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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.

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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.

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The Hansen Medical Magellan Robotic System and accessory components are intended to be used to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices.

The Magellan Robotic System is intended to be used with compatible Hansen Medical robotically steerable catheters.

The Hansen Medical Magellan Robotic System and Accessory Components are designed to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices. The fundamental concept of the system is based on a master/slave control system that enables and visualizes positioning of a steerable catheter tip at a desired point inside the vasculature, while enabling a physician to remain seated and away from the x-ray radiation source. The modification to the Magellan Robotic System is software update referred to as Magellan v1.9.1.

This document is a 510(k) premarket notification for the Hansen Medical Magellan Robotic System and Accessory Components (K151730). It primarily details a software update (Magellan v1.9.1) to an already cleared device (K141614). The core argument for substantial equivalence relies on the fact that the modifications do not change the intended use, fundamental scientific technology, or operating principles.

As such, this submission does not describe a study to prove a device meets acceptance criteria in the way a new or significantly modified device submission might. Instead, it aims to demonstrate that a software update to an existing device does not degrade performance and maintains substantial equivalence.

Therefore, many of the requested elements (like sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance details, training set size, etc.) are not applicable or not provided in this type of submission because the focus is on maintaining existing safety and effectiveness rather than establishing new performance benchmarks.

However, I can extract information related to the acceptance criteria and the study type that was mentioned:

1. Table of acceptance criteria and the reported device performance

Important Note: The document states that "All of the pre-determined acceptance criteria were met," but it does not explicitly list what those specific acceptance criteria were (e.g., specific thresholds for accuracy, reliability, or safety metrics). The document focuses on confirming that the updated software did not introduce new risks or deviations from the predicate device's expected performance.

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

• Sample Size: Not specified.
• Data Provenance: Not specified. Given the nature of software verification and system validation, these would typically be internal laboratory tests.

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

• Not applicable/Not specified. This type of information is typically relevant for clinical studies or studies involving human interpretation of data, which was not the focus here. The performance was assessed through engineering and system-level tests.

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

• Not applicable/Not specified. Adjudication methods are typically used in clinical trials where multiple human readers assess cases, which is not the case for this software update submission.

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. This submission concerns a software update to a robotic navigation system, not an AI-assisted diagnostic tool for human readers.

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

• Yes, in a sense. The "Software Verification Testing" and "System Validation Testing" represent standalone evaluations of the updated software and system to confirm they perform as expected without human intervention impacting the robotic movement or calculations directly. However, the performance is evaluated against the system's designed specifications, not necessarily an "algorithm only" in the AI sense.

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

• For "Software Verification Testing" and "System Validation Testing," the ground truth would be based on the design specifications, functional requirements, and safety standards established for the device. For example, a navigation system's ground truth could be its ability to accurately move the catheter to a programmed position within a defined tolerance. It does not involve medical ground truth like pathology or expert consensus on a diagnosis.

8. The sample size for the training set

• Not applicable/Not specified. This document pertains to a software update to an existing robotic control system, not a machine learning or AI model that uses a training set in the conventional sense.

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

• Not applicable. (See #8)

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