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The Medtronic Steerant Super Stiff Guidewire is intended to facilitate catheter placement and exchange during diagnostic or interventional procedures in the aorta. The guidewire is not indicated for coronary or neuro vasculature.

Steerant™ Super Stiff Guidewire (herein after referred to as Steerant) is a 0.035" diameter PTFE coated stainless steel guidewire. The Steerant guidewire is offered in 200 cm and 260 cm lengths and incorporates a flexible tip section and inner 8 cm radiopaque tungsten coil for enhanced visibility. The Steerant guidewire is offered in single and double curve tip configurations. The Steerant guidewire is sterile, non-pyrogenic, disposable and for single use only.

The provided text is a 510(k) premarket notification for a medical device (Steerant Super Stiff Guidewire). It focuses on demonstrating substantial equivalence to a predicate device, not on proving the device meets individual acceptance criteria for an AI/software component through a study.

Therefore, the information required to answer your prompt, specifically concerning acceptance criteria, study design for AI performance, sample sizes for training and test sets, expert involvement, and ground truth establishment, is not present in the provided document.

The document details the device's physical characteristics, indications for use, and a comparison to predicate and reference devices. It mentions "Non-Clinical Performance Data" and states that "All the predetermined acceptance criteria were met and results passed to support a determination of substantial equivalence." However, it does not elaborate on what those criteria were for the performance of the device (e.g., accuracy, sensitivity, specificity for an AI algorithm), nor does it describe a study involving humans and AI assistance or algorithm-only performance.

The "Non-Clinical Performance Data" section lists various engineering and regulatory tests such as:

• Design Verification Testing
• Design Validation Testing
• Sterilization Validation per requirements of ISO 11135
• Biocompatibility Testing per the requirements of ISO 10993-1
• Packaging Design Verification Testing per requirements of ISO 11607
• Shelf Life Testing

These are standard tests for a physical medical device and do not involve AI or software performance evaluation in the manner described in your prompt.

In summary, this document does not contain the information needed to answer your request about acceptance criteria and study data for an AI-powered medical device.

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The Medtronic Guide Catheter is designed to provide a pathway through which therapeutic devices are introduced. The Guide Catheter is intended to be used in the coronary or peripheral vascular system.

The Sherpa NX Balanced Guide Catheter design is fundamentally the same for both sizes of the device. The guide catheter is designed to provide a pathway for diagnostic and therapeutic devices in the coronary and peripheral vasculature. The basic design of Sherpa Guide Catheters is a cylindrical tube with a proximal and distal end. A single lumen extends from the proximal to the distal end of the catheter. The distal end of the catheter is towards the tip and the proximal end is towards the hub and strain relief. The catheter shaft has side holes present towards the distal end depending on the model. The Sherpa NX Balanced product line has two French sizes available, 6F and 7F. Sherpa is available in a range of lengths from 47 cm to 110 com.

The provided text describes a 510(k) premarket notification for the Medtronic 6F Sherpa NX Balanced Guide Catheter and 7F Sherpa NX Balanced Guide Catheter. It outlines the regulatory review and the company's summary of performance/non-clinical testing to demonstrate substantial equivalence to predicate devices. However, the document does not contain information about studies involving acceptance criteria related to a device with AI/algorithm performance.

The acceptance criteria mentioned are for the physical and biological properties of a medical catheter, not for an AI model's performance metrics (like accuracy, sensitivity, specificity, etc., with human-in-the-loop or standalone performance, MRMC studies, or ground truth establishment relevant to AI).

Therefore, based only on the provided text, I cannot complete a table or provide details for most of the requested points related to AI/algorithm acceptance criteria and performance studies.

Here's what can be extracted and what is missing:

Acceptance Criteria and Study for an AI-Powered Device (Information MISSING from provided text)

Since the provided document is for a physical medical device (a guide catheter) and not an AI/algorithm, the following sections will indicate "Not Applicable" or "Information Not Found" as the requested information pertains specifically to AI/algorithm performance studies.

1. Table of Acceptance Criteria and Reported Device Performance (for AI/Algorithm)

Note: The provided document details acceptance criteria for the physical properties and biocompatibility of the catheter (e.g., inner/outer diameters, leak resistance, tensile load, cytotoxicity). These are not AI/algorithm performance metrics.

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

• Test Set Sample Size: Information Not Found (Not applicable for a physical catheter).
• Data Provenance: Information Not Found (Not applicable for a physical catheter). The document only states that "no clinical testing data was required for this special 510k submission."

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

• Information Not Found (Not applicable for a physical catheter, as ground truth in the context of AI relates to diagnostic accuracy, not physical device integrity).

4. Adjudication Method for the Test Set

• Information Not Found (Not applicable for a physical catheter).

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

• Was it done?: No, an MRMC study was not done, as this submission is for a physical medical device, not an AI/algorithm. The document states "No clinical testing data was required for this special 510k submission."
• Effect size of human reader improvement with AI vs. without AI assistance: Not Applicable (No AI component).

6. Standalone (Algorithm Only) Performance Study

• Was it done?: No, a standalone algorithm performance study was not done. The submission is for a physical medical device.

7. Type of Ground Truth Used

• Information Not Found (Not applicable for a physical catheter, which doesn't involve "ground truth" in the AI diagnostic sense).

8. Sample Size for the Training Set

• Information Not Found (Not applicable, as this is a physical device, not an AI model requiring a training set).

9. How Ground Truth for the Training Set Was Established

• Information Not Found (Not applicable for a physical device).

Summary of what was actually performed and reported in the document:

The provided 510(k) summary describes non-clinical performance testing and biocompatibility assessment for the catheter:

• Biocompatibility Assessment:
  • Conducted according to ISO 10993-1.
  • Evaluated: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Material-Mediated Pyrogenicity, Hemocompatibility, Acute Systemic Toxicity.
• Product Performance Evaluation (Dimensional & Performance):
  • Tests included: Inner/Outer Diameters, Total/Effective/Exposed Tip Length, Luer Connector Performance, Leak Resistance, Draw-through stiffness, Shaft/Arch bending stiffness & kink resistance, Crush resistance, Torsional Stiffness, Rotational Kink Angle, Rotations to Separation, Curve retention, Soft tip stiffness, Peak shaft/segment/soft tip/hub-shaft tensile load, Internal lubricity.
  • Specific standards cited for some tests: ISO 594-1, ISO 594-2, EN ISO 80369-7 (for Luer Connector Performance); ISO 10555-1 (for Leak Resistance and Peak Hub/Shaft Tensile Load).
• Conclusion: "The necessary tests performed met the acceptance criteria and demonstrated that there are not safety or effectiveness concerns." and "The performance testing along with biocompatibility testing demonstrated that the subject device Sherpa Guide Catheter is substantially equivalent to the predicate device."
• Clinical Data: "No clinical testing data was required for this special 510k submission."

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The Medtronic guide catheter is designed to provide a pathway through which therapeutic devices are introduced. The guide catheter is intended to be used in the coronary or peripheral vascular system.

Launcher Guide Catheters are comprised of a cylindrical catheter having a proximal and distal end. A single lumen extends from the proximal to the distal end of the catheter. The distal end is the section of the catheter towards the tip and the proximal end is towards the hub and strain relief. The guide catheter is comprised of a luer hub, strain relief, shaft, segments, tungsten marker band, sleeve, and soft tip. The catheter shaft is made of three distinct layers. The guide catheter is available in various lengths ranging from 45 cm to 130 cm and four French sizes [5F, 6F, 7F, and 8F]. Launcher Guide Catheters have a lubricious inner lumen that runs from the proximal to the distal end of the catheter via a lubricious liner material or coating on the inner lumen.

The provided document is a 510(k) summary for the Medtronic Launcher Guide Catheter. It outlines the product's description, intended use, and substantial equivalence to a predicate device based on non-clinical performance and biocompatibility testing.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

| Acceptance Criteria Category | Specific Tests Performed | Reported Device Performance/Conclusion |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility Assessment | 1) Cytotoxicity
2) Sensitization
3) Intracutaneous Reactivity
4) Material-Mediated Pyrogenicity
5) Hemocompatibility
6) Acute Systemic Toxicity | Performed in accordance with FDA Guidance "Use of International Standard ISO 10993-1" and demonstrated no safety or effectiveness concerns. |
| Product Performance Evaluation (Dimensional & Performance) | 1) Inner Diameters (shaft, tip, & hub)*
2) Outer Diameters (shaft, segment, soft tip sleeve, & segment/shaft overlap)
3) Total Segment Length
4) Effective Length*
5) Exposed Tip Length
6) Luer Connector Performance*
7) Leak Resistance*
8) Draw-through stiffness of primary and secondary curve
9) Shaft bending stiffness & bending kink resistance (Body temperature and room temperature)
10) Arch bending stiffness & bending kink resistance (Body temperature and room temperature)
11) Shaft & distal segment crush resistance
12) Torsional Stiffness, Rotational Kink Angle, and Rotations to Separation
13) Curve retention after simulated seating
14) Peak shaft & segment tensile load
15) Peak soft tip tensile load
16) Soft tip stiffness
17) Peak hub/shaft tensile load*
18) Internal lubricity | Necessary tests performed met the acceptance criteria and demonstrated that there are no safety or effectiveness concerns. The performance testing, along with biocompatibility testing, demonstrated substantial equivalence to the predicate device. Specific standards used for some tests are noted: ISO 594-1, ISO 594-2, EN ISO 80369-7 for Luer Connector Performance; ISO 10555-1 for Leak Resistance and Peak Hub/Shaft Tensile Load. |

Note: Tests marked with an asterisk () were specifically highlighted as being performed on the subject device to demonstrate substantial equivalence for modifications in this premarket notification.*

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

The document does not explicitly state the sample sizes used for the non-clinical and biocompatibility tests. It broadly mentions "Summary of Nonclinical Data/Performance Testing" and "Product Performance Evaluation". Given the nature of these tests for medical devices, they would typically involve a statistically relevant number of samples to ensure robust results, but the exact numbers are not provided in this summary.

The data provenance is from non-clinical (laboratory) testing conducted by the manufacturer, Medtronic Vascular. No information regarding country of origin of the data or whether it was retrospective or prospective is mentioned (as these terms usually apply to clinical studies).

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

This information is not applicable to this submission. The "ground truth" concept usually applies to clinical studies where expert consensus or pathological findings are used to establish a definitive diagnosis or outcome. For non-clinical performance and biocompatibility testing, the "ground truth" is established by adherence to recognized international standards and engineering principles, with results evaluated against predefined acceptance criteria derived from these standards or predicate device performance. Experts involved would be engineers, scientists, and toxicologists specializing in medical device testing and regulatory compliance, but their specific numbers or detailed qualifications are not typically included in a 510(k) summary (beyond general statements about adherence to guidance documents like ISO 10993-1).

4. Adjudication Method for the Test Set

This information is not applicable to this submission. Adjudication methods (like 2+1, 3+1) are typically used in clinical trials where multiple experts assess cases and their disagreements need to be resolved to establish a ground truth. For the non-clinical tests described, the "adjudication" is inherent in the test methodology and adherence to international standards and acceptance criteria. Any deviations or failures would be investigated and resolved according to quality system procedures.

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 was done. This device is a physical medical device (catheter), not an AI-powered diagnostic or imaging tool that would involve human readers.

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

The ground truth for the non-clinical performance and biocompatibility testing is established by:

• Adherence to International/Recognized Standards: Such as ISO 594-1, ISO 594-2, EN ISO 80369-7, ISO 10555-1, and FDA Guidance "Use of International Standard ISO 10993-1".
• Predicate Device Performance: The subject device's performance is compared to the predicate device, aiming to demonstrate substantial equivalence by showing that any differences in characteristics do not raise different questions of safety and effectiveness.
• Engineering Specifications and Design Requirements: The tests verify that the device meets its own engineering specifications for parameters like dimensions, strength, flexibility, and resistance to various stresses.

8. The Sample Size for the Training Set

Not Applicable. There is no "training set" in the context of this device. Training sets are used in machine learning and AI model development.

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

Not Applicable. As there is no training set for this physical medical device, there is no ground truth to be established for it.

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The Everest 20cc Inflation Device/Survival Kit is to be used to facilitate the use of catheters and guide wires during interventional procedures. The Everest 20cc Inflation Device is designed to inflate/deflate balloon catheters as well as to monitor pressure within the balloon. The Y/Tri-Adapter with Hemostasis Valve is designed to be used on a guiding catheter or dilatation catheter to control backbleeding and to provide a port for introduction of fluids into the interventional system. The Guide Wire Insertion Tool is designed to facilitate placement of a guide wire tip through the Y/ Tri-Adanter and into the wire lumen of an interventional catheter. The Guide Wire Steering Handle is designed to hold a small diameter guide wire and provide a handle for manipulating the wire.

Medtronic's Everest™ Disposable Inflation Device is a sterile 20cc inflation device with a locking mechanism that is operated via a trigger. Normally, the locking mechanism is engaged. Once the trigger is pulled back, the locking mechanism is released and the piston can be manually manipulated. The Everest™ 20 Device is outfitted with a manometer with measuring pressures ranging from vacuum to 20 bars in 0.5bar increments. The Everest™ 30 Device is outfitted with a manometer with measuring pressure reading from vacuum to 30 bars in 1 bar increments. A high pressure connecting tube with a male rotating adapter and a disposable 3-way stopcock are also included to aid in preparation of the device. When purchased as a "Survival Kit", the package includes a Y-/ Tri-Adapter with hemostasis valve, a Guide Wire Insertion Tool and a Steering Handle.

The document describes a 510(k) premarket notification for Medtronic's Everest™ Inflation Device and Survival Kits. This is a medical device, and the submission focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing related to packaging and shelf-life, rather than clinical efficacy. Therefore, a traditional "study" proving the device meets acceptance criteria in terms of clinical performance or an AI algorithm's performance isn't applicable here.

Instead, the document details the acceptance criteria for packaging performance and shelf-life, and the tests conducted to show the device meets these criteria. The approval is based on the device being "substantially equivalent" to an existing, legally marketed predicate device, not on demonstrating new clinical efficacy.

Here's the information requested, adapted to the context of this device submission:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device relate to its packaging and shelf-life, ensuring it maintains sterility and integrity. The document states that "No new safety or effectiveness issues were raised during the testing. The test data demonstrated that the modified Medtronic's Everest™ Inflation Devices is as safe and effective as the legally marketed predicate device." This implies that all tested criteria were met.

Due to the nature of the document detailing specific tests rather than numerical performance metrics for each acceptance criterion, a direct table of "performance" for each against a criterion is not provided with exact values. However, the document lists the performed tests, which serve as the acceptance criteria. The "Reported Device Performance" is broadly stated as successful.

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

The document does not explicitly state the numerical "sample size" for the non-clinical packaging and shelf-life tests. This type of information is typically found in the full test reports, which are not included in this summary.

The "data provenance" is internal to Medtronic (manufacturer), based on testing performed on the modified Everest™ Inflation Devices. It is retrospective in the sense that the tests are performed on manufactured devices to confirm design and material changes maintain equivalence.

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

This question is not applicable to this type of device submission. The tests are physical and chemical property tests on packaging and product integrity, not diagnostic or clinical assessments requiring expert human interpretation or "ground truth" establishment in the medical sense. The "ground truth" here is the physical measurement or observation of the packaging and device components against engineering specifications and regulatory standards.

4. Adjudication Method for the Test Set

Not applicable. Physical performance tests on a device's parts and packaging do not typically involve adjudication methods like those used for interpreting medical images or clinical outcomes. The results are obtained directly from laboratory measurements and observations.

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 (inflation balloon and accessories) is a mechanical tool used in interventional procedures. It is not an AI-powered diagnostic or assistive tool, and therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant.

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

Not applicable. This device does not involve an algorithm or AI component.

7. The Type of Ground Truth Used

For the non-clinical tests (packaging and shelf-life), the ground truth is established by engineering specifications, industry standards (e.g., ISO 15223-1 mentioned for symbols), and regulatory requirements for medical device packaging integrity and sterility. The outcome of these tests determines if the device meets these pre-defined physical and performance benchmarks.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a "training set."

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

Not applicable. There is no training set for this device.

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The Pacific Plus PTA Catheter is intended to dilate stenoses in the illiofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent postdilatation in the peripheral arteries.

The Pacific Plus PTA catheter is an Over the Wire (OTW) peripheral balloon catheter, specifically designed for percutaneous transluminal angioplasty (PTA) in stenosed vessel segments. The OTW catheter is used to guide the balloon to the stenosed vessel segment. The balloon is then inflated to dilate the vessel.

The catheter is a coaxial dual lumen device. The lumen marked "WIRE" is the central lumen of the catheter, which terminates at the distal tip. This lumen is used to pass the catheter over a guidewire with a maximum outer diameter of 0.018 in (0.46 mm). The lumen marked "BALLOON" is the balloon inflation lumen, which is used to inflate and deflate the dilatation balloon with a mixture of contrast medium and saline solution.

The Pacific Plus PTA catheter is available in balloon diameters 4.0 mm - 7.0 mm, and balloon lengths from 20 mm to 300 mm, with 90 cm, 150 cm, and 200 cm catheter lengths. The distal section of the catheter includes a lubricious hydrophilic coating.

The provided text describes a 510(k) premarket notification for the Pacific Plus PTA Catheter. This document is a regulatory submission for a medical device and, therefore, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove a device meets specific clinical performance acceptance criteria in the manner one might find for a novel diagnostic or AI-driven decision support tool.

The "acceptance criteria" in this context refer to the benchmark performance of the predicate device and relevant industry standards for similar devices. The "study" proving the device meets these criteria is the bench testing and biocompatibility evaluation performed.

Here's an analysis of the provided information based on your request, keeping in mind the nature of a 510(k) submission for a catheter:

1. Table of Acceptance Criteria and Reported Device Performance

Note: For a device like a PTA catheter, "acceptance criteria" are typically defined by engineering specifications, safety standards, and performance characteristics demonstrated by equivalent predicate devices, rather than clinical metrics like sensitivity/specificity for diagnostic AI. The "reported device performance" are the results of bench tests confirming these specifications are met or are comparable to the predicate.

• Ability to withstand rated burst pressure.
• Resistance to fatigue under repeated inflation/deflation.
• Specific balloon compliance (expansion profile).
• Acceptable inflation/deflation times. | - Balloon Preparation, Deployment and Retraction: Demonstrated to function as intended.
• Balloon Rated Burst Pressure: Met specified pressure limits, comparable to predicate.
• Balloon Fatigue: Demonstrated acceptable durability.
• Balloon Compliance: Within expected range, comparable to predicate.
• Balloon Inflation/Deflation Time: Within acceptable limits. |
  | Mechanical Integrity | - Sufficient bond strength between components.
• Acceptable catheter flexibility and kink resistance.
• Adequate torque strength for navigation.
• Integrity of hydrophilic coating. | - Catheter Bond Strength and tip pull test: Met specified strength requirements.
• Catheter Flexibility and Kink Test: Demonstrated acceptable flexibility and kink resistance.
• Catheter Torque Strength: Met specified torque limits.
• Catheter coating Integrity: Confirmed to be intact and functional. |
  | Safety | - Absence of unacceptable particulate matter.
• Biocompatibility (cytotoxicity, pyrogenicity, systemic toxicity, sensitization, intracutaneous reactivity, hemocompatibility). | - Particulate Evaluation: Met acceptable limits.
• Biocompatibility Testing: All tests (Cytotoxicity, Pyrogenicity, Systemic Toxicity, Sensitization, Intracutaneous Reactivity, Haemocompatibility - Hemolysis, Complement Activation, Partial Thromboplastin Time (PTT), Thromboresistance) were passed, concluding the device is biocompatible for its intended use. |
  | Sterility | Sterility assurance level and method. | Same sterility assurance level and method of sterilization as predicate. |
  | Packaging | Suitable packaging materials. | Similar packaging materials to predicate. |

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

• Sample Size for Test Set: The document does not specify a numerical sample size for the bench tests. It refers to "internal risk analysis procedures" that determined the extent of testing. For medical device bench testing, the sample size is typically determined by statistical methods or established industry standards to ensure sufficient confidence in the results for each specific test (e.g., a certain number of catheters are tested for burst pressure, fatigue, etc.).
• Data Provenance: The data is "internal" research and development data, generated by Medtronic Vascular, Inc. through their bench testing and biocompatibility assessments. This is not clinical data, but rather engineering and laboratory testing data. The country of origin of the data is implicitly the USA, where Medtronic is headquartered and the submission was made to the FDA. The data is prospective in the sense that the tests were conducted specifically to support this 510(k) submission.

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

• Not Applicable in the traditional sense. For a PTA catheter, "ground truth" for bench testing is established by engineering specifications, validated test methods (e.g., ASTM, ISO standards), and the performance characteristics of the legally marketed predicate device. This is not a situation where human experts are adjudicating clinical images or patient outcomes to establish ground truth for an AI algorithm. The "experts" involved would be Medtronic's R&D engineers, quality assurance personnel, and regulatory affairs specialists who designed the tests, conducted them, and interpreted the results against established standards and predicate performance. Their qualifications would be in engineering, materials science, and medical device regulations.

4. Adjudication Method for the Test Set

• Not Applicable. As explained above, this is not a study requiring adjudication by experts to establish ground truth. The results of the bench tests are objectively measured against predefined acceptance criteria (e.g., a specific burst pressure, a certain bond strength, pH levels for biocompatibility assays).

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 type of study is specifically relevant for diagnostic AI or decision support systems where human interpretation of data is a key component. The Pacific Plus PTA Catheter is an interventional medical device, not a diagnostic AI tool, so an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.

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

• No. This question is relevant to AI algorithms. The Pacific Plus PTA Catheter is a physical medical device. The "performance" being evaluated is its physical and mechanical characteristics in a standalone bench testing environment, but this is distinct from an AI algorithm's standalone performance.

7. The Type of Ground Truth Used

• For bench testing, the "ground truth" consisted of engineering specifications, international standards (e.g., ISO 10993-1), and the established performance characteristics of the legally marketed predicate device (K123358) and reference devices. These benchmarks define what constitutes acceptable performance for each test. For biocompatibility, the ground truth is established by conformity to the biological safety limits specified in ISO 10993-1.

8. The Sample Size for the Training Set

• Not Applicable. This question is relevant to machine learning/AI models. The Pacific Plus PTA Catheter does not involve a "training set" in the context of AI. The development of the catheter relies on engineering design principles, material science, and prior knowledge from predicate devices, not on training an algorithm with a dataset.

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

• Not Applicable. As there is no AI training set, this question is not relevant.

In summary, the provided document details a 510(k) submission for a physical medical device. The "study" demonstrating performance involved extensive bench testing and biocompatibility evaluation against engineering specifications, international standards, and the characteristics of predicate devices. This is fundamentally different from the evaluation of an AI-driven diagnostic or decision support system, which would involve clinical studies, ground truth established by expert consensus or pathology, and various performance metrics like sensitivity, specificity, or AUC.

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The Medtronic Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The guiding catheter is intended to be used in the coronary or peripheral vascular system.

Medtronic 6F Taiga Guiding Catheter is an intravascular catheter that is supplied sterile and intended for single use only. The primary function of the 6F Taiga Guiding Catheter is to provide a pathway through which therapeutic devices are introduced. Medtronic 6F Taiga Guiding Catheter has a 6F outer diameter (0.082") and is be available in variety of curves and lengths, identical to the predicate Medtronic Taiga Guide Catheter. The various curves and lengths available, will allow the catheter to accommodate the varying patient vascular system anatomies

The Medtronic 6F Taiga Guiding Catheter is a physical medical device, not an AI/ML device. Therefore, the questions related to AI/ML specific aspects such as human readers, AI assistance, training sets, and ground truth for AI algorithms are not applicable.

Based on the provided text, the acceptance criteria and the study that proves the device meets them are as follows:

1. Table of Acceptance Criteria and Reported Device Performance

The device is a modified version of a legally marketed predicate device (Medtronic 6F Taiga™ Guiding Catheter - K083422). The modification involves a specification related to the soft tip component. Therefore, the acceptance criteria are generally based on demonstrating substantial equivalence to the predicate device through performance/bench testing and biocompatibility testing. The specific acceptance criteria for each test are not explicitly detailed in the provided summaries (e.g., specific thresholds for tensile strength or kink resistance). Instead, the document states that tests were conducted "in accordance to the relevant FDA guidance to demonstrate substantial equivalence."

For the modified soft tip component, two specific tests were performed on the subject device to demonstrate substantial equivalence to the predicate:

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

The document does not explicitly state the sample size (number of units) used for each specific bench test. It mentions that "Performance/Bench Testing" was conducted, and "biocompatibility tests were conducted." The testing is described as non-clinical data. The provenance of the data is from Medtronic Vascular, the manufacturer. The data is retrospective in the sense that it's reported after the tests were conducted for the 510(k) submission.

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

This question is not applicable as the device is a physical medical device and its performance is evaluated through objective bench testing and biocompatibility assessments, not through expert-driven ground truth establishment for an AI/ML algorithm.

4. Adjudication Method for the Test Set

This question is not applicable for the same reasons as point 3. Bench tests have objective measurements and pass/fail criteria, not subjective adjudication by experts.

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 question is not applicable as the device is a physical medical device and not an AI/ML-assisted diagnostic tool.

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

This question is not applicable as the device is a physical medical device and not an AI/ML algorithm.

7. The Type of Ground Truth Used

For a physical device, the "ground truth" for performance is typically defined by:

• Engineering Specifications/Standards: Each bench test will have predefined acceptance limits or ranges derived from engineering design specifications and relevant industry standards (e.g., ISO, ASTM) and FDA guidance for catheters.
• Predicate Device Performance: For substantial equivalence, the performance of the subject device is compared against the established performance characteristics of the predicate device.
• Biocompatibility Standards: Ground truth for biocompatibility is established by international standards like ISO 10993-1, which outlines the requirements for biological evaluation of medical devices.

8. The Sample Size for the Training Set

This question is not applicable as the device is a physical medical device and does not involve AI/ML requiring a training set.

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

This question is not applicable as the device is a physical medical device and does not involve AI/ML requiring a training set or its associated ground truth establishment.

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The Heli-FX EndoAnchor System is intended to provide fixation and sealing between endovascular aortic grafts and the native artery. The Heli-FX EndoAnchor system is indicated for use in patients whose endovascular grafts have exhibited migration or endoleak, or are at risk of such complications, in whom augmented radial fixation and/or sealing is required to regain or maintain adequate aneurysm exclusion.

The EndoAnchor may be implanted at the initial endograft placement, or during a secondary (i.e., repair) procedure.

The Heli-FXTM EndoAnchor™ Systems are each comprised of the respective Heli-FX Applier with EndoAnchor Cassette, containing ten EndoAnchor implants; the respective Heli-FX Guides; and the Ancillary EndoAnchor Cassette, containing five EndoAnchor implants.

The Heli-FX EndoAnchor System comprises the EndoAnchor implant, an intravascularly-applied suture, supplied with the Heli-FX Applier in a Cassette containing ten (10) EndoAnchor implants, or separately in an Ancillary Cassette containing five (5) EndoAnchor implants; the Heli-FX Applier, a catheter-based device for placement of the EndoAnchor; and the Heli-FX Guide, a deflectable sheath to position the Applier.

The EndoAnchor is an endovascularly-placed suture designed to attach aortic endografts to the native vessel wall. The EndoAnchor is manufactured from medical-grade nickel-cobalt wire and is wound in a helical shape. The leading end is sharpened to a conical point to act as an integral needle facilitating atraumatic deployment through the graft material and vessel wall. The proximal end of the EndoAnchor includes a diagonal crossbar, which functions as a suture anchor designed to prevent over penetration of the EndoAnchor. Ten (10) EndoAnchor implants are prepackaged into a cassette, which is supplied with the Heli-FX Applier. The cassette is designed to facilitate easy and accurate loading of the EndoAnchor into the Applier catheter. EndoAnchor implants are also supplied separately in an Ancillary Cassette containing five (5) additional EndoAnchor implants.

The Heli-FX Applier is designed to implant the EndoAnchor. The Applier implants one EndoAnchor at a time, and can be used to implant multiple EndoAnchor implants in a single patient. The Applier is designed for use with the Heli-FX Guide. The Applier is a 12Fr (OD) catheter with an integrated control handle. Two Applier lengths are available for anchoring in different regions of the aorta.

The Heli-FX Guide is a sterile, single use, disposable device designed to direct the Heli-FX Applier to the desired location for EndoAnchor implantation. The device is compatible with a 0.035" Guide wire. The Heli-FX Guide consists of a 12 Fr-compatible (inner diameter) Guide sheath with integrated control handle, and a matching 12 Fr OD obturator. Deflection of the distal tip of the catheter is accomplished by rotating the Control Knob located on the control handle. The Guide is available in both 62cm (16Fr OD) and 90cm (18Fr OD) working lengths. Multiple deflectable tip lengths are available to accommodate a range of aortic diameters. The Obturator is used during vessel access and is designed to follow the Guide wire and provide access through tortuous vasculature.

This document is a 510(k) summary for the Heli-FX EndoAnchor System, which is an endovascular suturing system. The purpose of this 510(k) submission is to demonstrate substantial equivalence to a previously cleared device (K171427) by stating that the Heli-FX EndoAnchor System is compatible with the Valiant Navion Stent Graft System.

Based on the provided text, the document states that "no new testing with the Valiant Navion Stent Graft System was needed" because "Adequate rationale was provided to support the compatibility of these systems based on the previously provided testing with the endografts that are currently listed as compatible with the Heli-FX EndoAnchor System in its IFU."

Therefore, the acceptance criteria and study information would refer to the previous submission (K171427) or prior testing, which is not detailed in this specific document. This document only describes the device and its intended use, and then asserts substantial equivalence based on prior testing and rationale.

Since the document explicitly states "no new testing," it does not contain the information requested in your prompt regarding acceptance criteria, device performance, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, or ground truth for a new study.

To provide the requested information, the details from the original 510(k) submission (K171427) would be required.

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The Admiral Xtreme PTA balloon dilatation catheter is intended to dilate stenoses in the iliac, femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The Admiral Xtreme is an Over the Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) catheter. The device is provided sterile (EtO).

The catheter has a dual-lumen shaft that is branched at the proximal end. One lumen forms the entrance to the central lumen for the guidewire, and the other lumen is used to inflate and deflate the dilatation balloon with a mixture of contrast medium and saline solution. The catheter and balloon are designed to reach targeted inflation diameters, depending on the balloon size and defined pressure.

The Admiral Xtreme is compatible with guidewires with a maximum diameter of 0.035" (0.89 mm) and with 5F, 6F or 7F introducer sheaths depending on balloon size. The catheter is provided with a hydrophilic coating and is available in useable catheter lengths of 80, 130 or 150cm.

Balloon sizes range from 3.0mm to 12.0mm in diameter, with balloon lengths from 20mm to 300mm. The balloons reach nominal diameter at 6atm or 8atm (Nominal Pressure) and have Rated Burst Pressure (RBP) of 14atm, 12atm and 11atm depending on the balloon diameter and balloon length.

The provided text describes the 510(k) summary for the Medtronic Admiral Xtreme PTA balloon dilatation catheter. It details the device, its intended use, and comparative testing to establish substantial equivalence to a predicate device. However, it does not describe the acceptance criteria or a study that proves the device meets specific acceptance criteria in the format requested, especially concerning AI/algorithm performance.

Instead, the document outlines bench testing, biocompatibility testing, and a comparison to a predicate device for safety and effectiveness. This is typical for a traditional medical device (catheter) submission, not an AI/algorithm-based device.

Therefore, many of the requested fields cannot be filled from the provided text as they are specific to the evaluation of AI/ML or diagnostic image analysis devices.

Here's an attempt to extract and interpret the information based on the provided text, while also noting what is not present:

Acceptance Criteria and Device Performance for Medtronic Admiral Xtreme PTA Balloon Dilatation Catheter (K173515)

This submission describes a traditional medical device (PTA balloon catheter), not an AI-powered or algorithm-only device for which acceptance criteria and studies would typically focus on diagnostic performance metrics like sensitivity, specificity, AUC, or reader studies with AI assistance. The "acceptance criteria" referred to in this document are engineering and performance specifications for a physical medical device.

1. Table of Acceptance Criteria and Reported Device Performance

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study described is a series of non-clinical bench tests and biocompatibility evaluations designed to demonstrate that the modified Admiral Xtreme PTA balloon catheter is substantially equivalent to a previously cleared predicate device. The testing plan was developed based on risk assessment of device modifications and recommendations from FDA guidance and ISO standards.

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

• Test Set Sample Size: Not explicitly stated. For bench testing, sample sizes typically refer to the number of individual devices or components tested for each specific test. This detailed breakdown is not provided in the summary.
• Data Provenance (Country of Origin, Retrospective/Prospective): Not applicable in the context of diagnostic data. The tests are bench tests performed in a lab setting, not on patient data.

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

• Not Applicable. This device is a physical catheter, not a diagnostic imaging or AI device requiring expert-established ground truth from medical images or data. Ground truth for performance tests would be established by measurement instruments against engineering specifications.

4. Adjudication Method for the Test Set:

• Not Applicable. No human adjudication of diagnostic data is involved as this is not a diagnostic device.

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

• No. This type of study (comparing human readers with or without AI assistance) is specific to AI/ML diagnostic tools. This device is a physical catheter.

6. Standalone (Algorithm Only) Performance Study:

• No. This is a physical medical device, not an algorithm.

7. Type of Ground Truth Used:

• The "ground truth" for the performance characteristics of this physical device are engineering specifications, material science standards, and established regulatory benchmarks for medical devices of its type. For biocompatibility, it's the biological response measured against ISO standards for safety.

8. Sample Size for the Training Set:

• Not Applicable. This is a physical 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 is no training set for an AI/ML algorithm, this question does not apply.

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The Sentrant Introducer Sheath with Hydrophilic Coating is intended to provide a conduit for the insertion of diagnostic or endovascular devices into the vasculature and minimize blood loss associated with such insertions.

The Sentrant Introducer Sheath is a single-use, disposable, hydrophilic-coated catheter designed to provide a flexible and hemostatic conduit for the insertion of endovascular devices and to minimize blood loss associated with vascular procedures. The system is comprised of a dilator and an introducer sheath. The system accommodates a 0.035 in (0.89 mm) guidewire and is available in 28 and 64 cm lengths and in sizes from 12 to 26 Fr in 2 French increments.

The dilator is radiopaque and has a flexible tapered tip that facilitates atraumatic tracking through the vasculature. There is a dilator grip at the proximal end of the dilator shaft. The dilator grip has a female Luer taper fitting on the proximal end to allow flushing of the device, and a threaded-feature at the distal end to allow the dilator to be secured to the sheath seal housing (dilator locking mechanism).

The introducer sheath is comprised of a hydrophilic-coated, coil-reinforced catheter that is attached to a rigid seal housing containing the hemostatic valve assembly. A sideport extension assembly with a 3-way valve is attached to the seal housing. A radiopaque (RO) marker band is located at the distal tip of the sheath. The device also has a suture loop for attaching it to the patient and a strain relief to minimize kinking of the catheter where it joins to the seal housing.

The provided text is a 510(k) summary for the Medtronic Sentrant Introducer Sheath with Hydrophilic Coating. This document describes the device and its equivalence to a predicate device, but it does not contain information about acceptance criteria and a study proving a specific device performance metric meets those criteria. Instead, it outlines a series of non-clinical performance tests conducted to demonstrate general safety and effectiveness for substantial equivalence to a predicate device, which had a different sterilization method.

Therefore, many of the requested details about acceptance criteria, reported device performance (in terms of specific clinical or technical metrics for an AI/device performance study), sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies are not present in this document.

However, I can extract the information that is available:

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

The document states that "All the predetermined acceptance criteria were met and results passed to support a determination of substantial equivalence" for the following non-clinical performance data. It does not provide specific numerical acceptance criteria or quantitative performance results for each test.

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

The document does not describe specific "test sets" in the context of clinical performance or algorithm evaluation with data provenance. The tests listed are non-clinical (e.g., sterilization, packaging, biocompatibility).

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

Not applicable. The document describes non-clinical tests, not expert-adjudicated ground truth for a clinical dataset.

4. Adjudication method for the test set

Not applicable. The document describes non-clinical 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

No. This document does not pertain to an AI-assisted device or a multi-reader multi-case study.

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

No. This document does not describe an algorithm or AI performance.

7. The type of ground truth used

Not applicable in the context of clinical accuracy or algorithm performance. The "ground truth" for the non-clinical tests would be the established scientific and engineering standards and methods for validating those specific device characteristics (e.g., ISO standards for sterilization, biocompatibility, packaging).

8. The sample size for the training set

Not applicable. The document does not describe an AI or machine learning model with a training set.

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

Not applicable. The document does not describe an AI or machine learning model with a training set.

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The SilverHawk and TurboHawk Peripheral Plaque Excision System are intended for use in atherectomy of the peripheral vasculature. The SilverHawk and TurboHawk Catheter is NOT intended for use in the coronary, carotid, iliac, or renal vasculature.

The TurboHawk Catheter (THS-LS-C, THS-LX-C) is indicated for use in conjunction with the SpiderFX Embolic Protection Device in the treatment of severely calcified lesions.

The SilverHawk and TurboHawk Peripheral Plaque Excision System consists of a Catheter and Cutter Driver, which are packaged separately, but shipped and used together during the plaque excision procedure. The catheter consists of a flexible shaft designed to track over a 0.014" guidewire. At the distal end of the catheter is a small cutting assembly comprised of a rotating inner blade contained within a tubular housing. The proximal end of the Catheter contains a connector and positioning lever designed to fit into a small, disposable, battery driven Cutter Driver, which powers the device.

The SilverHawk and TurboHawk Peripheral Plaque Excision System each have two switches: 1) the Cutter Driver main power switch and 2) the Catheter thumb switch. The Cutter Driver main power switch supplies power to the device when turned ON. When the thumb switch is fully forward (OFF), the cutting blade is closed and stored in the cutter housing with the motor off. This position is used during delivery of the device to the target lesion. Once the device has been positioned the Catheter thumb switch is pulled proximally to the ON position to activate the drive shaft and engage the cutter. Pulling back on the Catheter thumb switch simultaneously turns on the motor and causes the distal portion of the cutter housing to deflect, forcing the device against the target lesion. At the same time, this motion exposes the inner rotating blade, preparing the device for lesion treatment. With the blade spinning, the Catheter is slowly advanced across the lesion, "shaving" occlusive material from the artery. The excised tissue is captured and stored in the tip of the device. The cutting process is completed by advancing the Catheter thumb switch distally, deactivating the drive shaft, disengaging the cutter, and aligning the cutter and housing. The Catheter thumb switch is fully advanced distally to the OFF position in order to move the cutter forward within the tip and pack the excised plaque into the tip. This cutting sequence is repeated as necessary to achieve the desired degree of plaque excision.

The SilverHawk and TurboHawk Peripheral Plaque Excision System uses the following materials: stainless steel, platinum/iridium, carbide w/ 12% nickel binder, titanium, delrin, polyimide, PET lined tecothane, pebax, nylon, Teflon, tungsten carbide, ABS, PVC, silicone, Santoprene, polycarbonate, polypropylene and hydrophilic coating.

The provided document is a 510(k) summary for the Medtronic SilverHawk and TurboHawk Peripheral Plaque Excision Systems. It describes changes made to the device and the testing performed to demonstrate substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in a clinical setting.

Therefore, many of the requested data points related to clinical study design, such as sample size for test sets, data provenance, expert ground truth, adjudication methods, multi-reader multi-case studies, and standalone performance, are not applicable or available in this document. The document focuses on performance testing in a bench setting to support a 510(k) clearance.

Here's the information that can be extracted or deduced from the provided text:

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

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner for each test. Instead, it describes "Test Methods Used to Evaluate Change" and concludes that "The results from these tests demonstrate that the technological and performance characteristics of the proposed SilverHawk and TurboHawk devices perform in a manner equivalent to the predicate devices currently on the market."

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 explicitly stated for any of the individual bench tests. The document refers to "testing" or "tests" but does not give the number of units or replicates tested.
• Data provenance: Bench testing results. This implies the data was generated in a laboratory or engineering setting, likely within Medtronic. No geographical origin is specified beyond Medtronic Vascular, Inc. is located in Plymouth, MN, USA. The testing is prospective in the sense that it was conducted on the modified devices before market clearance.

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 "ground truth" for bench testing of a medical device's physical and functional properties is typically defined by engineering specifications, material properties, and comparative performance against predicate devices, not expert human interpretation.

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

Not applicable, as this refers to adjudication for expert consensus in clinical data, which is not present in this document.

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 document describes a 510(k) submission for a peripheral plaque excision system (a physical device for atherectomy), not an AI-assisted diagnostic tool. Therefore, MRMC studies are irrelevant to this submission.

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

Not applicable, as this is not an algorithm or AI device. The described tests evaluate the physical device's performance.

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

Not applicable. For this type of device and testing, the "ground truth" is defined by established engineering and material science principles, manufacturing specifications, and the performance characteristics of the predicate devices. The objective is to demonstrate that the modified device performs similarly to or within acceptable limits compared to the original/predicate design.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. This is not an AI/machine learning device.

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