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The Passeo-35 Xeo peripheral dilatation catheter is indicated to dilate stenosis in the iliac, femoral, popliteal and infrapopliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Passeo-35 Xeo is also recommended for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.

The Passeo-18 peripheral dilatation catheter is indicated to dilate stenosis in the femoral, popliteal and infrapopliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Passeo-14 is indicated for balloon dilatation of the stenotic portion of a lower limb artery for the purpose of improving perfusion.

The Oscar Peripheral Multifunctional Catheter system is indicated for percutaneous transluminal interventions in the peripheral vasculature to provide support during access into and to dilate stenoses in femoral, popliteal and infrapopliteal arteries. The product is also intended for injection of radiopaque contrast media for the purpose of angiography.

The Pantera LEO is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion and for post dilatation of coronary stents.

The Pantera Pro is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The Pantera Pro (balloon diameter 2.0 – 4.0 mm) is also indicated for post-delivery expansion of balloon expandable stents.

BIOTRONIK's Passeo 35 Xeo Catheter is an over-the-wire (OTW) balloon dilatation catheter, indicated for dilatation of stenotic segments in peripheral vessels. The Passeo 35 Xeo Catheter is a dual lumen design with both lumens contained within one tube. The smaller lumen is the balloon inflation/deflation lumen. The larger lumen permits the use of guide wires with a maximum diameter of 0.035" to facilitate advancement of the Passeo 35 Xeo Catheter towards and through the lesion(s) to be dilated.

The Passeo-18 peripheral dilatation catheter is intended for dilatation of stenotic segments in peripheral vessels and arteriovenous dialysis fistulae. The dilatation balloon is designed to inflate to a known diameter at a specific inflation pressure consistent with the compliance chart on the label. One radiopaque marker is located at each end of the balloon to facilitate fluoroscopic visualization and positioning of the balloon catheter towards and across the lesion. The dilatation catheter includes a soft tapered tip to facilitate advancement of the catheter. The dilatation catheter has two Luer-ports at the proximal end. One port (inflation port) serves for connecting an inflation device to inflate/deflate the balloon. The other port enables flushing of the guide wire lumen. The dilatation catheter has a hydrophobic silicone coating on the shaft outer surface and a hydrophobic patchwork coating on the balloon.

The Passeo-14 peripheral dilatation catheter is intended for the dilatation of stenotic segments in lower limb arteries. The dilatation balloon is designed to inflate to a known diameter at a specific inflation pressure consistent with the compliance chart on the label. One radiopaque marker is located at each end of the balloon to facilitate fluoroscopic visualization and positioning of the balloon catheter towards and across the lesion. The dilatation catheter includes a soft tapered tip to facilitate advancement of the catheter. The dilatation catheter has two Luer-ports at the proximal end. One port (inflation port) serves for connecting an inflation device to inflate/deflate the balloon. The other port enables flushing of the guide wire lumen.

The Oscar Peripheral Multifunctional Catheter system is an intravascular balloon catheter system, supplied with a retractable sheath (Oscar Support Catheter), a flexible catheter (Oscar Dilator) and a PTA balloon (Oscar PTA balloon), allowing a variable guide wire support and injection of fluids, and adjustable length inflatable balloon up to 180 mm. The over the wire (OTW) catheter has a retractable sheath allowing the balloon to be inflated at various lengths as determined by the physician. The balloon lengths are graduated with evenly spaced radiopaque markers. The Oscar Peripheral Multifunctional Catheter system is a 4F and 6F catheter system with a shaft working length of 60 cm or 120 cm, compatible with 0.014" (Oscar 4F) and 0.018" (Oscar 6F) guide wires. The device uses a semi-compliant balloon with a size dependent rated burst pressure and an indicated clinical use range of 6 atm to 16 atm. The balloon expands to a set nominal diameter (2.0, 2.5, 3.0, 4.0, 5.0, 6.0 and 7.0 mm). If required, separate PTA balloon catheters in same size range are also available separately.

Pantera LEO is a PTCA rapid exchange system with a balloon at the distal end of the catheter. A Luer port at the proximal end enables the attachment of an inflation device for the inflation of the balloon. The catheter provides a lumen, which enables the use of a guide wire to position the catheter. Radiopaque balloon markers aid in the placement of the catheter's balloon segment under fluoroscopy.

Pantera Pro is a PTCA rapid exchange system with a balloon at the distal end of the catheter. A Luer port at the proximal end enables the attachment of an inflation device for the inflation of the balloon. The catheter provides a lumen, which enables the use of a guide wire to position the catheter. Radiopaque balloon markers aid in the placement of the catheter's balloon segment under fluoroscopy.

The provided FDA 510(k) clearance letter (K250706) is for BIOTRONIK's peripheral and coronary dilatation catheters. This document describes several devices: Passeo-35 Xeo, Passeo-18, Passeo-14, Oscar Peripheral Multifunctional Catheter System, Pantera LEO PTCA Catheter, and Pantera Pro PTCA Catheter.

It's important to note that this 510(k) Summary does not describe an AI/ML powered device. Instead, it focuses on the physical and performance characteristics of medical devices (catheters). Therefore, many of the requested criteria, such as "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone algorithm performance," and details about training data, are not applicable to this type of submission.

The "performance testing" mentioned throughout the document refers to bench testing and engineering assessments to ensure the physical device meets its design specifications and performs safely and effectively. It does not involve AI model performance evaluation with clinical data.

Here's an attempt to answer the applicable parts of your request based on the provided text, with clear indications where the information is not present or not relevant to an AI/ML device:

Acceptance Criteria and Study to Prove Device Meets Criteria

The acceptance criteria for these devices are implicitly derived from the design specifications and are demonstrated through performance (bench) testing. The study proving these devices meet the acceptance criteria is a series of performance (bench) tests.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes technological characteristics and states that "All necessary performance testing was conducted... to ensure that the devices conform to the design specification." The "Subject Devices" column in the tables explicitly states "Identical" for most characteristics, meaning they meet the same specifications as the predicate devices. The only explicit change mentioned is that "Components will be brought into compliance with ISO 80369-7:2021" for Luer connectors and manifolds. The full set of specific performance acceptance criteria values (e.g., specific burst pressure thresholds, flexibility requirements, etc.) are not explicitly detailed in this summary but are indirectly stated as being met for "consistent performance during its intended use."

Here's a summary derived from the comparison tables, focusing on the acceptance of "identical" characteristics:

Overall Performance Conclusion: "The collective results of the performed testing demonstrated that the materials chosen, the manufacturing processes, and design of the components meet the established specifications necessary for consistent performance during its intended use. In addition, the collective bench testing demonstrates that the proposed device does not introduce new issues of safety or effectiveness when compared to the predicate device."

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

The document specifies "performance testing" or "bench testing," which refers to laboratory-based evaluations of the physical device. It does not mention a test set with patient data or any sample size related to clinical data. The provenance is not applicable as this concerns physical device characteristics, not data.

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

This information is not applicable as the evaluation is not based on expert-labeled ground truth for an AI/ML algorithm but on physical measurements and engineering tests of the device.

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

This information is not applicable as the evaluation is not based on expert consensus or adjudication of clinical cases for an AI/ML algorithm.

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

This information is not applicable as the device is a physical medical instrument (catheter), not an AI/ML diagnostic or assistive tool.

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

This information is not applicable as the device is a physical medical instrument (catheter), not an AI/ML algorithm.

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

The "ground truth" for these devices is the established engineering specifications, material properties, and performance benchmarks that the predicate devices have successfully met. These are verified through various physical and mechanical bench tests (e.g., burst pressure, flexibility, lubricity, dimensional accuracy, etc.). The document indicates these tests confirm the new devices' conformity to these specifications.

8. The sample size for the training set

This information is not applicable as the device is a physical medical instrument (catheter) and does not involve AI/ML training.

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

This information is not applicable as the device is a physical medical instrument (catheter) and does not involve AI/ML training or a training set with ground truth.

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The Pantera Pro is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The Pantera Pro (balloon diameter 2.0 - 4.0 mm) is also indicated for post-delivery expansion of balloon expandable stents.

The Pantera LEO is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion and for post dilatation of coronary stents.

Pantera Pro is a PTCA rapid exchange system with a balloon at the distal end of the catheter. A Luer port at the proximal end enables the attachment of an inflation device for the inflation of the balloon. The catheter provides a lumen, which enables the use of a guide wire to position the catheter. Radiopaque balloon markers aid in the placement of the catheter's balloon segment under fluoroscopy.

Pantera LEO is a PTCA rapid exchange system with a balloon at the distal end of the catheter. A Luer port at the proximal end enables the attachment of an inflation device for the inflation of the balloon. The catheter provides a lumen, which enables the use of a guide wire to position the catheter. Radiopaque balloon markers aid in the placement of the catheter's balloon segment under fluoroscopy.

The provided text is a 510(k) premarket notification for medical devices (Pantera Pro and Pantera LEO catheters). It focuses on demonstrating substantial equivalence to predicate devices, primarily through comparison of technological characteristics and performance data.

Crucially, this document does not contain information about studies related to Artificial Intelligence (AI) or machine learning (ML) models, nor does it provide details about human reader performance, expert adjudication, or ground truth establishment in the context of diagnostic or prognostic AI applications.

The "Performance Data" section solely mentions:

• Product performance - coating integrity and particulates
• Biocompatibility
• Microbiological - Bioburden
• Shelf-Life - coating integrity and particulates

These are standard performance metrics for physical medical devices like catheters, not for AI/ML software.

Therefore, I cannot provide the requested information for an AI/ML-based device based on this document. The information you're asking for would typically be found in a submission for a software as a medical device (SaMD) or an AI-enabled device, which this document is not.

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The Pantera LEO is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion and for post dilatation of coronary stents.

The Pantera LEO PTCA catheter is a sterile, single-use, intravascular balloon catheter for the dilatation of stenotic segments in coronary arteries or bypass grafts. The dilatation balloon is designed to inflate to a known diameter and length at a specific inflation pressure consistent with the compliance chart, which is included in the Instructions for Use (IFU), Compliance Data Card (CDC), and on the labels. The dilatation catheter has a soft tip that is tapered at the distal end of the catheter to facilitate advancement of the catheter. The balloon is folded to achieve a low crossing profile and is connected to the tip. A radiopaque marker is located at each end of the balloon cylindrical section to facilitate fluoroscopic visualization and positioning of the balloon catheter to and across the lesion. The proximal section of the catheter is a single lumen stainless steel hypotube with a single Luer port for the inflation / deflation of the balloon. The Pantera LEO has two coatings; a hydrophobic silicone coating on the outer surface of the hypotube (proximal outer shaft) and balloon, and a hydrophilic polymeric-based coating on the outer surface of the distal outer shaft. The dilatation catheter is compatible with guide wire and guiding catheter sizes according to the recommendations on the label.

Please note that the provided document is a 510(k) Summary for a medical device (Pantera LEO PTCA Catheter) seeking clearance as substantially equivalent to a predicate device. This type of regulatory submission primarily focuses on demonstrating equivalence through non-clinical (bench and biocompatibility) testing, rather than extensive clinical studies that would typically involve humans and advanced AI/algorithm performance.

Therefore, many of the questions related to AI performance, human reader studies, and large-scale clinical ground truth will not be applicable to this document. The focus here is on physical device performance and material safety.

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document does not specify exact sample sizes for each in-vitro bench test. However, these are generally performed on a sufficient number of device units (e.g., typically 3-10 or more, depending on the test) to statistically demonstrate compliance with engineering specifications.
• Data Provenance: All data presented is from non-clinical (in-vitro bench) testing and biocompatibility testing conducted by BIOTRONIK, Inc. This is prospective internal testing, not data from human subjects or clinical trials. The country of origin of the data is implicitly where the testing was performed, which would be associated with the manufacturer (BIOTRONIK, Inc. – Lake Oswego, Oregon, USA, with potentially some testing at manufacturing sites in other countries, though not specified).

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

• Not applicable. For this type of device (PTCA catheter), "ground truth" in the context of AI or diagnostic imaging is not relevant. The "ground truth" for the non-clinical tests is established by objective physical measurements against engineering specifications and accepted industry standards (e.g., ISO, ASTM, FDA guidance documents). These tests do not rely on expert consensus or interpretation of clinical images.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used for resolving discrepancies in expert interpretations, typically in clinical studies or image review. The non-clinical tests described are objective physical evaluations with pass/fail criteria based on measured performance against specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance.

• Not applicable. This document is for a physical medical device (catheter), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies comparing human reader performance with and without AI assistance were not conducted as they are irrelevant for this device.

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

• Not applicable. This device is a physical medical instrument (PTCA catheter), not an algorithm or AI system. Standalone algorithm performance studies are not relevant.

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

• For the non-clinical bench testing, the "ground truth" is defined by engineering specifications, industry standards, and regulatory guidance documents. For biocompatibility, the "ground truth" is adherence to ISO 10993-1 and FDA guidance, ensuring biological safety based on established scientific principles. There is no expert consensus, pathology, or outcomes data used as ground truth for these non-clinical tests.

8. The Sample Size for the Training Set

• Not applicable. This device is not an AI algorithm. There is no "training set" in the context of machine learning. The device design and manufacturing processes are developed through traditional engineering methods and validated through the referenced non-clinical tests.

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

• Not applicable. As there is no training set for an AI algorithm, this question is not relevant.

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