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The NanoCross™ Elite 0.014" Over-the-Wire PTA Balloon Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.

The NanoCross catheter is an over-the-wire (OTW) coaxial lumen percutaneous transluminal angioplasty (PTA) balloon catheter compatible with 0.014"guidewires with a distally mounted semi-compliant inflatable balloon and an atraumatic tapered tip. The distal portion of the catheter has a lubricious coating. The manifold includes a lumen marked "THRU". This 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 diameter of 0.014". 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 balloon has two radiopaque markers for positioning the balloon relative to the stenosis. The radiopaque marker bands indicate the dilating or working section of the balloon.

The NanoCross Elite catheter is available in balloon sizes ranging from 1.5 mm to 6 mm in diameter, and from 20 mm to 210 mm in length; reference labeling for introducer sheath compatibility.

The provided text describes a medical device, the NanoCross™ Elite 0.014" Over-the-Wire PTA Balloon Dilatation Catheter, and its substantial equivalence to predicate devices, rather than an AI/ML device with specific acceptance criteria and performance metrics. Therefore, many of the requested categories for AI/ML device studies are not applicable or cannot be extracted from this document.

However, I can extract information related to the device's performance testing and its acceptance criteria implicitly met through comparison to predicates.

Here's the information that can be extracted and how it relates to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that "The NanoCross Elite catheter met all acceptance criteria for the bench testing with results similar to the predicates." It then lists the types of bench tests performed. The specific numerical acceptance criteria and precise performance results are not detailed in this summary. Instead, it relies on the concept of "similarity to predicates" and conformance to "requirements for its intended use."

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

• Sample Size: Not explicitly stated for each individual bench test. The document mentions tests were performed "for one or more model sizes" or "leveraged from predicate devices for one or more model sizes." It does not provide specific numbers for units tested.
• Data Provenance: The testing was "Bench testing," meaning it was conducted in a laboratory setting, likely by the manufacturer (ev3 Inc.). It is not clinical data (retrospective or prospective). Country of origin is implied to be where ev3 Inc. operates (USA, as per address).

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

• Not Applicable. This is a physical medical device (catheter), not an AI/ML diagnostic tool or image analysis software. "Ground truth" in this context refers to the verifiable physical properties and performance characteristics of the device, established through standardized engineering and materials testing, not through expert human interpretation of data.

4. Adjudication Method for the Test Set:

• Not Applicable. As above, the "test set" here refers to physical devices undergoing bench testing. The results are typically quantitative measurements against predefined specifications, not subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, Not Applicable. This type of study assesses human reader performance with and without AI assistance, which is irrelevant for a physical medical device like a dilatation catheter.

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

• No, Not Applicable. There is no algorithm described for this physical device.

7. The Type of Ground Truth Used:

• For the performance data listed (e.g., burst pressure, dimensions, fatigue): The ground truth is established through physical measurement against engineering specifications and international standards (like ISO 10993-1 for biocompatibility). The acceptance criteria are based on conformance to these specifications and demonstrated similarity to predicate devices that have prior FDA clearance.

8. The Sample Size for the Training Set:

• Not Applicable. This is not an AI/ML device, so there is no "training set."

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

• Not Applicable. No training set exists.

In summary of the provided text:

The NanoCross™ Elite catheter demonstrated conformance to established performance requirements and substantial equivalence through a series of bench tests (physical and material properties, mechanical performance in simulated use) and biocompatibility testing. The "acceptance criteria" were implicitly met by achieving "results similar to the predicates" and adhering to "the requirements for its intended use" as determined by internal risk analysis procedures and industry standards. The submission is focused on demonstrating that the new device is as safe and effective as equivalent legally marketed devices based on these non-clinical tests.

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The NanoCross™ Elite 0.014" Over-the-Wire PTA Balloon Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.

The NanoCross catheter is an over-the-wire (OTW) coaxial lumen percutaneous transluminal angioplasty (PTA) balloon catheter compatible with 0.014"guidewires with a distally mounted semi-compliant inflatable balloon and an atraumatic tapered tip. The distal portion of the catheter has a lubricious coating. The manifold includes a lumen marked "THRU". This 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 diameter of 0.014". 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 balloon has two radiopaque markers for positioning the balloon relative to the stenosis. The radiopaque marker bands indicate the dilating or working section of the balloon.

The NanoCross Elite catheter is available in balloon sizes ranging from 1.5 mm to 4 mm in diameter, and from 20 mm to 210 mm in length; reference labeling for introducer sheath compatibility.

The provided text describes the 510(k) summary for the NanoCross™ Elite 0.014" Over-the-Wire PTA Balloon Dilatation Catheter. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a study measuring clinical performance or AI algorithm accuracy.

Therefore, many of the requested categories for AI/clinical studies are not applicable to this type of regulatory submission. The information below will detail what is available in the provided text.

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

The document lists "bench testing" and "biocompatibility testing" as the studies performed to support substantial equivalence. The acceptance criteria for these tests are implicitly that the device performs "similarly to the predicates" and "met all acceptance criteria." Specific quantitative acceptance criteria or detailed device performance metrics are not provided in this summary.

List of specific tests performed (acceptance criteria not detailed):

Performed for the NanoCross™ Elite:

• Balloon Dimensional Verification
• Catheter Dimensional Verification
• Balloon Rated Burst Pressure (Unconstrained and In Stent)
• Balloon Fatigue (Unconstrained and In Stent)
• Balloon Compliance
• Inflation/Deflation Time
• Catheter Bond Strength
• Kink
• Device Tracking
• Insertion Force
• Balloon Pull-back Force
• Torque Strength
• Radiopacity
• Presence of Coating
• Re-Insertion Force
• Pushability

Leveraged from predicate devices (implying the NanoCross Elite is expected to perform similarly):

• Balloon Dimensional Verification
• Balloon Rated Burst Pressure (Unconstrained and In Stent)
• Balloon Fatigue (Unconstrained and In Stent)
• Balloon Compliance
• Coating Durability
• Particle Generation

The following items are NOT APPLICABLE or NOT PROVIDED in this 510(k) summary, as it is a submission for a medical device (PTA balloon catheter) based on substantial equivalence, not an AI algorithm or clinical trial with specific performance metrics such as accuracy, sensitivity, or specificity against a ground truth.

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

• Not Applicable / Not Provided. This document describes bench and biocompatibility testing, not a clinical study with a test set of data.

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 / Not Provided. No ground truth for a clinical test set was established.

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

• Not Applicable / Not Provided. No adjudication for a clinical test set was performed.

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 not an AI device.

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

• Not Applicable. This is not an AI device.

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

• Not Applicable / Not Provided. The "ground truth" for the non-clinical tests would be the established engineering and ISO standards for device performance, but not clinical ground truth as specified in the question.

8. The sample size for the training set

• Not Applicable. This is not an AI device.

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

• Not Applicable. This is not an AI device.

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The RapidCross™ PTA Rapid Exchange Balloon Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.

The RapidCross PTA Rapid Exchange Balloon Dilatation Catheter (RapidCross catheter) is a rapid exchange (RX) coaxial catheter compatible with 0.014" guidewires, with a distally mounted semi-compliant inflatable balloon and an atraumatic, tapered tip. The distal portion of the catheter has a lubricious coating. The manifold includes an inflation lumen, which is used to inflate and deflate the dilatation balloon with a mixture of

The provided text describes a 510(k) summary for the RapidCross™ PTA Rapid Exchange Balloon Dilatation Catheter, a medical device. This document focuses on demonstrating substantial equivalence to predicate devices through bench testing and biocompatibility testing, not on clinical acceptance criteria or a study proving performance against such criteria in the context of diagnostic or AI-driven systems.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not applicable to this type of device submission. This is a premarket notification for a physical medical device, not a diagnostic algorithm or image analysis software.

Here's a breakdown of the relevant (and non-relevant) information based on the provided text:

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

• Acceptance Criteria: The document states that "The RapidCross catheter met all acceptance criteria for the bench testing with results similar to the predicates." However, specific numerical acceptance criteria for each test (e.g., "Balloon Burst Strength must be > X psi") are not detailed in this summary.
• Reported Device Performance: The document lists the types of tests performed. It doesn't provide specific numerical results, but rather states that the device performed "similar to the predicates" and "met all acceptance criteria."

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

• Sample Size: Not specified for any of the bench tests.
• Data Provenance: The testing was "Bench testing" and "biocompatibility testing." This is laboratory/engineering data, not clinical data from patients. Country of origin is not relevant for this type of testing.

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. This relates to physical device performance and biocompatibility, not diagnostic interpretation requiring expert ground truth.

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

• Not applicable. This applies to clinical data interpretation, not bench testing.

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, not an AI or 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 (expert consensus, pathology, outcomes data, etc)

• Ground Truth: For bench testing, the "ground truth" is typically defined by engineering specifications, validated test methods, and industry standards (e.g., ISO, ASTM). For biocompatibility, it's defined by ISO 10993-1.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an algorithm that requires a training set.

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

• Not applicable. This is a physical medical device.

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The RapidCross™ PTA Rapid Exchange Balloon Dilatation Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The RapidCross PTA Rapid Exchange Balloon Dilatation Catheter (RapidCross catheter) is a rapid exchange (RX) coaxial catheter compatible with 0.014" guidewires, with a distally mounted semi-compliant inflatable balloon and an atraumatic, tapered tip. The distal portion of the catheter has a lubricious coating. The manifold includes an inflation lumen, which is used to inflate and deflate the dilatation balloon with a mixture of contrast medium and saline solution. The balloon has two radiopaque markers for positioning the balloon relative to the stenosis. The radiopaque marker bands indicate the dilating or working section of the balloon. On the 150 mm and 210 mm devices, two additional marker bands denote the middle of the balloon body. A guidewire lumen starts at a guidewire port located 35 cm from the catheter tip and extends to the distal tip. The 90 cm useable length devices have proximal depth marks printed on the proximal shaft at lengths of 55 cm and 65 cm from the distal tip while the 170 cm useable length devices have depth marks at 90 cm and 100 cm to serve as a reference during catheter insertion.

The RapidCross catheter is available in balloon sizes ranging from 2 mm to 4 mm in diameter and 20 mm to 210 mm in length; and, all sizes are compatible with 4 F sheaths.

The provided document is a 510(k) summary for the RapidCross™ PTA Rapid Exchange Balloon Dilatation Catheter. It focuses on establishing substantial equivalence to predicate devices based on bench testing and biocompatibility, rather than clinical studies with human subjects or AI-based performance metrics. Therefore, many of the requested categories are not applicable.

Here's an analysis of the available information:

Acceptance Criteria and Device Performance

The document states that "The RapidCross catheter met all acceptance criteria for the bench testing with results similar to the predicates." It also lists various bench tests performed.

Study Information:

This document describes a premarket notification for a medical device (RapidCross™ PTA Rapid Exchange Balloon Dilatation Catheter) seeking substantial equivalence. The "study" referenced is a series of non-clinical, bench-top tests and biocompatibility assessments, not a clinical trial or AI model validation study.

1. 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 specified for each individual bench test. The number of devices tested for each parameter is not provided.
   • Data Provenance: The tests were "internal Risk Analysis procedures" and "bench testing." This likely refers to in-house laboratory testing by the manufacturer (ev3 Inc. in Plymouth, MN, USA). The data is prospective in the sense that the tests were conducted specifically for this submission.

2. 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. This is a physical device and the "ground truth" for its performance is determined by established engineering and materials science standards and test methods (e.g., measuring burst pressure, dimensions, tracking force). There were no human experts establishing ground truth in the context of diagnostic interpretation.

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

   • Not Applicable. This concept is relevant for studies involving human interpretation or clinical endpoints. For bench testing of physical properties, the results are typically quantitative measurements against predefined specifications.

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

   • Not Applicable. This device is a physical medical instrument (a balloon catheter), not an AI diagnostic or assistance tool. Therefore, MRMC studies and AI-related effectiveness metrics are not relevant.

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

   • Not Applicable. See above. There is no algorithm being tested in standalone mode.

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

   • Engineering Specifications and Biocompatibility Standards. The "ground truth" for this device's performance is its adherence to internal design specifications, industry standards for medical devices (e.g., ISO 10993-1 for biocompatibility), and comparability to legally marketed predicate devices.

7. The sample size for the training set:

   • Not Applicable. There is no "training set" as this is not an AI/machine learning device.

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

   • Not Applicable. See above.

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The SpiderFX Embolic Protection Device is indicated for use as a guidewire and embolic protection system to contain and remove embolic material in conjunction with the TurboHawk, either during standalone procedures or together with PTA and/or stenting, in the treatment of severely calcified lesions in arteries of the lower extremities.

The SpiderFX® Embolic Protection Device is a percutaneously delivered distal embolic protection system that can be delivered over any 0.014" or 0.018" guidewire. The SpiderFX Embolic Protection Device contains a Capture Wire composed of a nitinol mesh filter mounted on a 190 cm or a convertible 320/190 cm PTFE-coated 0.014" stainless steel guidewire and a dualended SpiderFX Catheter for delivery and recovery. The SpiderFX® Embolic Protection Device uses the following materials: pebax, grilamid, platinum/iridium, nitinol, stainless steel, PTFE coating, gold tungsten, and hydrophilic coating.

Here's a breakdown of the acceptance criteria and study information for the SpiderFX® Embolic Protection Device, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

Study Details

Clinical Study (DEFINITIVE Cat+)

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

   • Sample Size: 131 subjects.
   • Data Provenance: Prospective, multi-center, non-randomized, single-arm study. The country of origin is not explicitly stated, but it's typically a multi-national or US-based study for FDA submissions. The study involved comparison to a performance goal derived from an observational multi-center registry (TALON).

2. 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):

   • Number of Experts: Not explicitly stated, but a "clinical events committee (CEC)" was used for adjudication. Specific number and qualifications are not provided in this summary.

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

   • Adjudication Method: "as adjudicated by the clinical events committee (CEC)". The specific method (e.g., majority vote, consensus) for the CEC is not detailed.

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

   • MRMC Study: No, this was not an MRMC comparative effectiveness study involving human readers and AI assistance. This was a clinical study evaluating the device's safety and effectiveness.

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

   • Standalone Performance: Not applicable. This device is a physical embolic protection system, not an AI algorithm.

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

   • Ground Truth: For the primary safety endpoint, the "ground truth" was defined by the occurrence of Major Adverse Events (MAE) through 30 days post-procedure, as adjudicated by a Clinical Events Committee (CEC). This is essentially outcomes data, interpreted and confirmed by expert consensus within the CEC.

7. The sample size for the training set:

   • Training Set Sample Size: Since this is a physical medical device and not an AI algorithm, there isn't a "training set" in the conventional machine learning sense for the clinical study. The study population of 131 subjects served as the test set for the device's performance.

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

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

Pre-Clinical Performance Testing

For the extensive list of performance tests (Stent Compatibility, Filter Efficiency, Radial Outward Force, Simulated Use, Deployment/Retrieval Forces, In Vivo Animal Studies, Embolic Capture Efficiency and Retrieval Ability, Filter Capacity, Resistance to Filter Rupture During Removal of a Fully Loaded Filter, Flow Characteristics, Tip Flexibility, Tensile Strength, Torque Strength, Torque Response, Kink Resistance, Dimensional Verification, Package Integrity, Sterilization, Shelf Life):

• Sample Size, Data Provenance, Experts for Ground Truth, Adjudication, MRMC, Standalone, Ground Truth Type, Training Set: These details are not provided in the 510(k) summary for these specific pre-clinical tests. They are generally performed by engineers and technicians according to validated test methods, and the "ground truth" is typically the measured physical properties and performance against pre-defined engineering specifications or industry standards. The summary indicates that "Test results met the specified acceptance criteria" for these tests, leveraging data from predicate device submissions (K063204 or K052659).

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The TurboHawk® Peripheral Plaque Excision System is intended for use in atherectomy of the peripheral vasculature. The TurboHawk is indicated for use in conjunction with the SpiderFX® Embolic Protection Device in the treatment of severely calcified lesions. The TurboHawk is NOT intended for use in coronary, carotid, iliac or renal vasculature.

The TurboHawk® Peripheral Plaque Excision System (TurboHawk Catheter and ev3 Cutter Driver) is designed for the treatment of de novo and restenotic calcified and noncalcified atherosclerotic lesions located in native peripheral arteries. When used in complex, hard, calcified lesions, the TurboHawk should be paired with the SpiderFX® Embolic Protection Device to mitigate any risk of distal embolization that may be generated by the breakdown of heavily calcified plaque. The TurboHawk Catheter consists of a flexible shaft designed to track over a 0.014" guidewire. At the distal end of the TurboHawk Catheter is a small cutting assembly comprised of a rotating inner cutter contained within a tubular housing. The proximal end of the TurboHawk Catheter contains a connector and cutter positioning lever (thumb switch) designed to fit into the ev3 Cutter Driver. The ev3 Cutter Driver is a handheld, disposable, battery-driven unit which powers the system.

The TurboHawk Peripheral Plaque Excision System has two switches: 1) the ev3 Cutter Driver main power switch and 2) the TurboHawk Catheter thumb switch. The ev3 Cutter Driver main power switch supplies power to the device when turned ON. The TurboHawk Catheter thumb switch activates the drive shaft and engages the cutter when pulled proximally to the ON position. With the cutter engaged, the TurboHawk 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 TurboHawk Catheter thumb switch distally deactivating the drive shaft and disengaging the cutter. The TurboHawk Catheter thumb switch is fully advanced distally to the OFF position in order to pack the excised plaque into the tip. This cutting sequence is repeated as necessary to achieve the desired degree of plaque excision.

The TurboHawk Peripheral Plaque Excision System uses the following materials: stainless steel, polyimide, tecothane, pebax, nylon, delrin, PTFE, tungsten carbide, titanium, platinum/iridium, ABS, PVC, silicone, polypropylene and hydrophilic coating.

The provided text describes the 510(k) summary for the TurboHawk® Peripheral Plaque Excision System. It details the device, its indications for use, comparison to a predicate device, and performance testing, including a clinical summary.

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

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "The primary safety and effectiveness endpoints were derived from historical registry data using plaque excision," but it does not explicitly list the specific numerical acceptance thresholds for these endpoints. The table above presents the achieved performance, implying these met the pre-determined, but unquantified, acceptance criteria.

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

• Test Set Sample Size: 133 subjects. The document also states 163 lesions for the Angiographic Core Laboratory assessment and 167 lesions for the site assessment of the primary effectiveness endpoint.
• Data Provenance: Prospective, multi-center study ("DEFINITIVE Cat+"). The country of origin is not explicitly stated, but the context implies data from the United States, given the FDA regulatory submission. The study enrolled subjects from 17 centers.

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

• Number of Experts: Not explicitly stated as a number of individual experts.
• Qualifications of Experts: The ground truth for safety and effectiveness endpoints was established through an "independent Angiographic Core Laboratory and a Clinical Events Committee (CEC)." While specific individual qualifications (e.g., "Radiologist with 10 years of experience") are not provided, these are standard bodies in clinical trials, implying qualified medical professionals (e.g., interventional radiologists, cardiologists) with expertise in reviewing angiograms and clinical events. Their independence is highlighted.

4. Adjudication Method for the Test Set

• The document explicitly states that the "independent Angiographic Core Laboratory and a Clinical Events Committee (CEC) were employed to ensure unbiased review and classification of events and endpoints." This indicates a formal adjudication process was in place. While a specific "2+1" or "3+1" method is not detailed, the mention of "adjudication" by these committees suggests a consensus or formal review process for discrepancies.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance was not done. This study focuses on the performance of the device itself, with outcomes assessed by human experts (Core Lab, CEC). The device is an atherectomy system, not an AI diagnostic tool.

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

• No, a standalone algorithm performance study was not done. The device is a physical medical device (atherectomy system), not a software algorithm. The "performance testing" referenced (e.g., biocompatibility, cycle and life, tissue removal) are all related to the physical device's function.

7. The Type of Ground Truth Used

• The ground truth used was based on expert consensus/adjudication by an "independent Angiographic Core Laboratory and a Clinical Events Committee (CEC)" for both safety (30-day freedom from MAE) and effectiveness (residual diameter stenosis) endpoints.

8. The Sample Size for the Training Set

• The document does not mention a training set or its sample size. This is a medical device 510(k) submission, not an AI/algorithm development submission that would typically involve distinct training and test sets in the same manner. The "predicate device" (K093301) and the data supporting its clearance could be considered analogous to a "training" or "prior experience" in device safety and effectiveness, but it's not a formal dataset used to train an algorithm.

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

• As a training set is not explicitly referred to in the context of algorithm development, this question is not applicable. The device's design and performance are related to engineering principles and prior iterations of the device (K093301). The "ground truth" for the device's acceptable performance, more broadly, is established through various performance tests (bench and in-vivo) whose results "met the specified acceptance criteria" (refer to Section 7).

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The Marksman™ Catheter is indicated for the introduction of interventional devices and infusion of diagnostic or therapeutic agents into the neuro, peripheral and coronary vasculature.

The Marksman™ Catheter is a variable stiffness, single lumen catheter designed to access small, tortuous vascular areas. The outer surface of the catheter's distal segment is coated with a hydrophilic material to provide lubricity during use. The catheter also incorporates a PTFE liner to facilitate movement of introduction devices passed through its lumen. The Marksman™ Catheter has a radiopaque marker at the distal tip to facilitate fluoroscopic visualization. The distal tip of the catheter is shapeable. The Marksman™ Catheter is provided with various working lengths. The Marksman™ Catheter is for single use only.

This is not an AI/ML device. This is a medical device, a catheter, for which the manufacturer is seeking approval for a modified version with a different coating. Therefore, the questions related to AI/ML device performance metrics, such as accuracy, AUC, F1 score, expert consensus for ground truth, training/test set sizes, and MRMC studies, are not applicable here.

The submission is a Special 510(k) for the Marksman™ Catheter, focusing on demonstrating substantial equivalence to a predicate device after a change in the hydrophilic coating. The safety and performance verification is based on engineering and biocompatibility testing, not on AI/ML performance evaluation.

Here's how the provided information relates to the general concept of acceptance criteria and proving device meets them, adapted for a non-AI/ML medical device:

1. A table of acceptance criteria and the reported device performance
   • Acceptance Criteria/Performance Metrics: The primary "acceptance criteria" here is substantial equivalence to the predicate device, specifically demonstrating that the new Biocoat™ coating does not introduce new risks and that the device maintains its existing safety and performance characteristics.
   • Reported Device Performance: The submission states:
     • Biocompatibility: "The Marksman™ Catheter with Biocoat™ coating meets the requirements for biocompatibility." and "All test results obtained were acceptable for the device's intended use."
     • Safety and Performance Verification Tests: "These tests yielded acceptable results substantially equivalent to the predicate device."
   • Table: While not presented in a formal table in the provided text as numerical values for specific performance metrics (which are typical for AI/ML devices), the key areas of evaluation and their "performance" are summarized as "SAME" or "acceptable results".

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

   • This question is not applicable in the context of an AI/ML system evaluating data. For a physical medical device, testing typically involves a sufficient number of device units or components to ensure statistical confidence in the results for the specific tests performed (e.g., biocompatibility on samples, mechanical stress tests on multiple catheters). The document doesn't specify the exact number of units tested for each physical or biological test, but it indicates the tests were performed.
   • Provenance: The biocompatibility testing was performed by Toxikon (Bedford, MA), a certified laboratory. The nature of testing is likely prospective in that the new coating was specifically manufactured and then tested according to predetermined protocols.

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

   • This is not applicable to this type of device submission. There is no concept of "ground truth" established by experts in the context of evaluating the performance of a physical catheter with a new coating; rather, it relies on standardized physical, chemical, and biological testing methods.

4. Adjudication method

   • This is not applicable.

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.

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

   • This is not applicable.

7. The type of ground truth used

   • This is not applicable. For this device, "ground truth" is analogous to established scientific and engineering principles, material standards, and biological responses as measured by validated laboratory tests and existing clinical knowledge of similar devices and materials.
   • Specifically, biocompatibility relies on standardized in vitro and in vivo biological tests (e.g., per EN ISO 10993-1: 2009 for biocompatibility). Physical performance validation uses engineering and material testing methods.

8. The sample size for the training set

   • This is not applicable. There is no "training set" for this type of medical device.

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

   • This is not applicable.

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The EverCross 0.035" OTW PTA Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.

The EverCross Peripheral Dilatation Catheter is an over the wire (OTW) 0.035" dual lumen catheter with a distally mounted semi-compliant inflatable balloon and a flush cut tip to aid in crossing tight stenoses. The distal portion of the catheter shaft has a hydrophilic coating for lubricity. The catheter manifold includes two lumens. The lumen marked "THRU" 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 0.035 inches. The lumen, marked "BALLOON" is used to inflate and deflate the dilatation balloon with a solution of contrast medium and saline. The balloon has two radiopaque markers for positioning the balloon relative to the stenosis. The EverCross .035" OTW Dilatation Catheter uses the following materials: Nylon 12, Nylon/Pebax, Platinum/Iridium alloy, Thermoplastic Polyester Elastomer, Polycarbonate, hydrophilic coating.

This document does not describe a study involving an AI/ML medical device. It describes a conventional medical device (a dilatation catheter) and its clearance through the 510(k) pathway, which primarily relies on demonstrating substantial equivalence to a predicate device.

Therefore, many of the questions asked, which pertain to AI/ML device testing (e.g., sample size for test set, number of experts, MRMC studies, standalone performance, ground truth for training set), are not applicable to this document.

However, I can extract information related to the device's performance testing and how it met acceptance criteria for a conventional medical device.

Here's an analysis based on the provided text, addressing the applicable points:

The document describes the EverCross™ .035" OTW PTA Dilatation Catheter. This is a physical medical device used to dilate stenoses in various arteries and for stent post-dilatation. Its clearance is based on substantial equivalence to existing predicate devices (K082579, K103322).

The core of the acceptance criteria and proof of meeting them for this type of device lies in design verification testing to ensure the new device performs comparably to its predicate and adheres to established safety and effectiveness standards for such catheters.

Acceptance Criteria and Reported Device Performance (Applicable Information)

The document primarily focuses on demonstrating that the modified EverCross™ catheter (with new balloon sizes, a balloon design modification, and a change in tip) meets the same acceptance criteria as the predicate devices. The acceptance criteria themselves are explicitly stated as "identical to or based on predicate device acceptance criteria."

Non-Applicable Questions for this Document:

The following questions are designed for AI/ML device evaluations and are not addressed or relevant in this 510(k) summary for a physical medical device:

1. Sample size used for the test set and the data provenance: Not applicable. This refers to a dataset for an AI model. The "testing" here is physical and material properties testing.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth and expert review are concepts for diagnostic AI, not for mechanical device testing.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This refers to human review of AI output.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is for AI-assisted human performance.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
6. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. This relates to diagnostic accuracy, not physical device performance.
7. The sample size for the training set: Not applicable. There is no AI model to train.
8. How the ground truth for the training set was established: Not applicable.

Summary of Device Performance Proof:

The proof that the EverCross™ .035" OTW PTA Dilatation Catheter meets acceptance criteria is based on a comparative approach to predicate devices. The company performed a series of in vitro (bench) tests on the new device, as listed in the table above, to ensure it performs identically or equivalently to the predicate devices. The results of these tests, combined with the previously cleared in-vitro and in-vivo testing results for the predicate devices (K082579 and K103322), demonstrate that the modified catheter maintains the same safety and effectiveness profile. The ground truth in this context is the established performance and safety specifications of the predicate devices and general standards for PTA dilatation catheters.

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

The TurboHawk Peripheral Plaque Excision System (TurboHawk Catheter and ev3 Cutter Driver) is designed for the treatment of de novo and restenotic calcified and non-calcified atherosclerotic lesions located in native peripheral arteries. The TurboHawk Catheter consists of a flexible shaft designed to track over a 0.014" guidewire. At the distal end of the TurboHawk Catheter is a small cutting assembly comprised of a rotating inner cutter contained within a tubular housing. The proximal end of the TurboHawk Catheter contains a connector and cutter positioning lever (thumb switch) designed to fit into the ev3 Cutter Driver. The ev3 Cutter Driver is a handheld, disposable, battery-driven unit (Catalog No: 02550) which powers the system.

The TurboHawk Peripheral Plaque Excision System has two switches: 1) the SilverHawk Cutter Driver main power switch and 2) the TurboHawk Catheter thumb switch. The ev3 Cutter Driver main power switch supplies power to the device when turned ON. The TurboHawk Catheter thumb switch activates the drive shaft and engages the cutter when pulled proximally to the ON position. With the cutter engaged, the TurboHawk 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 TurboHawk Catheter thumb switch distally deactivating the drive shaft and disengaging the cutter. The TurboHawk Catheter thumb switch is fully advanced distally to the OFF position in order to pack the excised plaque into the tip. This cutting sequence is repeated as necessary to achieve the desired degree of plaque excision.

The provided document focuses on the 510(k) summary for the TurboHawk™ Peripheral Plaque Excision System and its substantial equivalence to predicate devices. It does not describe acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.

Instead, the document details physical and mechanical performance testing for a medical device (atherectomy catheter system) and demonstrates its substantial equivalence to previously cleared devices. Therefore, I cannot extract the requested information for an AI/ML device from this text.

Here's a breakdown of what the document does provide, and why it doesn't align with your request:

• Device Type: This is a physical medical device (atherectomy catheter system), not an AI/ML algorithm or system.
• Performance Testing: The "Performance Testing Summary" lists in vitro tests conducted to demonstrate the device's physical and mechanical characteristics (e.g., effective length, guidewire loading, cutter height, cycle and life, cut depth, cut mass per pass, embolization).
• Acceptance Criteria for the Device: The document states, "Test results met the specified acceptance criteria," but it does not explicitly list the quantitative acceptance criteria for each test. It implies these criteria were internal and part of the substantial equivalence claim.
• Study That Proves the Device Meets Acceptance Criteria: The document refers to "in vitro tests" performed. These tests are physical evaluations of the device's components and functionality, not clinical studies involving human patients or AI/ML model performance.
• No Information on AI/ML Specifics: There is no mention of:
  • AI/ML algorithms
  • Test sets, training sets
  • Data provenance (country of origin, retrospective/prospective)
  • Ground truth establishment (experts, pathology, outcomes data)
  • Adjudication methods
  • MRMC studies or effect sizes of AI assistance
  • Standalone algorithm performance

In summary, the provided text describes the regulatory filing for a conventional medical device, not an AI/ML-powered one. Therefore, it does not contain the information needed to answer your request about acceptance criteria and studies for an AI/ML device.

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