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Model BB811 and Model BB811-NS: 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.

Model BB841: Oxygenator with Integrated Arterial Filter: 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. Cardiotomy/Venous Reservoir: 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 Balance Biosurface (BB811), Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (BB841), and Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (Non-Sterile) (B811-NS) are collectively referred to as the Affinity Fusion Oxygenator in the summary. 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 Balance Biosurface bonded to the blood contacting surface of the device. 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 discusses the Affinity Fusion Oxygenator and its acceptance criteria, specifically focusing on the addition of an alternate hollow fiber supplier.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

Biocompatibility Testing:

*Note on "Pressure Integrity": Devices conditioned only to factors significant for leaks (per Two Proportion statistical test).

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

The document does not explicitly state the sample sizes for the test sets (number of oxygenator units tested) for design verification or biocompatibility. It also does not specify the country of origin of the data or whether the studies were retrospective or prospective. The nature of the tests (engineering performance and biocompatibility) suggests these were primarily laboratory-based prospective tests.

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 applicable to the type of device and testing described. The "ground truth" for a medical device like an oxygenator is established through objective performance measurements and standardized biocompatibility tests, not subjective expert assessment as would be the case for image interpretation or diagnosis.

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

This information is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies or studies involving subjective human interpretation (e.g., radiology reads) to resolve discrepancies. The tests described here are objective performance and safety 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:

This is not applicable. The device is an oxygenator, not an AI-powered diagnostic tool requiring human reader studies.

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

This is not applicable. The device is an oxygenator, not an algorithm.

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

The ground truth for this device is based on:

• Engineering specifications and standards: For performance characteristics like O2 Transfer, CO2 Transfer, Pressure Drop, Burst, Filtration Efficiency, etc. "PASS" implies meeting predefined, objective measurable criteria.
• International standards for biocompatibility (ISO 10993-1:2018): For tests like cytotoxicity, sensitization, genotoxicity, hemocompatibility, etc. "PASS" means meeting the established safety thresholds for these biological endpoints.

8. The sample size for the training set:

This is not applicable. This is not an AI/machine learning device that requires a training set. The "study" described is a series of laboratory-based design verification and biocompatibility tests.

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

This is not applicable, as there is no training set for this type of device.

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The autoLog IQ autotransfusion system and Medtronic wash kit are in the collection, concentration, washing, and reinfusion of autologous blood. Areas of application may include, but are not limited to, the following: · Surgeries including general, cardiovascular, orthopedic, vascular, plastic/reconstructive, obstetric/gynecologic, and neurological · Postoperative treatment areas

The autoLog IQ Autotransfusion System is used to collect autologous blood peri-operatively and post-operatively into a collection reservoir with an appropriate amount of anticoagulant. The system refers to the instrument (the subject of this submission); disposable devices are also required to operate the system: the Medtronic wash kit, collection reservoir, and suction line. This autologous blood is first filtered through the prefilter in the collection reservoir, and then processed by centrifugation, separating the red cells from the plasma. Contaminating debris is subsequently washed out by the introduction of normal saline in a wash cycle. The resulting packed red cells, suspended in normal saline, are pumped to a transfer bag, and may be reinfused to the patient. The autoLog IQ Autotransfusion System (also referred to as the "instrument" or the "system") is not patient contacting. However, the disposable devices needed to operate the system - the Medtronic wash kit, collection reservoir, suction line - are patient contacting, and are the same disposables used by the predicate autoLog Autotransfusion System device (K093535). The collection and concentration/washing of patient blood are handled independently by the system. The collection process requires the installation of a disposable reservoir and the activation and use of the integrated vacuum pump, which is built into the system, or an external vacuum source. The system has an integrated internal regulator which ensures safe vacuum levels. The blood is aspirated through a disposable collection suction tip/cannula and disposable suction line to the reservoir. Anticoagulant is delivered at the cannula through the anticoagulant line. The system's concentration/washing process requires the installation of the Medtronic wash kit and the activation and use of a pump, valve, and centrifuge. When the self-start switch registers a sufficient quantity of blood in the reservoir, the system automatically starts operation. The processing includes one cycle of filling the centrifuge bowl and concentrating the red cells (while transferring effluent waste to the waste bag), one cycle of washing the red cells with saline and one cycle of transferring the packed, washed red cells to the sterile holding bag. The pump pulls blood from the reservoir into the centrifuge bowl until the optical sensor detects a full bowl; then the roller pump stops and the wash solution is pumped into the packed red cell mass. After the washing cycle, the pump transfers the washed, packed red cells to the holding bag. Medical personnel complete the final reinfusion of the collected and washed blood to the patient. Hospital personnel are instructed to dispose the waste bag (containing plasma waste, saline, and contaminating debris) in accordance with hospital guidelines.

Here's an analysis of the acceptance criteria and study information for the Medtronic autoLog IQ Autotransfusion System, based on the provided text:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It does not contain a detailed report of a specific clinical study with granular data on patient outcomes, expert consensus for ground truth, or statistical power calculations typically found in a full clinical trial report. The "testing" referred to is primarily verification and validation testing for engineering and performance against a predicate device, not a human reader study or a standalone clinical effectiveness study.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" for the device's performance in terms of clinical outcomes or specific blood parameter thresholds. Instead, it relies on demonstrating that the device "passed" a series of verification and validation tests, and its performance is "substantially equivalent" to the predicate device. For the "Blood Washing Performance," which is the most relevant to the device's function, the reported performance is simply "Pass."

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

The document does not specify a "test set" in the context of a clinical study involving patients or human samples with a defined ground truth for evaluation. The testing described (Software, Enclosure, Cleanability, etc.) is engineering verification and validation. The "Blood Washing Performance" test would likely use simulated blood or animal blood, but the sample size and specific provenance are not detailed. It is not a retrospective or prospective clinical study on human patients.

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

This information is not provided because the type of testing described does not involve expert-adjudicated ground truth as would be relevant for image analysis or diagnostic AI. The "ground truth" for engineering tests would be defined specifications or measurements against known standards.

4. Adjudication Method for the Test Set

Not applicable, as no expert adjudication for a "test set" (in the clinical sense) is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study involving human readers or clinicians is not mentioned in this document. The device automates a process (autotransfusion), rather than assisting human interpretation (like an AI for radiology). Therefore, the concept of "human readers improving with AI vs without AI assistance" does not apply to this device.

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

Yes, in a sense, the primary evaluation of the autoLog IQ Autotransfusion System is its standalone performance in collecting, concentrating, and washing blood. The listed tests, including "Blood Washing Performance," are evaluations of the algorithm/system only without human intervention during the blood processing steps. The human interaction comes at the "setup and breakdown" and reinfusion stages, but the core function is automated.

7. The Type of Ground Truth Used

For the "Blood Washing Performance" and other engineering tests, the ground truth would be based on:

• Defined engineering specifications: For parameters like vacuum levels, pump rates, and sensor function.
• Laboratory measurements: For blood washing performance, this would likely involve analyzing the post-processed blood for red cell concentration, residual plasma, and contaminant removal, comparing these measurements against predetermined acceptable ranges or against the performance of the predicate device.
• Predicate device performance: The overall "ground truth" for regulatory submission is that the device is "substantially equivalent" in performance to the legally marketed predicate device (autoLog Autotransfusion System, K093535).

8. The Sample Size for the Training Set

This concept is not applicable here. The autoLog IQ Autotransfusion System is not an AI/machine learning model that undergoes a "training phase" with a dataset in the typical sense. It's an automated medical device with programmed functions and controls.

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

Not applicable, as there is no "training set" for this device in the context of AI/machine learning.

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The AF100 is indicated for use in cardiopulmonary bypass procedures up to 6 hours in duration for the removal of particulate and gaseous microemboli.

The AF100 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 AF100 with Carmeda BioActive Surface (CB851) is coated with a nonleaching bioactive surface (heparin) to enhance blood compatibility and provide thromboresistant blood-contacting surfaces. The device is single-use, nontoxic, nonpyrogenic, supplied STERILE in individual packaging. The AF100 is sterilized by ethylene oxide.

The provided text is a 510(k) Summary for a medical device (Affinity® AF100 Arterial Filter with Carmeda® BioActive Surface) seeking a determination of substantial equivalence to a predicate device. This type of regulatory submission in the U.S. FDA context focuses on comparing a new device to an already legally marketed one, rather than presenting a detailed study proving the new device's independent efficacy against acceptance criteria in the way clinical trials for novel devices do.

Therefore, many of the requested elements pertaining to a clinical study (like sample size for test sets and training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this type of document because it describes pre-clinical bench testing for substantial equivalence, not a clinical effectiveness study.

Here's a breakdown of the information that is available and a note on what is not:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists "performance tests" that were conducted to demonstrate substantial equivalence to the predicate device. However, it does not specify quantitative "acceptance criteria" for each test or detailed "reported device performance" against those criteria. It only states that these tests were conducted to "verify the performance characteristics."

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

• Sample Size for Test Set: Not applicable. Performance was verified through pre-clinical bench testing, not a clinical test set with human data. The document does not specify the number of devices or trials performed for each bench test.
• Data Provenance: Not applicable, as this was pre-clinical bench testing. There is no mention of country of origin or whether it was retrospective or prospective in a clinical sense.

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

• Not applicable. This was pre-clinical bench testing of a physical device, not an AI/diagnostic device requiring expert ground truth for image or data interpretation.

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

• Not applicable. This was pre-clinical bench testing, not a study involving human readers or expert adjudication.

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

• Not applicable. This device is an arterial filter for cardiopulmonary bypass, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.

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

• Not applicable. This device is a physical arterial filter, not an algorithm.

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

• For pre-clinical bench testing, "ground truth" would equate to established engineering and material science standards and measurement techniques for evaluating physical properties (e.g., pressure, filtration size, material strength). The document implies that industry standards and validated methods were used to conduct the described performance tests, but it does not detail them.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Not applicable. This is not an AI/machine learning device that requires a training set.

Summary of Device Acceptance & Study:

The "acceptance criteria" for this submission are primarily demonstrating substantial equivalence to the predicate device (Affinity Arterial Filter with Carmeda® BioActive Surface (20µm) Model CB353, K001138).

The study that "proves the device meets the acceptance criteria" is a series of pre-clinical bench tests. These tests were conducted to verify that despite a change in housing material (from polycarbonate to Bisphenol A-free (BPA-free) copolyester), the new device maintains similar technological characteristics, operating principles, design features, and performance as the predicate device. The conclusion of the submission states: "Pre-clinical bench testing was used to verify the performance characteristics of this device. Clinical testing was not required to establish substantial equivalence with the predicate devices."

The FDA's letter confirms that based on the provided information, the device is deemed "substantially equivalent" to legally marketed predicate devices, meaning it meets the regulatory requirements for market clearance under the 510(k) pathway.

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The MiRCSP cannula is intended for use during cardiopulmonary bypass for the delivery of cardioplegia retrograde through the coronary sinus for up to six hours. It is indicated for use during cardiac surgery for median sternotomy or minimally invasive (mini-sternotomy or right thoracotomy) access using direct, echocardiographic or fluoroscopic visualization techniques.

MiRCSP Cannulae are single-use, sterile, nonpyrogenic devices designed to deliver cardioplegia through the coronary sinus in a retrograde manner, for periods up to six hours during cardiopulmonary bypass surgery. These devices are available in models that feature manual and auto inflating cuffs, and contain an aid in verification of cannula placement. The removable malleable stylet is used to provide stiffness and shape to the cannula body during insertion and features additional deflectability and rotation at the distal cannula tip to aid in placement into the coronary sinus. These cannulae have features that make them easier to use when minimally invasive surgical approaches are utilized (i.e., mini-sternotomy and right thorocotomy).

This document describes the 510(k) summary for the Medtronic MiRCSP (Minimally Invasive Retrograde Coronary Sinus Perfusion) Auto and Manual Inflate Cannula. This is a premarket notification for a medical device seeking substantial equivalence to already marketed devices, rather than a study proving performance against new acceptance criteria. Such 510(k) submissions typically rely on performance data demonstrating that the new device is as safe and effective as existing, legally marketed predicate devices, without requiring extensive new clinical trials.

Therefore, the information you requested regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for clinical performance studies, are not directly applicable or available within this 510(k) summary in the comprehensive format you requested. The submission focuses on demonstrating substantial equivalence through bench and animal testing, and comparison of technological characteristics to predicate devices.

However, I can extract and infer some information based on the document's content:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a substantial equivalence submission, there isn't a table of new acceptance criteria established for this specific device. Instead, the performance characteristics were compared to existing cleared Medtronic RCSP models. The "acceptance criteria" are implicitly that the MiRCSP Cannulae perform equivalently to the predicate devices in the tested areas.

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

• Test Set: Not explicitly stated. The document mentions "Bench and animal testing" but does not provide specific numbers for these tests or the origins of data (e.g., country).
• Data Provenance: The tests were conducted internally by Medtronic ("Medtronic has demonstrated..."). The nature of the testing (bench and animal) suggests controlled laboratory environments.

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. Since clinical testing was "not required," there wouldn't have been a panel of clinical experts establishing ground truth in the traditional sense for this submission. Performance was likely evaluated against engineering specifications and comparisons to predicate device performance.

4. Adjudication Method for the Test Set:

• Not applicable/Not described. This typically relates to expert review of clinical data, which was not the primary basis of this 510(k) submission.

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 device is a physical medical instrument (cannula), not an AI-powered diagnostic or decision-support system. Therefore, MRMC studies and "human readers with/without AI assistance" are not relevant to this submission.

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

• Not applicable. This device does not involve algorithms in the sense of AI or image analysis.

7. The type of ground truth used:

• For the performance tests:
  • Flow Rate Versus Pressure Drop: Likely engineering specifications and comparison to predicate device performance data.
  • Visibility Under Ultrasound and Fluoroscopic Visualization Techniques: Visual assessment by trained personnel (possibly engineers or technicians) in a controlled environment, likely compared to known visibility characteristics of predicate devices.
  • Structural Integrity: Engineering tests (e.g., tensile strength, burst pressure) against predetermined specifications.
  • Biocompatibility Testing: Adherence to established ISO standards for medical device biocompatibility.
• The "ground truth" here is primarily based on engineering specifications, regulatory standards, and comparative performance data of predicate devices, rather than clinical outcomes or expert consensus on patient cases.

8. The Sample Size for the Training Set:

• Not applicable. This is not an AI/machine learning device, so there is no "training set" in that context. The device's design was likely informed by existing Medtronic RCSP models and engineering principles.

9. How the Ground Truth for the Training Set was Established:

• Not applicable, as there is no training set for an algorithm. The "ground truth" for the design of the device is implicitly based on established surgical practices, the clinical needs for minimally invasive procedures, and the proven performance of predicate devices.

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The Medtronic centrifugal blood pumping system is intended to pump blood through the extracorporeal bypass circuit for extracorporeal support for periods appropriate to cardiopulmonary bypass procedures (up to 6 hours).

The Bio-Console® 560 is an extracorporeal blood pumping console consisting of a Base Unit with a display and a User Interface (touch screen) with integrated flow control knob. In order to perform its intended function, the Bio-Console 560 is compatible with the Medtronic External Drive Motor, disposable Centrifugal Pump, Flow Transducer with disposable Insert, and Emergency Handcrank.

The provided text is a 510(k) summary for the Medtronic Bio-Console® 560. This document primarily focuses on demonstrating substantial equivalence to a predicate device based on minor software modifications and provides no information about a clinical study, acceptance criteria, or performance data for the device. The "Test Data" section explicitly states: "Software verification and validation testing confirms that the function of the Bio-Console 560 and its software-controlled functional characteristics are substantially equivalent to the predicate device. All test data obtained satisfied the documented product and performance specifications." This indicates that the assessment was based on engineering and software verification, not clinical performance with human data.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert involvement, and ground truth establishment cannot be extracted from the provided text. The device is a "cardiopulmonary bypass pump speed control," which is a piece of medical equipment, not an AI/ML algorithm that predicts or analyzes medical data and thus does not typically involve the kinds of studies described in your request (e.g., MRMC studies, standalone AI performance).

To directly answer your specific points based only on the provided text, without making assumptions:

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

   • Acceptance Criteria: Not explicitly stated in terms of clinical performance metrics. The document implies that the acceptance criteria were based on software verification and validation satisfying "documented product and performance specifications" for substantial equivalence to the predicate device.
   • Reported Device Performance: Not reported in clinical terms. The document states "All test data obtained satisfied the documented product and performance specifications," but these specifications and the test results are not detailed.

2. Sample sized 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 applicable/not provided. No clinical test set involving patient data is mentioned. The testing focused on software verification and validation.
   • Data Provenance: Not applicable/not provided.

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/not provided. No clinical ground truth was established as no clinical study is described. The "ground truth" for software validation would be adherence to design specifications, which is typically assessed by engineers and testers.

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

   • Not applicable/not provided.

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 MRMC study was done or mentioned. This device is not an AI diagnostic or assistance tool for human readers.

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

   • Not applicable in the context of typical AI device evaluation. The "software verification and validation testing" could be considered an "algorithm only" test for the embedded control software, but it's not a standalone diagnostic algorithm in the sense of modern AI.

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

   • The "ground truth" for the software modifications would be the functional requirements and design specifications of the device.

8. The sample size for the training set:

   • Not applicable/not provided. This is not an AI/ML device that requires a training set of data.

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

   • Not applicable/not provided.

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These cannulae are intended for use in perfusion of the ascending aorta during short term (6 hours or less) cardiopulmonary bypass.

The EOPA 3D™ Cannulae have clear flexible, thin wall wire-wound PVC bodies with a tapered distal tip. The proximal end of the cannula includes a 3/8" (0.95 cm) vented or non-vented connector. The vented connector allows air to be vented from the cannula before connection to the perfusion line. The EOPA 3D™ Arterial Cannula tip has three integrated flutes which help diffuse and disperse blood flow. The cannula body has multiple depth markings, catalog code, and French size marked. Overall cannula length is 12.5" (31.8 cm). It will be available in 20 and 22 Fr sizes and either uncoated or with a Carmeda coating.

The provided text describes a 510(k) summary for the EOPA 3D™ Arterial Cannula. It outlines the device, its indications for use, and a comparison to predicate devices. However, the document does NOT contain information about specific acceptance criteria or a detailed study proving the device meets those criteria in the way typically expected for a software or AI/ML device.

This submission is for a physical medical device (an arterial cannula), and the performance data described is "In vitro visual and functional testing" including "blood trauma testing." The criteria for substantial equivalence are based on "design, test results, and indications for use" compared to predicate devices.

Therefore, many of the requested fields are not applicable to this type of device submission as the prompt's questions are geared towards AI/ML device studies.

Here's an analysis based on the provided text, highlighting where information is unavailable or not applicable:

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

Note: The document states "In vitro visual and functional testing was used to establish the performance characteristic of the changes from the predicate devices This includes visual, functional, and blood trauma testing." It doesn't provide specific numerical acceptance criteria or detailed results, but concludes that the device is "substantially equivalent."

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: Not specified in the document.
• Data Provenance: Not specified, but generally, in-vitro testing for physical devices like this is conducted in a controlled lab environment by the manufacturer. It's not "retrospective or prospective" data in the context of patient studies.

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. "Ground truth" in the context of expert consensus is typically relevant for interpretative tasks, often in AI/ML or imaging. For a physical device's in-vitro testing, performance is measured against physical specifications or established benchmarks, not expert interpretation.

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

Not applicable. Adjudication methods are relevant for resolving discrepancies in expert interpretations, not for physical device testing.

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/ML device or an imaging interpretation device.

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

Not applicable. This is a physical medical device, not an algorithm.

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

• Type of "Ground Truth": The performance was assessed against established physical and functional parameters of the predicate device and engineering specifications. This is more akin to compliance with product design specifications and direct measurement (e.g., flow rates, material properties, visual inspection) rather than clinical ground truth from patients.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI/ML model that requires a training set.

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

Not applicable. This is a physical device, not an AI/ML model that requires a training set and associated ground truth.

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The percutaneous cannula is for use by trained physicians only, to cannulate vessels, perfuse vessels or organs in a patient for cardiopulmonary bypass circulation. Standard surgical or percutaneous insertion techniques can be employed. This product is intended for use up to six hours or less

The Biomedicus Femoral Cannula and Introducer Set include the new Bio-Medicus Femoral Venous Cannula and Introducer. The Cannula are one piece, wire wound bodies with basket type holes. Insertion depth marks aid in positioning the Cannula. All are supplied sterile, and non-pyrogenic and are single use. This new Biomedicus Femoral Venous Cannula and Introducer Set consists of a longer flexible cannula with multiple side holes, a longer introducer, an improved introducer to cannula tip transition and 3/8" barbed connector. The cannulae are available in 19 Fr, 21 Fr and 25 Fr sizes. The Cannula are intended to be used to cannulate vessels, perfuse vessels or organs and/or connect with accessory extracorporeal equipment. The Cannula Introducer is intended to facilitate proper insertion and placement of the appropriate sized Cannula within the vessel for cardiopulmonary bypass. The overall product length is approximately 30.125 inches. The device is sterile, nonpvrogenic and disposable, and is intended for short-term single use. The product will be available in both Carmeda coated and uncoated versions.

The provided 510(k) summary (K052524) describes a venous cannula and introducer set, which is a Class II medical device. The submission focuses on demonstrating substantial equivalence to a predicate device (K884129) rather than establishing new performance criteria through a standalone clinical study for a novel algorithm or AI.

Therefore, the following information cannot be extracted from the provided text as it typically applies to AI/ML-driven devices or devices requiring extensive clinical trials for efficacy claims beyond substantial equivalence:

• Acceptance Criteria and Reported Device Performance Table: The document states "Validation testing was used to establish the performance characteristic of the modifications of this device from the previously marketed device." However, it does not provide specific quantitative acceptance criteria or their corresponding reported performance values in a table. The assessment is qualitative, asserting "substantial equivalence" based on "design, test results, and indications for use."
• Sample size used for the test set and the data provenance: Not applicable. No test set for AI/ML performance is described. The "test results" refer to engineering validation, not clinical data for AI performance.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for AI/ML is described.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No adjudication for AI/ML is described.
• 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 device is a physical medical instrument, not an AI-assisted diagnostic tool.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No explicit "ground truth" as understood in AI/ML validation is mentioned. "Test results" likely refer to bench testing or in-vitro performance.
• The sample size for the training set: Not applicable. No AI/ML training set is described.
• How the ground truth for the training set was established: Not applicable. No AI/ML training set is described.

Summary of Acceptance Criteria and Study (based on available information):

The primary acceptance criterion for this 510(k) submission was to demonstrate substantial equivalence to the predicate device (Bio-Medicus Femoral Cannula and Introducer, K884129) in terms of:

1. Design: The device description details modifications such as a longer flexible cannula with multiple side holes, a longer introducer, an improved introducer to cannula tip transition, and a 3/8" barbed connector. These design changes were compared to the predicate.
2. Test Results: While specific tests and their outcomes are not detailed, the submission states that "Validation testing was used to establish the performance characteristic of the modifications of this device from the previously marketed device." This implicitly means the device met performance standards (e.g., flow rates, material compatibility, strength, patency, etc.) comparable to or better than the predicate, considering the intended use.
3. Indications for Use: The indications for use for the new device were compared directly to those of the predicate. Both devices are intended "to cannulate vessels, perfuse vessels or organs and/or connect with accessory extracorporeal equipment" for cardiopulmonary bypass. The new device specifies "for use by trained physicians only" and "up to six hours or less."

Study Proving Acceptance Criteria:

The study proving the acceptance criteria was a non-clinical validation testing described as "Validation testing" to establish "performance characteristic of the modifications." This type of study demonstrates that the new device's engineering and functional parameters are acceptable and do not raise new questions of safety or effectiveness compared to the predicate. The FDA's clearance letter confirms that based on the submitted information, the device was found to be "substantially equivalent."

In conclusion, for this specific 510(k) summary, the core "study" was the engineering and performance validation comparing the new device's characteristics to those of the legally marketed predicate device, demonstrating that its design and performance were substantially equivalent and supported the same indications for use.

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This cannula is intended for use in venous drainage via the right atrium and inferior vena cava simultaneously during cardiopulmonary bypass surgery.

The MC2X™ Multi-Stage Venous Cannulae are cannula with with with an approximate The MC2X™ Multi-Stage Vehous Calimitat are camage and with an appoximate side ports in the distal tip, with ported arrial basket drainage and with an any side ports in the distal tip, with ported annor ousset online the cannula. All are overall length of 15 ¼". Insertion depth marks and in positioning the cannula. All are a overall length of 15 % . Insertion depth mains are single use. The devices may include a supplied sterile, are non-pyrogenic and are single use. The devices may include atte supplied sterile, are non-pyrogenc and are smgre ass. The artistion with tubing attached with a quick disconnect.

This 510(k) summary describes a resubmission for the MC2X™ Multi-Stage Venous Cannula, which is a Class II device used in cardiopulmonary bypass surgery. The resubmission is for a modified version of the previously cleared MC2X™ Multi-Stage Venous Cannula (K031776).

The provided text focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria related to a novel device's clinical performance. Therefore, typical acceptance criteria tables and detailed study results demonstrating clinical efficacy or diagnostic accuracy are not present.

However, based on the provided text, we can infer the acceptance criteria for determining substantial equivalence and describe the study that demonstrates the device meets these criteria.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this resubmission are implicitly defined by the demonstration of substantial equivalence to the predicate device. The "study" conducted is a series of bench tests and a comparison of characteristics to the predicate device.

• Approximate side ports in the distal tip.
• Ported atrial basket drainage.
• Overall length of 15 ¼ inches.
• Insertion depth marks.
• Sterile, non-pyrogenic, single-use status.
• Option for tubing attached with a quick disconnect.
  Changes: The new models have "a thing basket, a slight change to the shape of the tip, and a three piece rather than one piece construction." These changes are implicitly deemed acceptable based on testing. |
  | Material Composition | The materials used in the modified device should be equivalent or demonstrably safe and effective for the intended use. | Implied to be equivalent or suitable for the intended use, as no specific material changes raising new safety/effectiveness questions are highlighted beyond structural construction. |
  | Functional Performance (Bench Testing) | The device must meet established performance benchmarks for critical functions in a controlled environment, demonstrating no adverse impact from design changes. | Qualification tests included:
• Visual inspection
• Collapse test
• Flow test
• Kink test
• Tensile testing
  Conclusion: These tests "were performed to qualify the devices," indicating successful performance and implicitly meeting internal specifications derived from the predicate device's performance. |
  | Intended Use/Indications for Use (IFU) | The fundamental intended use of the device should remain the same as the predicate device. | Predicate IFU: "venous drainage via the right atrium and vena cava..."
  Modified Device IFU: "venous drainage via the right atrium and inferior vena cava simultaneously during cardiopulmonary bypass surgery."
  The IFU is stated to be essentially the same: "The predicate devices also provide drainage of the vena cava at the vena cava at the drainage indications for use." The minor rephrasing for "simultaneously" does not indicate a new intended use. |
  | Safety and Effectiveness (Implicit from Substantial Equiv.) | The modified device should be as safe and effective as the legally marketed predicate device. | The conclusion states: "Medtronic Perfusion Systems has demonstrated that the modified MC2X Multi-Stage Venous Cannulae are substantially equivalent to the predicate devices based upon design, test results, and indications for use." This implicitly means that safety and effectiveness are considered maintained. |

Study Details

The "study" conducted for this 510(k) submission is a series of bench tests and a direct comparison to the predicate device's characteristics. This is a retrospective comparison to an already cleared device, supplemented by prospective bench testing on the new design.

1. Sample Size Used for the Test Set and Data Provenance:

   • Test Set Sample Size: Not explicitly stated as "sample size" in the context of a clinical trial. For bench testing, the sample size would refer to the number of devices or components tested for each specific qualification test (e.g., number of cannulae subjected to flow testing). This number is not provided in the summary.
   • Data Provenance: The data is generated internally by Medtronic Perfusion Systems through bench testing ("Qualification including visual inspection, collapse, flow, kink and tensile testing were performed to qualify the devices.") and a direct comparison of specifications to their own previously cleared predicate device (K031776). This is prospective data generation for the physical properties of the new device, but a retrospective comparison to the predicate device's cleared characteristics and performance.
   • Country of Origin: Implied to be the USA, where Medtronic Perfusion Systems is located.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

   • This type of information is not applicable to a 510(k) submission based on bench testing and substantial equivalence. Ground truth in this context is established by engineering specifications, validated test methods, and regulatory requirements rather than subjective expert assessment of images or clinical outcomes on a test set.

3. Adjudication Method for the Test Set:

   • Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or diagnostic studies where there's a need to resolve discrepancies in expert opinions on clinical endpoints or image interpretations. This submission relies on objective engineering tests.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, an MRMC study was NOT done. This type of study investigates diagnostic efficacy or reader performance, typically with AI-assisted interpretation of medical images. The device in question is a physical medical device (cannula), not an AI-driven diagnostic tool.

5. Standalone (Algorithm Only) Performance Study:

   • No, a standalone performance study in the context of an algorithm's performance was NOT done. This submission is for a physical medical device, not an algorithm or AI. The "standalone" performance here refers to the device's functional integrity as demonstrated in bench tests.

6. Type of Ground Truth Used:

   • The "ground truth" for this submission is established through:
     • Engineering specifications and design requirements: These define the target performance and characteristics for the device.
     • Physical measurements and validated bench testing: Objective data from tests like flow, tensile, collapse, and kink provide the "truth" about the device's physical and functional properties.
     • Regulatory standards and predicate device characteristics: The established safety and effectiveness profile of the predicate device (K031776) serves as the benchmark against which the modified device's equivalence is assessed.

7. Sample Size for the Training Set:

   • Not applicable. There is no "training set" in the context of an AI/ML algorithm. This device is a physical medical device. The "training" in the engineering sense would be the iterative design and development process, which doesn't involve a distinct "training set" of data for an algorithm.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable. See point 7.

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The Medtronic centrifugal blood pumping system is intended to pump blood through the extracorporeal bypass circuit for extracorporeal support for periods appropriate to cardiopulmonary bypass procedures (up to 6 hours).

The Bio-Console® 560 is a cardiopulmonary bypass pump speed controller. It is intended to pump blood through the extracorporeal bypass circuit for extracorporeal support for periods appropriate to cardiopulmonary bypass procedures (up to 6 hours).

The provided text does not contain specific acceptance criteria or an in-depth study description with performance metrics for the Bio-Console® 560. Instead, it describes a 510(k) premarket notification for a Class II medical device, the Bio-Console® 560, a cardiopulmonary bypass pump speed controller. The submission aims to demonstrate substantial equivalence to previously marketed predicate devices (Bio-Console® 550 and Bio-Console® 550M).

The key takeaway is that the manufacturer performed functional, hardware, and software testing to establish the device's performance characteristics. However, the details of these tests and the specific quantitative acceptance criteria and results are not provided in this summary.

Therefore, I cannot complete the table or answer most of the specific questions as the information is not present in the provided text.

Here's an assessment based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified.
• Data Provenance: Not specified, but implied to be from internal testing by the manufacturer (Medtronic Perfusion Systems). It is not stated whether it was retrospective or prospective, or the country of origin of the data.

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

• This is not applicable as the device is a pump speed controller, and the "ground truth" would likely be based on engineering specifications and measurement standards, not expert clinical interpretation.

4. Adjudication method for the test set

• Not applicable for this type of device testing.

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 device is a hardware speed controller, not an AI-assisted diagnostic or interpretative system.

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

• The performance assessment likely focused on the device's standalone functional performance, as it's a pump speed controller. However, specific details of "standalone" testing are not provided beyond "functional, hardware and software testing."

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

• The "ground truth" for a device like this would typically involve engineering specifications, calibration standards, and established metrics for pump performance (e.g., flow rate, pressure, RPM accuracy). The document does not specify these details.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that would require a "training set" in the conventional sense. The "training" here refers to the engineering design and development process.

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

• Not applicable. As above, this is not an AI/machine learning device.

Summary of available information:

The 510(k) summary states that "Functional, hardware and software testing was used to establish the performance characteristic of the modifications of this device from previously marketed devices." The conclusion drawn is that the Bio-Console® 560 is "substantially equivalent to the predicate devices based upon design, test results, and indications for use." This implies that the testing performed demonstrated performance comparable to the predicate devices, meeting the requirements for substantial equivalence, but the specific details of these tests and their numerical outputs are not included in this document.

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