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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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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 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.

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

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

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

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

The provided text is a 510(k) summary for the Medtronic Bio-Medicus Life Support Catheter and Introducer. It details the device, its intended use, comparison to a predicate device, and performance testing. However, it does not describe acceptance criteria for an AI-powered device, nor does it detail a study proving such a device meets acceptance criteria.

The information provided pertains to a traditional medical device (a catheter and introducer) with a material formulation change, and the "performance testing" described is bench testing and biocompatibility assessments to demonstrate substantial equivalence to a predicate device. There is no mention of AI, machine learning, or software performance in terms of diagnostic accuracy or effect on human readers.

Therefore,Based on the provided text, it is not possible to describe the acceptance criteria or a study that proves a device meets acceptance criteria for an AI-powered device. The document pertains to a traditional medical device (catheter and introducer), specifically addressing a material change to a component (luer cap). There is no mention of AI, machine learning, or any form of algorithm-driven performance evaluation.

The "Summary of Performance Testing" section focuses on demonstrating substantial equivalence of the modified luer cap through risk-based testing, functional testing, and biocompatibility assessment, which are standard for physical medical devices.

Here's a breakdown of why the requested information cannot be provided from the given text:

• No AI Component: The device described (Bio-Medicus Life Support Catheter and Introducer) is a physical medical device. The document explicitly states the "device modification was made to the predicate device: Luer cap material formulation change (vented connector models)." This is a hardware change, not a software or AI change.
• No Diagnostic or Classification Task: The device's function is to facilitate extracorporeal support procedures (CPB, ECMO, ECLS), not to interpret data, diagnose conditions, or assist human readers in a diagnostic capacity.
• No Performance Metrics for AI: The "performance testing" described is for the physical integrity and biocompatibility of the luer cap ("functional testing and biocompatibility assessment"), which are not the types of metrics (e.g., sensitivity, specificity, AUC, human reader improvement) that would be used for AI device acceptance criteria.

To directly answer your request based on the provided text, I must state that the information is not present:

1. A table of acceptance criteria and the reported device performance: Not applicable. The document describes bench testing to qualify a material change, not AI performance metrics.
2. Sample sized used for the test set and the data provenance: Not applicable. The "test set" here refers to physical components for bench testing, not a dataset for AI evaluation.
3. Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth as typically defined for AI validation (e.g., for image interpretation) is not established for this physical device.
4. Adjudication method: Not applicable. There is no interpretive task requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This type of study is for AI-assisted human performance, which is not relevant to this device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable. There is no training set for an AI model.
9. How the ground truth for the training set was established: Not applicable.

In conclusion, the provided FDA document is for a traditional medical device (catheter) and does not contain any information related to AI acceptance criteria or AI performance studies.

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The Medtronic tubing and accessories sets for extracorporeal membrane oxygenation (ECMO) with Balance biosurface are indicated for use in ECMO and extracorporeal life support (ECLS) procedures for adult patients with acute respiratory failure or acute cardiopulmonary failure when other available treatment options have failed, and when continued clinical deterioration is expected or the risk of death is imminent.

The Medtronic Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance™ Biosurface ("eSets") contain components used to prepare an extracorporeal circuit for extracorporeal membrane oxygenation (ECMO) and extracorporeal life support (ECLS) procedures. The Base eSet Model BB22LSB contains a preassembled drainage and return loop, tubing assemblies, and other components used to prepare a basic extracorporeal circuit. The Accessory eSet Model BB22LSA contains nonstandard components to supplement the basic extracorporeal circuit, as needed per case and hospital protocols. This product is nonpyrogenic, is intended for single use, and has been sterilized using ethylene oxide. Maximum transit temperature: 50°C (122°F). Standard storage conditions are sufficient to safeguard the device. Store the device in the original packaging at room temperature in a dry place.

The provided text describes a medical device, "Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance™ Biosurface" and its substantial equivalence submission to the FDA. The information focuses on regulatory compliance, device characteristics, and performance data from pre-clinical bench studies.

Based on the provided text, the device is a Class II medical device (Extracorporeal Circuit And Accessories For Long-Term Respiratory/Cardiopulmonary Failure). The device does not involve AI. Therefore, the questions related to AI-specific performance criteria, test sets, ground truth, experts, and human-in-the-loop performance are not applicable.

Here's the information that can be extracted:

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

The acceptance criteria are derived from the "Special Controls" identified in 21 CFR 870.4100, as outlined by the FDA Final Order 81 FR 7451, February 12, 2016. The reported device performance is a statement of compliance with these controls, supported by various bench studies.

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

The text mentions "pre-clinical bench studies" for performance testing. Specific sample sizes for each bench test are not provided. The testing is conducted by Medtronic, a US-based company, implying the studies were conducted internally or through contracted labs, but the specific country of origin for the data is not explicitly stated. The studies are described as "pre-clinical bench testing," which are inherently controlled laboratory experiments, not reflecting a "retrospective or prospective" study design in the clinical sense.

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 physical medical device clearance based on bench testing of its mechanical, material, and functional properties, not an AI or diagnostic device requiring expert interpretation of results to establish ground truth.

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

Not applicable, as this refers to expert adjudication in diagnostic studies, not bench testing of a physical device.

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. The device does not involve AI.

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

Not applicable. The device does not involve AI.

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

For the non-clinical performance evaluation, the "ground truth" is defined by established engineering and medical device standards (e.g., ISO 10993-1 for biocompatibility) and the device's design specifications for properties like durability, tensile strength, pressure resistance, kink resistance, blood trauma, and coating coverage. The "truth" is whether the device meets these pre-defined physical and functional requirements.

8. The sample size for the training set

Not applicable. The device does not involve AI, therefore there is no "training set."

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

Not applicable. The device does not involve AI.

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The Affinity Fusion Oxygenator with Integrated Arterial Filter and 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 procedures up to 6 hours in duration. The Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface is designed to filter from the circuit microemboli larger than the specified micron size for periods up to six hours during cardiopulmonary bypass surgery.

The Affinity Fusion Cardiotomy/Venous Reservoir with Balance Biosurface is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to 6 hours in duration. The CVR is also intended for use during vacuum assisted venous drainage (VAVD) procedures. The Affinity Fusion Cardiotomy/Venous Reservoir with Balance Biosurface is also intended for use after open heart surgery to collect autologous blood from the chest and to aseptically return the blood to the patient for blood volume replacement.

The Affinity Fusion oxygenator with integrated arterial filter and Cortiva bioactive surface 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 Fusion oxygenator with integrated arterial filter and Cortiva bioactive surface is designed to filter from the circuit microemboli larger than the specified micron size for periods up to 6 hours during CPB surgery.

The Affinity Fusion Oxygenator is intended to be used in an extracorporeal perfusion blood circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration. The Affinity Fusion Oxygenator contains both an integrated arterial filter and integrated heat exchanger. The Affinity Fusion Oxygenator is a microporous, hollow-fiber, gas-exchange devices available with Cortiva BioActive Surface or Balance Biosurface bonded to the blood contacting surface of the integrated arterial filter is designed to filter from the circuit microemboli larger than the specified micron size from the circuit for periods up to six hours during cardiopulmonary bypass surgery. Some models of the Affinity Fusion Oxygenator are packaged with an Affinity Fusion Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface which is designed to be an integral part of a cardiopulmonary bypass circuit for use during cardiac surgery. The Affinity Fusion CVR is designed to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to six (6) hours in duration. Additionally, the Affinity Fusion CVR may be used during vacuum assisted venous drainage (VAVD) procedures and collect autologous blood from the chest and to aseptically return the blood to the patient for blood volume replacement during open heart surgery.

The provided text is a 510(k) Summary for the Medtronic Affinity Fusion Oxygenator System. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed acceptance criteria and performance data for a novel device. Therefore, much of the requested information about a specific study proving the device meets acceptance criteria is not explicitly provided in this type of regulatory submission.

However, I can extract the relevant information that is available and clarify what is not present.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format for performance metrics relevant to an "AI system" or "medical device performance" in the general sense, as typically sought in such a request. Instead, it refers to "predetermined requirements" and "improved bond performance" for specific components.

The "performance" referred to in this document primarily relates to the device meeting its intended function as an oxygenator and arterial filter during cardiopulmonary bypass. The summary states that "Operation and performance qualification... were completed" and that "the manufacturing process consistently produces product that meets predetermined requirements."

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

The document does not specify a "test set" in the context of an AI/algorithm evaluation. For the physical device modifications, it mentions "random sampling and statistical modeling" for the TMA seal, but no specific sample sizes or data provenance (country, retrospective/prospective) are provided for these manufacturing/design evaluations.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable to the provided document. The submission pertains to modifications of a physical medical device (oxygenator) and its manufacturing process, not to an AI/algorithm that requires expert-established ground truth from a dataset.

4. Adjudication Method

This information is not applicable to the provided document, as it does not describe an AI/algorithm evaluation requiring adjudication of ground truth.

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

This information is not applicable to the provided document. The submission is for a physical medical device and does not involve AI assistance to human readers.

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

This information is not applicable to the provided document. The submission is for a physical medical device and does not involve an AI algorithm.

7. Type of Ground Truth Used

This information is not applicable in the context of an AI/algorithm. For the physical device, the "ground truth" or verification is based on engineering specifications, performance testing (pressure integrity, burst, torque, insertion depth), and biocompatibility standards (ISO 10993).

8. Sample Size for the Training Set

This information is not applicable to the provided document, as it does not describe an AI/algorithm that would require a training set.

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

This information is not applicable to the provided document, as it does not describe an AI/algorithm.

Summary of what the document does provide:

The document describes a 510(k) premarket notification for the Affinity Fusion Oxygenator System, which involves modifications to a legally marketed predicate device (K203111). The core of the submission is to demonstrate substantial equivalence to this predicate device.

The study presented is not a classic "clinical trial" or "AI validation study" but rather a series of engineering and qualification tests to ensure that the modifications (specifically, changes to the Temperature Monitoring Adapter (TMA) insert component material and insertion depth, and different bioactive surfaces) do not alter the fundamental performance, safety, or efficacy of the device.

Key points from the document regarding "proof" and "acceptance":

• Proof of Meeting Acceptance Criteria: The proof is based on "Operation and performance qualification (OQ/PQ)" and "Design Characterization" activities. These activities evaluate various physical properties and manufacturing consistency.
• Acceptance Criteria (Implied): The implied acceptance criteria are that the modified device's performance (e.g., pressure integrity, burst, torque, insertion depth, biocompatibility) meets internal predetermined requirements and does not introduce new hazards compared to the predicate device. For example, the TMA bond evaluation "indicated improved bond performance relative to the current material," suggesting a performance target was met or exceeded. Biocompatibility was accepted based on the new material already being used in another cleared device and conforming to ISO 10993.
• Study Design: The study is a non-clinical engineering and bench testing evaluation rather than a clinical trial or AI performance study. It's focused on validating the impact of specific component changes.
• Conclusion: The manufacturer concluded, and the FDA agreed by clearing the device, that these modifications maintain substantial equivalence to the predicate device, meaning it is as safe and effective as a device already on the market.

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The Cardioblate™ Gemini™ Surgical Ablation Device is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy. The system is indicated for use, under direct or endoscopic visualization, in surgical procedures, including minimally invasive surgical procedures.

The Cardioblate Gemini surgical ablation device (Model 49351), figure 1 below, is a handheld, single-use, bipolar, radio-frequency (RF) ablation device for use in cardiac surgery. It has a saline irrigation system to deliver fluid at the contact point between the tissue and electrode to cool the tissue during RF energy delivery. This device is intended for intermittent operation.

Model 49260 of the Cardioblate Gemini surgical ablation device is intended for use with Cardioblate 68000 Generator (figure 2), whereas Model 49351 is intended for use with the Valleylab™ FT10 Energy(figure 3), whereas model 49260 is intended for use with Cardioblate 68000 Generator(figure 3). The devices are provided sterile and nonpyrogenic, are disposable, and are for single use only. They are sterilized using ethylene oxide.

The Cardioblate Gemini-s is a bipolar electrode device that transmits radio frequency energy, generated by an external generator, between the two electrodes. The device has dual linear electrodes, 6.3 cm in length, with integral fluid delivery to the electrodes. The Gemini-s device is port accessible, intended for open or closed chest procedures to ablate tissue through resistive heating due to radiofrequency energy passing through tissue. The device is designed to reproduce the Cox-Maze lesion pattern by creating linear transmural lesions in both atria of the heart during cardiac procedures.

The Gemini-s surgical ablation device has a flexible neck design that provides the physician with the ability to access various anatomies utilizing a neck curve through the full range from 0 to 180-degree configuration.

Once the electrodes are correctly positioned, the parallel jaws lock by squeezing the handle. The electrodes have full contact with the tissue and the locking mechanism must be fully engaged to ensure accurate transmurality readings. Simultaneous with the actuation of the trigger and jaw closure is the opening of the (normally closed) fluid path to start the flow of saline. The device automatically shuts off the saline when the jaws are open and when the device is not in use.

The provided document is a 510(k) summary for the Medtronic Cardioblate Gemini-s 49260 and 49351 Surgical Ablation Devices. It states that the submission is a "Special 510(k) Notification" and that modifications were verified through "design verification testing." It also indicates that the "DFMECA file was updated along with the Risk Management File to reflect the current status and risk evaluations at the device and system level."

However, the document does not describe specific acceptance criteria and the study that proves the device meets those criteria, nor does it provide the detailed information requested in points 1-9 of your prompt.

The document focuses on demonstrating substantial equivalence to predicate devices (K121767 and K200514) based on having the same:

• intended use/indications for use
• contraindications
• operating principle
• energy type
• mechanism of action
• radiofrequency generator and delivery system
• patient contacting materials
• shelf life
• sterilization process
• dimensions
• performance
• irrigation
• electrical characteristics
• packaging configuration and materials

The only changes mentioned are "IFU updates (new warning and updated directions for use)." The document concludes that these changes "do not arise from different technological characteristics of the devices or raise different questions of safety and effectiveness."

Therefore, based solely on the provided text:

No information is available regarding specific acceptance criteria, reported device performance data, study design details (sample size, data provenance, expert involvement, adjudication), comparative effectiveness studies (MRMC), standalone performance, or training set details as requested. The document refers to "design verification testing" broadly, but does not provide any specifics about these tests, the criteria used, or the results obtained.

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