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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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