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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 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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