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The device is indicated for temporary use during the creation of anastomosis for medical conditions requiring beating heart coronary artery bypass procedures.

The disposable intracoronary shunts consist of a flexible tube. Both ends of the tube feature a teardrop shaped tip made from radiopaque material with 14 mm between the ends. Tip diameters range from 1.00 mm to 3.00 mm. A tether with a tag made of radiopaque material is permanently attached to the shunts. These devices are sterile, nonpyrogenic, disposable and intended for single use only. They are sterilized using ethylene oxide and are categorized as external communicating devices, with limited contact (<=24 hours) circulating blood contact.

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Cardiopulmonary Bypass (CPB):
Bio-Medicus Life Support catheters are peripheral-access catheters used to perfuse vessels or organs in conjunction with extracorporeal cardiopulmonary bypass (CPB) procedures. The catheter introducer is intended to facilitate proper insertion and placement of the appropriately sized catheter within the vessel. Catheter models with tip lengths of 18 cm (7.09 in), 50 cm (19.7 in), or 55 cm (21.7 in) and without additional side holes may be used as either drainage or reinfusion catheters. This product is intended for use in adult and pediatric patients for up to 6 hours.

Extracorporeal Membrane Oxygenation (ECMO) and Extracorporeal Life Support (ECLS):
The Bio-Medicus Life Support catheters and introducers are single-lumen drainage or reinfusion peripheral-access catheters to be used in ECMO or ECLS with an extracorporeal circuit intended for use in adult and pediatric patients with acute respiratory or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent.

The Bio-Medicus Life Support catheter is a single-lumen catheter used to drain or reinfuse blood. The introducer facilitates proper insertion and placement of the appropriately sized catheter over a guidewire within the vessel. These devices are intended to perfuse vessels or organs in conjunction with extracorporeal support, including cardiopulmonary bypass (CPB), Extracorporeal Membrane Oxygenation (ECMO) and Extracorporeal Life Support (ECLS). Catheter models with tip lengths of 18 cm (7.09 in), 50 cm (19.7 in), or 55 cm (21.7 in), with and without additional side holes may be used as either drainage or reinfusion catheters.

These devices are sterile, nonpyrogenic, disposable, intended for single use only. Do not store the product above 25°C (77°F).

Extracorporeal membrane oxygenation (ECMO): Bench studies were performed after device preconditioning including exposure (21 days) to simulated in vivo use conditions to demonstrate safety and reliability.

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The Concerto Versa™ Detachable Coil is indicated for arterial and venous embolization in the peripheral vasculature.

The Concerto Versa™ Detachable Coil is an embolization coil indicated for arterial and venous embolization in the peripheral vasculature. It consists of a platinum-tungsten embolization implant coil attached to a composite delivery pusher, and a hand-held Instant Detacher (I.D.) which, when activated, detaches the coil from the delivery pusher tip. The Instant Detacher is an accessory sold separately. The Concerto Versa™ Detachable Coil is for single use and provided sterile.

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This non-therapeutic delivery system is intended to aid in the introduction and placement of cardiac leads into the right chambers of the heart. The leads are implanted in patients who are indicated for a cardiac implantable electronic device (CIED) for treatment of heart rhythm disorders. Refer to the respective CIED instructions for use for details about the types of heart rhythm abnormalities or patient conditions treated by each type of CIED.

The C320LBB delivery system is composed of a single-use, disposable, fixed-shape catheter with integrated hemostasis valve, two integrated radiopaque marker bands at the distal segment and a dilator. These components are used together to provide a flexible and hemostatic conduit for insertion of intravascular devices into the right chambers of the heart.

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This cannula is intended for use in venous drainage via the right atrium and inferior vena cava simultaneously during cardiopulmonary bypass surgery up to six hours or less.

The MC2™ Two-Stage Venous Cannula and MC2X™ Three-Stage Venous Cannula models feature wire wound polyvinyl chloride (PVC) bodies with side ports in the distal tip, a ported atrial basket drainage site located along the length of the cannula body, and a 3/8-inch (0.95 cm) to 1/2-inch (1.27 cm) connection site. The overall length of each cannula body is approximately 15¼ inch (38.7 cm). Insertion depth marks are provided to aid in positioning of the cannula. Each cannula is nonpyrogenic, is intended for single use, and has been sterilized using ethylene oxide.

This document is a 510(k) clearance letter for a medical device: the MC2™ Two-Stage Venous Cannula and MC2X™ Three-Stage Venous Cannula. It does not contain any information about an AI/ML-driven medical device, nor does it discuss acceptance criteria, test sets, ground truth establishment, or human reader studies related to AI performance.

The clearance is for a physical device used in cardiopulmonary bypass surgery, and the summary of performance data refers to pre-clinical bench testing related to material formulation changes, not algorithmic performance.

Therefore, I cannot provide the requested information based on the provided text. The prompt asks for details about AI/ML device performance, which are entirely absent from this 510(k) clearance.

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C315: This non-therapeutic delivery system is intended to aid in the introduction and placement of cardiac leads into the right chambers of the heart. The leads are implanted in patients who are indicated for a cardiac implantable electronic device (CIED) for treatment of heart rhythm disorders. Refer to the respective CIED instructions for use for details about the types of heart rhythm abnormalities or patient conditions treated by each type of CIED.

C304: This non-therapeutic delivery system is intended to aid in the introduction and placement of cardiac leads into the right chambers of the heart. The leads are implanted in patients who are indicated for a cardiac implantable electronic device (CIED) for treatment of heart rhythm disorders. Refer to the respective CIED instructions for use for details about the types of heart rhythm abnormalities or patient conditions treated by each type of CIED.

C315 Delivery System: The Medtronic C315 Delivery System contains one catheter and one dilator constructed of Polyether Block Amide and Polyethylene respectively. It is designed to aid in the introduction of various types of pacing or defibrillator leads and catheters. There are seven models in the Medtronic C315 Delivery Catheter product family, all of which have the same inner and outer diameter (5.4Fr and 7.0Fr respectively). The models differ in useable length, which varies from 20cm to 43cm. Proximally, the C315 is equipped with a hemostatic valve, and the distal tip is radiopaque to facilitate imaging under fluoroscopy. The C315 is designed to be slittable, thereby allowing its removal after device placement. A variety of curves are available to accommodate various anatomies and different lead locations.

SelectSite C304 Deflectable Catheter System: The SelectSite C304 Deflectable Catheter System contains a single deflectable catheter, deflectable catheter dilator, universal slitter, valve, guidewire, needle, and syringe. The SelectSite C304 Deflectable Catheter System is designed to access the coronary sinus and the chambers of the heart. The percutaneous needle and syringe are used to access to venous insertion site, the guidewire to access the vein, the introducer valve to reduce blood loss during the implant procedure, the deflectable catheter to introduce a transvenous device, the deflectable catheter dilator to facilitate deflectable catheter passage and the guide catheter slitter to remove the deflectable catheter. The SelectSite C304 Deflectable Catheter System is available in three models which are the C304-S59, C304-L69, and C304-XL74. All components except the deflectable catheter and dilator are identical in each model.

This document, a 510(k) Premarket Notification from Medtronic Inc., describes two catheter delivery systems, the SelectSite C304 Deflectable Catheter System and the C315 Delivery System. The notification primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study proving a novel device meets specific acceptance criteria based on performance metrics (e.g., accuracy, sensitivity, specificity for a diagnostic device).

Therefore, the provided text does NOT contain the information necessary to answer the questions about acceptance criteria and a study proving a device meets these criteria in the context of, for example, an AI/ML diagnostic or predictive device.

The document states:

• "The technology of the subject devices is identical to the respective predicates." (Page 6)
• "There are no changes to the design, physical characteristics, materials, packaging, or sterilization presented in this submission." (Page 6)
• "The subject devices have identical indications for use to the respective predicate devices." (Page 6)
• The only difference mentioned is "updated instructions for use (IFU) to indicate warning for potential small-bore misconnection." (Page 6)
• "The labeling modification is supported by verification activities and makes the products compliant with clause 7f of ISO 80369-7." (Page 6)

This indicates that the submission is about demonstrating that the modified devices (with updated IFUs) are still substantially equivalent to the original predicate devices, implying that their performance is expected to be the same as the already cleared devices. This is typical for a 510(k) submission where there are minor changes but the fundamental performance of the device is not being re-evaluated through a new clinical performance study.

To answer your specific questions, the document does not provide the following information:

1. A table of acceptance criteria and the reported device performance: Not applicable. Performance is established through the predicate device.
2. Sample size used for the test set and the data provenance: No test set in the context of clinical performance evaluation is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This document is not about AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document is not about an algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable for this type of submission.
9. How the ground truth for the training set was established: Not applicable for this type of submission.

In summary, this document is a regulatory submission for a medical device that has undergone minor labeling changes, and its purpose is to demonstrate substantial equivalence to existing devices, not to present a de novo study proving new performance criteria.

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The Affera Integrated Mapping System is intended to be used cardiac electrophysiological mapping. The mapping system allows pacing and real-time visualization of compatible catheters as well as display of cardiac maps in multiple formats. The acquired patient signals, including body surface electrocardiograms and intracardiac electrograms, may also be recorded and displayed on the system's display screen.

The Affera Integrated Mapping System (integrated mapping system) is a computerized storage and display system with embedded software designed to present the user with information regarding the state and location of compatible catheters within the body. The integrated mapping system provides real-time visualization of compatible catheters as well as display of cardiac maps in multiple formats. The integrated mapping system uses magnetic localization technology similar to localization systems used in other EP mapping systems, with a magnetic field generator placed under the table and one or more passive magnetic-based tracking and navigation, the integrated mapping system provides optional capability for hybrid electromagnetic-impedance tracking and navigation, including the ability to visualize Medtronic and third-party therapeutic and diagnostic devices that do not contain electromagnetic location sensors. The integrated mapping system collects and displays surface electrocardiogram (ECG) signals using commercially available body surface electrodes. Electrogram signals from electrodes on connected catheters can also be collected. Data derived from these signals can be overlayed on the reconstructed anatomy to display cardiac maps in multiple formats. The integrated mapping system can connect to electrophysiology (EP) catheter lab equipment such as external stimulators to deliver pacing stimuli through third-party intracardiac (IC) catheters. Internally generated pacing stimuli can also be routed directly from the integrated mapping system CIU. The integrated mapping system can be used with compatible cardiac ablation systems for tracking and navigation of catheters during ablation procedures. When connected via a communication link to a compatible ablation system, the integrated mapping system displays ablation data such as temperature and power on the user interface.

The provided text does not contain specific acceptance criteria or details of a study that proves the device meets those criteria in a quantitative manner. The document is a 510(k) summary for the Affera Integrated Mapping System, indicating it has undergone performance testing, but the results and acceptance thresholds are not explicitly stated.

However, based on the information provided, here's what can be extracted and what is missing:

1. Table of acceptance criteria and reported device performance:

The document states: "Performance testing applicable to the subject devices was completed to ensure it performs as intended per the product specifications and requirements... all acceptance criteria were met in accordance with appropriate standards". However, it does not provide a table of

• specific acceptance criteria (e.g., accuracy thresholds, precision values, sensitivity/specificity targets)
• the reported device performance measurements against those criteria.

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

• Test set sample size: Not specified.
• Data provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

• Not specified, as the type of ground truth and method of establishment are not detailed in the provided text.

4. Adjudication method for the test set:

• Not specified.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• Not explicitly mentioned. The document focuses on the device's performance against its own specifications rather than a comparative study with human readers with or without AI assistance.

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

• The device is a "computerized storage and display system with embedded software" for "electrophysiological mapping". The testing mentioned ("Design verification testing", "Design validation", "Pre-clinical animal testing", "Software validation") generally refers to the standalone performance of the system, but this is not explicitly stated as "algorithm only without human-in-the-loop performance". The system is intended to provide "real-time visualization" and "display" of information to a user, implying a human-in-the-loop context for clinical use.

7. The type of ground truth used:

• Not explicitly stated. The testing includes "Design verification testing", "Design validation", and "Pre-clinical animal testing", which would imply some form of established "truth" or reference standard relevant to cardiac mapping, but the specific nature of this ground truth (e.g., direct measurement, expert consensus on a gold standard, pathology) is not detailed.

8. The sample size for the training set:

• Not specified. The document does not mention details about the development or training of any AI/algorithm components, only general software validation.

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

• Not specified, as information about a training set is not provided.

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Affera Integrated Mapping System:
The Affera Integrated Mapping System is intended to be used cardiac electrophysiological mapping. The mapping system allows pacing and real-time visualization of compatible catheters as well as display of cardiac maps in multiple formats. The acquired patient signals, including body surface electrocardiograms and intracardiac electrograms, may also be recorded and displayed on the system's display screen.

Magnetic Localization Patch Kit:
Refer to the instructions for use accompanying the compatible electrophysiology catheter(s) used with the compatible mapping system for the specific indications for use.

Affera Integrated Mapping System:
The Affera Integrated Mapping System (integrated mapping system) is a computerized storage and display system with embedded software designed to present the user with information regarding the state and location of compatible catheters within the body. The integrated mapping system provides real-time visualization of compatible catheters as well as display of cardiac maps in multiple formats. The integrated mapping system uses magnetic localization technology similar to localization systems used in other EP mapping systems, with a magnetic field generator placed under the table and one or more passive electromagnetic sensors embedded in the catheter. In addition to magnetic-based tracking and navigation, the integrated mapping system provides optional capability for hybrid electromagnetic-impedance tracking and navigation, including the ability to visualize Medtronic and third-party therapeutic and diagnostic devices that do not contain electromagnetic location sensors.

The integrated mapping system collects and displays surface electrocardiogram (ECG) signals using commercially available body surface electrodes. Electrogram signals from electrodes on connected catheters can also be collected. Data derived from these signals can be overlayed on the reconstructed anatomy to display cardiac maps in multiple formats. The integrated mapping system can connect to electrophysiology (EP) catheter lab equipment such as external stimulators to deliver pacing stimuli through thirdparty intracardiac (IC) catheters. Internally generated pacing stimuli can also be routed directly from the integrated mapping system CIU.

The integrated mapping system can be used with compatible cardiac ablation systems for tracking and navigation of catheters during ablation procedures. When connected via a communication link to a compatible ablation system, the integrated mapping system displays ablation data such as temperature and power on the user interface.

Magnetic Localization Patch Kit:
The Magnetic Localization Patch Kit is an accessory device that includes 2 surface localization patches and is used with the Affera Integrated Mapping System for electromagneticbased tracking and navigation only. The patches are placed in fixed positions in contact with the patient's skin and provide a provide a stable mounting point for magnetic sensors within the intended connecting cable, which are used to provide information regarding patient position and movement during electromagnetic-based tracking and navigation procedures.

The provided FDA 510(k) summary for the Medtronic Affera Integrated Mapping System and Magnetic Localization Patch Kit does not contain information typically found in a study proving the device meets acceptance criteria for an AI/ML-driven medical device, such as detailed performance metrics (sensitivity, specificity, accuracy), sample sizes for test sets, establishment of ground truth by expert consensus, multi-reader multi-case studies, or standalone algorithm performance.

This document is a premarket notification for a hardware accessory (Magnetic Localization Patch Kit) and a comprehensive mapping system, not specifically for an AI/ML diagnostic or prognostic algorithm that would require the in-depth performance study details requested. The "Programmable diagnostic computer" classification refers to the broader functional capabilities of the mapping system, not necessarily an AI deep learning component.

The "Safety and Performance Data" section states: "Performance testing applicable to the subject device was completed to ensure it performs as intended per the product specifications and requirements. The following testing has been completed in support of the Magnetic Localization Patch Kit, and all acceptance criteria were met in accordance with appropriate standards:

• Design verification testing
• Design validation
• Pre-clinical animal testing
• Biocompatibility testing
• Packaging validation"

This indicates engineering and functional validation for a hardware component, not a clinical study to evaluate an AI's diagnostic performance for which the detailed criteria in the prompt would apply.

Therefore, it is not possible to extract the requested information (performance table, sample sizes, expert involvement, MRMC study, standalone performance, ground truth details, training set specifics) from the provided text, as this document does not describe such a study for an AI/ML component. The acceptance criteria mentioned ("all acceptance criteria were met") refer to the successful completion of the listed engineering and biological tests for the hardware, not diagnostic performance metrics for an AI.

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Affera Integrated Mapping System: The Affera Integrated Mapping System is intended to be used for catheter-based cardiac electrophysiological mapping. The mapping system allows pacing and real-time visualization of compatible catheters as well as display of cardiac maps in multiple formats. The acquired patient signals, including body surface electrocardiograms and intracardiac electrograms, may also be recorded and displayed on the system's display screen.

Impedance Localization Patch Kit: Refer to the instructions for use accompanying the compatible electrophysiology catheter(s) used with the compatible mapping system for the specific indications for use.

Affera Integrated Mapping System: The Affera Integrated Mapping System (integrated mapping system) is a computerized storage and display system with embedded software designed to present the user with information regarding the state and location of compatible catheters within the body. The integrated mapping system provides real-time visualization of compatible catheters as well as display of cardiac maps in multiple formats. The integrated mapping system uses magnetic localization technology similar to localization systems used in other EP mapping systems, with a magnetic field generator placed under the table and one or more passive electromagnetic sensors embedded in the catheter. In addition to magneticbased tracking and navigation, the integrated mapping system provides optional capability for hybrid electromagnetic-impedance tracking and navigation, including the ability to visualize Medtronic and third-party therapeutic and diagnostic devices that do not contain electromagnetic location sensors.

The integrated mapping system collects and displays surface electrocardiogram (ECG) signals using commercially available body surface electrodes. Electrogram signals from electrodes on connected catheters can also be collected. Data derived from these signals can be overlayed on the reconstructed anatomy to display cardiac maps in multiple formats. The integrated mapping system can connect to electrophysiology (EP) catheter lab equipment such as external stimulators to deliver pacing stimuli through thirdparty intracardiac (IC) catheters. Internally generated pacing stimuli can also be routed directly from the integrated mapping system CIU.

The integrated mapping system can be used with compatible cardiac ablation systems for tracking and navigation of catheters during ablation procedures. When connected via a communication link to a compatible ablation system, the integrated mapping system displays ablation data such as temperature and power on the user interface.

Impedance Localization Patch Kit: The Impedance Localization Patch Kit is an accessory device used with the Affera Integrated Mapping System that includes 6 surface localization patches. Patches are placed in fixed positions in contact with the patient's skin to deliver low energy patient auxiliary signals to enable the integrated mapping system to allow visualization of catheters that do not contain electromagnetic location sensors, and to support detection of respiratory motion and to provide information regarding patient position and movement.

The provided text is a 510(k) summary for the Affera Integrated Mapping System and Impedance Localization Patch Kit. Unfortunately, this document does not contain the detailed acceptance criteria and performance study results in the format requested.

Here's an analysis of what is available and what is missing:

What is present in the document:

• Device Name: Affera Integrated Mapping System; Impedance Localization Patch Kit
• Intended Use: Catheter-based electrophysiological mapping and stimulation.
• Indications for Use: Detailed for both the mapping system and the patch kit.
• Predicate Devices:
  • Affera Integrated Mapping System: Affera Mapping System – K233943
  • Impedance Localization Patch Kit: EnSite Precision Surface Electrode Kit – K201148
• Technological Characteristics Comparison: Provides a high-level comparison of the subject device with its predicate devices, highlighting similarities and differences in intended use, technology (magnetic vs. hybrid electromagnetic-impedance tracking), key components, mapping capabilities, stimulation, and ECG/EGM acquisition.
• Safety and Performance Data Overview: States that "Performance testing applicable to the subject devices was completed to ensure it performs as intended per the product specifications and requirements, including specifications and requirements related to use with compatible catheters and ablation systems." It lists categories of testing performed:
  • Design verification testing
  • Design validation
  • Summative usability evaluation
  • Pre-clinical animal testing
  • Electrical safety and EMC testing
  • Biocompatibility testing (AFR-00015)
  • Packaging validation
  • Software validation and cybersecurity testing
• Conclusion: The device is considered substantially equivalent to the predicate devices, and "all acceptance criteria were met in accordance with appropriate standards."

What is missing from the document (and therefore cannot be provided in the table/answers):

1. A table of acceptance criteria and the reported device performance: The document explicitly states "all acceptance criteria were met," but it does not provide a table detailing those criteria or the quantitative results of the device's performance against them. For example, it doesn't specify what constitutes "met" for design verification or what the specific performance metrics (e.g., accuracy, precision, latency) were for localization or mapping.
2. Sample size used for the test set and the data provenance: There is no mention of the specific sample sizes for any performance tests, nor their origin (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 present.
4. Adjudication method for the test set: This information is not present.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size: The document does not mention an MRMC study or any quantitative improvement metrics for human readers with AI assistance. The device is a "mapping system" and "patch kit," not primarily an AI algorithm for reader interpretation.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done: While it's a mapping system with embedded software, the document doesn't explicitly describe standalone algorithm performance studies in the way requested for AI/diagnostic devices. The description focuses on its function with human interaction (e.g., displaying information to the user).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): This is not specified for any of the mentioned testing.
8. The sample size for the training set: There is no mention of a "training set" or its size, as this document focuses on the performance testing for regulatory clearance, not the development process of an AI/ML model for which a training set would be typical.
9. How the ground truth for the training set was established: Not applicable, as no training set is mentioned.

In summary, while the document confirms that performance testing was conducted and acceptance criteria were met, it does not provide the granular details required to complete your request. It primarily serves as a regulatory summary for substantial equivalence, not a detailed technical report of performance metrics.

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