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The Advance Serenity 18 Hydrophilic PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) of the peripheral vasculature in the iliac, femoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The Advance Serenity™ 18 Hydrophilic PTA Balloon Dilatation Catheter is a coaxial catheter with a semi compliant balloon near the distal tip. It is an Over-the-Wire (OTW) Percutaneous Transluminal Anqioplasty (PTA) device with various shaft lengths. The balloon has two radiopaque markers that aid in the placement of the balloon within the stenosis. The clearance between the inner and outer shafts acts as the passage for the inflation medium for balloon expansion. The proximal end of the catheter has a bifurcated manifold & strain relief that allows for the 0.018" guidewire and the attachment of a balloon inflation device via a standard luer connector. The inflation device is used to inflate and deflate the balloon with a contrast medium. The device is used by positioning the balloon catheter over a guidewire. The balloon is aligned under fluoroscopy in the diseased vessel at the area to be treated. The balloon is then inflation media to pressures ranging between the nominal and the rated burst pressure to dilate the occluded area. On completion the balloon is then deflated under vacuum and removed from the patient. The Advance Serenity™ 18 Hydrophilic PTA Balloon Dilatation Catheter is to be provided sterile (via ethylene oxide, EtQ) and is intended for single use only.

The provided text is an FDA 510(k) clearance letter and its associated summary for a medical device: the "Advance Serenity™ 18 Hydrophilic PTA Balloon Dilatation Catheter." This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the safety and effectiveness of a novel device through clinical trials and rigorous statistical validation against predefined acceptance criteria.

Therefore, the information regarding acceptance criteria, study design for proving device performance, sample sizes for test sets, establishment of ground truth, expert adjudication, MRMC studies, standalone performance, training set details, and ground truth for training data is not present in the provided text.

The document primarily outlines:

• Acceptance Criteria (Implicit via Substantial Equivalence): The implicit acceptance criterion for this 510(k) submission is that the device must be shown to be "substantially equivalent" to a legally marketed predicate device. This means it has the same intended use, similar technological characteristics, and any differences do not raise new questions of safety or effectiveness.
• Reported Device Performance: Instead of a detailed table of acceptance criteria and performance against them, the document lists bench tests performed to demonstrate that the small changes (expanded matrix of balloon sizes) compared to the predicate device do not compromise safety or effectiveness.

Here's a breakdown of what is available and what is missing from your request based on the provided text:

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

• Acceptance Criteria: Not explicitly stated as pass/fail thresholds for specific performance metrics in a table. The overall acceptance criterion is "substantial equivalence" to the predicate.

• Reported Device Performance: The document lists bench tests performed, indicating that the results "demonstrate that the technological differences identified do not raise new questions of safety or effectiveness." Specific quantitative results or acceptance criteria for these bench tests are not provided.

  Performed Bench Tests (as listed):

  • Rated burst pressure (RBP)
  • Inflation & deflation time
  • Balloon diameters at nominal pressure to RBP
  • Simulated use - Pushability & Trackability & Sheath Compatibility
  • Coating integrity (b)
  • Multiple inflation/fatigue & leak test
  • Tensile strength Balloon to Shaft (proximal bond)
  • Particulate
  • Balloon Length & Marker Band Position (Leveraged from predicate)
  • Radiopacity (Leveraged from predicate)
  • Ancillary Tool Compatibility (Guidewire) (Leveraged from predicate)
  • Catheter Effective Length (Leveraged from predicate)
  • Tensile Strength Manifold to Shaft (Manifold Bond) (Leveraged from predicate)
  • Tensile Strength (Distal / Tip Bond) (Leveraged from predicate)
  • Tip Profile (Geometry of the catheter most distal tip) (Leveraged from predicate)
  • Simulated Use, Push & Track (Leveraged from predicate)
  • Flexibility & Kink (Leveraged from predicate)
  • Coating Lubricity (Leveraged from predicate)
  • Coating Integrity (a) (Leveraged from predicate)
  • Torque Strength (Leveraged from predicate)

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

• Sample Sizes: Not specified. This document refers to bench testing of a medical device, which typically involves a number of units tested to engineering specifications, but these numbers are not disclosed.
• Data Provenance: The tests are bench tests, not clinical data, so country of origin/retrospective/prospective doesn't apply in the same way. The manufacturer is based in Ireland (Creagh Medical Ltd. dba Surmodics, Inc.).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• This is not part of a bench test evaluation for a substantial equivalence determination. Experts are not typically used to establish "ground truth" for physical device performance metrics like burst pressure.

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

• Not applicable to 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

• No MRMC study was done. This device is a physical catheter, not an AI/software device that assists human readers.
• The document explicitly states: "No clinical studies were required for the Advance Serenity 18 Hydrophilic PTA Balloon Dilatation Catheter."

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

• Not applicable as it's not an AI/software device.

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

• Not applicable. Performance is measured against engineering specifications and industry standards for physical device properties, not against "ground truth" derived from clinical data or expert consensus.

8. The sample size for the training set

• Not applicable; there is no training set for a physical medical device. (This is relevant for AI models).

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

• Not applicable; there is no training set.

In summary, the provided FDA document is a 510(k) clearance letter for a physical medical device, based on demonstrated "substantial equivalence" through bench testing, not clinical studies or AI model validation. Therefore, most of the detailed information requested regarding clinical study design, data characteristics, expert involvement, and AI model evaluation (points 2-9) is not found in this type of submission.

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The UHP Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The Surmodics™ Arise™ UHP Dilatation Catheter is a coaxial Over the Wire (OTW) 0.035' PTA Balloon Dilatation Catheter with a distal inflatable balloon intended to be used for the treatment of peripheral arteries and treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The UHP Dilatation Catheter obtains a low compliance at high pressure over a large working range. The proximal portion of the catheter has a bifurcated manifold which includes a balloon lumen marked "BAL" and a guidewire lumen. Two radiopaque marker bands indicate the dilatating section of the balloon and aid in the balloon placement. The catheter is designed so that a specific balloon diameter can be reached depending on the balloon size and defined pressure.

The provided text is a 510(k) Premarket Notification from the FDA for a medical device called the Arise™ UHP Dilatation Catheter. This document details the regulatory approval process for a new medical device and focuses on establishing "substantial equivalence" to a predicate device, rather than proving a device's performance against specific clinical acceptance criteria in the manner one might see for an AI/ML diagnostic or prognostic device.

Therefore, many of the requested criteria, such as those related to AI model performance, expert ground truth establishment, MRMC studies, and training/test set details, are not applicable to this type of device and submission.

Here's a breakdown based on the provided document:

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

The document states that "All test results met documented acceptance criteria and/or included justification of values." However, it does not provide a table with specific quantitative acceptance criteria or the reported performance values for each test. Instead, it lists the types of tests performed:

• Balloon Diameter at Nominal Pressure
• Inflation & Deflation Time
• Balloon Length & Marker Band Position
• Radiopacity
• Ancillary Tool Compatibility (Guidewire)
• Catheter Effective Length
• Tip Profile (Geometry of the catheter most distal tip)
• Simulated Use
• Crossing Profile
• Multiple Inflation/Fatigue & Leak Test
• Tensile Strength (strength of the catheter shafts, bonds, and tip)
• Flexibility & Kink | "All test results met documented acceptance criteria and/or included justification of values." (Specific values not provided in this document). Testing demonstrated that "technological differences identified do not raise new questions of safety or effectiveness." |
  | Biocompatibility | - Cytotoxicity
• Irritation / Intracutaneous Reactivity
• Sensitization
• Acute Systemic Toxicity
• Pyrogenicity
• Hemocompatibility (Hemolysis ASTM Method (Direct and Indirect), C3a Complement Activation Assay, O SC5b Complement Activation Assay, In Vivo Thrombogenicity)
• Genotoxicity
• Bacterial Reverse Mutation
• Chemical Characterization | "All test results met documented acceptance criteria and did not raise new questions of safety or effectiveness." (Specific values not provided). Biocompatibility evaluated per ISO 10993-1 and FDA Guidance. |
  | Sterilization | Product testing for Ethylene Oxide (EtO) sterilization | "Sterilization method... meets the requirements of ISO 11135, and that the sterility of the device will be maintained over the entirety of shelf life." |

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

For the bench testing, the specific sample sizes for each test are not detailed in this summary. The data provenance is laboratory-based testing on the device components and the assembled device itself (e.g., testing the mechanical properties of the catheter, balloon, etc.). There is no patient data or clinical data utilized for testing in this submission.

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

Not applicable. This is not an AI/ML device relying on expert-labeled ground truth from medical images or clinical data. The "ground truth" for this device's performance is established through engineering specifications, material science, and established test methodologies (e.g., ISO standards, ASTM methods).

4. Adjudication method for the test set

Not applicable. There is no human interpretation or adjudication involved in the bench testing described.

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-assisted diagnostic or imaging device. No MRMC study was performed.

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

Not applicable. This is not an algorithm; it is a physical medical device (catheter). Standalone performance refers to the device's mechanical, material, and functional properties as tested in the lab.

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

The "ground truth" for this device's safety and effectiveness is primarily based on:

• Engineering specifications and design requirements: Whether the device meets its intended physical and mechanical properties.
• Established international standards (ISO, ASTM): Compliance with recognized standards for medical device performance, biocompatibility, and sterilization.
• Comparison to a predicate device: Establishing substantial equivalence by demonstrating similar performance characteristics to a legally marketed device.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of an AI/ML model for this type of device.

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

Not applicable. This is not an AI/ML device.

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The 018 Radial Balloon Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) dilation of peripheral vasculature stenosis in the iliac, femoral, poplited, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The 018 Radial Access Rx Dilatation Catheter is a co-axial rapid exchange (RX) catheter system with a semi compliant balloon at the distal end designed for use with a 0.018" guidewire. The guidewire will pass through a lumen from an RX access bond. The balloon has two radiopaque markers that aid in the placement of the balloon within the stenosis. The balloon and catheter shaft are coated with a hydrophilic coating. The proximal end of the catheter has a single standard luer hub connector for connection of an inflation device. The inflation device is used to inflate and deflate the balloon with a contrast medium. The clearance between the inner and outer shafts acts as the passage for the inflation medium for balloon expansion. The device is used by positioning the balloon catheter over a guidewire. The balloon is aligned under fluoroscopy in the diseased vessel at the area to be treated. The balloon is then inflated with inflation media to pressures ranging between the nominal and the rated burst pressure to dilate the occluded area. On completion the balloon is then deflated under vacuum and removed from the patient. The 018 Radial Access Rx Dilatation Catheter is provided sterile via ethylene oxide and is intended for single use only.

This document is a 510(k) premarket notification for a medical device called the "Sublime Radial Access 018 RX Dilatation Catheter." It is NOT a study describing the acceptance criteria and proof that a device meets them.

The document states:

• No clinical studies were required for this device.
• The device was compared to a predicate device (Sublime™ Radial Access 014 RX PTA Dilatation Catheter K200700).
• Differences between the new device and the predicate device were verified through performance bench testing.

Therefore, the information requested regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information is not available in this document because no clinical study was conducted.

The document lists performance bench tests that were conducted:

• Rated burst pressure (RBP)
• Inflation & deflation time
• Balloon diameters at nominal pressure
• Simulated use - pushability & trackability
• Coating lubricity
• Coating durability
• Coating length
• Ancillary tool compatibility (guidewire)
• Tip profile
• Multiple inflation/fatigue & leak test
• Tensile strength
• Flexibility & kink
• Particulates
• Torque Strength

These bench tests are "performance data" that were used to demonstrate substantial equivalence to a predicate device, not to prove the device meets specific acceptance criteria based on human clinical data. The acceptance criteria for these bench tests would typically be established specifications derived from the predicate device's performance or industry standards. However, the specific values for these acceptance criteria and the reported performance for each are not provided in this document.

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The Sublime™ Radial Access 014 RX PTA Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) dilation of peripheral vasculature stenoses in the iliac, femoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The 014 RX PTA Dilatation Catheter is a co-axial rapid exchange (RX) catheter system with a semi compliant balloon at the distal end designed for use with a 0.014" guidewire. The guidewire will pass through a lumen from an RX access bond. The balloon has two radiopaque markers that aid in the placement of the balloon within the stenosis. The balloon and catheter shaft are coated with a hydrophilic coating. The proximal end of the catheter has a single standard luer hub connector for connection of an inflation device. The inflation device is used to inflate and deflate the balloon with a contrast medium. The clearance between the inner and outer shafts acts as the passage for the inflation medium for balloon expansion. The device is used by positioning the balloon catheter over a guidewire. The balloon is aligned under fluoroscopy in the diseased vessel at the area to be treated. The balloon is then inflated with inflation media to pressures ranging between the nominal and the rated burst pressure to dilate the occluded area. On completion the balloon is then deflated under vacuum and removed from the patient. The 014 RX PTA Dilatation Catheter is to be provided sterile (via ethylene oxide, EtO) and is intended for single use only.

The provided text describes a 510(k) premarket notification for a medical device, the Surmodics™ Sublime™ Radial Access 014 RX PTA Dilatation Catheter. This document asserts substantial equivalence to a predicate device, meaning it's claimed to be as safe and effective as a legally marketed device, and therefore does not typically involve the extensive clinical trials and efficacy studies seen with novel devices.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a formalized table of acceptance criteria with quantified performance targets and corresponding results. Instead, it states that "All test results met documented acceptance criteria and did not raise new questions of safety or effectiveness." for the biocompatibility tests and that performance bench testing results "demonstrate that the technological differences identified do not raise new questions of safety or effectiveness compared to the predicate device."

Here's a summary of the types of tests performed and the implicit "acceptance criteria" met:

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

The document does not specify the sample sizes for the performance bench tests, biocompatibility tests, or sterilization tests. It only lists the types of tests performed.

Regarding data provenance:

• The tests were conducted by the manufacturer, Creagh Medical, Ltd., dba Surmodics, Inc.
• The sterilization site is Synergy Health Ireland.
• The device is intended for the U.S. market, regulated by the FDA.
• The data would be considered retrospective in the sense that these are studies conducted on manufactured devices as part of the development and regulatory submission process, not ongoing clinical data collection.

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

This information is not provided in the document. The type of device (dilatation catheter) and the studies performed (bench, biocompatibility, sterilization) do not inherently require "ground truth" to be established by experts in the same way an AI diagnostic device would. For these types of tests, ground truth is typically established by physical measurement against engineering specifications and industry standards.

4. Adjudication Method for the Test Set:

This information is not applicable and therefore not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or expert panel reviews for diagnostic devices to resolve discrepancies in interpretations of medical images or patient data. The current document describes bench, biocompatibility, and sterilization testing, which rely on standardized laboratory procedures and measurements.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a physical medical instrument (a dilatation catheter), not an AI algorithm assisting human readers. Therefore, the concept of human readers improving with or without AI assistance is not applicable to this device.

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

No, a standalone algorithm performance study was not done. This device is a physical medical instrument and does not involve any artificial intelligence algorithms.

7. The Type of Ground Truth Used:

For the performance bench testing, the "ground truth" would be the engineering specifications, industry standards (e.g., ISO), and design requirements for a PTA balloon catheter.
For biocompatibility, the ground truth is established by internationally recognized standards and guidelines (ISO 10993-1), with testing against biological responses (e.g., cytotoxicity, irritation, hemolysis).
For sterilization, the ground truth is established by sterilization standards (ISO 11135) and validated procedures to ensure sterility assurance levels.

8. The Sample Size for the Training Set:

This information is not applicable and therefore not provided. "Training set" refers to data used to train machine learning models. This device is a physical catheter, not an AI algorithm.

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

This information is not applicable for the same reason as above (not an AI device).

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The 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) of the peripheral vasculature in the iliac, femoral, popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The catheter is a coaxial catheter with a semi compliant balloon near the distal tip. It is an Over-the-Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) device with various shaft lengths. The balloon has two radiopaque markers that aid in the placement of the balloon within the stenosis. The clearance between the inner and outer shafts acts as the passage for the inflation medium for balloon expansion. The proximal end of the catheter has a bifurcated manifold & strain relief that allows for the use of the 0.018" guidewire and the attachment of a balloon inflation device via a standard luer connector. The inflation device is used to inflate and deflate the balloon with a contrast medium. The device is used by positioning the balloon catheter over a guidewire. The balloon is aligned under fluoroscopy in the diseased vessel at the area to be treated. The balloon is then inflation media to pressures ranging between the nominal and the rated burst pressure to dilate the occluded area. On completion the balloon is then deflated under vacuum and removed from the patient. The 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter is to be provided sterile (via ethylene oxide, EtO) and is intended for single use only.

The provided text describes a medical device, the "018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter," and its FDA 510(k) submission. This document is a premarket notification for a medical device and is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria based on its performance in a clinical study (like an AI/ML device would).

Therefore, there is no information present in the provided document to fulfill the request concerning:

• A table of acceptance criteria and reported device performance for a study directly proving the device meets the acceptance criteria. The document discusses design verification testing to demonstrate substantial equivalence to a predicate device, not necessarily performance against pre-defined clinical acceptance criteria.
• Sample size for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone (algorithm only) performance.
• Type of ground truth used.
• Sample size for the training set.
• How the ground truth for the training set was established.

The document explicitly states: "No clinical data is being submitted for the 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter." This confirms that there was no clinical study conducted to establish performance metrics against acceptance criteria in the way one would for an AI/ML diagnostic device.

The study that was done to support this device's submission focused on:

• Performance Bench Testing: This involved tests like Rated Burst Pressure, Balloon Diameter, Inflation/Deflation Time, Tensile Strength, etc., to ensure the device performs as intended in a non-clinical setting and is comparable to the predicate. These are engineering specifications and internal quality assurance metrics, not "acceptance criteria" in the context of clinical performance or AI/ML evaluation.
• Biocompatibility: Testing to ensure the device is safe for human contact.
• Sterilization: Verifying the sterilization process.

These tests were performed to demonstrate "substantial equivalence" to a predicate device (Sterling™ Over-the-Wire™ (OTW) PTA Balloon Dilatation Catheter, K132430), meaning it has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. This is a common path for medical device clearance, especially for devices that are variations of existing technology.

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The ELM PTA Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and the renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.

The ELM is a coaxial PTA Balloon Dilatation Catheter with a distal inflatable balloon. One lumen is used for inflation of the balloon with contrast medium; the other lumen permits the use of a guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. Two radiopaque marker bands indicate the dilating section of the balloon and aid in the balloon placement. The marker bands also indicate the nominal length of the balloon. The catheter tip is designed to ease entry into the peripheral arteries and to facilitate the crossing of tight stenoses.

The provided text describes a Special 510(k) Summary for the ELM PTA Balloon Dilatation Catheter, focusing on demonstrating substantial equivalence to a previously cleared device (K102645). This type of submission is for modifications to an already cleared device, not for a new device requiring extensive clinical trials for performance validation. Therefore, the study described is primarily focused on design verification and validation testing rather than human clinical trials or AI algorithm performance studies.

Here's the breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance metrics like accuracy, sensitivity, or specificity. Instead, it refers to "design verification and validation testing" performed according to ISO 10993 Part 1 for biocompatibility and a list of specific engineering tests. The "reported device performance" is implicitly that the device met these engineering test criteria, allowing for a substantial equivalence determination.

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

• Sample Size for Test Set: The document does not specify a distinct "test set" sample size in terms of clinical cases or patient data. The tests performed are described as "non-clinical design verification/validation tests and analyses." These tests typically involve a sample of manufactured devices (e.g., a certain number of catheters for burst testing, or a specific quantity of material for biocompatibility). The exact number of units or samples tested for each engineering parameter is not mentioned.
• Data Provenance: The data provenance is from non-clinical design verification/validation testing conducted by the manufacturer, Creagh Medical, in Ireland. It is not patient or human data, so terms like "retrospective" or "prospective" do not apply in a clinical sense.

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

Ground truth as defined by expert consensus or interpretations is not applicable here, as the study is a non-clinical device validation. The "ground truth" for these engineering tests would be established by validated test methods, industry standards (e.g., ISO), and internal specifications, not by human expert interpretation of clinical data. Therefore, no experts in a clinical context were used for this purpose.

4. Adjudication Method for the Test Set

Adjudication methods like "2+1" or "3+1" are relevant for expert review of clinical cases. Since this study involves non-clinical engineering tests, these methods are not applicable. The "adjudication" for these tests would involve comparing test results against pre-defined engineering specifications and acceptance criteria.

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

No MRMC comparative effectiveness study was done. This type of study (comparing human readers with and without AI assistance) is relevant for AI algorithms interpreting medical images, not for evaluating the mechanical performance of a medical device like a balloon catheter.

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

A standalone study, implying an AI algorithm's performance, was not conducted. The device in question is a physical medical instrument (a catheter), not a software algorithm.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical engineering tests was based on:

• Engineering Specifications: Internal design requirements and performance limits for the device.
• Industry Standards: Compliance with relevant international standards, such as ISO 10993 Part 1 for biocompatibility.
• Validated Test Methods: Established laboratory procedures for measuring characteristics like burst pressure, tensile strength, and inflation/deflation times.

8. Sample Size for the Training Set

A "training set" as understood in machine learning (used to train an AI algorithm) is not applicable here. The device does not involve an AI algorithm, and the manufacturing process does not typically involve a "training set" of data in this context. The production and testing are based on established engineering principles and quality control.

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

Not applicable, as there is no training set for an AI algorithm.

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The WILLOW PTA Balloon Dilatation Catheter is intended to dilate stenoses in the illac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The ELM PTA Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.

Both the WILLOW and ELM are co-axial PTA Balloon Dilatation Catheters with a distal inflatable balloon. The lumen between the inner shaft is used for inflation of the balloon with contrast medium; the inner shaft lumen permits the use of a quide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. Two radiopaque marker bands indicate the dilating section of the balloon and aid in the balloon placement. The marker bands also indicate the nominal length of the balloon. The catheter tip is designed to ease entry into the peripheral arteries and to facilitate the crossing of tight stenoses.

The following materials are used in the WILLOW PTA Balloon Dilatation Catheter: Nylon 11, Polyethylene, Polycarbonate, and 90% Platinum/10% Iridium. The following materials are used in the ELM PTA Balloon Dilatation Catheter: Nylon 11, Pebax, Polycarbonate, Polyethylene, and 90% Platinum/10% Iridium. All materials in both devices were tested per ISO 10993-1 and determined to be biocompatible.

The provided document describes the Creagh Medical WILLOW and ELM PTA Balloon Dilatation Catheters, submitted for 510(k) clearance in 2010. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving de novo safety and effectiveness through clinical trials with specific acceptance criteria related to a disease state or imaging modality.

Therefore, the acceptance criteria and study detailed below relate to device performance characteristics intended to show that the new devices are as safe and effective as their legally marketed predecessors.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined "acceptance criteria" in a numerical or percentage format for all performance aspects, nor does it provide detailed quantitative results for every test. Instead, it broadly states that "performance testing demonstrated that the device performed as intended and in compliance with relevant consensus standards." However, for specific critical performance metrics, quantitative results are provided to support substantial equivalence.

*Other V&V Tests include: multiple inflation/fatigue and leak tight, balloon lengths and marker band position, inflation and deflation time, wire compatibility, catheter effective length, tensile strength, device profile/sheath compatibility, tip profile, radiopacity, simulated use including pushability and trackability and sheath compatibility, and manifold testing.

2. Sample Size for Test Set and Data Provenance

The document does not specify a "test set" in the context of clinical data for algorithmic performance testing. Instead, it refers to non-clinical design verification/validation tests and analyses.

• Sample Size: The document indicates that for rated burst pressure and compliance testing, the results are presented "with 95% confidence that 99.9% of the product meet the rated burst pressure specification" and "with 95% confidence that 99.7% of the product meets the compliance specification." While this phrasing suggests statistical sampling was used, the exact sample sizes (n) for each specific test are not reported.
• Data Provenance: This is a retrospective non-clinical study conducted by the manufacturer, Creagh Medical, whose address is in Ballinasloe, Co. Galway, Ireland. The data is from internal laboratory testing, not from patients or a specific country of origin in the clinical sense.

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

Not applicable. This is a submission for a medical device (PTA balloon catheter) based on non-clinical engineering and performance testing, not an AI or diagnostic device that requires expert-established ground truth for image interpretation or disease diagnosis. The "ground truth" here is objective physical and mechanical measurements against established engineering and safety standards.

4. Adjudication Method for the Test Set

Not applicable. As described above, this is non-clinical device testing, not a study involving human interpretation or adjudication of results. The "adjudication" would be performed by test engineers against predefined engineering specifications and regulatory standards.

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

Not applicable. This is a non-clinical submission for a physical medical device. MRMC studies are typically used for evaluating the performance of diagnostic imaging devices or AI algorithms where human readers are involved in interpreting results.

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

Not applicable. This is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for this submission is based on objective engineering specifications, performance standards (e.g., ISO, internal design documents), and comparison to the characteristics of the predicate devices. For example:

• Rated Burst Pressure: Ground truth is the specified pressure value the balloon must withstand.
• Compliance: Ground truth is the specified change in balloon diameter for a given pressure.
• Biocompatibility: Ground truth is compliance with ISO 10993-1.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI algorithm requiring a training set. The "training" for such devices would involve manufacturing process development and optimization, not data-driven machine learning.

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

Not applicable. There is no training set as this is not an AI/algorithmic device.

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