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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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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 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 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 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. Bench studies were performed after device preconditioning including exposure (21 days) to simulated in vivo use conditions to demonstrate safety and reliability. Do not store the product above 25°C (77°F).

The provided document is a 510(k) summary for the Medtronic Bio-Medicus Life Support Catheter and Introducer. It describes a medical device, specifically a catheter and introducer for use in ECMO/ECLS, and assesses its substantial equivalence to a predicate device.

Crucially, this document is for a medical device (catheter and introducer), not an AI/ML device or a software device. Therefore, the standard acceptance criteria and study designs typically associated with AI/ML devices (e.g., standalone performance, MRMC studies, expert ground truth for image analysis, etc.) are not applicable to this submission.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the performance tests and regulatory requirements for a physical medical device. They are focused on mechanical properties, biocompatibility, sterility, shelf-life, and in vivo performance in an animal model, rather than AI/ML model performance metrics like accuracy, sensitivity, or specificity.

Therefore, I cannot populate the requested table and answer the questions in the context of an AI/ML device. The document does not contain information on:

• A table of acceptance criteria and reported device performance related to AI/ML metrics.
• Sample size for a "test set" or "training set" in the AI/ML sense.
• Number of experts for ground truth or adjudication methods for an AI/ML model.
• MRMC studies or effect sizes for human readers with/without AI assistance.
• Standalone algorithm performance.
• Type of ground truth (expert consensus, pathology, outcomes data) for an AI/ML context.
• How ground truth for a training set was established for an AI/ML model.

What the document does provide relevant to device acceptance is:

• Acceptance Criteria (Special Controls for the device type): These are outlined under "Comparison to Predicate (Special Controls)" on page 5 and include:
  • Technological Characteristics (geometry, design, compatibility)
  • Biocompatibility (ISO 10993-1:2009 compliance)
  • Sterility and Shelf-life (demonstrates sterility, integrity, durability, reliability)
  • Non-clinical Performance (bench, mechanical integrity, durability, reliability testing)
  • In vivo Evaluation (performance over 7-day duration of use)
  • Labeling (detailed summary of non-clinical and in vivo evaluations, instructions, compatibility, maintenance)
• Study Proving Device Meets Criteria (Summary of Performance Data): This is detailed on pages 5-6 under "Summary of Performance Data" and includes:
  • Pre-clinical bench testing: Used to verify performance characteristics.
    • 21-day Simulated use durability testing (Tensile strength after life conditioning, Pressure test after life conditioning)
    • Blood trauma testing
    • Kink testing
    • Birds Mouth testing
    • ID occlusion due to suture ring
    • Suture Collar Slide Force
    • Introducer removal and insertion forces
  • In vivo animal testing: 7-day GLP in vivo study.

In conclusion, the requested information pertains to AI/ML device validation, which is not the subject of this 510(k) submission. This document describes the testing and regulatory compliance for a physical medical device.

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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.

The Bio-Medicus Life Support catheter is a single-lumen catheter used to drain or reinfuse blood. These devices are sterile, nonpyrogenic, disposable, and intended for single use only. Do not store the product above 25°C (77°F).

This document is a 510(k) summary for the Bio-Medicus Life Support Catheter and Introducer. It is a premarket notification for a medical device seeking clearance from the U.S. FDA, not a study report that details acceptance criteria and device performance in the way a clinical trial or a deep learning algorithm validation would.

Therefore, the requested information elements related to AI models, ground truth establishment, expert adjudication, sample sizes for training/test sets, MRMC studies, or standalone algorithm performance are not applicable (N/A) to this device or document. This document pertains to a physical medical device (catheter and introducer) and its pre-clinical testing, not an AI/ML algorithm.

However, I can extract the information that is available about the "device performance" in the context of this 510(k) submission, interpreted as the pre-clinical bench and in-vivo animal testing conducted.

1. Table of Acceptance Criteria and the Reported Device Performance:

The document summarises that "Pre-clinical bench testing was used to verify the performance characteristics of this device. In vivo animal testing was also completed to establish substantial equivalence with the predicate device." It also lists the types of performance tests conducted.

However, the document does not provide specific acceptance criteria values or detailed quantitative results for each test. It only states that the data is "sufficient to demonstrate that the Medtronic Bio-Medicus Life Support Catheter and Introducer is substantially equivalent to the legally marketed predicate devices."

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

• Sample Size for Test Set: Not specified in this summary. The tests listed are "pre-clinical bench testing" and "in vivo animal testing," which implies physical testing samples rather than human clinical data sets. The exact number of catheters/introducers tested or animals used is not detailed.
• Data Provenance: Not specified in this summary. These are pre-clinical tests, so "country of origin of data" is not typically a relevant factor like it would be for a clinical trial with human subjects. The tests would have been conducted in a lab environment.
• Retrospective or Prospective: These would be considered prospective tests, as they are specifically conducted to evaluate the performance of the new device for regulatory submission.

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):

• N/A. This information is not relevant for a physical device's pre-clinical performance testing. There is no "ground truth" to be established by human experts in the context of catheter performance testing, such as flow rates, tensile strength, or blood trauma. These are typically measured by laboratory equipment and standardised protocols.

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

• N/A. Not applicable for pre-clinical bench or animal testing of a physical medical device. Adjudication methods are typically used in clinical trials or for subjective assessments by human readers/experts, which is not the case here.

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:

• N/A. This is a clearance for a physical medical device (catheter and introducer), not an AI/ML diagnostic or assistive tool. Therefore, no MRMC study, human readers, or AI assistance is involved.

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

• N/A. Not applicable for a physical medical device. This is relevant for AI/ML algorithms.

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

• N/A. For pre-clinical bench testing, the "ground truth" would be objective measurements obtained through calibrated equipment and validated test methods (e.g., specific flow rates under defined pressures, measured tensile strength, observed material characteristics under stress, analysis of blood components for trauma). For animal testing, it would involve direct physiological measurements or observation of biological responses, with controls. It's not "ground truth" in the sense of expert diagnosis or pathology.

8. The sample size for the training set:

• N/A. There is no "training set" in the context of a physical medical device. This term applies to machine learning algorithms.

9. 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 O-arm O2 Imaging System is a mobile x-ray system designed for adults and pediatric patients weighing 601bs or greater and having an abdominal thickness greater than 16cm, and is intended to be used where a physician benefits from 2D and 3D information of anatomical structures and objects with high x-ray attenuation such as bony anatomy and metallic objects.

The O-arm O2 Imaging System in compatible with certain image guided surgery systems.

The O-arm™ O2 Imaging System is a mobile x-ray system that provides 3D and 2D imaging. O-arm O2™ Imaging System was originally cleared for market under the original 510(k) K151000 and subsequently via special 510(k) K173664. The device is classified under primary product code OWB (secondary product codes OXO, JAA) ref 21 CFR 892.1650.

This submission for the O-arm™ O2 Imaging System 4.2.0 software release introduces following features:

• . "2D Long Film" Imaging Protocol (Intraoperative Radiographic Scan)
• . Gantry Rotor Angle and Tilt Angle Display
• User Access Enhancements ●

The O-arm™ O2 Imaging System consists of two main assemblies that are used together:

• The Image Acquisition System (IAS) ●
• The Mobile View Station (MVS) .

The two units are interconnected by a single cable that provides power and signal data. The IAS has an internal battery pack that provides power for motorized transportation and gantry positioning. In addition, the battery pack is used to power the X-ray tank. The MVS has an internal UPS to support its function when mains power is disconnected.

The O-arm™ O2 Imaging System operates off standard line voltage within the following voltages:

• VAC 100, 120 or 240 ●
• Frequency 60Hz or 50Hz ●
• Power Requirements 1440 VA

The provided text describes a 510(k) premarket notification for the Medtronic O-arm™ O2 Imaging System 4.2.0 software. This submission aims to demonstrate substantial equivalence to a predicate device (O-arm™ O2 Imaging System 4.1.0 software).

The key takeaway is that this submission modifies an existing imaging device, adding new features, rather than being a new AI/ML-driven diagnostic/CADe device that would typically have specific AI-driven acceptance criteria. Therefore, the "acceptance criteria" and "study" described in the document are primarily focused on demonstrating that the modified device remains safe and effective and performs as intended, similar to the predicate device, for its original intended use. There is no mention of AI/ML components in this submission.

Given this context, I will address the questions as they relate to the information provided about the device's modifications and the performance testing conducted to support its substantial equivalence.

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

Based on the provided document, the acceptance criteria are implicitly tied to demonstrating substantial equivalence to the predicate device and showing that the new features function as intended without introducing new risks. The "reported device performance" is described through various testing types.

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

The document does not specify exact sample sizes for all tests beyond general statements like "Usability Testing was conducted" or "The Image Quality Assessment... provides a quantitative image quality assessment."

The "O-arm™ Cadayer Image Pair Study" is the most relevant test mentioned for clinical utility:

• Sample Size: Not explicitly stated in the provided text.
• Data Provenance: Not explicitly stated (e.g., country of origin). It's likely a controlled, prospective study given the nature of a "Cadayer Image Pair Study" for comparing device versions. However, the specific type (retrospective vs. prospective) is not detailed.

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)

This information is not provided in the excerpt. For the "O-arm™ Cadayer Image Pair Study," it's highly probable that medical professionals (e.g., radiologists, surgeons) were involved in evaluating image utility, but their number and specific qualifications are not mentioned.

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

The document does not specify any adjudication methods for the "O-arm™ Cadayer Image Pair Study" or other performance tests.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• MRMC Study: The "O-arm™ Cadayer Image Pair Study" mentioned sounds like it could potentially involve multiple readers evaluating images. However, the document does not explicitly state that it was an MRMC study, nor does it describe its design in detail.
• AI Assistance: This device and the listed modifications do not involve AI/ML. The effect size of human readers improving with AI assistance is therefore not applicable and not discussed. The study's purpose was to compare the image utility of the new software version to the predicate software version of the imaging system itself.

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

• Standalone Performance: This question is typically asked for AI/ML algorithms. Since the O-arm™ O2 Imaging System 4.2.0 software does not contain an AI/ML algorithm within the scope of this 510(k) submission, this concept is not applicable. The device is an imaging system, and its performance is evaluated as a system (hardware and software combined), not as a standalone algorithm. The "2D Long Film" feature is described as an automated stitching process which is a traditional image processing function, not an AI/ML algorithm requiring separate "standalone" validation.

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

For the "O-arm™ Cadayer Image Pair Study," the "ground truth" would likely be the clinical utility or perceptual quality of the images as evaluated by medical professionals. This would closer resemble expert opinion/consensus on image quality and usefulness in a clinical context, rather than a definitive "true positive/negative" based on pathology or outcomes data, as it's a comparison of imaging system versions. However, the document doesn't explicitly define what "ground truth" means for this specific study.

8. The sample size for the training set

This device does not appear to utilize AI/ML algorithms that would necessitate a "training set." Therefore, this question is not applicable.

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

As there is no mention of a "training set" for AI/ML, this question is not applicable.

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