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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 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 or synthetic arteriovenous dialysis fistulae. Passeo-35 is also recommended for post-dilatation of balloon expanding stents in the peripheral vasculature.

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.

This is information on a medical device, not AI/ML. The provided text is a 510(k) premarket notification for the "Passeo-35 Xeo Peripheral Dilatation Catheter." It describes the device, its indications for use, and a comparison to a predicate device. The information requested in the prompt, such as acceptance criteria, study details, sample sizes, expert qualifications, and ground truth, is typically relevant for studies evaluating the performance of AI/ML-driven medical devices, especially for diagnostic or prognostic purposes.

Since the document provided is for a physical medical device (a catheter), these AI/ML-centric questions are not applicable. The performance data section focuses on bench testing of physical characteristics and safety, not on evaluating an algorithm's performance.

Therefore, I cannot provide the requested information as the document does not pertain to an AI/ML device.

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The Passeo-35 Peripheral Dilatation Catheter is indicated to dilate stenosis in the renal, iliac, femoral, popliteal and infrapopliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The Passec-35 Peripheral Dilatation Catheter (Passeo-35) is intended for dilatation of stenotic segments in peripheral vessels. One radiopaque marker is located at either end of the balloon to facilitate fluoroscopic visualization and positioning of the balloon catheter towards and across the lesion. The dilatation balloon is designed to inflate to a known diameter at a specific inflation pressure consistent with the compliance chart on the label. The balloon catheter includes a tapered soft tip to facilitate advancement of the catheter.

The balloon catheter shaft has two Luer ports at the proximal end. One port) serves for connecting an inflation device to inflate/deflate the balloon. The other port) enables insertion of the guide wire. The balloon catheter is a dual lumens contained within one tube. The smaller lumen is the balloon inflation/deflation lumen permits the use of guide wires with a maximum diameter of 0.035" to facilitate advancement of the Passeo-35 catheter towards and through the lesion(s) to be dilated. The balloon catheter is compatible with introducer) sizes according to the recommendations on the label. The balloon catheter has a silicone coating (hydrophobic) to improve the trackability characteristics.

This document describes the Biotronik Passeo-35 Peripheral Dilatation Catheter (K142379) and its substantial equivalence to a predicate device (K082933). The submission primarily focuses on non-clinical performance testing for additional device size configurations and material changes.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a comprehensive list of non-clinical tests performed on the Passeo-35 Peripheral Dilatation Catheter. The "Test Conditions / Specifications" column often implicitly or explicitly states the acceptance criteria, while the "Summary Results" column indicates whether these criteria were met.

Due to the length, a complete table is not feasible here. Instead, a representative sample of acceptance criteria and results is provided.

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

The document does not explicitly state the sample sizes (number of devices or tests) for each specific non-clinical test. It generally refers to "test article," "samples," or "all sizes." For example, for "Balloon RBP," it mentions "all sizes," implying multiple devices were tested across the range of diameters and lengths.

• Test Set: No specific number for a single "test set" is provided across all tests. Each test likely utilized a relevant number of samples appropriate for the specific test's statistical requirements, though these numbers are not detailed.
• Data Provenance: The studies are described as "non-clinical performance testing," indicating they were conducted in a laboratory or simulated environment (e.g., "anatomical model," "Crossover model," "polymer tube"). There is no mention of country of origin, but given it's a submission to the FDA by BIOTRONIK, Inc. (Lake Oswego, Oregon), it's reasonable to infer the testing was conducted either internally by the manufacturer or by a contracted lab, adhering to international standards (e.g., ISO, ASTM, DIN EN ISO, USP). The studies are prospective in the sense that they were conducted specifically for this submission to demonstrate the performance of the modified device.

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

This information is not applicable to the provided document. The studies are non-clinical, mechanical, and biocompatibility tests. They do not involve expert interpretation or human assessment of image data or clinical outcomes that would require a "ground truth" established by experts in the sense of a medical device intended for diagnostic or prognostic purposes.

4. Adjudication Method for the Test Set

This information is not applicable as there is no expert human reading involved in these non-clinical tests. The results are typically quantitative measurements or qualitative observations by trained technicians or automated systems according to defined protocols.

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

No MRMC comparative effectiveness study was done. The document explicitly states: "The determination of substantial equivalency on this subject device does not rely upon the clinical data. There is no clinical data submitted in this application." Therefore, there is no effect size reported for human readers with or without AI assistance.

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

This information is not applicable. The device is a physical medical device (catheter), not a software algorithm or AI that would have "standalone performance."

7. Type of Ground Truth Used

The concept of "ground truth" as typically used for AI/software in medicine (e.g., pathology, clinical outcomes) is not directly applicable here. For these non-clinical tests, "ground truth" would correspond to:

• Engineering specifications and standards: e.g., ISO, ASTM, DIN EN ISO, USP standards that define acceptable performance ranges and test methodologies.
• Predicate device performance: The performance of the previously cleared Passeo-35 (K082933) serves as a benchmark or "ground truth" for demonstrating substantial equivalence for many parameters.
• Material properties: Established properties of materials (e.g., for biocompatibility tests).
• Defined physical measurements: e.g., specified balloon diameters, lengths, pressures.

8. Sample Size for the Training Set

This information is not applicable. There is no "training set" as this is a physical device undergoing non-clinical validation studies, not an AI or machine learning model.

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

This information is not applicable for the reasons stated above.

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The Passeo-35 peripheral dilatation catheter is indicated to dilate stenosis in the renal, iliac, femoral, popliteal and infrapopliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The Passeo-35 peripheral transluminal angioplasty (PTA) balloon catheter is indicated for dilatation of stenotic segments in peripheral vessels. One radiopague marker is located at either end of the balloon to facilitate fluoroscopic visualization and positioning of the balloon catheter towards and across the lesion. The dilatation balloon is designed to inflate to a known diameter at a specific inflation pressure consistent with the compliance chart on the label. The balloon catheter includes a tapered soft tip to facilitate advancement of the catheter. The balloon catheter shaft 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 (guidewire port) enables insertion of the guide wire. The balloon catheter is a dual lumen design with both lumens contained within one tube. The smaller lumen is the balloon inflation lumen. The larger lumen permits the use of guide wires with a maximum diameter of 0.035" to facilitate advancement of the Passeo-35 catheter towards and through the lesion(s) to be dilated. The balloon catheter is compatible with introducer sheath (introducer) sizes according to the recommendations on the label. The balloon catheter has a silicone coating to improve the trackability and pushability characteristics.

This 510(k) K130161 is for a Special 510(k) notification, indicating that the device (Passeo-35 PTA Catheter) is a modification of a previously cleared device (Passeo-35 PTA Catheter, K082933).

Crucially, the document states:

• "The determination of substantial equivalency on this subject device does not rely upon the nonclinical test data. There is no nonclinical test data submitted in this application."
• "The determination of substantial equivalency on this subject device does not rely upon the clinical data. There is no clinical data submitted in this application."

This means that no new studies (clinical or non-clinical) were conducted or submitted to demonstrate that the modified device meets any acceptance criteria. The substantial equivalence is based solely on the fact that the changes are minor (only labeling changes) and the device's technological characteristics, materials, and manufacturing remain unchanged from the previously cleared predicate device.

Therefore, the requested information about acceptance criteria and studies cannot be provided from this document, as none were performed for this specific 510(k) submission. Any original studies or acceptance criteria would have been part of the original K082933 submission.

For completeness, if this were a submission requiring new clinical or non-clinical data, the table and details would be structured as follows:

1. Table of Acceptance Criteria and Reported Device Performance

(This information is not available in the provided document as no new studies were conducted for this Special 510(k).)

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

(This information is not available in the provided document as no new studies were conducted for this Special 510(k).)

• Sample Size (Test Set): N/A
• Data Provenance: N/A (e.g., country of origin, retrospective/prospective)

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

(This information is not available in the provided document as no new studies were conducted for this Special 510(k).)

• Number of Experts: N/A
• Qualifications: N/A

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

(This information is not available in the provided document as no new studies were conducted for this Special 510(k).)

• Adjudication Method: N/A

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 available in the provided document as no new studies were conducted for this Special 510(k). This is also not an AI device.)

• MRMC Study Conducted: No
• Effect Size: N/A

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

(This information is not available in the provided document as no new studies were conducted for this Special 510(k). This is not an AI device.)

• Standalone Study Conducted: No

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

(This information is not available in the provided document as no new studies were conducted for this Special 510(k).)

• Type of Ground Truth: N/A

8. The sample size for the training set

(This information is not available in the provided document as no new studies were conducted for this Special 510(k). This is not an AI device.)

• Training Set Sample Size: N/A

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

(This information is not available in the provided document as no new studies were conducted for this Special 510(k). This is not an AI device.)

• Ground Truth Establishment (Training Set): N/A

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The Passeo-35 peripheral dilatation catheter is indicated to dilate stenosis in the renal, iliac, femoral, popliteal and infrapopliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The Passeo-35 peripheral transluminal angioplasty (PTA) balloon catheter is indicated for dilatation of stenotic segments in peripheral vessels. One radiopaque marker is located at either end of the balloon to facilitate fluoroscopic visualization and positioning of the balloon catheter towards and across the lesion. The dilatation balloon is designed to inflate to a known diameter at a specific inflation pressure consistent with the compliance chart on the label. The balloon catheter includes a tapered soft tip to facilitate advancement of the catheter. The balloon catheter shaft 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 insertion of the guide wire. The balloon 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 catheter towards and through the lesion(s) to be dilated. The balloon catheter is compatible with introducer sheath (introducer) sizes according to the recommendations on the label. The balloon catheter has a silicone coating to improve the trackability and pushability characteristics.

The provided text is a 510(k) premarket notification for the BIOTRONIK Passeo-35 PTA Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data with acceptance criteria and detailed performance metrics as would be found in a Premarket Approval (PMA) application or a more comprehensive clinical trial report.

Therefore, the input does not contain the specific information required to complete the detailed table and answer all questions related to acceptance criteria, study design, and performance. The document primarily describes the device, its intended use, and identifies predicate devices.

Here's what can be extracted and what is missing:

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

This information is not available in the provided document. 510(k) submissions typically rely on design verification and validation testing (bench and/or animal studies) to demonstrate that a new device performs as intended and is as safe and effective as a predicate device. Specific acceptance criteria and quantitative performance results for a clinical study with human subjects, in the format requested, are not included.

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

This information is not available in the provided document. There is no mention of a clinical "test set" with human subjects for the Passeo-35, nor details on data provenance. The submission focuses on device characteristics and substantial equivalence to predicates.

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 information is not available in the provided document. "Ground truth" establishment by experts is a concept typically associated with studies involving diagnostic accuracy or image interpretation, which is not the focus of this device (a PTA catheter).

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

This information is not available in the provided document. Adjudication methods are relevant for studies where expert consensus is needed for outcome assessment, which, again, is not detailed here.

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 available in the provided document. An MRMC study is not relevant for a PTA catheter, nor is AI assistance mentioned.

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

This information is not available in the provided document. A "standalone algorithm" is not applicable to an interventional medical device like a PTA catheter.

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

This information is not available in the provided document. As a physical device for dilatation, the concept of "ground truth" for the device's performance often relates to physical and mechanical properties (e.g., balloon diameter at pressure, burst strength, trackability), verified through engineering and bench testing, rather than clinical "ground truth" derived from expert consensus, pathology, or outcomes data in a clinical trial.

8. The sample size for the training set:

This information is not available in the provided document. The concept of a "training set" is typically associated with machine learning or AI models, which are not described here.

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

This information is not available in the provided document for the reasons stated above.

Summary based on available information:

The document describes the BIOTRONIK Passeo-35 PTA Catheter as a device for dilating stenotic segments in peripheral vessels (renal, iliac, femoral, popliteal, infrapopliteal arteries) and for treating obstructive lesions in arteriovenous dialysis fistulae.

The device's safety and effectiveness are established through demonstration of substantial equivalence to predicate devices:

• BIOTRONIK's Pheron PTA Catheter (K033217, K052757)
• BIOTRONIK's Passeo-18 PTA Catheter (K072765)

The submission implies that the device meets its intended performance through its design, materials, and manufacturing, consistent with the cleared predicate devices. Specific clinical acceptance criteria and results from human studies are not detailed in this 510(k) summary. The FDA's clearance (K082933) indicates that they reviewed the submission and determined the device is substantially equivalent to legally marketed predicate devices.

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