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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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Stedi Guidewire is intended for use to introduce and position catheters during interventional procedures within the chambers of the heart, including transcatheter aortic valve replacement (TAVR).

The Medtronic Stedi™ Extra Support Guidewire (herein after referred as Stedi Guidewire) is design for use to introduce and position catheters during interventional procedures within the chambers of the heart, including transcatheter aortic valve replacement (TAVR) procedures.

The Stedi Guidewire has a 0.035" diameter and is 275cm in length and composed of two primary components: a core, and a coil. Both components are made of stainless steel. The core wire component is a piece of stainless-steel wire which is ground on the distal end to fit into the coil and provide flexibility. The coil and the ground core are joined in two locations: a proximal bond and a distal weld. The distal end of the Stedi Guidewire is comprised of a preformed 540° curved tip is available in 2 sizes (3cm and 4cm). The Stedi Guidewire has a polytetrafluoroethylene (PTFE) coating applied to the entire length of the device in order to aid in lubricity.

The Stedi Guidewire is sterilized using ethylene oxide, nonpyrogenic, disposable, and for single use only.

Based on the provided FDA 510(k) clearance letter for the Medtronic Stedi Extra Support Guidewire, here's a detailed breakdown of the acceptance criteria and the study information.

It's important to note that the provided document is a 510(k) clearance letter, which focuses on demonstrating substantial equivalence to a predicate device. For medical devices like guidewires, the "studies" primarily consist of non-clinical (bench) performance testing to ensure the new device meets established safety and performance requirements, rather than clinical trials with human subjects in the way AI/software devices typically undergo. Therefore, many of the questions related to human readers, ground truth, and training sets are not applicable in this context.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Medtronic Stedi Extra Support Guidewire are demonstrated through various non-clinical (bench) performance tests. The FDA guidance "Coronary, Peripheral and Neurovascular Guidewires Performance Tests and Recommended Labeling (October 10, 2019)" was utilized to establish these tests. The conclusion states that the device "met all design input requirements based on the intended use."

Here's a table summarizing the types of tests conducted, which imply the acceptance criteria were met by the device's performance in these areas:

Study Details

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

   • Sample Size: The document does not specify exact sample sizes for each non-clinical test. However, it indicates "samples were analyzed according to predetermined acceptance criteria" for the various bench tests. In medical device bench testing, sample sizes are typically determined statistically to ensure sufficient power to detect differences or to demonstrate compliance with specifications.
   • Data Provenance: The data is generated from non-clinical bench testing performed by Medtronic Inc. This is not clinical data (i.e., no patient data is involved). It is prospective in the sense that the tests were designed and executed to evaluate the new device.

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

   • N/A. For this type of medical device (guidewire), ground truth is established through engineering specifications, material science standards (e.g., ISO standards), and performance benchmarks derived from predicate devices and historical data. It does not involve human expert consensus in the diagnostic sense. The "experts" are the engineers, material scientists, and testers who design and conduct the tests and interpret the results against predetermined specifications.

3. Adjudication method for the test set:

   • N/A. Adjudication methods like "2+1" or "3+1" are relevant for clinical studies or studies involving human interpretation of data (e.g., image analysis). For bench testing of a guidewire, results are quantitative or qualitative against predetermined engineering specifications, and "adjudication" typically refers to the pass/fail criteria established for each test.

4. 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:

   • No. This is a physical medical device (guidewire), not an AI/software device that assists human readers/clinicians, so an MRMC study is not applicable.

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

   • N/A. This is a physical medical device, not an algorithm. The "standalone" performance is the device's performance in the bench tests, independent of its use in a patient for the initial testing and FDA clearance.

6. The type of ground truth used:

   • The "ground truth" for each test is based on pre-established engineering specifications, material standards (e.g., ISO), and performance characteristics derived from the predicate device and FDA guidance documents. For example, the "ground truth" for tensile strength is a minimum force value, for biocompatibility it's compliance with ISO 10993, and for dimensions it's adherence to specified tolerances.

7. The sample size for the training set:

   • N/A. This is a physical medical device undergoing non-clinical testing, not a machine learning model, so there is no "training set."

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

   • N/A. As there is no training set for a physical device, this question is not applicable.

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The VitalFlow Console controls the speed of the VitalFlow Centrifugal blood pump during extracorporeal cardiopulmonary life support for adult patients with acute respiratory failure 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 VitalFlow Centrifugal pump is driven by the VitalFlow Motor Drive or the VitalFlow Emergency Handcrank.

The VitalFlow Console provides control of blood pumping through an extracorporeal circuit during extracorporeal membrane oxygenation (ECMO) procedures. The console powers the VitalFlow motor drive unit which provides rotation of the VitalFlow Centrifugal pump. Pump motor speed (RPM) can be adjusted by the user and flow and bubble detection is provided by an ultrasonic flow probe and displayed on the touchscreen. The touchscreen display allows users to set alarm limits for all measured parameters. The device will alarm visually and audibly when limits are exceeded. Status indicators, power/battery life and secondary RPM indicator are provided. Data download and data streaming from the console is available for ECMO circuit data only; no patient data is stored for output.

The provided FDA 510(k) clearance letter for the VitalFlow Console (K250199) generally describes the device and its indications for use, and makes a case for substantial equivalence to a predicate device. However, it does not provide specific details about acceptance criteria or the study that proves the device meets those criteria, particularly regarding AI or algorithm performance.

The core of this submission is about a software upgrade to an existing hardware device (VitalFlow Console) which enables software upgrades via USB. The FDA clearance is based on demonstrating that this change does not raise new questions of safety or effectiveness and maintains the existing performance characteristics. Therefore, the information typically requested in your prompt (e.g., sample size for test sets, number of experts for ground truth, MRMC studies, AI effect size, etc.) would primarily be relevant if the upgrade introduced a new AI/algorithmic component or significantly altered a measurement or diagnostic function that required such validation.

Based on the document, here's what can be extracted and what cannot:

Analysis of the Provided Document Regarding Acceptance Criteria and Performance Study:

The document explicitly states:
"Software verification (which included Cybersecurity) was used to verify the performance characteristics of the subject device with the upgrade over USB change."
And:
"Substantial equivalence of the performance characteristics is demonstrated through regression testing. The VitalFlow Console (Upgrade Over USB) continues to meet international standards for safety and has demonstrated effectiveness at maintaining the device performance."

This indicates that the performance study focused on regression testing to ensure the new software upgrade feature (upgrade over USB) did not negatively impact the existing performance of the device or introduce new risks, especially related to cybersecurity. It was not a de novo study to establish new performance metrics for an AI or algorithmic component, as the device's fundamental function (controlling a blood pump) remains unchanged, and the cleared modification is about the method of software updating.

Therefore, most of the specific questions about AI/algorithm performance studies (e.g., number of experts, ground truth type, MRMC study) are not applicable to the scope of this particular 510(k) submission.

Extracted Information:

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

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

• Sample Size: Not explicitly stated. The testing mentioned is "Software verification" and "regression testing." For software changes, the "test set" would typically refer to the test cases used in the verification and validation (V&V) activities. The document does not provide the number of test cases run or the duration/number of runs for regression testing.
• Data Provenance: Not explicitly stated. Given that it's regression testing for a software update on an existing device, it would likely involve internal testing data and potentially real-world data from the existing predicate device's operational environment. It's implicitly a combination of retrospective (based on existing device performance) and prospective (new tests for the updated software) testing, but the document doesn't specify. Country of origin not mentioned.

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

• Not Applicable / Not Stated. This type of information is typically required for studies establishing diagnostic accuracy or clinical effectiveness, often involving human readers/interpreters. This submission focuses on a software update for a control console, where "ground truth" would relate to the correct functioning of the software and hardware rather than clinical interpretation by experts. "Software verification" and "regression testing" would involve engineering and software quality assurance expertise to establish whether the device performed as specified.

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

• Not Applicable / Not Stated. Adjudication methods are relevant for subjective interpretations (e.g., medical images). For software verification and regression testing, failures are objective (e.g., a test case passes or fails, a function behaves as expected or not).

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:

• No. An MRMC study was not conducted as this submission is not about a diagnostic AI/CAD device or a device that assists human interpretation in a new way. It's about a software update for a control console.

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

• Not Applicable / Not Stated in this context. The "algorithm" here is the control software for the blood pump. Its "standalone" performance would be measured by its ability to precisely control the pump's RPM, detect flow, and manage alarms, which is what "software verification" and "regression testing" would assess. The document confirms these existing performance characteristics are maintained.

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

• Not Applicable in the traditional sense. For software verification and regression testing, the "ground truth" is the established functional and performance requirements of the device. This is confirmed through testing against design specifications, system requirements, and pre-existing performance benchmarks of the predicate device.

8. The sample size for the training set:

• Not Applicable. This is not an AI/Machine Learning device where a "training set" is relevant. The "software update" refers to a traditional software engineering change, not an AI model retraining.

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

• Not Applicable. As above, no training set for an AI model.

Summary of Device and Changes:

• Device: VitalFlow Console, controls a centrifugal blood pump for extracorporeal cardiopulmonary life support.
• Predicate: VitalFlow Console (K230364).
• Change in K250199: Enables software upgrades to be uploaded through the USB port (previously required Medtronic service personnel to open the console and connect laptops to individual boards).
• Regulatory Focus: Ensuring the new USB update feature does not compromise the safety or effectiveness of the device, particularly regarding cybersecurity and maintaining existing performance.
• Performance Study Type: Software verification and regression testing, indicating an engineering-focused validation rather than a clinical outcome or AI performance study.

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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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Streamline temporary leads and wires treat an irregular heartbeat during or after cardiac surgery by providing electrical stimulation to the heart.

• Models 6491, 6494, 6495, and 6500 are intended for atrial and ventricular use.
• Model 6492 is intended for atrial use only.
• Model 6491 and Model 6492 have smaller chest fixation coils and are appropriate for use in thin heart tissue and, in the case of Model 6491, a smaller chest cavity (for example, in a pediatric patient).

Each Streamline temporary pacing lead or wire comprises a lead body with a distal and a proximal segment. The distal segment has a separate electrode. A polypropylene monofilament (PP) fixation coil (except for model 6494) extends from the distal electrode end and is attached to a small, curved needle. The curved needle creates a channel in the myocardium for embedding the electrode. The PP fixation coil provides a means of securing the electrode in place. The proximal lead body terminates into a chest needle used to penetrate the chest wall, followed by pulling the proximal portion of the lead through the chest. The device is supplied sterile and intended for single use only.

The provided text describes a 510(k) premarket notification for Medtronic Streamline Temporary Pacing Leads and Wire. The submission is a "Special 510(K)" which indicates changes to a previously cleared device. The focus of the changes and the study conducted is related to Magnetic Resonance Imaging (MRI) compatibility.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

The document does not explicitly state "acceptance criteria" in a tabular format with corresponding "reported device performance" in the way one might see for a diagnostic AI device. Instead, the "acceptance criteria" are implied by adherence to established ASTM standards for MRI safety, and the "reported device performance" is the conclusion that the devices are "MR Conditional" under specific conditions.

Specific MR Conditions (from IFU - effectively performance details):

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

The document specifies "Each Streamline Model" was tested in "two configurations (bundled and extended)". The exact number of individual devices or test samples per model is not provided.

The testing is described as "nonclinical MRI testing" which implies a controlled laboratory environment rather than patient data. Therefore, data provenance is "laboratory setting" and not retrospective or prospective from human subjects.

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 study described is nonclinical testing of physical devices (MRI compatibility) against engineering standards, not a diagnostic assessment where expert ground truth would be established. The "ground truth" here is the physical measurement against an engineering standard.

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

This information is not applicable/provided. Adjudication methods like 2+1 or 3+1 are typically used for medical image interpretation studies where expert consensus is needed. For nonclinical engineering tests, the results are typically objectively measured against pre-defined thresholds from standards.

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 provided and is not applicable to the type of device and study presented. The Streamline Temporary Pacing Leads are physical medical devices, not an AI software diagnostic tool.

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

This information is not provided and is not applicable. The device is a physical pacing lead, not an algorithm.

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

The "ground truth" for this nonclinical study is the physical measurement against established engineering standards (ASTM F2192-19e2 for RF Heat, and ASTM F2052-15w for Force and Torques).

8. The sample size for the training set

This information is not applicable/provided. The study is nonclinical testing of physical devices, not a machine learning model, so there is no "training set."

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

This information is not applicable/provided as there is no training set.

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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 VitalFlow Set with Balance Biosurface is indicated for respiratory/cardiopulmonary support up to 48 hours that provides assisted extracorporeal circulation and physiologic gas exchange (oxygenation) of the patient's blood in adults with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent.

VitalFlow Sets with Balance™ Biosurface contain components used to prepare an extracorporeal circuit for ECMO procedures. The components include the VitalFlow Tubing Sets packaged together with the legally marketed Nautilus VF Oxygenator and VitalFlow Centrifugal Pump as a standard kit. The components are connected together to prepare an extracorporeal circuit for ECMO procedures.

The VitalFlow Tubing Set contains a preassembled drainage and return loop "ECMO Circuit," tubing assemblies, and other components used to prepare a basic extracorporeal circuit. The tubing assembly is provided pre-connected to the inlet of the VitalFlow Centrifugal Pump. The "Priming Circuit" contains components to supplement the basic extracorporeal circuit, as needed per hospital protocols for setting up the ECMO circuit. A venous reservoir and one-way valve are included in the priming circuit to facilitate ease of priming the ECMO circuit.

This product is nonpyrogenic, is intended for single use, and has been sterilized using ethylene oxide.

The Medtronic VitalFlow™ Set with Balance™ Biosurface is indicated for respiratory/cardiopulmonary support up to 48 hours for adults with acute respiratory or cardiopulmonary failure. The acceptance criteria and supporting study details are as follows:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the VitalFlow Set with Balance Biosurface primarily focus on demonstrating substantial equivalence to a predicate device and ensuring acceptable performance through pre-clinical bench testing and real-world clinical evidence. While explicit numerical acceptance criteria for many mechanical and biocompatibility tests are not provided in the summary, the overall conclusion is that the device "does not raise different questions of safety or effectiveness" compared to the predicate. The clinical summary provides comparative performance data for complications.

• Oxygenator Failure (Prevalence): VitalFlow Set: 4.6% (9/195) vs. All other ECMO Systems: 8.0% (4878/61176).
• Oxygenator Failure (Rate per 1000 Hrs): VitalFlow Set: 0.30 vs. All other ECMO Systems: 0.35.
• Pump Failure (Prevalence): VitalFlow Set: 2.6% (5/195) vs. All other ECMO Systems: 0.6% (368/61176).
• Pump Failure (Rate per 1000 Hrs): VitalFlow Set: 0.16 vs. All other ECMO Systems: 0.02.
• Thrombosis/Clots in Circuit Component: VitalFlow Set: 1.0% (2/195) vs. All other ECMO Systems: 2.1% (1272/61176).
  Hemolysis:
• Moderate or Severe Hemolysis: VitalFlow Set: 2.1% (4/195) vs. All other ECMO Systems: 5.2% (3197/61176).
  (Other specific complication rates are listed in the table in the document and generally show comparable or lower rates for VitalFlow Sets, with the exception of pump failure prevalence and rate). |
  | Labeling | Include detailed summary of non-clinical evaluations, instructions for anticoagulation, circuit setup, performance, and maintenance. | Instructions for Use include the required details. |

2. Sample Size for Test Set and Data Provenance

• Sample Size for Clinical "Test Set": 195 patients (VitalFlow Set group).
• Data Provenance: The data comes from a "summary of real-world evidence (195 reports) of the clinical experience with the VitalFlow Set from the ELSO Registry." This indicates the data is retrospective and derived from a registry, which typically collects data from multiple institutions/countries. The specific country of origin is not explicitly stated but the ELSO Registry is an international organization.

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

The document does not specify the number of experts or their qualifications for establishing ground truth for the clinical complication data from the ELSO Registry. Registry data often involves reporting by treating clinicians, and data validation/adjudication processes vary by registry but are not detailed here.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the clinical complication data from the ELSO Registry. It is implied that the reported complication rates are based on the data as collected and recorded within the registry.

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

No MRMC comparative effectiveness study was mentioned. The study evaluates the device's performance in a real-world setting rather than comparing human readers with and without AI assistance.

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

This question is not applicable as the device is a medical device (extracorporeal circuit components) and not an AI algorithm. Its performance is inherent to its mechanical and biological functions, not an algorithm's output.

7. Type of Ground Truth Used

The ground truth for the clinical performance data (complication rates) is based on real-world outcomes data collected and reported to the ELSO Registry. For the pre-clinical tests, the ground truth would be established by validated test methods and engineering specifications.

8. Sample Size for the Training Set

This question is not applicable as the device is not an AI algorithm requiring a training set. The "training set" concept does not apply to the development and evaluation of this type of medical device.

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

This question is not applicable for the reasons stated above.

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Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541);
The AFFINITY NT Integrated CVR Membrane Oxygenator with Plasma Resistant Fiber is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood, cool or warm the blood and oxygenate and remove carbon dioxide from the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.

Indications for Use(541B)
The Affinity NT oxygenator with Balance biosurface is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass (CPB) procedures up to 6 hours in duration. The Affinity NT cardiotomy/venous reservoir (CVR) is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine CPB procedures up to 6 hours in duration.

The Affinity NT Oxygenator with /without Balance Biosurface is a sterile membrane Oxygenator with plasma resistant fiber. It is a single-use gas exchange device with integral stainless-steel heat exchanger. Models 541 and 541B include a cardiotomy/venous reservoir.

The Luer cap 1140008-503 that is the 'subject' of this special 510(k) serve as protection of the Luer Access Port. This port can be used to prime the circuit or connect to another support device with a luer connector.

This is a 510(k) summary for a medical device change, not a study proving device meets acceptance criteria. Here's a breakdown of why and what information is provided:

This document describes a "Special 510(k) submission" for a change in a small component (a luer cap) within an already cleared medical device (Affinity NT Oxygenator). It is not a standalone study proving the device meets general acceptance criteria for a new device. The purpose of this submission is to demonstrate that the change to the luer cap does not adversely affect the safety and effectiveness of the previously cleared device, maintaining substantial equivalence to the predicate.

Therefore, most of the requested information (sample sizes, expert consensus, MRMC studies, etc.) is not applicable or not provided in the context of this specific regulatory submission.

Here's how to address the prompt based on the provided text:

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

The document doesn't explicitly define acceptance criteria in a quantitative table form for the overall device's performance. Instead, it focuses on demonstrating that the change to the luer cap does not negatively impact the device's functionality. The "acceptance criteria" for this specific change are implicitly tied to maintaining the original device's performance and safety.

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

• Test Set Sample Size: Not explicitly stated for specific tests related to the luer cap change. The document mentions "Risk-based testing and evaluations," suggesting a sample size appropriate for these specific tests, but the number is not provided.
• Data Provenance: Not specified. Given it's a regulatory submission by Medtronic, it's presumably internal testing conducted to support the change.

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 is a technical validation of a component change, not an evaluation requiring expert clinical interpretation for ground truth.

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

Not applicable. This is not a study requiring adjudication of interpretations.

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-enabled device or an MRMC study.

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

Not applicable. This is not an algorithm-only device.

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

For the luer cap change, the "ground truth" is established through engineering and biological testing:

• Biocompatibility: Conformance to ISO 10993-1:2018 standards, which involves specific chemical and biological tests. The "ground truth" here is the pass/fail result based on laboratory analysis against these standards, leveraged from a previous clearance (K240534) for a higher-risk product.
• Functionality: Direct measurements and observations (dimensional comparison, torque removal, pressure integrity) against established engineering specifications.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable.

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