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The V2K Rinspiration System is intended to infuse physician specified fluids and remove/aspirate fluid, fresh, soft emboli and thrombi from the peripheral vasculature.

The V2K Rinspiration System is comprised of the V2K Rinspiration Catheter and two accessory components; an Infusion Syringe and a Filter Line. The V2K Rinspiration Catheter is a multi-lumen catheter that has infusion holes located near the distal end of the catheter to dispense an infusible fluid. The central lumen of the catheter is used for aspiration. Simultaneous infusion and aspiration can be performed through these lumens to perform fluid mechanical thrombectomy to remove fluid, fresh, soft emboli and thrombi from peripheral vasculature. The Rinspiration Catheter will be placed in the target vasculature of a patient over an 0.014" guide wire. The V2K Rinspiration Catheter uses a rapid exchange (a.k.a. rail) configuration for the guidewire lumen. The Rinspiration catheter distal tip will be positioned at the intended treatment site. Infusion occurs approximately 1 to 2cm proximal to the distal tip. The catheter includes a smaller radiopaque marker band at the distal tip and two larger radiopaque marker bands designating the infusion portion of the catheter. The catheter has a V-hub on the proximal end that allows access to the infusion and aspiration lumens. Included in the same packaging as the V2K Rinspiration Catheter is a 12cc Infusion Syringe with an attached check valve. The Infusion Syringe is intended to be used for infusing physician specified fluids through the V2K Rinspiration Catheter. The V2K Rinspiration Catheter will also be supplied with an accessory Filter Line which is intended to be used to connect the catheter to a continuous vacuum source such as an aspiration pump or hospital vacuum line. The Filter Line has two connections, one male Luer and one slip-fit connector. The male Luer is connected to the aspiration lumen of the V2K Rinspiration Catheter. The slip-fit connector is connected to the continuous vacuum source. The Filter Line also has an in-line flow control switch and an in-line filter. The in-line flow control switch is used to open/close the connection between the continuous vacuum source and the aspiration lumen of the catheter. This allows the user a simple method to manage the aspiration flow. The in-line filter is used to collect any debris that is aspirated through the catheter and allows the user to clearly visualize what has been aspirated. This also allows for temporary storage, inspection, analysis, transport and / or disposal of the aspirated materials.

The provided document is a 510(k) Summary for the V2K Rinspiration System, outlining its substantial equivalence to a predicate device. It details various performance tests conducted for this medical device, which is an embolectomy/infusion catheter.

However, the questions posed (related to acceptance criteria and study data for an AI/ML powered medical device) are not applicable to the content of this document. This submission does not describe an AI/ML powered device, nor does it contain information about clinical studies with human readers, ground truth establishment by experts, or training/test sets for an algorithm. It focuses on the physical and biological performance characteristics of a catheter system.

Therefore, I cannot extract the requested information from the provided text as it pertains to a different type of medical device and regulatory submission.

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The Kerberos Proximal Solutions Rinspiration System is intended to infuse and aspirate physician specified fluid in the coronary and peripheral vasculature.

The system consists of a Rinspiration™ Catheter, and a Rinspirator™ with accessories, The Rinspiration Catheter is a multi-lumen, rail configuration catheter that has perforations located near the distal end of the catheter to dispense an infusible fluid. The Rinspiration Catheter will be placed in the vasculature of a patient over a quide wire. The Rinspiration Catheter is offered with a standard tip and a short tip. The catheter includes a radiopaque marker band at the distal tip and two radiopaque marker bands designating the infusion portion of the catheter. The catheter has a hub on the proximal end that allows access to the infusion and aspiration lumens. The Rinspirator and accessories is a sterile, single-use mechanical device. This hand activated device allows for simultaneous infusion and aspiration of fluids at the treatment site. The device activates two syringes, one for infusion and one for aspiration. This simultaneous infusion and aspiration action is known as "Rinspiration."

The KPS Rinspiration System is a medical device intended to infuse and aspirate physician-specified fluid in the coronary and peripheral vasculature. The provided text describes the regulatory submission for this device but does not contain acceptance criteria or a study proving that the device meets specific performance criteria in terms of clinical effectiveness or accuracy.

Instead, the document focuses on functional testing, biocompatibility, and sterility to demonstrate substantial equivalence to predicate devices, which is a regulatory pathway for approval.

Here's a breakdown of the information that can be extracted, and what cannot be found based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided text.

The document states: "Functional testing was conducted on the KPS Rinspiration System to ensure that the product will function according to its Instructions for Use. This functional testing was performed per KPS protocol and referenced International Standard ISO 10555, Sterile, Single Use Intravascular Catheters - Part 1. All testing conducted confirmed the acceptability of the KPS Rinspiration System to perform as intended."

This indicates that internal protocols and an international standard were used, and the device met these, but the specific quantifiable acceptance criteria (e.g., flow rate, aspiration volume, catheter strength, etc.) and the exact performance results are not reported.

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

Not applicable for clinical effectiveness/accuracy study as one was not described.

For the functional tests, the sample size is not mentioned. The data provenance is internal to KPS (Kerberos Proximal Solutions).

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable as no clinical effectiveness/accuracy study with ground truth establishment was described.

4. Adjudication Method

Not applicable as no clinical effectiveness/accuracy study with ground truth establishment was described.

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

No MRMC comparative effectiveness study was described. The provided text does not mention any study comparing human readers with and without AI assistance, nor does it mention AI.

6. Standalone (Algorithm Only) Performance Study

No standalone performance study for an algorithm was described. The device is a physical catheter system, not an AI algorithm.

7. Type of Ground Truth Used

Not applicable as no clinical effectiveness/accuracy study requiring ground truth was described. The testing mentioned was functional, biocompatibility, and sterility testing, not clinical performance against a true clinical outcome.

8. Sample Size for the Training Set

Not applicable as this refers to a training set for an AI algorithm, and no AI algorithm or training was described.

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

Not applicable as this refers to a training set for an AI algorithm, and no AI algorithm or training was described.

Summary of what was reported:

The provided document describes the regulatory submission for a medical device (KPS Rinspiration System). The "study" mentioned refers to:

• Functional Testing: This was performed according to KPS's internal protocols and referenced ISO 10555 (Sterile, Single Use Intravascular Catheters - Part 1). The document states, "All testing conducted confirmed the acceptability of the KPS Rinspiration System to perform as intended." However, no specific quantitative acceptance criteria or detailed results are provided.
• Biocompatibility Testing: Conducted according to ISO 10993-1. The device materials "passed the necessary biocompatibility tests."
• Sterilization Validation: Conducted according to ISO 11135 to assure a sterility assurance level (SAL) of 10⁻⁶.

These tests are standard for demonstrating the safety and fundamental functionality of a device for regulatory clearance through substantial equivalence, rather than proving performance against specific clinical efficacy metrics.

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The KPS Rinspiration™ System is intended to infuse and aspirate in the peripheral vasculature.

The system consists of a Rinspiration™ Catheter and a KPS Rinspirator™ with accessories. The KPS Rinspiration™ Catheter is a multi-lumen catheter that has perforations located near the distal end of the catheter to dispense an infusible fluid. The Rinspiration™ Catheter will be placed in the peripheral vasculature of a patient over a quide wire. The catheter has a hub on the proximal end that allows access to the infusion and aspiration lumens. The KPS Rinspirator™ with accessories is a hand activated mechanical device that connects to the hub of the catheter. It allows for simultaneous irrigation and aspiration of the treatment site. The device activates two syringes for infusion and aspiration. This action is known as "Rinspiration™ ,"

The provided text describes a 510(k) premarket notification for the KPS Rinspiration™ System and does not contain detailed information about specific acceptance criteria, a study that rigorously proves device performance against those criteria, or the methodology for establishing ground truth or training data. The document focuses on demonstrating substantial equivalence to a previously cleared device (K031485).

However, I can extract the information that is present and indicate what is not available.

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information:

• Specific numerical targets or thresholds for "safe" and "effective."
• Detailed metrics or quantitative results from the "bench testing" that demonstrated safety and effectiveness.

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

Missing Information:

• There is no mention of a "test set" in the context of clinical data or a specific cohort of patients.
• The document states "Results of bench testing prove that the KPS Rinspiration™ System is safe and effective for its intended use." This implies the testing was done in a laboratory environment, not on human patients or a derived dataset from human patients. Therefore, information about data provenance (country of origin, retrospective/prospective) is not applicable or provided.

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

Missing Information:

• No information is provided about experts used to establish a ground truth. Since the reported testing was "bench testing," it's unlikely that clinical expert review for ground truth was part of this submission's provided summary.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:

Missing Information:

• No information is provided about an adjudication method, as there's no mention of a test set requiring expert review.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of human readers improvement with AI vs. without AI assistance:

Missing Information:

• No MRMC comparative effectiveness study was mentioned. The device is a mechanical system, not an AI or imaging-based diagnostic tool. Therefore, the concept of "human readers improving with AI assistance" is not applicable to this device.

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

Missing Information:

• This device is not an algorithm or AI system. It is a physical catheter system for infusion and aspiration. Therefore, standalone algorithm performance is not applicable.

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

Missing Information:

• For the "bench testing," the "ground truth" would likely be engineering specifications, measurable physical properties, and established industry standards for material compatibility and performance. However, the specific type of "ground truth" used for each aspect of safety and effectiveness (e.g., flow rate measurements, pressure tolerance, material degradation assessment) is not detailed in the summary.

8. The sample size for the training set:

Missing Information:

• There is no mention of a "training set" as this is not an AI/ML device.

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

Missing Information:

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

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The KPS Rinspiration™ System is intended to infuse and aspirate in the peripheral vasculature.

The system consists of a Rinspiration™ Catheter and a KPS Rinspirator™ and its accessories. The KPS Rinspiration™ Catheter is a multi-lumen catheter that has perforations located near the distal end of the catheter to dispense an infusible fluid. The Rinspiration™ Catheter will be placed in the peripheral vasculature of a patient over a guide wire. The Rinspiration™ Catheter is available in over the wire and rail configurations. The catheter includes a radiopaque marker band at the distal tip and two radiopaque marker bands designating the infusion portion of the catheter. The catheter has a hub on the proximal end that allows access to the infusion and aspiration lumens. The KPS Rinspirator™ and its accessories is a sterile, single-use mechanical device. This hand-activated device allows for simultaneous irrigation and aspiration of the treatment site. The device activates two syringes for infusion and aspiration. This action is known as "Rinspiration™."

Here's an analysis of the provided text regarding the acceptance criteria and study for the KPS Rinspiration™ System:

1. Table of Acceptance Criteria and Reported Device Performance:

Critique: The provided document does not explicitly state quantitative acceptance criteria for the device's performance. Instead, it makes general statements about safety, effectiveness, and biocompatibility, and concludes substantial equivalence based on these.

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

• Sample Size: Not specified. The document mentions "bench testing," but doesn't provide details on the number of units tested or the specific conditions.
• Data Provenance: Not specified. It's implied to be internal testing by the applicant ("Results of bench testing demonstrate..."), but no country of origin or whether it's retrospective/prospective is mentioned.

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

• Number of Experts: Not applicable. This study appears to be a bench test of a physical device, not related to interpretation of images or clinical data by experts.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. This study appears to be a bench test, not requiring adjudication of expert opinions.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The submission describes bench testing, not a study involving human readers or clinical cases.
• Effect Size of AI assistance: Not applicable, as no AI component or human-in-the-loop study was conducted.

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

• Standalone Study: Yes, in a sense, the "Functional Test Results" which state "Results of bench testing demonstrate that the KPS Rinspiration™ System is safe and effective for its intended use" represent the standalone performance of the device itself. However, this is for a physical medical device, not a software algorithm.

7. Type of Ground Truth Used:

• Ground Truth Type: For the functional test results, the ground truth is likely based on engineering specifications and performance metrics defined by the manufacturer and accepted industry standards for infusion/aspiration systems in the peripheral vasculature. For biocompatibility, the ground truth is established by the ISO 10993-1 standard and its specific testing requirements.

8. Sample Size for the Training Set:

• Sample Size: Not applicable. The device is a physical catheter system, not an AI model that requires a "training set."

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

• Ground Truth Establishment: Not applicable, as there is no training set for an AI model.

Summary of deficiencies in the provided information relative to AI/software device submission expectations:

The provided document is a 510(k) summary for a physical medical device (catheter system) from 2003. It predates the widespread regulatory focus on AI/ML-driven medical devices and therefore does not contain the type of information typically required for an AI/ML device submission, particularly concerning:

• Quantitative performance metrics (e.g., sensitivity, specificity, AUC)
• Detailed test set characteristics (sample size, data provenance, expert labels)
• Specific ground truth establishment methods for algorithms
• Any mention of training sets, validation sets, or AI model development
• Studies involving human readers or comparative effectiveness with or without AI assistance

The "acceptance criteria" discussed are primarily about general safety, effectiveness, and biocompatibility, demonstrating substantial equivalence to predicate devices through bench testing, rather than the rigorous statistical evaluation of algorithm performance against a defined ground truth that would be expected for an AI-powered device today.

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