offered to the clinician; the decision to administer a fluid bolus is made by the clinician, based upon review of the patient's hemodynamics. No therapeutic decisions should be made based solely on the assisted fluid management suggestions.

Acumen IQ Fluid Meter
The Acumen IQ fluid meter is a sterile single use device that is intended to be used with the HemoSphere Alta AFM cable and AFM software feature to inform the user of the rate of flow. The device is intended to be used by qualified personnel or clinicians in a clinical setting for up to 24 hours.

HemoSphere Alta Advanced Monitor with ForeSight Oximeter Cable
The non-invasive ForeSight oximeter cable is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the sensors in individuals at risk for reduced flow or no-flow ischemic states. The ForeSight oximeter cable is also intended to monitor relative changes of total hemoglobin of blood under the sensors. The ForeSight oximeter cable is intended to allow for the display of StO2 and relative change in total hemoglobin on the HemoSphere Alta monitor.

• When used with large sensors, the ForeSight Oximeter Cable is indicated for use on adults and transitional adolescents ≥40 kg.
· When used with Medium Sensors, the ForeSight Oximeter Cable is indicated for use on pediatric subjects ≥3 kg.
· When used with Small Sensors, the ForeSight Oximeter Cable is indicated for cerebral use on pediatric subjects < 8 kg and non-cerebral use on pediatric subjects <5kg.

The Edwards Algorithm for Measurement of Blood Hemoglobin is indicated for continuously monitoring changes to hemoglobin concentration in the circulating blood of adults and transitional adolescents ≥ 40 kg receiving advanced hemodynamic monitoring using HemoSphere ForeSight Oximeter Cable and ForeSight IQ Sensors in cerebral locations.

HemoSphere Alta Advanced Monitor with ClearSight Technology
The HemoSphere Alta Monitor when used with the HemoSphere ClearSight technology, pressure controller and a compatible Edwards finger cuff are indicated for Adult and Pediatric patients of age in which the balance between cardiac function, fluid status and vascular resistance needs continuous assessment. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. In addition, the noninvasive system is indicated for use in patients with co-morbidities for which hemodynamic optimization is desired and invasive measurements are difficult. The HemoSphere Alta monitor and compatible Edwards' finger cuffs noninvasively measures blood pressure and associated hemodynamic parameters.

The Edwards Lifesciences Acumen Hypotension Prediction Index feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events and the associated hemodynamics. The Acure is intended for use in surgical patients or non-surgical patients receiving advanced hemodynamic monitoring. The Acumen HPI feature is considered to be additional quantitative information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the Hypotension Prediction Index (HPI) parameter.

The HemoSphere Alta Advanced Monitoring Platform is Edwards' next-generation platform that provides a means to interact with and visualize hemodynamic and volumetric data on a screen. It incorporates a comprehensive view of patient hemodynamic parameters with an intuitive and easy user interface. The HemoSphere Alta Advanced Monitoring Platform is designed to provide monitoring of cardiac flow with various core technologies coupled with other technologies-based features such as Algorithms and Interactions. It integrates Edwards existing Critical Care technologies into a unified platform.

The Right Ventricular Cardiac Output (RVCO) feature is a machinelearning algorithm that calculates and displays continuous cardiac output (CORV) from the right ventricle using as inputs the right ventricular pressure waveform and derived right ventricular pressure parameters such as SYSRVF, DIARVP, MRVP, RVEDP, PRRV and Max RV dP/dt from the existing Right Ventricular Pressure (RVP) algorithm and if available, intermittent cardiac output (iCO).

The provided text describes the HemoSphere Alta Advanced Monitoring Platform and its various features, as well as the testing conducted to support its 510(k) clearance. However, it does not contain specific acceptance criteria and detailed device performance data in the format of a table, nor does it provide a detailed study that proves the device meets specific acceptance criteria for any of its algorithms.

The document makes general statements about testing, such as:

• "Completion of all verification and validation activities demonstrated that the subject devices meet their predetermined design and performance specifications."
• "Measured and derived parameters were tested using a bench simulation."
• "All tests passed."
• "Software verification testing were conducted, and documentation was provided per FDA's Guidance..." "All tests passed."
• "Usability study was conducted per FDA's guidance document... The usability study demonstrated that the intended users can perform primary operating functions and critical tasks of the system without any usability issues that may lead to patient or user harm."

While it mentions the Right Ventricular Cardiac Output (RVCO) algorithm as a new algorithm and states that "clinical data (waveforms) were collected in support of the design and validation of the RVCO algorithm," it does not present the detailed results of this validation study, nor does it define specific acceptance criteria for the RVCO algorithm and its performance against those criteria.

Therefore,Based on the provided text, I cannot provide the requested information in the form of a table of acceptance criteria and reported device performance for any specific algorithm, nor can I describe a detailed study that proves the device meets these criteria. The document contains general statements about testing and compliance but lacks the specific quantitative data and study design details needed to answer all aspects of your request.

To provide a complete answer, specific study reports and performance data would be required, which are not present in the provided FDA 510(k) summary.

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The CorPath GRX System is intended for use in the remote delivery and manipulation of guidewires and rapid exchange catheters, and remote manipulation of guide catheters during percutaneous coronary and vascular procedures.

The CorPath GRX System is intended to allow physicians to deliver and manipulate commercially available guidewires, rapid exchange catheters and guide catheters during percutaneous coronary and vascular procedures. During the use of the CorPath GRX System, the physician maneuvers interventional devices using intuitive controls under independent angiographic fluoroscopy visual quidance using computer controlled movements while in a seated position away from the radiation source.

The CorPath GRX System is composed of the following two functional sub-units:

• 1. Bedside Unit Which consists of the Extended Reach Arm, Robotic Drive and Single-use Cassette
• 2. Remote Workspace Which consists of the Control Console, angiographic monitor(s), hemodynamic monitors, X-ray foot pedal, and optional Interventional Cockpit.

Commercially available guidewires, rapid exchange catheters, and guide catheters are loaded into the Singleuse Cassette. By using the joysticks or the Control Console touch screen, the physician can control the Robotic Drive to advance, retract, and rotate the guidewire, advance and retract the rapid exchange catheter, and advance, retrace, and rotate the guide catheter. The Robotic Drive and Control Console communicate via a single communication cable.

The provided text is a 510(k) summary for the CorPath GRX System, a medical device used for remote delivery and manipulation of guidewires and catheters during percutaneous coronary and vascular procedures. However, the document does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria for the following reasons:

• This is a 510(k) for a modified device, not a new AI/algorithm driven device. The current 510(k) (K221464) describes a modification to a previously cleared device (CorPath GRX System, K202275). The modification is specifically "limited to modified cassette design to allow an alternate off-the-shelf hemostasis valve to be utilized with the Single-Use Cassette."
• The testing described is for substantial equivalence of the modification. The "Verification/validation testing" mentioned focuses on demonstrating that the modified system is substantially equivalent to the predicate, specifically through "Performance Testing Single-Use Cassette." This is typical for a 510(k) update for a minor change.
• There is no mention of AI, machine learning, or algorithm performance. The questions you've posed (acceptance criteria for AI, training/test sets, human readers, ground truth, etc.) are highly relevant to AI/ML medical devices where the algorithm's performance is the primary subject of evaluation. This document describes a mechanical/hardware modification, not an AI component.

Therefore, based solely on the provided text, I cannot answer the questions about acceptance criteria for an AI device or a study proving an AI device meets those criteria. The information required (e.g., performance metrics like sensitivity/specificity, sample sizes for AI validation, expert consensus for ground truth) is not present because this 510(k) is not about an AI-driven device or its performance.

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The CorPath GRX System is intended for use in the remote delivery and manipulation of guidewires and rapid exchange catheters, and remote manipulation of guide catheters during percutaneous coronary and vascular procedures.

The CorPath GRX System is intended to allow physicians to deliver and manipulate commercially available guidewires, rapid exchange catheters and guide catheters during percutaneous coronary and vascular procedures. During the use of the CorPath GRX System, the physician controls the movement and maneuvering of the devices using intuitive controls under independent angiographic fluoroscopy visual guidance using computer controlled movements while in a seated position away from the radiation source.

The CorPath GRX System is composed of the following two functional sub-units:

• 1. Bedside Unit Which consists of the Extended Reach Arm, Robotic Drive and Single-use Cassette
• 2. Remote Workspace Which consists of the Control Console, angiographic monitor(s), hemodynamic monitors, X-ray foot pedal, and optional Interventional Cockpit.

Commercially available guidewires, rapid exchange catheters, and guide catheters are loaded into the Singleuse Cassette. By using the joysticks or the Control Console touch screen, the physician can control the Robotic Drive to advance, retract, and rotate the guidewire, advance and retract the rapid exchange catheter, and advance, retract, and rotate the guide catheter. The Robotic Drive and Control Console communicate via a single communication cable.

In addition, the CorPath GRX Software contains the following functionality for automated movements (also referred to as the technIQ automated movements), of the interventional devices:

• . Rotate on Retract - When selected, rotates the guidewire a set amount upon retraction of the quidewire joystick to facilitate redirection of the quidewire while it is being navigated to the target location (previously cleared under CorPath GRX System, K173806).
• Wiggle - When selected, this movement enables a small clockwise and counterclockwise rotation of the guidewire while advancing to assist in navigation.
• . Spin - When selected, this movement will enable a large clockwise and counterclockwise rotation of the quidewire while advancing to assist in lesion crossing.
• . Constant Speed - When selected, the guidewire or device joysticks will advance and retract at a constant speed of either 2mm/second or 5mm/second depending on the speed selected by the operator.
• . Dotter - When selected, this movement will enable a linear back and forth motion of the device when advancing to assist in lesion crossing and delivery of therapy.

This document describes a 510(k) premarket notification for the CorPath GRX System, a robotic system for percutaneous coronary and vascular procedures. The submission focuses on software changes introducing four additional automated features (spin, wiggle, dotter, and constant speed) to the already cleared CorPath GRX System.

Here's an analysis based on the provided text:

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

The document does not explicitly present a table of acceptance criteria with specific numerical targets. Instead, it states that "All testing has demonstrated that the device is substantially equivalent to the predicate device." The acceptance criterion is, therefore, demonstrating substantial equivalence to the predicate device (CorPath GRX System, K173806, and K173288).

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

The document mentions "Simulated Use Testing" and states that "Clinical data from the post-market PRECISION GRX Study was used to help demonstrate substantial equivalence." However, it does not specify the sample size for either the simulated use testing or the PRECISION GRX Study, nor does it provide details on the data provenance (e.g., country of origin, retrospective or prospective) for the 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 provided in the document. The study appears to be focused on technical verification and validation, and a comparison against a predicate, rather than an expert-adjudicated performance study where "ground truth" would typically be established by multiple experts.

4. Adjudication method for the test set

This information is not provided in the document. Given the nature of the testing described (functional, simulated use, software verification), a formal adjudication method by multiple experts is unlikely to have been used in the same way it would be for a diagnostic AI study.

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

There is no indication that an MRMC comparative effectiveness study was done. The device is a "Steerable Catheter Control System," not an AI diagnostic tool, so the concept of "human readers improving with AI assistance" does not directly apply in the context of this submission. The "technIQ automated movements" are intended to assist the physician in manipulating devices, but the document does not include a comparative study of physician performance with vs. without these specific automated features.

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

The device is a robotic system designed to be operated by a physician ("human-in-the-loop"). The "automated movements" are features within this system, not a standalone AI algorithm. Therefore, a standalone (algorithm only) performance study as typically understood for AI diagnostic devices was not done and would not be relevant for this type of device. The verification and validation testing would have involved the system with its automated features, likely within simulated use or benchtop environments.

7. The type of ground truth used

For the non-clinical laboratory tests (Functional, Simulated Use, Particulate, Software V&V, Cybersecurity), the "ground truth" would be established by engineering specifications, design requirements, and established testing protocols. For the "Clinical data from the post-market PRECISION GRX Study," the document does not specify the type of ground truth, but for a robotic intervention system, it would typically relate to procedural success, safety outcomes, and possibly ergonomic benefits, rather than a diagnostic "ground truth" like pathology.

8. The sample size for the training set

This information is not applicable/provided. The submission concerns software updates to a robotic control system with "automated movements," which are likely rule-based or control algorithms, rather than a machine learning model that requires a distinct "training set." Therefore, no training set size is mentioned.

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

This information is not applicable/provided for the same reasons as #8. If the automated movements involve control algorithms rather than learned AI models, the "ground truth" for their development would be based on engineering principles, clinical requirements for device manipulation, and pre-defined operational parameters, not a labeled dataset.

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The CorPath GRX System is intended for use in the remote delivery and manipulation of guidewires and rapid exchange catheters, and remote manipulation of guide catheters during percutaneous coronary and vascular procedures.

The CorPath GRX System is intended to allow physicians to deliver and manipulate commercially available guidewires, rapid exchange catheters and guide catheters during percutaneous coronary and vascular procedures. During the use of the CorPath GRX System, the physician maneuvers interventional devices using intuitive controls under independent angiographic fluoroscopy visual quidance using computer controlled movements while in a seated position away from the radiation source.

The CorPath GRX System is composed of the following two functional sub-units:

• 1. Bedside Unit Which consists of the Extended Reach Arm, Robotic Drive and Single-use Cassette
• 2. Remote Workspace Which consists of the Control Console, angiographic monitor(s), hemodynamic monitors, X-ray foot pedal, and optional Interventional Cockpit.

Commercially available guidewires, rapid exchange catheters, and guide catheters are loaded into the Singleuse Cassette. By using the joysticks or the Control Console touch screen, the physician can control the Robotic Drive to advance, retract, and rotate the guidewire, advance and retract the rapid exchange catheter, and advance, retrace, and rotate the guide catheter. The Robotic Drive and Control Console communicate via a single communication cable.

The provided text is a 510(k) summary for the CorPath GRX System, which is a steerable catheter control system used for remote delivery and manipulation of guidewires, rapid exchange catheters, and guide catheters during percutaneous coronary and vascular procedures.

This document describes a submission for a modificiation (K180517) to an already cleared device, the CorPath GRX System (K173288). The modification is specifically "limited to a new bedrail connection design for the Extended Reach Arm component."

Based on the information provided, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document describes non-clinical laboratory tests rather than studies involving human subjects or real-world patient data. Therefore, the concepts of "sample size for the test set" and "data provenance (e.g., country of origin of the data, retrospective or prospective)" as typically applied to clinical or AI performance studies are not directly applicable here. The testing was performed on the device itself and its components.

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. The study involved engineering and safety testing of a medical device, not a diagnostic or prediction task that would require expert-established ground truth on a test set.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as point 3.

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 was a 510(k) submission for a robotic catheter control system, not an AI-assisted diagnostic or interpretation device that would involve human readers or MRMC studies. The device itself performs actions (delivery and manipulation of catheters) under human control.

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

The device is inherently a "human-in-the-loop" system, as physicians maneuver interventional devices using controls. The testing described focuses on the device's mechanical, electrical, and safety performance following a modification, not on an "algorithm only" performance.

7. The Type of Ground Truth Used:

The "ground truth" for this type of submission is the functional and safety standards (e.g., IEC 60601-1) and the performance characteristics of the predicate device. The testing's purpose was to demonstrate that the modified device's performance meets these established benchmarks and remains substantially equivalent to the original cleared device despite the design change.

8. The Sample Size for the Training Set:

This information is not applicable. This is not an AI/machine learning device that involves a training set. The "training" for such a device would be its design, engineering, and manufacturing processes, culminating in verification and validation testing.

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

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

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The CorPath GRX System is intended for use in the remote delivery and manipulation of guidewires and rapid exchange balloon/stent catheters, and remote manipulation of guide catheters during percutaneous coronary intervention (PCI) procedures.

The CorPath GRX System is intended to allow physicians to deliver and manipulate commercially available guidewires, rapid exchange balloon/stent catheters and guide catheters during percutaneous coronary intervention procedures. During the use of the CorPath GRX System, the physician maneuvers the devices using intuitive controls under independent angiographic fluoroscopy visual quidance using computer controlled movements while in a seated position away from the radiation source.

The CorPath GRX System is composed of the following two functional sub-units:

• 1. Bedside Unit Which consists of the Extended Reach Arm, Robotic Drive and Single-use Cassette
• 2. Remote Workspace Which consists of the Control Console, angiographic monitor(s), hemodynamic monitors, X-ray foot pedal, and optional Interventional Cockpit.

Commercially available guidewires, rapid exchange balloon/stent catheters, and guide catheters are loaded into the Single-use Cassette. By using the joysticks or the Control Console touch screen, the physician can control the Robotic Drive to advance, retract, and rotate the guidewire, advance and retract the rapid exchange catheter, and advance, retract, and rotate the guide catheter. The Robotic Drive and Control Console communicate via a single communication cable.

In addition, the CorPath GRX System Software contains a functionality for an automated movement of the guidewire, known as "Rotate on Retract." This feature, when enabled by the physician will rotate the quidewire a set amount upon retraction of the quidewire joystick to facilitate redirection of the guidewire which it is being directed to the lesion location.

The medical device in question is the CorPath GRX System, a steerable catheter control system used for remote delivery and manipulation of guidewires and rapid exchange balloon/stent catheters, and remote manipulation of guide catheters during percutaneous coronary intervention (PCI) procedures.

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 doesn't explicitly state "acceptance criteria" for performance in a quantitative manner. Instead, it focuses on demonstrating substantial equivalence to a predicate device (CorPath GRX System, K160121). The "acceptance criteria" are implied to be that the модифицированный CorPath GRX System maintains the same performance, safety, and functionality as its predicate.

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

The document describes non-clinical laboratory tests (Performance Testing, Functional Testing, Software Verification and Validation testing). It does not mention a "test set" in the context of clinical data, human subjects, or images from a specific country. This is a submission for a robotic system, not an AI diagnostic algorithm. Therefore, the testing refers to bench testing and software validation.
The provenance of these non-clinical tests is internal to the manufacturer (Corindus, Inc.).

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

Not applicable. This device is a robotic system for performing PCI, not an AI diagnostic device that requires expert-established ground truth for image interpretation. The "ground truth" for this device's performance would be its ability to correctly manipulate catheters and guidewires as designed and safely.

4. Adjudication Method for the Test Set:

Not applicable, as this is a non-clinical device performance and verification study, not a study involving human interpretation of data requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. The document assesses the substantial equivalence of an updated robotic system to its predicate, not the impact of AI assistance on human readers for a diagnostic task.

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

Not applicable in the context of typical AI diagnostic algorithms. The CorPath GRX System itself is a system that operates with "human-in-the-loop" (the physician controls it). The "Rotate on Retract" feature is an automated movement (an algorithm within the system), but its standalone performance as a diagnostic tool is not relevant here. The overall system's performance is intrinsically linked to the physician's operation.

7. Type of Ground Truth Used:

The "ground truth" for this device is based on engineering specifications, functional requirements, and safety standards demonstrated through non-clinical laboratory testing. This includes verifying that the device correctly performs the mechanical movements for guidewire and catheter manipulation, and that its software functions as intended, adhering to safety protocols. It is not based on expert consensus, pathology, or outcomes data in the way a diagnostic AI would be.

8. Sample Size for the Training Set:

Not applicable. This document describes the validation of a robotic system, not the training of an AI algorithm from a dataset of cases. The "training" of the system refers to its design, engineering, and programming according to established principles, not machine learning from a data set.

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

Not applicable. As noted above, there isn't a "training set" in the machine learning sense. The "ground truth" for the development and testing of such a system is established through a rigorous engineering design process, functional specifications, and adherence to relevant standards for medical device safety and performance.

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The CorPath GRX System is intended for use in the remote delivery and manipulation of guidewires and rapid exchange catheters, and remote manipulation of guide catheters during percutaneous coronary and vascular procedures.

The CorPath GRX System is intended to allow physicians to deliver and manipulate commercially available guidewires, rapid exchange catheters and guide catheters during percutaneous coronary and vascular intervention procedures. During the use of the CorPath GRX System, the physician maneuvers interventional devices using intuitive controls under independent angiographic fluoroscopy visual guidance using computer controlled movements while in a seated position away from the radiation source.

The CorPath GRX System is composed of the following two functional sub-units:

1. Bedside Unit Which consists of the Extended Reach Arm, Robotic Drive and Single-use Cassette
2. Remote Workspace - Which consists of the Control Console, angiographic monitor(s), hemodynamic monitors, X-ray foot pedal, and optional Interventional Cockpit.

Commercially available guidewires, rapid exchange catheters, and guide catheters are loaded into the Singleuse Cassette. By using the joysticks or the Control Console touch screen, the physician can control the Robotic Drive to advance, retract, and rotate the guidewire, advance and retract the rapid exchange catheter, and advance, retrace, and rotate the guide catheter. The Robotic Drive and Control Console communicate via a single communication cable.

The provided text describes a 510(k) premarket notification for the CorPath GRX System, a steerable catheter control system used in percutaneous coronary and vascular procedures. The submission states that the device is substantially equivalent to previously cleared predicate devices (CorPath 200 System and an earlier CorPath GRX System).

However, the document does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and a study proving the device meets those criteria. Specifically, it lacks:

• A table of acceptance criteria with reported device performance.
• Sample sizes for test sets, data provenance, specific ground truth methods, or expert qualifications for performance evaluation.
• Details on MRMC studies or standalone algorithm performance.
• Information regarding training set size or how ground truth was established for training.

The document primarily focuses on demonstrating substantial equivalence through non-clinical laboratory testing (Device Compatibility Testing and Simulated Use Testing) and referencing prior clinical evaluations of predicate devices for safety. It does not provide performance metrics or studies of the current device against specific acceptance criteria.

Therefore, I can only extract limited information based on what is available in the text:

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

The document does not provide a specific table of acceptance criteria or quantitative performance metrics for the CorPath GRX System itself. It asserts that "All testing has demonstrated that the device is substantially equivalent to the predicate devices." and "The testing demonstrated that the device is safe for its intended use and can be considered substantially equivalent to the predicate devices."

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

The document does not specify the sample size used for the "non-clinical laboratory tests" (Device Compatibility Testing and Simulated Use Testing) for the CorPath GRX System. It also does not mention data provenance.

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 non-clinical testing described does not involve expert-established ground truth in the context of diagnostic or interpretive performance.

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

Not applicable. The non-clinical testing described does not involve an adjudication method among experts for establishing ground truth.

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 MRMC comparative effectiveness study is mentioned for the CorPath GRX System itself. This device is a steerable catheter control system, not an AI diagnostic tool, so such a study would not be directly relevant in the context of human reader improvement with AI assistance.

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

Not applicable. The CorPath GRX System is a robotic control system for medical procedures, inherently designed for human-in-the-loop operation, not a standalone algorithm.

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

For the non-clinical laboratory tests (Device Compatibility Testing and Simulated Use Testing) conducted for the CorPath GRX System, the "ground truth" would be the engineering specifications, functional requirements, and expected performance under simulated conditions. This is not comparable to clinical ground truth types like pathology or expert consensus.

The document mentions a "clinical evaluation of the predicate device (reference K152999) demonstrates that the device is safe for use in a clinical setting." However, it does not detail the specific ground truth used in that predicate device's clinical evaluation.

8. The sample size for the training set:

Not applicable. As a robotic control system, the CorPath GRX System does not describe a "training set" in the context of machine learning or AI models. Its development would involve engineering design, calibration, and verification/validation testing.

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

Not applicable, for the same reasons as #8.

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The CorPath GRX is intended for use in the remote delivery and manipulation of guidewires and rapid exchange balloon/ stent catheters, and remote manipulation of guide catheters during percutaneous coronary intervention (PCI) procedures.

The CorPath GRX System is intended to allow physicians to deliver and manipulate commercially available coronary guidewires, rapid exchange balloon/stent catheters, and guide catheters during percutaneous coronary intervention (PCI) procedures. During the use of the CorPath GRX System, the physician maneuvers interventional devices using intuitive controls under independent angiographic fluoroscopy visual guidance using computer controlled movements while in a seated position away from the radiation source.

The CorPath GRX System is composed of the following two functional sub-units:

1. Bedside Unit: Which consists of the Articulated Arm, Robotic Drive and Single-use Cassette, and the
2. Remote Workspace: Which consists of the Interventional Cockpit (radiation shielded) which houses the Control Console, angiographic monitor(s), hemodynamic monitors and X-ray foot pedal.

Commercially available guidewires, rapid exchange balloon/stent catheters, and guide catheters are loaded into the Single Use Cassette. By using the joysticks or the Control Console touch screens the physician can control the Robotic Drive to advance, retract, and rotate the guide wire, advance and retract the balloon/stent catheter, and advance, retract and rotate the guide catheter. The Robotic Drive and Control Console communicate via a single communication cable.

The provided document describes the CorPath GRX System, a robotic system for remote delivery and manipulation of guidewires, balloon/stent catheters, and guide catheters during percutaneous coronary intervention (PCI) procedures. The document confirms substantial equivalence to a predicate device, the CorPath 200 System.

Here's an analysis of the acceptance criteria and study information:

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

The document does not explicitly state quantitative acceptance criteria in a table format with corresponding reported device performance values. Instead, it describes various tests performed to demonstrate safety and effectiveness for substantial equivalence. The focus is on functionality and performance matching the predicate device.

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

• Bench Testing: The document lists several bench tests (Performance, Functional, Guide Catheter Particulate Analysis, Simulated Procedure Testing, Biocompatibility, Software V&V, EMC).
  • Sample Size: Not specified. Standard testing typically uses a statistically appropriate number of units or iterations per test, but the exact numbers are not provided.
  • Data Provenance: Not specified, but generally, bench tests are conducted in a controlled laboratory environment by the manufacturer.
• Pre-Clinical Study (In-vivo):
  • Sample Size: Eight (8) pigs underwent PCI using the CorPath GRX System, and four (4) pigs served as a control group for manual treatment.
  • Data Provenance: This was an animal study (porcine), conducted specifically for this device (prospective). Country of origin is not specified but is typically within the country of the manufacturer or a designated contract research organization.

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

• Bench Testing: Not applicable in the sense of expert consensus for ground truth. Tests are against defined specifications or engineering standards.
• Pre-Clinical Study (In-vivo): The document implies that the study involved performing PCI and comparing outcomes, likely assessed by veterinary or interventional cardiology experts. However, the number of experts used to establish "ground truth" (e.g., successful PCI, absence of adverse events) and their specific qualifications are not explicitly stated in this document. It implies standard veterinary/clinical assessment.

4. Adjudication method for the test set

• Bench Testing: Adjudication methods are not specified. Typically, these tests are objective, with pass/fail criteria.
• Pre-Clinical Study (In-vivo): Adjudication method for the animal study outcomes (successful PCI, comparison to control) is not specified.

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, an MRMC comparative effectiveness study was not done. The CorPath GRX System is a robotic surgical assistance system, not an AI-assisted diagnostic imaging device that would typically involve human readers interpreting images. The study involved device performance during PCI procedures, not diagnostic accuracy improvement for human readers.

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

• Not applicable in the typical sense of AI standalone performance. The CorPath GRX System is explicitly described as a "robot-assisted" system where the physician *maneuvers interventional devices using intuitive controls... using computer controlled movements." It's a human-in-the-loop system by design; it doesn't operate independently as a standalone algorithm without a physician. The pre-clinical study compared robotic-assisted PCI (human + robot) vs. manual PCI (human only).

7. The type of ground truth used

• Bench Testing: Ground truth is established by engineering specifications, functional requirements, and recognized standards for biocompatibility, software validation, and electromagnetic compatibility.
• Pre-Clinical Study (In-vivo): The ground truth for the animal study would be based on clinical outcomes observed during and after the PCI procedures in the pigs (e.g., successful guidewire advancement, balloon inflation, stent deployment, patency of the vessel, lack of complications upon necropsy/follow-up). This is outcomes data combined with direct observation and assessment by veterinary/medical professionals.

8. The sample size for the training set

• Not applicable / Not specified. The CorPath GRX System is a robotic control system for medical devices, not a machine learning or AI system that requires a "training set" in the conventional sense of data-driven model training. Its functionality is based on electromechanical design and control algorithms, not learning from large datasets.

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

• Not applicable. As the device does not employ a machine learning model requiring a training set, the concept of establishing ground truth for a training set is not pertinent to this submission.

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The CorPath 200 System is intended for use in the remote delivery and manipulation of guidewires and rapid exchange catheters during percutaneous vascular interventional (PVI) procedures.

The CorPath 200 System is intended for use by physicians in the delivery and manipulation of guidewires and rapid exchange catheters during percutaneous vascular interventional (PVI) procedures. The CorPath 200 System allows the physician to deliver and manipulate guidewires and catheters through the vasculature under angiography-assisted visual guidance using computer controlled movements while in a seated position and away from the radiation source.

The CorPath 200 System is composed of two functional sub-units; the Bedside Unit and the Remote Workspace. The Bedside Unit consists of the Articulated Arm, the Robotic Drive and the single-use Cassette. The Remote Workspace consists of the Interventional Cockpit (radiation shield) which houses the Control Console, as well as angiographic monitor(s). Commercially available guidewires and rapid exchange catheters are loaded into the single-use Cassette. By using the joysticks or touch screen of the Control Console, the physician can send commands to the Robotic Drive via a communication cable that advances, retracts or rotates the guidewire, and/or advances or retracts the catheters. The CorPath 200 System's software continuously monitors the communication between the Control Console and the Robotic Drive and alerts the physician if any communication error occurs.

Here's an analysis of the provided text, focusing on the acceptance criteria and study data for the CorPath 200 System:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in the form of pre-defined thresholds that the device needed to meet. Instead, it presents the reported performance directly from two clinical studies. However, based on the studies' objectives and reported outcomes, we can infer the implicit "acceptance criteria" related to safety and effectiveness.

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

• PRECISE Clinical Study (PCI):
  • Sample Size: 164 subjects.
  • Data Provenance: Prospective, multi-center, non-randomized study. The document does not explicitly state the country of origin, but "nine (9) clinical sites" typically implies a domestic (US) study for FDA submissions unless otherwise specified.
• RAPID Study (PVI):
  • Sample Size: 20 Rutherford Class 2 to 5 subjects (with 29 treated lesions).
  • Data Provenance: Prospective, non-randomized feasibility evaluation. The document does not explicitly state the country of origin.

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

• PRECISE Clinical Study (PCI):
  • Specifics of ground truth experts are not explicitly detailed. However, it mentions "post-procedure stenosis of less than 30% (as evaluated by a Core Laboratory)." A Core Laboratory implies a specialized facility with imaging experts (e.g., interventional cardiologists, radiologists) responsible for standardized, blinded evaluation of angiographic images. The number and specific qualifications (years of experience) are not provided.
• RAPID Study (PVI):
  • Specifics of ground truth experts are not explicitly detailed. Angiographic assessments (e.g., <50% residual stenosis) would typically be made by the interventional cardiologists or radiologists involved in the study, likely with independent verification, but this is not explicitly stated.

4. Adjudication Method for the Test Set

• PRECISE Clinical Study (PCI):
  • The document refers to a "Core Laboratory" for stenosis evaluation. Core laboratories typically employ adjudicated methods to ensure consistency and minimize bias, often involving multiple readers and consensus, but the specific adjudication method (e.g., 2+1, 3+1) is not explicitly mentioned.
• RAPID Study (PVI):
  • The document does not describe the adjudication method for the performance metrics.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improving with AI vs. Without AI Assistance

• No, an MRMC comparative effectiveness study, as typically understood for AI-assisted diagnostic devices, was explicitly described. The provided studies (PRECISE and RAPID) evaluated the robotic system's performance during the procedure, not as an AI diagnostic tool assisting human readers in interpreting medical images.
• The PRECISE trial did demonstrate "a reduction of radiation exposure to the primary operator," which is a beneficial effect related to using the robotic system, allowing the operator to be further from the radiation source. This is a safety benefit for the human operator, not an improvement in diagnostic accuracy or speed for human readers.

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

• No, a standalone algorithm performance study was not done because the CorPath 200 System is a robotic-assisted catheter control system designed for human-controlled manipulation during procedures, not a diagnostic AI algorithm. Its function is to execute the physician's commands remotely, not to provide independent analysis or decisions. The performance metrics reflect the combined performance of the system and the physician using it.

7. The Type of Ground Truth Used

• PRECISE Clinical Study (PCI):
  • Expert Consensus/Clinical Outcomes: This includes evaluation by a "Core Laboratory" for angiographic stenosis, and clinical endpoints like Major Adverse Cardiac Events (MACE) and overall procedural success. MACE is an important clinical outcome.
• RAPID Study (PVI):
  • Clinical Outcomes/Procedural Success: This includes successful cannulation, <50% residual stenosis, absence of device-related SAEs, and absence of angiographic complications, all as determined by clinical assessment during and after the procedure.

8. The Sample Size for the Training Set

• Not Applicable / Not Provided. The CorPath 200 System, as described, is a robotic control system for physical manipulation of medical devices, not an AI/machine learning algorithm that requires a training set in the conventional sense. Its "software continuously monitors the communication," but this refers to operational control, not a learning algorithm that processes data to improve its diagnostic or predictive capability. Therefore, there is no mention of a "training set" for the device's core functionality.

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

• Not Applicable / Not Provided. As there is no described training set for an AI algorithm, the method for establishing its ground truth is not relevant to this device's description.

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The CorPath 200 System is intended for use in the remote delivery and manipulation of coronary guidewires and rapid exchange balloon/stent catheters during percutaneous coronary interventional (PCI) procedures.

The CorPath 200 System is intended for use by physicians in the delivery and manipulation of coronary guidewires and rapid exchange balloon/stent catheters during percutaneous coronary intervention ("PCI") procedures. The CorPath 200 System allows the physician to deliver and manipulate guidewires and balloon/stent catheters through the coronary vasculature under angiography-assisted visual guidance using computer controlled movements while in a seated position and away from the radiation source.

The CorPath 200 System is composed of two functional sub-units; the Bedside Unit and the Remote Workspace. The Bedside Unit consists of the Articulated Arm, the Robotic Drive and the single-use Cassette. The Remote Workspace consists of the Interventional Cockpit (radiation shield) which houses the Console, as well as angiographic monitor(s). Commercially available guidewires and balloon/stent catheters are loaded into the single-use Cassette. By using the joysticks or touch screen of the Control Console, the physician can send commands to the Robotic Drive via a communication cable that advances, retracts or rotates the guidewire, and/or advances or retracts the balloon/stent catheters. The CorPath 200 System's software continuously monitors the communication between the Control Console and the Robotic Drive and alerts the physician if any communication error occurs.

Here's an analysis of the provided text regarding the acceptance criteria and study for the CorPath 200 System:

1. Table of acceptance criteria and reported device performance:

The document primarily focuses on the clinical outcomes of the PRECISE Clinical Study and a subsequent study evaluating radial access. It doesn't explicitly state quantitative acceptance criteria for each- metric prior to the study. Instead, the reported results are presented as evidence of safety and effectiveness, implying that these results met internal criteria for substantial equivalence.

Note: The document does not clearly define numerical acceptance criteria that were pre-specified for these metrics. The reported performance is the evidence evaluated for substantial equivalence.

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

• PRECISE Clinical Study:
  • Sample Size: 164 subjects
  • Data Provenance: Prospective, multi-center, single-arm study. The country of origin is not explicitly stated, but clinical studies for FDA submissions are typically conducted in the US or in countries with comparable regulatory standards.
• Radial Access Study:
  • Sample Size: 30 patients, treating 36 lesions.
  • Data Provenance: Clinical study. The country of origin is not explicitly stated. It's prospective.

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

The document mentions that "post-procedure stenosis of less than 30% (as evaluated by a Core Laboratory)" was a key outcome.

• Number of experts: Not specified, but "Core Laboratory" implies a group of trained professionals.
• Qualifications of experts: Not specified beyond being a "Core Laboratory," which denotes a specialized group performing standardized, blinded assessments in clinical trials. They would typically involve experienced interventional cardiologists or cardiovascular imaging specialists.

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

The document does not explicitly state an adjudication method for the clinical endpoints such as MACE or stenosis evaluation. The use of a "Core Laboratory" suggests standardized assessment protocols, which often include blinded, independent review, but the specific adjudication process (e.g., how disagreements were resolved) is not detailed.

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

No, the provided text does not describe a multi-reader multi-case (MRMC) comparative effectiveness study comparing AI-assisted vs. non-AI-assisted human readers. The CorPath 200 System is a robotic system that assists a single operator, not an AI for image interpretation or diagnosis that would typically be evaluated with MRMC studies. The "PRECISE Trial demonstrated a reduction of radiation exposure to the primary operator," which is a comparative benefit to traditional manual PCI, but not an MRMC study in the typical sense of evaluating diagnostic accuracy with and without AI.

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

The CorPath 200 System is a robotic device designed for human interaction and control (physician sends commands via joysticks/touch screen). It is not an "algorithm only" device that operates autonomously or performs diagnostic tasks. Therefore, a standalone performance evaluation in the context of an AI algorithm is not applicable or described. The performance data presented (clinical outcomes, technical success) are inherently "human-in-the-loop."

7. The type of ground truth used:

• Clinical Outcomes (PRECISE Study & Radial Access Study):
  • Stenosis < 30%: Evaluated by a "Core Laboratory," likely using quantitative coronary angiography (QCA) or similar imaging analysis, which serves as an established expert consensus-based ground truth.
  • MACE (Major Adverse Cardiac Events): Clinical events, typically adjudicated by an independent clinical events committee based on pre-defined clinical definitions and patient outcomes data. This represents outcomes data.
  • Procedural Success/Technical Success: Based on intra-procedural observations and immediate post-procedural assessments, reflecting clinical and technical outcomes.

8. The sample size for the training set:

The document describes the CorPath 200 System as a robotic device, not an AI/machine learning algorithm that requires a "training set" in the conventional sense of data used to train a model. Therefore, a sample size for a training set is not applicable to the description of this device. The development process would involve engineering, bench testing, and optimization, not data-driven machine learning training.

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

As the CorPath 200 System is not an AI/machine learning algorithm requiring a "training set," this question is not applicable. The "ground truth" for its development would be engineering specifications, performance benchmarks from predicate devices, and user requirements, rather than a labeled dataset.

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