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The RenovoCath is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapentic agents, to selected sites in the peripheral vascular system. The RenovoCath is also indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. The RenovoCath is intended for general intravascular use in the peripheral vasculature in arteries 3mm and larger. The RenovoCath is intended for use in arteries from 3mm in diameter for vessel entry and to occlude vesses ranging between 3mm to 11mm in diameter.

The diagnostic and/or therapents are to be used in accordance with specifications outlined by the respective agent manufacturer.

The RenovoCath is a multi-lumen, dual-balloon catheter with a two-part handle that is designed for targeted delivery of fluids, including radiopaque material and therapeutic agents, to selected sites in the peripheral vascular system. The distance between the proximal and distal balloons is adjustable. The effective length is 75cm to 85cm (adjustable). Radiopaque markers are located between the balloons to allow for identification of targeted site and position adjustment under fluoroscopic guidance. The RenovoCath is intended to be used with 6 Fr guide sheaths and 7 Fr guide catheters and is compatible with 0.014" guidewires.

Here's a breakdown of the acceptance criteria and study information for the RenovoCath device, based on the provided text:

Key Takeaway: This submission is for a device that is substantially equivalent to a previously cleared device. The "study" here refers to bench testing performed to demonstrate that the new device performs comparably to the predicate device (the previously cleared version) despite minor design changes. Therefore, there isn't a typical "study" in the sense of a clinical trial with human subjects, AI assistance, or complex ground truth establishment as might be seen for novel AI/ML devices.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission seeking substantial equivalence to a predicate device, the "acceptance criteria" are implicitly that the subject device performs functionally the same as the predicate device across various performance measures. The "reported device performance" demonstrates this equivalence.

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

• Sample Size: The document does not specify exact sample sizes for each of the bench tests (Dimensional Inspection, Insertion and Tracking Testing, Balloon Testing, Infusion Flow Rate Testing, Simulated In-Vivo Testing). It generally refers to these as "testing" using "the same methods previously established."
• Data Provenance: The data is from bench testing performed by RenovoRx, Inc. It is prospective testing designed to evaluate the new device against the predicate. The country of origin for the testing would be the USA, where RenovoRx, Inc. is located.

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

This type of information is generally not applicable to this 510(k) submission. The "ground truth" for this device, which is a physical catheter, is its physical and functional specifications. The "ground truth" for its performance is derived from bench testing that measures physical characteristics and operational performance against predefined engineering specifications and comparison to the predicate device's known performance. This does not involve clinical "experts" establishing ground truth in the way an AI/ML diagnostic device would.

4. Adjudication Method for the Test Set

Not applicable. The 'adjudication' in this context is the comparison of bench testing results to the predicate device's performance and to engineering specifications. There is no mention of a human adjudication process for interpreting results in a subjective manner.

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 is a medical device (catheter), not an AI-powered diagnostic tool. No MRMC study or AI assistance is mentioned or relevant to this submission.

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

Not applicable. This is a physical medical device. There is no algorithm or AI component.

7. The Type of Ground Truth Used

The ground truth used for the subject device is its engineering specifications and the established performance characteristics of the legally marketed predicate device (RenovoCath® K191606). The goal of the testing was to demonstrate that the new device met its own specifications and performed comparably to the predicate.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device. There is no training set in the context of AI/ML.

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

Not applicable. As there is no training set in the AI/ML sense, this question is not relevant.

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The RenovoCath is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to selected sites in the peripheral vascular system. The RenovoCath is also indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. The RenovoCath is intended for general intravascular use in the peripheral vasculature in arteries 3mm and larger. The RenovoCath is intended for use in arteries from 3mm in diameter for vessel entry and to occlude vesses ranging between 3mm to 11mm in diameter.

The diagnostic and/or therapents are to be used in accordance with specifications outlined by the respective agent manufacturer.

The RenovoCath is a multi-lumen, dual-balloon catheter with a two-part handle that is designed for targeted delivery of fluids, including radiopaque material and therapeutic agents, to selected sites in the peripheral vascular system. The distance between the proximal and distal balloons is adjustable. The effective length is 76cm to 86cm (adjustable). Radiopague markers are located between the balloons to allow for identification of targeted site and position adjustment under fluoroscopic guidance. The RenovoCath is intended to be used with 6 Fr guide sheaths and 7 Fr guide catheters and is compatible with 0.014" guidewires.

The provided text is a 510(k) Premarket Notification from the FDA for the RenovoCath device. This document focuses on demonstrating substantial equivalence to a predicate device (RenovoCath™ RC120 Catheter K160067) rather than detailing a study that proves the device meets specific performance acceptance criteria in the manner one might see for a novel AI/software as a medical device (SaMD).

For a SaMD, acceptance criteria often relate to clinical performance metrics like sensitivity, specificity, AUC, or reader agreement improvement. For this medical device (a catheter), the "acceptance criteria" are demonstrated through engineering bench testing and comparison to an existing similar device.

Therefore, many of the requested items (e.g., sample size for training/test sets, expert adjudication methods, MRMC studies, standalone performance of an algorithm) are not applicable to this type of medical device submission. This document highlights a predicate pathway where the primary goal is to show that the new device is as safe and effective as a legally marketed device, not to prove clinical superiority or novel diagnostic capabilities via extensive clinical studies involving human readers or AI algorithms.

Here's how to address the request based on the provided document:

Acceptance Criteria and Device Performance (as demonstrated for a medical device)

1. Table of "Acceptance Criteria" and Reported Device Performance

For this medical device, "acceptance criteria" are demonstrated by a battery of engineering and bench tests, ensuring the device functions as intended and is comparable to the predicate. The "reported device performance" is essentially that the new device passed these tests and functions similarly to the predicate.

2. Sample Size for the Test Set and Data Provenance

• Sample Size: The document does not specify a numerical sample size for each bench test (e.g., number of catheters tested for flow rate or bond strength). It refers to "the RenovoCath was tested for the following using the same methods previously established." This implies standard quality control and engineering test sample sizes appropriate for device manufacturing and validation, but not formal clinical study sample sizes.
• Data Provenance: Not applicable in the context of clinical data for AI/SaMD. The data comes from internal engineering and bench testing. It's not clinical data from patients or a specific country.
• Retrospective/Prospective: Not applicable. These are lab-based tests.

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

Not applicable. Ground truth for a catheter's physical and functional performance is established by engineering specifications, validated test methods (often based on ISO or ASTM standards), and comparison to a predicate device's established performance, not by human experts interpreting clinical images or outcomes.

4. Adjudication Method for the Test Set

Not applicable. This is not a clinical study involving human interpretation or consensus. Performance is measured objectively through engineering tests.

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, not an AI or software device. No human readers or AI assistance are involved in its primary function or evaluation for this submission.

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

Not applicable. There is no algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on:

• Engineering Specifications: Defined parameters for flow rate, dimensions, material properties, etc.
• Bench Testing Results: Objective measurements from controlled laboratory experiments (e.g., burst pressure, flow rate measurement).
• Predicate Device Performance: The established safety and effectiveness of the legally marketed predicate device (RenovoCath™ RC120 Catheter K160067) serves as the reference for substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. There is no training set as this is not an AI/ML product.

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

Not applicable. There is no training set.

Study Summary

The "study" in this context is the 510(k) Premarket Notification process, which demonstrates substantial equivalence to a predicate device.

• Objective: To show that the RenovoCath is as safe and effective as the predicate device (RenovoCath™ RC120 Catheter K160067) for its stated indications for use.
• Methodology: The manufacturer conducted a series of bench tests and engineering evaluations to compare the RenovoCath to its predicate and to ensure it met its own performance specifications. These tests included:
  • Flow Rate
  • Vessel Occlusion
  • Visibility Under Fluoroscopy
  • Bench testing for 3mm occlusion (specifically to support the expanded vessel diameter range)
  • Visual inspection
  • Dimensional verification
  • Insertion and tracking testing
  • Balloon performance verification
  • Infusion flow rate testing
  • Simulated use testing
  • Bonds strength testing
  • Infusion port burst testing
• Key Findings: The collective results of these tests demonstrated that the RenovoCath meets its specifications and performs as intended, and that its technological characteristics and performance are substantially equivalent to the predicate device, despite minor changes in indications for use/contraindications (e.g., expanded vessel diameter range, updated contrast ratio, moved contraindications).

In summary, for a traditional medical device like the RenovoCath, "acceptance criteria" are primarily related to engineering performance and functional equivalence to a predicate, rather than the statistical clinical performance metrics typical of an AI/SaMD. The "study" proving this is a series of comprehensive bench and engineering tests.

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The RenovoCath™ RC120 Catheter is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to selected sites in the peripheral vascular system. The RenovoCath™ RC120 is also indicated for temporary vessel occlusions including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. The RenovoCath™ RC120 is intended for general intravascular use in the peripheral vasculature in arteries 3mm and larger. The RenovoCath™ RC120 is intended for use in arteries from 3mm in diameter for yessel entry and to occlude vessels ranging between 4mm to 11mm in diameter.

The diagnostic and/or therapeutic agents are to be used in accordance with specifications outlined by the respective agent manufacturer.

The RenovoCath™ RC120 Catheter is not intended for use in coronary and intracranial arteries.

The RenovoCath™ RC120 Catheter is not intended for embolic protection or as an aspiration catheter.

The RenovoCath™ RC120 Catheter ("RenovoCath") is a multi-lumen, dual-balloon catheter. The distance between the proximal and distal balloons is adjustable. The RenovoCath is provided with two off-the-shelf 3cc syringes that facilitate precise inflation of the balloons under fluoroscopic guidance.

This document is a 510(k) premarket notification for the RenovoCath™ RC120 Catheter. It claims substantial equivalence to a predicate device, the Boston Scientific Equalizer™ Occlusion Balloon Catheter (K140273), rather than providing detailed acceptance criteria and a study to prove a device meets those criteria from scratch. Therefore, the information you're requesting, particularly specific acceptance criteria with numerical performance data like sensitivity/specificity, sample sizes for test and training sets, details on expert ground truthing, and MRMC studies, is not present in this type of regulatory submission.

Instead, the document focuses on demonstrating that the RenovoCath has the same intended use and similar technological characteristics as the predicate device, and that any differences do not raise new issues of safety or effectiveness.

Here's an analysis based on the information provided in the document, framed by your request, explaining why certain details are missing for this type of submission:

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

This document does not present quantitative acceptance criteria or reported device performance in the format of a table with specific metrics like sensitivity, specificity, or AUC, as would be common for diagnostic AI algorithms.

Instead, the "acceptance criteria" are implied by the claim of substantial equivalence to the predicate device and the results of the bench testing. The "performance" is described in qualitative terms:

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

This document describes bench testing for physical characteristics of the device, not clinical studies involving patient data or images. Therefore, the concepts of "test set sample size" and "data provenance" (country/retrospective/prospective) related to patient data are not applicable here. The testing was conducted on devices and materials in a laboratory setting. No information on the specific number of units tested for each bench test is provided in this summary.

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 is not applicable as the study involves bench testing of a physical medical device, not evaluation of an AI algorithm based on human expert ground truth.

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

This 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

This is not applicable. The device is a physical catheter, not an AI-powered diagnostic or assistive tool for human readers.

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

This is not applicable. The device is a physical catheter, not an algorithm.

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

For the bench testing described, the "ground truth" would be established by engineering specifications, validated test methods, and industry standards for medical device performance. For example, a balloon inflation time would be measured against a specified range, or an infusion flow rate against a required minimum, rather than an expert consensus or pathology report.

8. The sample size for the training set

This is not applicable as this document describes bench testing for a physical device, not an AI algorithm requiring a training set.

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

This is not applicable for the same reasons as point 8.

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The RenovoCath™ RC120 Catheter is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to selected sites in the peripheral vascular system. The RenovoCath™ RC120 is intended for general intravascular use in the peripheral vasculature in arteries 3mm and larger. The RenovoCath™ RC120 is intended for use in arteries from 3mm in diameter for vessel entry and to occlude vessels ranging between 4mm to 11mm in diameter.

The diagnostic and/or therapeutic agents are to be used in accordance with specifications outlined by the respective agent manufacturer.

The RenovoCath™ RC120 Catheter is not intended for use in coronary and intracranial arteries.

The RenovoCath™ RC120 Catheter is not intended for embolic protection or as an aspiration catheter.

The RenovoCath™ RC120 Catheter ("RenovoCath") is a multi-lumen, dual-balloon catheter. The RenovoCath is designed for targeted delivery of fluids, including diagnostic agents, to selected sites in the peripheral vascular system. The distance between the proximal and distal balloons is adjustable. The RenovoCath is provided with two off-the-shelf 3cc syringes that facilitate precise inflation of the balloons under fluoroscopic guidance.

The provided documentation describes the RenovoCath™ RC120 Catheter, a medical device, and its 510(k) premarket notification (K141175). This type of notification focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, rather than providing extensive clinical study data proving performance against specific acceptance criteria in the same way a new drug or novel medical imaging AI might.

Therefore, the information provided does not contain acceptance criteria and a study proving the device meets those criteria in the typical sense of a detailed clinical performance study with statistical metrics. Instead, it focuses on demonstrating equivalence through bench testing.

Here's an analysis based on the available information:

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

Since this is a 510(k) for a physical medical device (catheter) based on substantial equivalence, the "acceptance criteria" are primarily related to passing various engineering and materials tests to demonstrate it functions similarly and safely to the predicate device. The document states:

• Biocompatibility
• Sterilization
• Shipping and Packaging
• Accelerated Aging
• Design Verification (Visual, Dimensional, Insertion/Tracking, Balloon Performance, Infusion Flow Rate, Simulated Use, Bonds Strength, Infusion Port Burst) | "All necessary bench testing was conducted on the RenovoCath to support a determination of substantial equivalence to the predicate device."
  "The collective results of the testing demonstrate that the RenovoCath meets its specifications and performs as intended."
  "The collective bench testing demonstrates that the RenovoCath does not raise new questions of safety or effectiveness as compared to the predicate device." |

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

• Sample Size for Test Set: Not specified. For bench testing of physical devices, sample sizes are typically determined by engineering and quality assurance standards relevant to the specific test (e.g., number of catheters tested for burst pressure, number of samples for biocompatibility). These details are not provided in this summary document.
• Data Provenance: The testing was conducted by or for RenovoRx, Inc. in the USA. It is prospective testing designed to support the 510(k) application.

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

• This is not applicable in the context of this 510(k) submission. Bench testing for device functionality does not typically involve "experts" establishing a "ground truth" in the way clinical studies or AI algorithm evaluations do. The "truth" is determined by engineering specifications and physical measurements.

4. Adjudication method for the test set:

• Not applicable. This is not a study requiring adjudication of expert opinions.

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 is a physical medical device (catheter), not an AI-assisted diagnostic tool.

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

• Not applicable. This is a physical medical device.

7. The type of ground truth used:

• For the bench testing, the "ground truth" or reference for performance is established by engineering specifications, industry standards, and comparison to the predicate device's known performance characteristics. For example, a balloon must inflate to a certain diameter without bursting, or a catheter must withstand a certain tensile force.

8. The sample size for the training set:

• Not applicable. This is a physical medical device, not a machine learning algorithm.

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

• Not applicable. This is a physical medical device.

In summary: The RenovoCath™ RC120 Catheter received 510(k) clearance based on demonstrating "substantial equivalence" to a predicate device (ThermopeutiX, Inc. TAPAS Catheters, K112219). This was supported by a range of bench tests (biocompatibility, sterilization, shipping/packaging, accelerated aging, and various design verification tests) that collectively confirmed the RenovoCath met its specifications, performed as intended, and did not raise new questions of safety or effectiveness compared to the predicate. The documentation does not provide specific quantitative acceptance criteria or detailed sample sizes for each test but indicates that "all necessary bench testing was conducted."

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