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

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

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

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

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

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

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

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

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

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

4. Adjudication Method for the Test Set:

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

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

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

6. Standalone (Algorithm Only) Performance Study:

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

7. Type of Ground Truth Used:

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

8. Sample Size for the Training Set:

• Not Applicable. This is a physical device, not an AI/ML algorithm that requires a training set of data.

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

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

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The ADMIRAL XTREME™ 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.

The ADMIRAL XTREME™ PTA Balloon Dilatation Catheter is an over-the-wire percutaneous transluminal angioplasty (PTA) catheter consisting of a proximal hub, dual lumen shaft, and a distal dilatation balloon. The ADMIRAL XTREME™ PTA Balloon Dilatation Catheter is compatible with guidewires with a maximum diameter of 0.035" and with 5, 6 or 7 FR introducer sheaths, depending on the diameter/length of the dilatation balloon. The catheter is provided with a hydrophilic coating and is available in useable catheter lengths of 40cm, 80cm and 120cm. The ADMIRAL XTREME™ PTA Balloon Dilatation Catheter includes additional balloon lengths of 150 mm, 200 mm, 250 mm and 300 mm. The modified ADMIRAL XTREME™ PTA Balloon Dilatation Catheter is manufactured from the same materials as the predicate ADMIRAL XTREME™ PTA Catheter and has the same Intended Use.

This is a 510(k) summary for a medical device, the ADMIRAL XTREME™ PTA Balloon Dilatation Catheter. It's important to understand that this document describes a submission for regulatory clearance, not a scientific study proving clinical effectiveness or diagnostic accuracy in the way an AI algorithm study would.

Therefore, many of the requested categories related to AI performance, ground truth, expert consensus, and comparative effectiveness studies are not applicable to this type of device submission. This submission focuses on demonstrating substantial equivalence to a previously cleared predicate device, primarily through engineering performance testing.

Here's an breakdown of the available information based on your request, with clarifications on why certain categories are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "Verification testing of the ADMIRAL XTREME™ PTA Balloon Dilatation Catheter demonstrated that the device met the acceptance criteria." While the specific numerical acceptance criteria values are not provided in this summary, the types of tests performed indicate the areas of acceptance.

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

• Sample Size for Test Set: This document does not specify the exact sample sizes used for each of the verification tests. These would typically be determined by engineering and statistical principles relevant to device testing (e.g., number of units tested for burst strength, fatigue, etc.).
• Data Provenance: The testing appears to be internal verification testing performed by the manufacturer (Invatec S.p.A.). The country of origin of the data would therefore be Italy (where Invatec S.p.A. is located). This is prospective testing, as it was conducted specifically for this submission to verify the performance of the modified device.

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

• Not Applicable. This is a physical medical device. "Ground truth" in the context of expert consensus, as typically applied to AI or diagnostic image analysis, is not relevant here. The "ground truth" for these engineering tests are established physical standards, measurements, and specifications.

4. Adjudication Method for the Test Set

• Not Applicable. As explained above, this is physical device testing, not a clinical study requiring expert adjudication of outcomes or diagnostic findings. The results are based on objective measurements against predefined engineering specifications.

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 submission is for a physical medical device (PTA balloon catheter), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study and AI-related effectiveness metrics are not relevant.

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

• Not Applicable. As above, this is not an AI algorithm.

7. The Type of Ground Truth Used

• Engineering Specifications and Standards: The "ground truth" for this device's performance is based on established engineering specifications, industry standards (e.g., ISO 10993 for biocompatibility), and regulatory requirements. For example, balloon burst strength is measured against a specified pressure value, and dimensions are checked against design blueprints.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI algorithm that requires a "training set."

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

• Not Applicable. As above, this is not an AI algorithm.

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The ADMIRAL XTREME™ (PTA) 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.

The ADMIRAL XTREME™ PTA Catheter is an OTW PTA catheter with a semi-compliant inflatable balloon mounted at the distal tip. It is a dual lumen catheter with a guidewire lumen and a balloon inflation lumen. The catheter tapers beneath the balloon segment to achieve the lowest possible deflated profile. Two radiopaque marker bands are placed under the balloon segment of the catheter shaft to provide visual reference points for balloon positioning within the vessel. The distal catheter shaft and balloon cones are hydrophilic coated (balloon excluded). The maximum recommended guidewire diameter is 0.035". The device is available in balloon diameters of 3-12mm, balloon lengths of 20, 40, 60, 80 and 120mm and catheter lengths of 80 and 130cm.

The provided text describes a 510(k) summary for the ADMIRAL XTREME™ Percutaneous Transluminal Angioplasty (PTA) Catheter. This document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a clinical study with acceptance criteria for a novel device's performance.

Therefore, many of the requested details about acceptance criteria, clinical studies, sample sizes, and expert validation are not applicable as this submission is for a medical device cleared via the 510(k) pathway, which relies on demonstrating equivalence to an already approved device rather than proving clinical efficacy or diagnostic accuracy through a standalone study.

However, I can extract the relevant information regarding the performance data provided to establish equivalence.

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

Since this is a 510(k) submission for a non-diagnostic device, the "acceptance criteria" are related to in vitro engineering performance equivalence rather than clinical outcomes or diagnostic metrics. The document states that the testing "met the specified requirements" and were "comparable with the predicate device." Specific numerical acceptance values are not provided in this summary.

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 in vitro tests.
• Data Provenance: The testing was "in vitro," implying laboratory testing rather than human subject data. Country of origin not specified, but the manufacturer is Invatec Innovative Technologies in Roncadelle (BS) Italy, and the submitter is ev3 Inc. in Plymouth, MN, USA.
• Retrospective or Prospective: Not applicable for in vitro laboratory 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 device's performance was evaluated through engineering in vitro testing; it does not involve expert-established ground truth like in a diagnostic AI study.

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

Not applicable. There was no human expert adjudication of test results in the context of diagnostic accuracy.

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 (catheter), not an AI diagnostic tool. No MRMC study was conducted.

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

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

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

Not applicable. The "ground truth" for the performance evaluation of this catheter was based on established engineering specifications and benchmarks to demonstrate equivalence to the predicate device. For example, balloon burst pressure would have a specified engineering tolerance rather than an expert consensus.

8. The sample size for the training set

Not applicable. This is not an AI/ML device; therefore, there is no "training set."

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

Not applicable. As there is no training set.

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