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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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The Amplatz Goose Neck Snare kit is intended for use in the cardiovascular system to retrieve and manipulate foreign bodies.

The Amplatz Goose Neck Snare kit (Snare device) contains the snare, snare catheter, snare introducer, and torque device. The snare is made of a nitinol cable and a gold-plated tungsten loop. The preformed snare loop can be introduced through catheters without risk of snare deformation because of the snare's superelastic construction. The snare catheter contains a platinum-iridium, radiopaque marker band.

The provided text describes a 510(k) premarket notification for the Amplatz™ Goose Neck Snare Kit and does not contain information about acceptance criteria or a study proving that an AI/ML device meets those criteria. The document is for a traditional medical device (a snare kit) and primarily focuses on its substantial equivalence to a predicate device, along with verification and validation testing for its physical and biocompatibility properties.

Specifically, the document lists:

• Biocompatibility tests: ISO MEM Elution, Guinea Pig Maximization Sensitization Test, Intracutaneous Irritation Test, Acute Systemic Injection Test, Materials Mediated Rabbit Pyrogen, ASTM Hemolysis Assay - Direct Contact Method, Complement Activation SC5b-9 Assay, ISO Standard Thrombogenicity in Canine, ISO Standard Thrombogenicity in Ovine.
• Design Verification tests: Snare Catheter Length, Snare Catheter OD, Snare Catheter Tip OD, Guide Catheter Compatibility.
• Packaging Validation tests: Visual Inspection (Gross Physical Damage to Package System), Visual Inspection (Label Legibility and Adhesion), Visual Inspection (Carton), IFU / eIFU Leaflet (Legibility), Visual Inspection (Device), Visual Inspection (Sterile Barrier Seal Integrity and Width), Package Integrity (Bubble Test), Peel-Open/Aseptic Presentation, Seal Strength Test.
• Shelf Life tests: Catheter Visual Inspection, Snare Catheter Tip Configuration, Snare Catheter ID and OD, Snare Catheter Length, Snare OD, Functional (general), Catheter Shaft Tensile Strength, Hub Bond Tensile Strength, Snare Catheter Tip OD, Guide Catheter Compatibility.
• Sterilization tests: Sterilization validation per ISO 11135 (overkill half cycle approach), Sterilization Residuals Testing.

These are standard engineering and safety tests for a physical medical device, not performance criteria for a software or AI/ML-driven device. The document explicitly states: "Animal testing was not required for the determination of substantial equivalence. Clinical testing was not required for the determination of substantial equivalence." This further indicates that no human clinical or AI/ML performance study, as typically described by your prompt's questions, was conducted or reported in this submission.

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The LINQ II ICM is an insertable automatically-activated and patient-activated monitoring system that records subcutaneous ECG and is indicated in adult patients, and in pediatric patients who are at least 2 years old, in the following cases:

· patients with clinical syndromes or situations at increased risk of cardiac arrhythmias

· patients who experience transient symptoms such as dizziness, palpitation, syncope, and chest pain that may suggest a cardiac arrhythmia

The LINQ II Insertable Cardiac Monitor (ICM) Model LNQ22 is a programmable device that continuously monitors a patient's ECG and other physiological parameters. The device records cardiac information in response to automatically detected arrhythmias and patient-initiated activation or markings. The device is designed to automatically record the occurrence of an episode of arrhythmia in a patient. Note: Arrhythmias are classified as tachyarrhythmia, bradyarrhythmia, pause, atrial tachyarrhythmia, or atrial fibrillation. Patients may also manually record symptoms. To manually record symptoms, the patient will also need either the MyCareLink Heart App (patient app on mobile device) or the Patient Assistant Model PA97000. The patient can use the MyCareLink Heart App or the Patient to manually record his or her cardiac rhythm while experiencing or immediately after a symptomatic event.

This document describes post-market changes rather than initial device approval, meaning that the full clinical study details are not provided in the typical format for proving initial efficacy or safety against a specific set of acceptance criteria. Instead, the focus is on demonstrating that a modification to an already approved device does not negatively impact its performance or safety, maintaining substantial equivalence to its predicate.

Therefore, the information regarding acceptance criteria and study details for device performance is limited to information on the modifications and the verification/validation activities assessing those modifications.

Here's a breakdown of the available information based on your requested categories:

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

Based on the provided text, the device itself (LINQ II ICM) is already cleared. The current submission (K240693) describes a modification to the LINQ II ICM. The acceptance criteria and "reported device performance" here refer to the evaluation of this modification.

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

The document does not specify a "test set" sample size in the context of a new clinical study. Instead, it refers to "design verification and validation activities" for the modification. These are typically laboratory-based tests or engineering evaluations, not patient studies with specific sample sizes. Therefore, information on data provenance (country of origin, retrospective/prospective) for a clinical test set is not applicable here.

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

This information is not provided as the submission focuses on design verification and validation of a modification, not a new clinical trial requiring expert consensus for ground truth establishment.

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

This information is not provided as the submission focuses on design verification and validation of a modification, not a new clinical trial that typically employs adjudication.

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 type of study is not mentioned as the LINQ II ICM is an insertable cardiac monitor that automatically detects arrhythmias and allows patient-initiated recordings. It's a monitoring device, not an AI-assisted diagnostic tool for human readers.

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

The device is inherently "standalone" in its automatic detection function, as it continuously monitors and records without constant human intervention. The submission focuses on ensuring this existing functionality is maintained after the modification. No specific "standalone performance study" in the context of a new algorithm is detailed. The device's primary function is automatic arrhythmia detection, which is essentially an algorithm-only function.

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

For the original LINQ II ICM, ground truth would likely have been established through clinical correlation with electrophysiologist interpretations or other diagnostic methods. However, for this modification, the "ground truth" for the verification and validation activities would be engineering specifications, established performance standards, and comparison to the predicate device's known characteristics.

8. The sample size for the training set

This information is not provided. The document describes a modification to an existing device, not the development of a new algorithm with a training set.

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

This information is not provided, as a training set for a new algorithm is not discussed in this submission.

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Affera Mapping System: The Affera mapping system is intended to be used for catheter based cardiac electrophysiological 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 intracardiac electrograms, may also be recorded and displayed on the system's display screen.

Location Reference Patch Kit: Refer to the instructions for use accompanying the compatible navigation-enabled electrophysiology catheter that is used with the compatible mapping system for the specific indications for use.

Affera Mapping System (AFR-00003): The Affera Mapping System (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 one or more magnetic sensors connected to cardiac catheters. The mapping system provides real-time visualization of compatible catheters as well as display of cardiac maps in multiple formats. The 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 sensors embedded in the catheter.

The Affera Mapping System connects to electrophysiology (EP) catheter lab equipment such as the EP recording system and external stimulators. The mapping system can also be connected to third-party intracardiac (IC) catheters to display electrograms from and deliver pacing stimuli.

The mapping system can be used with cardiac ablation systems for tracking and navigation of magnetic sensor-equipped catheters during ablation procedures. When used with the Affera Ablation System, the mapping system displays ablation data on the workstation user interface.

Location Reference Patch Kit (AFR-00007): The Location Reference Patch (LRP) Kit is a disposable device sold separately from the mapping system. The LRP Kit includes two non-sterile single-use patches, each containing a passive magnetic location sensor, which are placed in fixed positions on the patient's body surface (one anterior (A-patch) and one posterior (P-patch) to detect respiratory motion and to provide information regarding patient position and movement, respectively. The LRP Kit employs a hydrogel adhesive material for skin contact and for repositioning/ reapplication, and which is intended for extended duration topical use.

The provided text describes the regulatory clearance for the Affera Mapping System (K233943). Unfortunately, it does not contain the detailed acceptance criteria or the specific study that directly proves the device meets those criteria for the main mapping functionalities, typically found in a clinical performance study summary.

The document states:

• "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. The following testing has been completed in support of the Affera Mapping System and accessory devices, and all acceptance criteria were met in accordance with appropriate standards:"

It then lists various types of testing (Design Verification, Design Validation, Performance-based Characterization, Summative Usability, Pre-clinical Animal Testing, Software V&V, Electrical Safety, Biocompatibility, Packaging Validation). While these are essential, they generally refer to aspects like safety, software integrity, and basic functionality, rather than detailed clinical performance metrics for mapping accuracy against defined benchmarks.

The only mention of a "clinical study" is:

• Clinical Evaluation: "Investigator scoring of electroanatomical mapping was collected from the Sphere-Per-AF clinical study as a secondary performance endpoint, including scoring using the Affera Mapping System and a control device. Based on the mapping assessment data reported, no statistical difference was found between the investigational and control populations across the investigator scoring of geometries, voltage maps, and activation maps. Investigator scoring was 'good' or better in at least 97% of cases across all mapping categories for both treatment groups."

This section provides some performance data regarding the assessment of maps by investigators, but not quantitative acceptance criteria for the device's generation of those maps (e.g., accuracy of a 3D geometry or voltage measurement within a certain tolerance). It's an assessment of usability and qualitative agreement, not a direct measure of the device's intrinsic mapping accuracy against a gold standard or predefined numerical target.

Therefore, many of the requested details about acceptance criteria and a study proving their direct fulfillment are not explicitly present in this FDA 510(k) summary document. Regulatory summaries often abridge detailed study findings.

Below is a template of what such an answer would look like if the information were available, with "N/A" for details not found in the provided text.

Device: Affera™ Mapping System, AFR-00003

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size: Not explicitly stated for the "clinical evaluation" (Sphere-Per-AF study) in terms of patient count, or the number of maps/cases assessed.
• Data Provenance: The document does not specify the country of origin. The "Sphere-Per-AF clinical study" is mentioned, implying prospective clinical data. The pre-clinical animal study is likely prospective. Other testing (design verification, usability) could be internal lab/simulated data.

3. Number and Qualifications of Experts for Ground Truth

• Number of Experts: Not specified.
• Qualifications of Experts: Referred to as "Investigator" who performed the scoring. Their specific qualifications (e.g., years of experience, specialization) are not detailed in this summary.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. The data refers to "Investigator scoring," implying individual assessments, but whether multiple investigators scored the same maps and how disagreements were resolved (e.g., 2+1, 3+1) is not detailed.

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

• MRMC Study: A comparative evaluation was performed as part of the "Clinical Evaluation" where "Investigator scoring of electroanatomical mapping was collected from the Sphere-Per-AF clinical study as a secondary performance endpoint, including scoring using the Affera Mapping System and a control device."
• Effect Size (Improvement with AI vs. without AI assistance): This was a comparison of the Affera Mapping System device to a control device, not a human-AI assisted workflow comparison. The study found "no statistical difference" in investigator scoring between the investigational (Affera) and control populations. This suggests non-inferiority in mapping quality as perceived by the investigators, rather than an improvement with AI assistance (as AI assistance usually implies an algorithmic output assisting human interpretation/diagnostics, which isn't the primary focus here for a mapping system itself, which generates the maps).

6. Standalone (Algorithm Only) Performance

• Standalone Performance: The Affera Mapping System itself is a device that generates maps. The "Performance-based Characterization Testing" likely involved evaluating the device's intrinsic accuracy and performance (e.g., tracking, navigation) in a standalone manner, but quantitative results or specific metrics for this "algorithm only" performance are not provided. The clinical evaluation focused on investigator perception of the generated maps.

7. Type of Ground Truth Used

• Type of Ground Truth: The "Clinical Evaluation" used "Investigator scoring" of electroanatomical maps (geometries, voltage maps, activation maps) as a form of ground truth for assessing map quality. For other tests like "Design Verification" and "Performance-based Characterization," the ground truth would likely be defined by engineering specifications, known phantom/model dimensions, or established physiological parameters. For the pre-clinical animal testing, the ground truth would be based on "existing mapping systems" and potentially pathology or direct measurement validation in the animal model.

8. Sample Size for the Training Set

• Training Set Sample Size: Not applicable/not provided. This device is a mapping system, not explicitly an AI/ML model for diagnostic interpretation that would typically require a training set in this context. While its internal software would have undergone extensive development and testing, typical AI/ML "training set" concepts are not detailed here.

9. How Ground Truth for Training Set was Established

• Ground Truth for Training Set: Not applicable, as detailed training set information for an AI/ML model is not discussed for this device.

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The DLP™ Silicone Coronary Artery Ostial Cannulae, Models 30315, 30317, and 30320 are intended for use in conjunction with cardiopulmonary bypass surgery up to six hours or less for delivery of cardioplegia solutions directly to the coronary arteries.

The DLP™ Silicone Coronary Artery Ostial Cannulae, Models 30315, 30317, and 30320 feature a soft bulb beveled tip with a silicone body. The Cannulae terminate with a locking female luer fitting. The Cannulae are nonpyrogenic, single use, and sterile.

The provided text describes a 510(k) premarket notification for a medical device, the DLP Silicone Coronary Artery Ostial Cannulae. It discusses a material formulation change to an adhesive used in the device and the testing performed to demonstrate substantial equivalence to a predicate device.

However, the request asks for information related to a study proving device meets acceptance criteria for an AI/machine learning device, including aspects like:

• Acceptance criteria table and reported performance
• Sample size and data provenance for test sets
• Number and qualifications of experts for ground truth
• Adjudication methods
• MRMC studies for human reader improvement
• Standalone algorithm performance
• Type of ground truth
• Training set sample size and ground truth establishment

The provided FDA document is for a physical medical device (cannulae) and focuses on demonstrating substantial equivalence due to a material change, not on the performance evaluation of an AI or machine learning algorithm. Therefore, the document does not contain any of the information requested regarding acceptance criteria, study design, expert involvement, or AI performance metrics.

In summary, none of the specific information requested in the prompt can be extracted from the provided text because the text describes a physical medical device submission, not an AI/machine learning device submission.

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The LINQ II ICM is an insertable automatically-activated and patient activated monitoring system that records subcutaneous ECG and is indicated in adult patients, and in pediatric patients who are at least 2 years old, in the following cases:

• · patients with clinical syndromes or situations at increased risk of cardiac arrhythmias
• patients who experience transient symptoms such as dizziness, palpitation, syncope, and chest pain that may suggest a cardiac arrhythmia

The LINQ II Insertable Cardiac Monitor (ICM) Model LNQ22 is a programmable device that continuously monitors a patient's ECG and other physiological parameters. The device records cardiac information in response to automatically detected arrhythmias and patient-initiated activation or markings. The device is designed to automatically record the occurrence of an episode of arrhythmia in a patient. Note: Arrhythmias are classified as tachyarrhythmia, bradyarrhythmia, pause, atrial tachyarrhythmia, or atrial fibrillation. Patients may also manually record symptoms. In order to manually record symptoms, the patient will also need either the MyCareLink Heart App (patient app on mobile device) or the Patient Assistant Model PA97000. The patient can use the MyCareLink Heart App or the Patient to manually record his or her cardiac rhythm while experiencing or immediately after a symptomatic event. LINO II ICM includes the following accessories: LINQ II Tool Kit Model LNQ22TK, Reveal LINQ™ Mobile Manager Model MSW002, Device Command Library Model 2692, Instrument Command Library Model 2691, and AccuRhythm AI ECG Classification System Models ZA400, ZA410, ZA420 and CareLink SmartSync LINQ II ICM Application Model D00U024. New to the LINQ II ICM system is the CareLink SmartSync LINQ II Platform Application Model D00U027.

I am sorry, but based on the provided text, I cannot extract any information about the acceptance criteria for device performance, a study proving the device meets acceptance criteria, sample sizes used, data provenance, number of experts, adjudication methods, MRMC comparative effectiveness studies, standalone performance, type of ground truth, or training set details.

The document discusses the substantial equivalence of the LINQ II Insertable Cardiac Monitor (ICM) when used with the CareLink SmartSync LINQ II Platform Application to a predicate device. It states that design verification and validation were performed to ensure the application met design requirements and established performance criteria, and that "all test executions resulted in a status of Passed" and "All results met the criteria in the Validation Plan." However, it does not specify what those performance criteria or validation plan criteria were, nor does it provide details about any specific studies conducted to establish device performance in terms of diagnostic accuracy or clinical effectiveness.

The document focuses on regulatory approval based on substantial equivalence to a predicate device, and the testing mentioned appears to be primarily related to software and system design verification and validation, rather than a clinical performance study with specific acceptance criteria that would include the metrics you've asked for (e.g., sensitivity, specificity, accuracy against a ground truth from experts).

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The Cosine-10 Diagnostic Catheter is indicated for electrophysiological mapping (stimulation and recording) of cardiac structures, including in the coronary sinus.

The Cosine-10 Diagnostic Catheter is a sterile, single-use, steerable decapolar mapping catheter with a bidirectional deflecting tip intended for electrophysiological mapping of cardiac structures (i.e., stimulation and recording). The catheter contains 10 electrodes spaced in 5 pairs, including a distal dome electrode. Two electrode spacing configurations are available: 2-8-2 (AFR-00017) or 2-5-2 (AFR-00018). All catheter electrodes may be used for recording or stimulation. The catheter can be used with a compatible introducer sheath (7.5Fr minimum).

The provided text is a 510(k) Premarket Notification from the FDA for a medical device called the Cosine-10TM Diagnostic Catheter. This document primarily focuses on establishing substantial equivalence to a predicate device and does not contain the detailed acceptance criteria or the specific study results related to AI/algorithm performance that your request asks for.

Therefore, I cannot provide the requested information, which includes:

1. A table of acceptance criteria and the reported device performance: This document does not specify quantitative acceptance criteria or detailed performance metrics from a study related to an algorithm's diagnostic accuracy (e.g., sensitivity, specificity, AUC). It only states that "all acceptance criteria were met" for various engineering and biological tests (sterilization, biocompatibility, design verification, etc.).
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not mentioned, as this device is a physical catheter, not an AI/software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical diagnostic catheter.
7. The type of ground truth used: Not applicable in the context of an AI study. The document mentions "electrophysiological mapping" and "stimulation and recording" as the device's function.
8. The sample size for the training set: Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable.

The document describes the device, its intended use, and its similarities and differences to a predicate device (DECANAV Mapping Catheter K231312). It states that "Safety and performance testing applicable to the subject device was completed to ensure it performs as intended per product specifications and requirements/user needs." The list of completed testing includes:

• Sterilization validation and adoption
• Biocompatibility
• Design verification
• Packaging validation
• Design validation
• Pre-clinical animal testing

These are standard engineering and biological tests for a physical medical device, not studies of an AI's diagnostic performance. The document concludes that "No questions of safety or effectiveness are raised as a result of the testing. The subject device is as safe and effective as the predicate device and the subject device is considered substantially equivalent to the predicate device."

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