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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 lead delivery system, consisting of Selectra catheters in conjunction with the Selectra Accessory Kit, is used to facilitate implantation of leads in the heart chambers or in the coronary veins via the coronary sinus.

Selectra 3D catheters are also indicated to facilitate Solia S lead implantation in the left bundle branch area to achieve left bundle area pacing (LBBAP).

BIOTRONIK's Selectra 3D lead introducer system is a combination of guiding catheters and implantation accessories used to facilitate access to the heart for suitable leads and catheters. The Selectra 3D lead introducer system consists of several individually available quiding catheters with various curve shapes and the Selectra accessory kit.

The Selectra Accessory Kit includes the following components in a single sterile package:

• 1 Selectra Slitter Tool .
• . 1 quide wire
• 2 7F Transvalvular Insertion Tools (TVI)
• 1 syringe
• 1 torque tool ●
• 2 check valves ●
• 2 stopcocks
• 1 Tuohy Borst Adapter (TBA) ●

The catheters facilitate implantation of leads into the heart. The Selectra catheters are compatible with one another as well as the Selectra Accessory Kit.

The provided FDA 510(k) summary describes the acceptance criteria and study for the Selectra 3D Lead Delivery System. However, it's important to note that this document is for a medical device (lead delivery system), not an AI/software device. Therefore, many of the typical acceptance criteria and study design elements requested for AI/software (e.g., test set sample size, data provenance, number of experts for ground truth, MRMC studies, standalone performance) are not applicable in this context.

The study presented focuses on the physical device's safety and effectiveness for lead implantation, particularly for left bundle branch area pacing (LBBAP).

Here's a breakdown based on the provided text, highlighting what is applicable and what is not for an AI/software device:

1. Table of acceptance criteria and the reported device performance

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

• Sample Size for Test Set: 157 patients were enrolled. This serves as the study population for evaluating the device's safety and effectiveness.
• Data Provenance:
  • Country of Origin: "ten investigational sites across Europe, Asia, and Australia."
  • Retrospective or Prospective: Prospective study.

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)

• Number of Experts: An "Endpoint Adjudication Committee" determined the relatedness of SADEs to the Selectra 3D catheter. The exact number of experts and their qualifications beyond being part of this committee are not specified in the provided text.
• Ground Truth for Effectiveness: "Successful His bundle or left bundle branch area pacing was determined by the implanting physician." The qualifications of these physicians are not detailed, but they are implied to be specialists performing these cardiac procedures.

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

• Adjudication Method: For the primary safety endpoint, an "Endpoint Adjudication Committee" assessed the relatedness of SADEs. The specific method (e.g., consensus, majority vote) is not detailed in this summary. For effectiveness, the implanting physician made the determination, which does not involve a multi-expert adjudication among different readers of an image, for example.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This study is for a physical medical device, not an AI/software product, so the concept of "human readers improve with AI vs without AI assistance" is not applicable.

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

• Standalone Performance: No, a standalone performance study (in the context of an algorithm) was not done. This device is a tool used by a human implanter, not an algorithm.

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

• Ground Truth for Safety: Expert consensus/adjudication by an "Endpoint Adjudication Committee" for SADE relatedness.
• Ground Truth for Effectiveness: Clinical determination by the "implanting investigator" regarding the success and stability of lead implantation for conduction system pacing. This is an outcome evaluated by the treating physician in real-time or soon after implantation.

8. The sample size for the training set

• Training Set Sample Size: This study describes the evaluation of a physical medical device. There is no concept of a training set in the context of this type of clinical study for a traditional device. The study uses a prospective cohort to gather safety and effectiveness data.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this type of device study.

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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 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) quide 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.

This document, a 510(k) summary for the Oscar Peripheral Multifunctional Catheter System, does not describe an acceptance criteria and study as defined in the request. This document is a regulatory submission to the FDA, demonstrating substantial equivalence to a predicate device, rather than a clinical study evaluating diagnostic performance and establishing new acceptance criteria.

Therefore, I cannot provide the requested information. The document focuses on bench testing and mechanical properties rather than clinical performance metrics with human readers or standalone AI performance.

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The BIOMONITOR IV is indicated to detect the following cardiac arrhythmias:

• · Atrial fibrillation
• · Bradycardia
• Sudden rate drop
• · Tachycardia
• · Pause

The BIOMONITOR IV is indicated for use in:

• Patients with clinical syndromes or situations at increased risk of cardiac arrhythmias
• · Patients who experience transient symptoms that may suggest a cardiac arrhythmia

The device has not been tested for and it is not intended for pediatric use.

BIOMONITOR IV is a programmable, subcutaneous insertable cardiac monitor able to record subcutaneous ECGs (sECGs) and other physiological parameters.

The BIOMONITOR IV is designed to automatically record the occurrence of arrhythmias in a patient. Arrhythmia may be classified as atrial fibrillation (AF), bradyarrhythmia, pause, sudden rate drop, or tachycardia. In addition, the BIOMONITOR IV can be activated by the patient using the Remote Assistant III to record cardiac rhythm during symptomatic episodes. BIOMONITOR IV may be used with the current legally marketed BIOTRONIK Home Monitoring® technology, which is an automatic, wireless, remote monitoring system for management of patients with implantable cardiac monitors.

The provided text describes the 510(k) premarket notification for the BIOMONITOR IV, an implantable cardiac monitor. However, it explicitly states that "No clinical performance data was submitted or relied upon in support of the substantial equivalence determination."

Therefore, I cannot provide information regarding acceptance criteria and a study that proves the device meets them, as such data was not provided in this FDA 510(k) summary. The submission focuses on validating the device against its predicate through non-clinical testing and functional equivalence.

The available information indicates that the device has undergone "thorough validation and verification testing to ensure final device functionality," including:

• Mechanical and Electrical Verification Testing for BIOMONITOR IV

This testing aimed to demonstrate that the BIOMONITOR IV functions as intended and is substantially equivalent to the predicate devices (BIOMONITOR III and BIOMONITOR IIIm) based on its principle of operation, physical characteristics, and software features. The submission does not detail specific performance metrics, sample sizes, ground truth establishment, or expert involvement for these verification tests, as those are generally internal engineering validations rather than clinical performance studies.

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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 BIOMONITOR III/BIOMONITOR IIIm is indicated to detect the following cardiac arrhythmias:

• atrial fibrillation
• · bradycardia
• · sudden rate drop
• · high ventricular rate (HVR)
• · asystole

The BIOMONITOR III/BIOMONITOR IIIm is indicated for use in:

• · Patients with clinical syndromes or situations at increased risk of cardiac arrhythmias
• · Patients who experience transient symptoms that may suggest a cardiac arrhythmia

The device has not been tested for and it is not intended for pediatric use.

BIOMONITOR III and BIOMONITOR IIIm are programmable, subcutaneous insertable cardiac monitors able to record subcutaneous ECGs (sECGs) and other physiological parameters.

The BIOMONITOR III and BIOMONITOR IIIm are designed to automatically record the occurrence of arrhythmias in a patient. Arrhythmia may be classified as atrial fibrillation (AF), bradvarrhythmia, asystole, sudden rate drop, or high ventricular rate. In addition, the BIOMONITOR III and BIOMONITOR IIIm can be activated by the patient using the Remote Assistant III to record cardiac rhythm during symptomatic episodes. BIOMONITOR III and BIOMONITOR IIIm may be used with the current legally marketed BIOTRONIK Home Monitoring® technology, which is an automatic, wireless, remote monitoring system for management of patients with implantable cardiac monitors.

This FDA filing (K221856) addresses changes to the BIOMONITOR III and BIOMONITOR IIIm, rather than a new device. Therefore, a full clinical study to prove the device meets acceptance criteria as would be required for a completely novel device is not presented. The submission focuses on demonstrating substantial equivalence to the predicate device (BIOMONITOR III and BIOMONITOR IIIm, K201865) following minor hardware changes.

The document explicitly states: "No clinical performance data was submitted or relied upon in support of the substantial equivalence determination." and "The BIOMONITOR III and BIOMONITOR IIIm have undergone thorough validation and verification testing to ensure final device functionality." and "Verification Testing for BIOMONITOR III and BIOMONITOR IIIm hardware changes".

Based on this information, we cannot provide the requested details about acceptance criteria derived from a substantial new clinical study, as such a study was not performed or deemed necessary for this specific submission. The focus was on demonstrating that the minor hardware changes did not negatively impact the established performance and safety characteristics of the already cleared predicate device.

Therefore, the questions regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment (items 1-9 in your request) cannot be answered from the provided document, as these typically relate to a de novo device approval or a submission requiring new clinical evidence.

The document primarily states that the updated device maintains the same principle of operation, physical device characteristics, software features, and functionality as the predicate, with minor component changes for manufacturing optimization. The validation and verification testing mentioned (Section 7.1) would likely be engineering-focused and aimed at confirming that the hardware changes did not introduce new risks or alter the device's electrical or mechanical performance, ensuring it still meets the specifications of the predicate device.

In summary, as per the provided text, a comparative effectiveness study or a new standalone clinical performance study was NOT conducted to prove the device met acceptance criteria, because the submission was a "Special 510(k)" for hardware changes to an already cleared device, not a new device.

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In conjunction with the Selectra accessory kit, Selectra guiding catheters are used to facilitate lead implantation in the heart chambers or in the coronary veins via the coronary sinus.

The Selectra lead introducer system is used to facilitate implantation of leads in the coronary veins via the coronary sinus or to facilitate lead implantation into the heart chambers.

Selectra accessories are used in conjunction with the lead introducer system to facilitate lead implantation in the coronary veins via the coronary sinus or to facilitate lead implantation into the heart chambers.

BIOTRONIK's Selectra lead introducer system is a combination of quiding catheters and implantation accessories used to facilitate access to the heart for suitable leads and catheters. The Selectra lead introducer system consists of several individually available guiding catheters with various curve shapes and the Selectra accessory kit.

The Selectra Accessory Kit includes the following components in a single sterile package:

• 1 Selectra Slitter Tool .
• 1 quide wire ●
• 2 7F Transvalvular Insertion Tools (TVI) ●
• 1 syringe ●
• 1 torque tool ●
• 2 check valves ●
• 2 stopcocks
• 1 Tuohy Borst Adapter (TBA) ●

The catheters are available as inner (5F) and outer (7F) catheters which jointly form a telescopic system and facilitate implantation of leads into the heart. The Selectra catheters are compatible with one another as well as the Selectra Accessory Kit.

The provided text describes a 510(k) premarket notification for a medical device, the "Selectra Lead Implantation System." This document is NOT about an AI/ML device, but rather a traditional medical device (a percutaneous catheter system). Therefore, most of the requested information about acceptance criteria, study design for AI/ML models (e.g., sample size for test/training sets, expert adjudication, MRMC studies, ground truth establishment), and AI-specific performance metrics is not applicable or present in this document.

The document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.

Here's what can be extracted from the document regarding acceptance criteria and performance data, re-framing it for a traditional medical device:

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

Since this is a 510(k) for minor modifications to an existing device, the performance data provided are primarily non-clinical bench testing to confirm that the modifications do not negatively impact safety and effectiveness and that the device continues to meet established performance criteria. The document states: "To demonstrate that the modified Selectra lead introducer system meets the same performance criteria, the following tests were conducted using the same test methods and acceptance criteria for the predicate devices."

The specific values or detailed acceptance criteria for each test (e.g., "burst pressure > X psi" for functional testing) are not detailed in this summary document. Regulatory summaries typically only list the types of tests performed and the conclusion that they were "successfully performed."

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

• Sample Size: Not specified for the non-clinical tests. For bench testing, sample sizes are typically determined by engineering standards and statistical confidence limits, but these specifics are not in the provided summary.
• Data Provenance: Non-clinical test data, likely generated in a laboratory setting by the manufacturer (Biotronik, Inc.). This is retrospective as it was conducted prior to the 510(k) submission. No patient data or geographical provenance is applicable here.

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 traditional medical device (catheter system) and not an AI/ML device. There is no concept of "ground truth" established by experts in the context of image interpretation or diagnosis for this specific device. Performance is assessed through engineering and biocompatibility testing.

4. Adjudication method for the test set:

• Not Applicable. As above, no expert adjudication is involved for this type of device's performance 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:

• Not Applicable. This is not an AI/ML diagnostic aid. No MRMC study was performed as it's not relevant to this device's function.

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

• Not Applicable. This is not an AI/ML algorithm.

7. The type of ground truth used:

• Not Applicable directly for "ground truth" as typically defined for AI/ML. For this device, the "ground truth" or reference for performance is established by engineering specifications, material standards, and successful function as an introducer system (e.g., ability to facilitate lead implantation without breakage, material non-toxicity, appropriate dimensions). The "ground truth" is adherence to pre-defined technical specifications.

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML device, so there is no training set.

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

• Not Applicable. As above, no AI/ML training set.

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The Oscar Peripheral Multifunctional Catheter system is indicated for percutaneous transluminal interventions in the peripheral vasculature to provide support during access in femoral, popliteal and infrapopliteal arteries.

The product is also intended for injection of radiopaque contrast media for the purpose of angiography.

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 quide 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.

The provided text is a 510(k) summary for the Oscar Peripheral Multifunctional Catheter system. This type of regulatory document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing. It does not contain information about clinical studies involving human readers, AI assistance, or detailed ground truth establishment that would typically be found in algorithms designed for diagnostic or prognostic purposes.

Therefore, many of the requested fields are not applicable to the information provided in this document.

Here's an analysis based on the provided text:

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

The document states, "All necessary performance testing was conducted on the Oscar Peripheral Multifunctional Catheter System to ensure that the device conforms to the design specification and to support a determination of substantial equivalence to the predicate device." It lists several performance tests, indicating that the device met these specifications, but it does not explicitly state the quantitative acceptance criteria for each test or the exact reported performance values. It generally concludes that the device's performance meets specifications.

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

The document describes non-clinical bench testing. It does not specify sample sizes for each test in the provided text, nor does it refer to "data provenance" in the context of clinical data (e.g., country of origin, retrospective/prospective). These are engineering tests performed on the device itself.

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 document describes a medical device (catheter system) and its non-clinical performance testing, not an AI/diagnostic algorithm that requires expert-established ground truth from medical images or patient data.

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

Not applicable. See point 3.

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 medical device, not an AI-assisted diagnostic tool. No MRMC study was conducted or is relevant for this type of submission.

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

Not applicable. This refers to an algorithm's performance. The submission is for a physical medical device.

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

For the non-clinical bench tests (e.g., balloon compliance, burst pressure), the "ground truth" would be established by engineering standards, material specifications, and validated measurement techniques. For example, a burst pressure test would compare the actual burst pressure to a pre-defined engineering specification. It is not expert consensus, pathology, or outcomes data as these are not clinical tests.

8. The sample size for the training set

Not applicable. This is a medical device, not an AI algorithm requiring a training set.

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

Not applicable. See point 8.

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The catheter is indicated for electrophysiological mapping of cardiac structures in adult patients; i.e., stimulation and recording only.

The MultiCath* and the AcQRate Dx Fixed Curve Catheter are pre-shaped multipolar catheters for sensing of intracardiac signals and diagnostic pacing, in combination with an electrophysiological investigation and recording device.

The device consists of a catheter body with a distal curve, an array of platinum/iridium (PtIr) electrodes, and a proximal multipolar connector. Multiple electrode configurations are available with various numbers of electrodes and electrode spacing.

• Unless otherwise noted, the term "MultiCath" is used throughout to represent either MultiCath or the AcQRate Dx Fixed Curve Catheter.

The provided text is a 510(k) Summary for the BIOTRONIK MultiCath and AcQRate Dx Fixed Curve Catheter, and related MPK patient cables. It details the device's characteristics, intended use, and the non-clinical testing performed to establish substantial equivalence to a predicate device.

However, the document does NOT describe a study that proves the device meets specific acceptance criteria in terms of AI/algorithm performance (e.g., sensitivity, specificity, accuracy). The device in question is an electrophysiological catheter and patient cables for cardiac mapping and recording, which are hardware devices, not AI/algorithm-based diagnostic software.

Therefore, I cannot fulfill your request for information related to AI/algorithm performance, acceptance criteria for such algorithms, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance.

The provided text focuses on the following types of performance data for a medical device (hardware):

• Nonclinical Bench Testing: This includes design verification (dimensional, visual inspection, functional/compatibility, mechanical, corrosion testing) and design validation (usability testing).
• Biocompatibility Testing: To ensure the materials are safe for human contact.
• Sterilization, Shelf Life, and Packaging Validations: To ensure the device remains sterile and functional over time.

The acceptance criteria are implicitly that the device passes these various engineering and safety tests and demonstrates substantial equivalence to the predicate device in terms of functionality and safety. The reported device performance is "pass" for all listed tests.

To directly answer your request based only on the provided text, while acknowledging the mismatch with an AI/algorithm context:

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

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

• The document does not specify exact sample sizes (N) for each individual test. It states "All bench testing was conducted on the MultiCath Catheters necessary for Electrophysiological Diagnostics."
• Data provenance: Not explicitly stated, but implies internal company testing (BIOTRONIK / VascoMed GmbH in Germany) for the devices. It is non-clinical bench data.

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

• Not applicable as this is hardware testing against engineering standards, not a diagnostic algorithm requiring expert ground truth for interpretation.

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

• Not applicable; standard engineering and laboratory testing protocols are followed, where pass/fail is determined by objective measurements against predefined 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 device is a catheter and cables, not an AI-assisted diagnostic tool. No MRMC study was performed or required.

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

• Not applicable. This is a hardware device submission.

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

• For hardware, "ground truth" is established by adherence to recognized international and national standards (e.g., ISO, IEC, ASTM) and the manufacturer's own validated design specifications. The performance is objectively measured against these, not against human expert consensus or clinical outcomes data in the context of this 510(k).

8. The sample size for the training set:

• Not applicable. This is not an AI/ML algorithm that requires training data.

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

• Not applicable.

In summary, the provided document is a 510(k) submission for a physical medical device (catheter and cables), not an AI/ML-based diagnostic software. Therefore, many of the questions regarding AI/ML performance metrics, data sets, and expert involvement are not relevant to this document's content.

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