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The 6F Proxis System controls the flow of fluids in the coronary and peripheral vasculature. This is achieved by temporary vessel occlusion to hold a column of fluid in the vessel stagnant. The stagnant column can be used to aid in the visualization of the lesion or be used as a means of local and temporary delivery of therapeutic solutions.

The 6F Proxis System is also indicated for use as an aid in the removal of fresh, soft emboli and thrombi in the coronary and peripheral vasculature.

The safety and efficacy of this device as an embolic protection system has not been established. The 6F Proxis System is not indicated for use for embolic protection. The device is not intended to be used as a thrombectomy system.

The 6F Proxis System (Proxis System) is a proximal flow control system used in conjunction with other interventional devices. The Proxis System controls the flow of fluids in the coronary and peripheral vasculature. This is achieved by temporarily occluding the vessel which holds the column of fluid stagnant. The stagnant column can be used to aid in the visualization of the lesion and for the delivery of therapeutic solution(s).

The Proxis System consists of an Evacuation Sheath Catheter (Proxis Catheter), inflation device. aspiration syringe, lip seal, and strainer basket. In addition, an optional accessory called the Proxis Infusion Catheter (packaged separately) may be used with Proxis System.

The Proxis Catheter is loaded onto the guide wire and tracked down to the distal portion of the guide catheter and proximal to the lesion. When the sealing balloon is inflated, antegrade flow of the fluid in the target vessel is prevented.

While the vessel is occluded, therapeutic solutions may be infused through the Proxis Catheter and stagnated in the target vessel/lesion during the delivery of the therapeutic device or after the deployment of the therapeutic device.

The aspiration syringe is provided for the removal of stagnated fluid and/or fresh, soft thrombi and emboli during aspiration. Additionally, if there is insufficient venous or collateral flow, the Proxis Infusion Catheter (optional accessory) may be used to infuse saline to augment the retrograde flow of fluid and removal of stagnated fluid.

The provided text describes a Special 510(k) submission for the 6F Proxis™ System. This type of submission is used when modifications to a legally marketed device do not raise new questions of safety or effectiveness. As such, the study performed is a verification study against established specifications of predicate devices, rather than a clinical trial with acceptance criteria for device performancemetrics.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a "test set sample size" in the context of a clinical study. Instead, it refers to verification testing against specifications. The sample sizes for these engineering and laboratory tests (e.g., for dimensional, strength, functional properties) are not detailed in this summary, but would typically be part of the underlying design verification documentation. The data provenance is implied to be from the manufacturer's internal testing facilities, used for previous 510(k) clearances (K063638 and K052523), and is retrospective in the sense that the current submission leverages prior clearance data. No specific country of origin for the data is mentioned for these engineering tests.

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

Not applicable. For this type of submission (Special 510(k) based on device modifications), clinical expert consensus for "ground truth" on patient data is not the primary basis for demonstrating safety and efficacy. Instead, the focus is on engineering and laboratory performance meeting established specifications.

4. Adjudication Method for the Test Set

Not applicable. Given that this is a Special 510(k) submission primarily relying on design verification and substantial equivalence to predicate devices, an adjudication method for a clinical test set is not described or required.

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

No. An MRMC comparative effectiveness study is designed to assess human reader performance, often with and without AI assistance, or comparing different diagnostic methods. This submission for the 6F Proxis™ System is for a physical medical device (catheter system) and its modifications, not a diagnostic imaging AI algorithm. Therefore, such a study was not performed.

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

No. This question typically pertains to AI/CADe (Computer-Aided Detection) or CADx (Computer-Aided Diagnosis) devices. The 6F Proxis™ System is a percutaneous catheter system; therefore, a standalone algorithm performance study is not relevant.

7. The Type of Ground Truth Used

The "ground truth" in this context is defined by engineering specifications and performance parameters established for the device components and system. These specifications are derived from recognized standards, clinical needs for the intended use, and the performance of previously cleared predicate devices. The "truth" is that the device meets these predetermined technical and functional requirements.

8. The Sample Size for the Training Set

Not applicable. The concept of a "training set" applies to machine learning algorithms. The 6F Proxis™ System is a physical medical device, not an AI/ML product.

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

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

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The Proxis System is indicated for use as a proximal embolic protection system to prevent distal release of and to aspirate embolic material (thrombus/debris) in saphenous vein coronary bypass graft(s) (3.0 mm - 5.0 mm) during percutaneous transluminal coronary angioplasty and/or stenting procedures.

The Proxis System is also indicated to control the flow of fluids and aid in the removal of fresh, soft emboli and thrombi in the coronary and peripheral vasculature.

The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid or peripheral vasculature; native coronary arteries; or for treatment of patients with acute myocardial infarction. The device is not intended to be used as a thrombectomy system.

The Proxis System (Proxis Embolic Protection System) is a proximal embolic protection system used in conjunction with other interventional devices. The Proxis System protects the patient from distal embolization by preventing antegrade flow of emboli release during an interventional procedure and then removing it from the vessel. The Proxis System consists of an Evacuation Sheath Catheter (Proxis Catheter), Inflation device, Aspiration syringe, Lip Seal and Strainer basket.

In addition, an optional accessory called the Proxis Infusion Catheter (packaged separately) may be used with Proxis System.

In the stagnant flow, the guide wire is advanced across the lesion site and the interventional device is tracked over the guide wire. Upon completion of the interventional device procedure, fluid and particles from the procedure may be aspirated using the aspiration syringe. If there is insufficient venous or collateral flow, the Proxis Infusion Catheter (optional accessory) may be used to deliver saline distal to the treatment site while simultaneously applying vacuum to aspirate fluid and particles from the treatment site.

Here's a breakdown of the acceptance criteria and study information based on the provided text, using the structure you requested:

Acceptance Criteria and Device Performance

This 510(k) submission for the Proxis System is for a minor modification (material change in the occluding balloon) to an already cleared device. Therefore, the "acceptance criteria" are not reported as specific performance metrics in this summary, but rather as meeting all previously established verification specifications. The device did not undergo a new clinical trial for this specific submission because the changes were deemed non-significant.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is actually based on the previous clearances of the Proxis System (K060651 and K052523), not a new study for this specific submission (K073563).

1. Sample size used for the test set and the data provenance: No new clinical test set was used for this 510(k) submission. The decision was made that "no additional animal or clinical data was deemed necessary" due to the non-significant nature of the modification. The original test data would have come from the studies supporting K060651 and K052523, but details like sample size, country of origin, or retrospective/prospective nature are not provided in this document.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for this submission as no new clinical test data was generated. For the predicate device clearances, this information is not available in the provided text.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for this submission.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a medical instrument (an embolic protection system), not an AI-based diagnostic or imaging device used by human readers.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable for this submission. For the predicate device clearances, this information is not available in the provided text, but it would presumably involve a combination of in-vitro testing, animal studies, and potentially clinical trial outcomes demonstrating safety and effectiveness in preventing embolization.

7. The sample size for the training set: Not applicable. This is not an AI/ML-based device that relies on a "training set."

8. How the ground truth for the training set was established: Not applicable.

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The Proxis Flow Control System controls the flow of fluids in the coronary and peripheral vasculature. This is achieved by temporary vessel occlusion to hold a column of fluid in the vessel stagnant. The stagnant column can be used to aid in the visualization of the lesion or be used as a means of local and temporary delivery of therapeutic solution(s). The safety and efficacy of this device as an embolic protection system has not been established. The Proxis Flow Control System is not indicated for use for embolic protection.

The Proxis System has five major components: the Evacuation Sheath Catheter, Inflation System, Infusion Catheter, Lip Seal, and an Aspiration syringe.

The Evacuation Sheath Catheter has one proximal low-pressure compliant sealing balloon that is inflated to occlude the arterial vessel. A radiopaque marker at the balloon site facilitation and intravascular placement of the catheter prior to inflation. The Evacuation Sheath has a sufficiently large inner diameter to accommodate standard therapeutic devices within its size range. The balloon is inflated using the Inflation System.

Devices can be deployed through the Evacuation sheath to the target site before, during or after the sealing balloon is inflated to occlude the vessel. Infusing ~0.5cc of contrast dye through the evacuation sheath catheter will produce a continuous "roadmap" of the lesion as an aid for the physician in guiding the therapeutic device to the lesion site.

Alternatively, while the vessel is occluded, therapeutic solutions like anticoagulant, cardioplegia and thrombolytics may be infused through the evacuation sheath catheter and stagnated in the target vessel/lesion during the delivery of the therapeutic device or after the deployment of the therapeutic device.

The Aspiration syringe is provided for the removal of stagnated fluid during aspiration. The infusion catheter may be used to infuse saline to augment the retrograde flow of fluid and the removal of stagnated fluid.

The provided text is a 510(k) Summary for the Proxis Flow Control System and a subsequent FDA equivalency letter. It describes a medical device, its intended use, and its comparison to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way you've outlined for AI/algorithm performance studies.

This type of submission (510(k)) focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving novel clinical safety and effectiveness through extensive clinical trials with specific performance endpoints.

Therefore, many of the requested items, particularly those related to algorithm performance, ground truth, expert adjudication, and comparative effectiveness studies with AI, are not applicable to this document. The "Test Summary" section explicitly states that no additional animal or clinical data was deemed necessary due to the scope of modifications and the substantial equivalence argument.

Here's a breakdown of the information that can be extracted based on the provided text, and where your requested information is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: The document implies that the device must perform similarly to its predicate devices and meet specific verification tests. However, it does not provide quantitative acceptance criteria (e.g., sensitivity, specificity thresholds) in the context of clinical performance or algorithm accuracy. Instead, the acceptance criteria are related to engineering and functional performance, and biocompatibility in comparison to the predicate devices.
• Reported Device Performance:
  • Dimensional, Strength, Functional, Packaging, Sterilization, Biocompatibility, and Shelf Life tests: "Passed all verification criteria." (No specific numerical performance metrics are given for these tests, just a statement of compliance).
  • Clinical Performance: "The device performs as intended without raising additional questions of safety and efficacy," based on substantial equivalence to predicate devices and the scope of modifications. No new clinical performance metrics are reported.

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

• Not Applicable. No clinical test set data is described or analyzed in this 510(k) submission. The decision was made that "no additional animal or clinical data was deemed necessary." The "Test Summary" refers to engineering and functional verification tests, not clinical performance studies with patient data.

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

• Not Applicable. As there was no clinical test set requiring ground truth establishment, this information is not present.

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

• Not Applicable. No clinical test set requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable. This device is a physical catheter system, not an AI or algorithm-driven diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is irrelevant and not performed.

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

• Not Applicable. This is a physical medical device, not an algorithm.

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

• Not Applicable. No clinical ground truth was established for performance evaluation within this submission.

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set of data.

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

• Not Applicable. As there's no training set for an algorithm, this question is not relevant.

Summary of Device-Related Information from K063638:

• Device Name: Proxis Flow Control System
• Intended Use: Controls the flow of fluids in the coronary and peripheral vasculature for temporary vessel occlusion to hold a column of fluid stagnant (for visualization or local therapeutic solution delivery).
• Key Modification (from predicate): Decreased diameter of the catheter and sealing balloon.
• Key Similarities to Predicates: Identical in function, mechanism of action, and intended use as K042117 (rapid-exchange Proxis System). Has the same technological characteristics and flow control indication as K060651 (over-the-wire Proxis System).
• Key Distinction / Not Indicated For: Embolic protection (explicitly stated).
• Regulatory Conclusion: Substantially Equivalent to predicate devices K042117 and K060651.

In essence, this 510(k) demonstrates that the modified device is substantially equivalent to existing, legally marketed devices, and therefore does not require new comprehensive clinical studies or performance evaluations that would typically involve acceptance criteria and data sets as described in your prompt for AI/algorithm assessment.

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The Proxis System is indicated for use as a proximal embolic protection system to prevent distal release of and to aspirate embolic material (thrombus/debris) in saphenous vein coronary bypass graft(s) (3.0 mm – 5.0 mm) during percutaneous transluminal coronary angioplasty and/or stenting procedures.

The Proxis System is also indicated to control the flow of fluids in the coronary and peripheral vasculature.

The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid or peripheral vasculature; native coronary arteries; or for treatment of patients with acute myocardial infarction.

The Proxis System is a proximal embolic protection system used in conjunction with other interventional devices. The Proxis System protects the patient from distal embolization by preventing antegrade flow of emboli release during an interventional procedure and then removing it from the vessel. The Proxis System consists of an Evacuation Sheath Catheter compatible with 7F or larger guide catheters, Inflation device, Aspiration syringe, Lip Seal and Strainer basket. In addition, an optional accessory called the Proxis Infusion Catheter (packaged separately, K023548) may be used with Proxis System.

The Proxis catheter is loaded onto the guide wire and tracked down to the distal portion of the guide catheter and proximal to the lesion site. To minimize the occlusion time, the interventional devices are advanced through the Proxis catheter and positioned near the distal tip. When the sealing balloon is inflated, antegrade flow of the fluid in the target vessel is prevented. To minimize the release of embolic material, stagnation of flow is accomplished before any devices touch or cross- the lesion(s).

In the stagnant flow, the guide wire is advanced across the lesion site and the interventional device is tracked over the guide wire. After the treatment, fluid and particles from the procedure are evacuated using the aspiration syringe. If there is insufficient venous or collateral flow, the Proxis Infusion Catheter (optional accessory) may be used to deliver saline distal to the treatment site while simultaneously applying vacuum to evacuate fluid and particles from the treatment site.

Here's a breakdown of the acceptance criteria and study information for the Proxis System, based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as distinct numerical targets but are implicitly derived from the non-inferiority comparisons to predicate devices in terms of major adverse cardiac events (MACE). The reported device performance is presented as the MACE rates for the Proxis System compared to the control arm (using market-cleared distal protection devices). The goal was to demonstrate non-inferiority of the Proxis System.

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The Proxis System is indicated for use as a proximal embolic protection system to prevent distal release of and to aspirate embolic material (thrombus/debris) in saphenous vein coronary bypass graft(s) (3.0 mm – 5.0 mm) during percutaneous transluminal coronary angioplasty and/or stenting procedures.

The Proxis System is also indicated to control the flow of fluids and aid in the removal of fresh, soft emboli and thrombi in the coronary and peripheral vasculature.

The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid or peripheral vasculature; native coronary arteries; or for treatment of patients with acute myocardial infarction.

The Proxis Embolic Protection System is used in conjunction with other percutaneous transluminal coronary angioplasty devices (PTCA). It is compatible with 8F guide catheters. The Proxis System protects the patient from distal embolization by preventing antegrade flow of emboli released during a PTCA and then removing it from the vessel. The Proxis System consists of an Evacuation Sheath Catheter, Accessory Pack (contains an inflation system, evacuation syringe and double y-adaptor) and an optional additional accessory called the Proxis Infusion Catheter (packaged separately).

The Evacuation Sheath Catheter is loaded into the hemostasis valve and tracked down to the distal portion of the guide catheter. The Evacuation Sheath lines the inner lumen of the distal end of the guide catheter. When the sealing balloons are inflated, the proximal balloon seals against the guide catheter wall and the distal balloon seals against the blood vessel wall and the antegrade flow of the fluid in the target vessel is stopped. The stagnation of flow is accomplished before any devices touch or cross the lesion(s). This minimizes the distal release of embolic material.

Interventional devices are passed through the evacuation sheath to the treatment site and the procedure is performed in stagnant fluid. After the procedure, fluid and particles from the procedure are evacuated using the Evacuation Syringe. The Proxis Infusion Catheter may be used to augment the retrograde flow during the evacuation by infusing saline distal to the treatment site while simultaneously applying vacuum to evacuate fluid and particles from the treatment site.

This document describes the Proxis System, an embolic protection device, and the study supporting its expanded indications. Here's an analysis of the acceptance criteria and the study details:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the "Proximal Trial" which assessed the safety and effectiveness of the Proxis System for embolic protection. The primary acceptance criterion appears to be non-inferiority in the 30-day Major Adverse Cardiac Event (MACE) rate compared to existing distal protection devices.

Interpretation: The reported performance of the Proxis System (9.2% MACE in the test arm) and the control arm (10.0% MACE) demonstrates a difference of -0.8% (Proxis

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The Proxis System controls the flow of fluids in the coronary and periphery vasculature. This is achieved by the temporary occlusion of vessels and holding the column of fluid in the vessel stagnant. The stagnant column can be used to aid in the visualization of the lesion or be used as a means of local and temporary delivery of therapeutic solution(s). The safety and efficacy of this device as an embolic protection system has not been established. The Proxis Flow Control device is not indicated for use for embolic protection.

The Proxis System has four major components: The Evacuation Sheath Catheter, the Inflation System, Infusion Catheter, and an Evacuation syringe.

The Evacuation Sheath Catheter has two low-pressure compliant sealing balloons that are inflated simultaneously. The proximal balloon stays within the guide catheter while the distal balloon resides in the arterial vessel. Radiopaque markers at the two balloon sites facilitate visualization and intravascular placement of the catheter prior to inflation. The Evacuation Sheath has sufficiently large inner diameter to accommodate standard therapeutic devices within its size range. The balloons are inflated using the Inflation Svstem.

Devices can be deployed through the Evacuation sheath to the target site before, during or after the sealing balloons are inflated to occlude the vessel. Infusing ~0.5cc of contrast dye through the guide catheter will produce a continuous "roadmap" of the lesion as an aid for the physician in guiding the therapeutic device to the lesion site.

Alternatively, while the vessel is occluded, therapeutic solutions like anticoagulant, cardioplegia and thrombolytics may be infused through the guide catheter and stagnated in the target vessel/lesion during the delivery of the therapeutic device or after the deployment of the therapeutic device.

The Evacuation syringe is provided for the removal of the fluid and the emboli/thrombi during aspiration. The infusion catheter may be used to infuse saline to augment the retrograde flow of fluid and the removal the emboli/thrombi.

This document describes a 510(k) premarket notification for the Velocimed Proxis System, a percutaneous catheter. The submission primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain a study demonstrating device performance against specific acceptance criteria for diagnostic or clinical effectiveness. Instead, it describes compliance with various performance requirements and standards for medical devices.

Here's an analysis of the provided text in relation to your request:

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

The document does not present specific acceptance criteria in a quantitative table format for clinical performance or diagnostic accuracy. Instead, it lists broader performance requirements and compliance with international standards for medical devices.

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

The document describes performance testing of the device, primarily focusing on physical and mechanical properties, and biological safety. It does not describe a clinical study with a "test set" in the context of diagnostic accuracy or clinical effectiveness on patients. Therefore, information on sample size, data provenance, and study design for such a "test set" (e.g., patient data) is not applicable or provided in this submission for this type of device. The testing described would typically involve laboratory-based testing of device units.

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)

This information is not applicable as the document does not describe a study involving expert-established ground truth on patient data for diagnostic or clinical performance. The "ground truth" for the performance tests described (dimensional, tensile, etc.) would be established by engineering specifications and objective measurements against those specifications.

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

This information is not applicable as there is no mention of a "test set" requiring expert adjudication for clinical or diagnostic outcomes.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. The Proxis System is a medical device (a catheter) for controlling fluid flow and temporary occlusion, not an AI or diagnostic imaging device that would involve human readers or AI assistance in interpretation.

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

This information is not applicable. The Proxis System is a physical medical device, not an algorithm, and therefore does not have a "standalone" algorithmic performance.

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

Given the nature of the device and the performance data described, the "ground truth" would be based on:

• Engineering specifications and objective physical measurements for dimensional verification, balloon compliance, tensile strength, torque, flexibility, and trackability.
• Established biological testing protocols for ISO 10993 (biological evaluation).
• Standardized testing procedures for packaging integrity and sterilization validation.

8. The sample size for the training set

This information is not applicable. The Proxis System is a physical medical device, not an AI model, and therefore does not have a "training set" in the context of machine learning.

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

This information is not applicable for the reasons stated in point 8.

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