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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 EverCross 0.889 mm (0.035 in) OTW PTA Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, illofemoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.

EverCross 0.035" OTW PTA Dilatation Catheter is an over the wire (OTW) 0.035" dual lumen catheter with a distally mounted semi-compliant balloon and an atraumatic tapered tip. The distal portion of the catheter, proximal to the balloon, has a hydrophilic 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 0.035". The lumen marked "BALLOON" is the balloon inflation lumen, which is used to inflate and deflate the dilatation balloon. 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 EverCross 0.035" OTW PTA Dilatation Catheter is available in multiple balloon sizes and three catheter working lengths. Nominal balloon diameter and length are printed on the strain relief.

This document describes the regulatory clearance of a medical device, the EverCross™ 0.035" OTW PTA Dilatation Catheter (K190753), based on its substantial equivalence to previously cleared predicate and reference devices. The information provided outlines the non-clinical testing used to demonstrate this equivalence, rather than a clinical study evaluating the device's performance in humans or an AI-powered diagnostic tool.

Therefore, many of the requested items related to acceptance criteria, ground truth, expert adjudication, and human reader studies (MRMC, standalone AI performance) are not applicable to this submission as it focuses on in vitro (bench) testing of a physical medical device.

However, I can extract the relevant information from the provided text regarding the device and its testing.

Device Type: This is a physical medical device: a Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter. It is a Class II medical device.

Purpose of the Submission: The submission (K190753) is a 510(k) premarket notification to demonstrate Substantial Equivalence (SE) to a legally marketed predicate device (EverCross™ .035'' OTW PTA Dilatation Catheter, K110319) and a reference device (Fortrex™ 0.035" OTW PTA Balloon Catheter, K142654). This means the study does not aim to prove clinical efficacy or determine the performance of an AI model, but rather to show that the new device is as safe and effective as existing, cleared devices through non-clinical testing.

Acceptance Criteria and Device Performance (Based on Non-Clinical Testing):

The acceptance criteria for this type of device are typically based on engineering specifications and performance benchmarks derived from the predicate device and relevant guidance documents. The "reported device performance" would be the test results confirming the device met these specifications.

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is described as non-clinical in vitro testing.

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

• Sample Size: The document does not specify the exact sample sizes for each in vitro test (e.g., number of catheters tested for kink resistance). However, for non-clinical bench testing, standardized test methods (e.g., ISO standards, ASTM standards) often dictate minimum sample sizes to ensure statistical validity for engineering tests.
• Data Provenance: The tests are in vitro (bench testing) performed by Medtronic, Inc. (Plymouth, MN). This is not patient data, so "country of origin" and "retrospective/prospective" are not applicable in the typical clinical sense. The tests were performed to compare the new device to established predicate devices.

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

• N/A. For non-clinical bench testing of a physical device, "ground truth" is established by engineering specifications, validated test methods, and measurement equipment. It does not involve expert readers or clinical interpretation in the same way as an AI diagnostic device.

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

• N/A. Adjudication is not applicable as this is in vitro engineering testing, not clinical data review.

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

• No. This is not an AI or diagnostic device that relies on human interpretation of images. Therefore, an MRMC study was not performed.

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

• N/A. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

• The "ground truth" for this submission is established through engineering specifications, validated test methodologies (in accordance with FDA Guidance Documents and internal Risk Analysis procedures), and comparison against the performance of the predicate and reference devices. For instance, a "kink" test has a measurable outcome (e.g., force to kink, angle of kink), which is compared to a defined acceptance limit.

8. The Sample Size for the Training Set:

• N/A. This is not a machine learning/AI device, so there is no "training set."

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

• N/A. As there is no training set for an AI model, this question is not applicable.

Summary of the Study:

The study described is a series of non-clinical bench tests designed to demonstrate that the EverCross™ 0.035" OTW PTA Dilatation Catheter (K190753) has technological characteristics and performance criteria comparable to its predicate (K110319) and reference (K142654) devices. The tests included: Kink, Kink Extreme, Inflation time, Deflation Time/No Deflate, Trackability, Manifold Bond Tensile, and Torque to Failure. The report states that the results of these tests confirm the subject device performs equivalently to the predicate and reference devices for the same intended use. This approach is standard for 510(k) submissions of physical medical devices demonstrating substantial equivalence based on engineering and performance characteristics.

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The TrailBlazer™ angled support catheters are percutaneous, single lumen catheters designed for use in the peripheral vascular system. The TrailBlazer™ angled support catheters are intended to guide and support a guide wire during access of the vasculature, to allow for guide wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

The TrailBlazer™ angled support catheter is an over-the-wire (OTW) single lumen catheter with a tapered angled distal tip. The catheter system is compatible with 0.36 mm (0.014in.), 0.46 mm (0.018 in.), or 0.89 mm (0.035 in.) guidewires. The support catheter has working lengths of 65 cm. 90 cm. 135 cm. and 150 cm depending on the model. All models are compatible with a 4 Fr introducer sheath. The manifold provides proximal access to the lumen which transitions to the catheter shaft and terminates at the angled distal tip. The lumen is used to pass the catheter over a guidewire. The manifold is constructed from elastomer and molded to the catheter proximal shaft. The guidewire compatible diameter and length are marked on the strain relief that is clipped to the manifold post molding. The multi-layer elastomer catheter shaft is designed with a stainless steel braided mesh. Three radiopaque markers starting at the distal tip aid in positioning the catheter. The distal tip of the catheter is molded to a predetermined angle to optimize vessel subselection with a guidewire. The distal 40cm portion of the catheter is coated with a hydrophilic coating. Finished catheters are packaged in hoops, sealed in pouches and provided in 5-pack cartons with an IFU.

The provided text describes the 510(k) summary for the Medtronic TrailBlazer™ Angled Support Catheter (K162384). This document focuses on demonstrating substantial equivalence to predicate devices through bench testing and does not contain information about clinical studies involving human patients or ground truth established by medical experts for diagnostic performance.

Therefore, many of the requested elements related to clinical study design, sample sizes for test and training sets, expert involvement, and comparative effectiveness (MRMC) cannot be answered from the provided text.

Here's an overview of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various tests performed to demonstrate substantial equivalence. It does not explicitly state numerical acceptance criteria or specific quantitative performance values for each test in a table format. Instead, it generally states "All testing was performed in accordance with recognized standards. Results from this testing provide assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use."

However, the types of tests conducted can be considered the acceptance criteria categories:

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

The document describes bench testing, not a clinical study with a test set of patient data. Therefore, this information is not applicable.

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

Not applicable as this was a bench study, not a study requiring expert ground truth for diagnostic performance assessment.

4. Adjudication method for the test set

Not applicable as this was a bench study.

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

Not applicable. This device is a catheter, not an AI-assisted diagnostic tool, and the studies were bench tests, not MRMC studies.

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

Not applicable. This device is a physical medical device, not an algorithm. The "standalone" performance here refers to the physical and functional aspects of the catheter in isolation, which were assessed through the listed bench tests.

7. The type of ground truth used

For the bench tests, the "ground truth" was defined by recognized standards and specifications for medical devices. For example, a bond strength test would have a specified minimum acceptable force, and the outcome of the test (e.g., whether the bond held) would be compared against that standard.

8. The sample size for the training set

Not applicable. This device is a physical medical device where performance characteristics are often established through engineering design and testing against specifications, rather than machine learning training sets.

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

Not applicable.

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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.

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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 SilverSpeed™, Mirage™, X-celerator™ Exchange , and X-pedion™ Hydrophilic Guidewires are indicated for general intravascular use to aid in the selective placement of catheters in the peripheral, visceral and cerebral vasculature during diagnostic and/or therapeutic procedures.

The Hydrophilic Guidewire is a stainless steel guidewire with a radiopaque, platinum distal coil. The guidewire is hydrophilically coated on the distal portion. For the Xcelerator ™ Hydrophilic Guidewire labeled as an "Exchange" quidewire, the proximal portion is coated with polytetrafluoroethylene (PTFE). The Exchange guidewire facilitates the exchange of one interventional device for another, while maintaining guidewire position in the anatomy.

The following modifications have been made to the device:

• Change in the degree of polymerization with the base coat . material.
• . Elimination of Brown Oxide pigment from base coat material.

The provided text describes a 510(k) premarket notification for a Hydrophilic Guidewire and its substantial equivalence determination. It does not include details of a clinical study or acceptance criteria with associated performance metrics for a device to meet specific performance targets. Instead, it focuses on non-clinical (bench and biocompatibility) testing to support changes to an existing device, and then a determination of substantial equivalence to predicate devices.

Therefore, many of the requested sections (e.g., sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to the information provided.

However, I can extract the information related to the non-clinical performance and substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission primarily relying on substantial equivalence and non-clinical testing for minor device modifications, the "acceptance criteria" are implied by successful completion of standard evaluations and demonstration of comparable performance to predicate devices. Specific quantitative targets for each test are not explicitly detailed in the provided text.

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

• Sample Size (Test Set): Not specified for any of the non-clinical tests. The text indicates "no clinical or animal testing was performed" beyond the specified biocompatibility and bench tests. The dog study (thromboresistance) is an animal study, but its sample size is not mentioned.
• Data Provenance: The tests are standard laboratory/bench tests and an animal study. No human clinical data from any country is presented. The testing would have been conducted by the manufacturer or contracted labs.

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

• Not applicable. The "ground truth" here is determined by objective physical and chemical testing standards and biological responses in laboratory settings, not by expert interpretation of patient data.

4. Adjudication Method for the Test Set

• Not applicable. As above, this pertains to clinical data interpretation, not objective non-clinical testing.

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

• No, a MRMC comparative effectiveness study was not done. The submission explicitly states "no clinical or animal testing was performed as there is no change in the indications for use or the fundamental scientific technology of the device," except for the listed biocompatibility and bench tests.

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

• Not applicable. This device is a physical medical device (guidewire), not a software algorithm.

7. The Type of Ground Truth Used

• For biocompatibility: Established ISO and ASTM standards, and direct biological responses (e.g., cytotoxicity, sensitization, hemolysis, pyrogenicity, in-vivo thromboresistance in dogs).
• For bench testing: Engineering specifications, performance characteristics comparable to predicate devices, and internal quality control standards.
• For shelf-life: Stability and performance measurements over time, extrapolated from accelerated aging data.

8. The Sample Size for the Training Set

• Not applicable. This is for a physical device, not an AI/ML model that requires a training set. The "training" for this device's development would be engineering design, material science, and manufacturing process development.

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

• Not applicable. See point 8.

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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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