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The VitalFlow™ Centrifugal Pump is intended to pump blood through the extracorporeal circuit for circulatory support up to 48 hours, in adult patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent.

The VitalFlow™ Centrifugal Pump is driven by the VitalFlow™ Console and Drive Motor, or the Emergency Handcrank.

The VitalFlow Centrifugal Pump is a sterile, single-use centrifugal blood pump. It is a non-invasive, nonpyrogenic device designed to move blood through the extracorporeal circuit by centrifugal force. The pump is the disposable portion of the pumping system and it is electromagnetically coupled to an instrument that monitors and displays the flow and pressure of the blood. Blood enters the inlet port of the pump, where a cone with impeller blades within the pump housing rotates and the blood is gently accelerated toward the outlet of the pump.

The VitalFlow Centrifugal Pump can be driven through magnetic coupling by an External Drive Motor or the Emergency Handcrank.

The provided document is a 510(k) Summary for the VitalFlow™ Centrifugal Pump, a Class II medical device. It details the device's indications for use, description, and studies conducted to demonstrate its substantial equivalence to predicate and reference devices.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with quantitative targets in the way one might expect for a diagnostic AI device (e.g., target specificity, sensitivity). Instead, the acceptance criteria are framed within the context of demonstrating substantial equivalence to predicate devices and meeting specific "Special Controls" outlined in 21 CFR 870.4100. The performance is assessed through various bench, animal, and real-world clinical data.

Therefore, the table below summarizes the Special Controls as acceptance criteria and how the device's performance, as reported, addresses them.

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

The document describes several types of studies:

• Bench Performance Evaluations: No specific sample size is given for individual tests, but it states "Design verification studies were performed by the original manufacturer... and supplemented by MC3 bench performance testing, including long-term characterization." This implies multiple samples were tested for each characteristic.
• Animal Studies (In vivo evaluation): A sample size of 13 sheep was used for the 96-hour study. The data provenance is a controlled research environment.
• Clinical Performance (Real-world evidence): This utilized 1048 reports from the ELSO.org registry for the Affinity CP Centrifugal Blood Pump (AP40 group). The document states this is a "summary of real-world evidence," implying retrospective data extraction from an international registry. The country of origin for the data isn't explicitly stated but the ELSO registry collects data internationally. The comparison group ("All Other Pumps") involved 51,032 reports.

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

This device is not an AI diagnostic device that relies on expert interpretation of images or signals to establish a "ground truth" in the traditional sense. The "ground truth" for its performance is established through objective measures in bench testing (e.g., flow, pressure, mechanical integrity), physiological parameters in animal studies (e.g., presence/absence of clots, functionality), and reported clinical outcomes in the ELSO registry.

Therefore, there is no mention of "experts" establishing ground truth in the context of adjudication for a test set. Design verification and animal study results would be assessed by engineers, veterinarians, and researchers involved in those studies. Clinical outcomes in the ELSO registry are reported data.

4. Adjudication Method for the Test Set

Given that this is not an AI diagnostic device evaluating, for example, medical images requiring consensus on findings, there is no adjudication method (e.g., 2+1, 3+1) mentioned or applicable for the test sets described.

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

No, an MRMC comparative effectiveness study was not done. This type of study typically assesses the performance of human readers (e.g., radiologists) with and without AI assistance for tasks like diagnosis or detection. The VitalFlow™ Centrifugal Pump is a mechanical device, not an AI diagnostic tool, so such a study is not relevant.

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

No, a standalone (algorithm-only) performance study was not done, as the VitalFlow™ Centrifugal Pump is a physical medical device. The "standalone" performance here would refer to the device's function outside of a human-in-the-loop context, which is effectively what the bench and animal studies demonstrate regarding its mechanical integrity and ability to pump blood.

7. The Type of Ground Truth Used

The "ground truth" for evaluating the VitalFlow™ Centrifugal Pump's performance is multi-faceted:

• Bench Testing: Engineering specifications and performance metrics (e.g., pressure-flow curves, durability, wear, integrity, blood trauma data).
• Animal Studies: Direct observation of device functionality, physiological parameters, and absence of adverse events like clot formation in a living system over a defined period (96 hours).
• Clinical Performance (Real-world evidence): Reported clinical outcomes and complication rates from a large patient registry (ELSO.org), providing real-world data on pump failure, hemolysis, circuit changes, and other adverse events. This relies on the accuracy of data submitted to the registry.

8. The Sample Size for the Training Set

The document is for a traditional medical device (centrifugal pump), not an AI/Machine Learning device. Therefore, there is no "training set" in the context of AI model development that would typically have a distinct sample size. The design verification, bench testing, and animal studies serve as part of the overall development and validation process.

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

As there is no AI training set, this question is not applicable. The "ground truth" for the device's design and engineering would be based on established medical and engineering principles, material science, and regulatory requirements, which are then verified through rigorous testing, as mentioned above.

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The Capiox® iCP Centrifugal Pump with Xcoating™ is a sterile, single use device, used as an extracorporeal blood pump for use in cardiopulmonary bypass procedures for up to 6 hours.

The pump is intended for use with Terumo® Advanced Perfusion System 1 / Sams™ Centrifugal Pump Systems or may be used with the Stockert / Sorin Centrifugal Pump Consoles.

The Capiox® iCP Centrifugal Pump with Xcoating™ is a sterile, single use device, used as an extracorporeal blood pump.

This document is a 510(k) clearance letter from the FDA for a medical device called the "Capiox iCP Centrifugal Pump with Xcoating". It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information regarding acceptance criteria, device performance testing data, sample sizes, expert qualifications, ground truth establishment, or any details typically found in a study proving a device meets acceptance criteria.

The document is primarily an administrative letter granting market clearance based on substantial equivalence, not a detailed report of the studies performed to demonstrate that equivalence. It refers to the "Indications for Use" but does not detail the technical performance or the studies that underpinned the clearance.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC study details or effect size.
6. Standalone performance details.
7. Type of ground truth used.
8. Training set sample size.
9. Ground truth establishment for the training set.

The provided text does not contain the information necessary to answer your questions.

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The FloPump 57mL Centrifugal Pump is a device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:

i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or

ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.

The FloPump 57mL is a single use disposable centrifugal pump has an inlet that draws blood from a patient and an outlet that pushes the blood out, where it then passes through an oxygenator and back to the patient. The pump mates with the Sorin Group Stöckert Centrifugal Pump Console and rotates the internal impeller using a magnetic driver. The FloPump 57mL is a non-occlusive pump. The pump has a spinning rotor with flow channels which imparts rotary motion to the incoming blood, directing it through a spiral housing to the outflow port. The FloPump 57mL is part of the extracorporeal circuit, and is therefore in contact with the patient's blood while circulating. The FloPump 57mL does not have any other patient contact.

This document describes the FloPump 57mL Centrifugal Pump, a non-roller type blood pump intended for use in extracorporeal circuits for periods less than 6 hours.

Here's an analysis of the acceptance criteria and supporting studies as presented in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list specific quantitative "acceptance criteria" with corresponding "reported device performance" in a structured table as might be expected for an AI/CAD device. Instead, it states that non-clinical testing was performed and the results were "Substantially equivalent to predicates" for a range of performance characteristics.

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

The provided text does not contain any information regarding sample sizes for a standalone (test set) for clinical performance, as it explicitly states that clinical testing was not required. The testing mentioned is non-clinical, likely laboratory-based or bench testing. Therefore, there's no information on data provenance (country of origin, retrospective/prospective) related to a clinical test set.

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

Since no clinical testing was required or performed, there is no information on experts establishing ground truth for a clinical test set. The "ground truth" for the non-clinical tests would have been established by engineering specifications, validated test methods, and comparison against the performance of predicate devices.

4. Adjudication Method for the Test Set:

Given that no clinical testing requiring human interpretation or judgment was performed, there is no information on an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size:

No MRMC comparative effectiveness study was done as clinical testing was not required for this device. This device is a mechanical pump, not an AI/CAD diagnostic tool.

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

This is not applicable to the FloPump 57mL Centrifugal Pump. This device is a physical, mechanical blood pump, not an algorithm or AI system. The "standalone" performance here refers to the device's functional performance on its own, which was evaluated through the non-clinical tests listed.

7. The Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" was based on:

• Engineering specifications and design requirements: For parameters like priming volume, flow rates, and maximum rated pressure.
• Established test methods and standards: For sterilization (SAL of 10^-6), biocompatibility, and perhaps reliability testing.
• Performance of predicate devices: The primary method for proving substantial equivalence was demonstrating similar performance to legally marketed predicate devices for flow curves, heat generation, prime volume, air handling, hemolysis, and reliability. This implies that the accepted performance range of the predicate devices served as the "ground truth" for comparison.

8. The Sample Size for the Training Set:

Not applicable. This device is a mechanical blood pump, not an AI/ML algorithm that requires a "training set" of data.

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

Not applicable. As stated above, this is a mechanical device, not an AI/ML system requiring a training set.

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The Sarns® Centrifugal Pump with or without X-Coating™ is a sterile, single use device, used as an extracorporeal blood pump for use in cardiopulmonary bypass procedures for up to 6 hours. The pump is intended for use with the Sarns® Centrifugal Systems or may be used with Stöckert Centrifugal Pump Systems by attaching the Sarns® Centrifugal Pump Adapter.

The Sarns® Centrifugal Pump (with or without X-Coating™) is a single use, sterile and disposable device. It is used to pump blood through the extracorporeal circuit during cardiopulmonary bypass surgery and may be used for up to 6 hours. The pump has a priming volume of 48ml. The pump rotational speed is 0-3600 RPM resulting in a flow capacity of 0-9.9 LPM. With this submission, the sterile disposable Sarns® Centrifugal pump may be used with Stöckert Centrifugal pump systems when the reusable Sarns® Centrifugal Pump Adapter is used. The Sarns® Centrifugal Pump Adapter is a device designed with geometries that mate the Stöckert centrifugal systems to the Sarns® Centrifugal pump. The housing is a hard plastic (acetal) that slides easily onto the Sarns® Centrifugal pump then clips into place. The adapted pump is then mounted onto the Stöckert Centrifugal pump systems.

Here's a summary of the acceptance criteria and study information for the Sarns® Centrifugal Pump, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes used for each test. The studies appear to be prospective in nature, as they involve testing the "proposed device" configuration against "predicate device" configurations or established standards. There is no information regarding 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 information is not applicable. The studies described are engineering and performance validation tests, not clinical evaluations requiring expert interpretation of medical images or data to establish ground truth.

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

This information is not applicable. The studies described are engineering and performance validation tests with objective pass/fail criteria, not clinical evaluations requiring adjudication from multiple experts.

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 a medical device (centrifugal pump) and not an AI-powered diagnostic or assistive technology that would involve human readers.

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

Not applicable. This device is a mechanical pump, not an algorithm.

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

The "ground truth" for these tests is based on pre-defined performance standards, technical specifications, and comparisons to the legally marketed predicate device's established performance. For example:

• Flow curves: Comparison to predicate device's established flow characteristics.
• Clip fatigue: Designed lifetime use specification (7 years).
• Change out time: Statistical similarity to predicate device's change out time.
• Shipping and durability: Absence of damage and intended function, likely against internal or industry standards.
• Hemolysis: Absence of statistical difference in blood parameters compared to performance without the adapter.
• Disconnection force: Greater than or similar to predicate device.
• Interaction with HLM: No interference with control and safety components.

8. The sample size for the training set:

Not applicable. This device does not use machine learning or AI, so there is no "training set."

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

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

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The Sorin Centrifugal Pump (CP5) is a cardiopulmonary bypass speed control device indicated for use exclusively with the Sorin Revolution®, for speedcontrolled pumping through the cardiopulmonary bypass circuit for typical durations of six hours or less.

The CP5 has been qualified only for typical durations of six hours or less, appropriate to cardiopulmonary bypass procedures and has not been qualified through in vitro, in vivo, or clinical studies, for long term use as a bridge to transplant, pending recovery of the natural heart, or extracorporeal membrane oxygenation (ECMO) procedures.

The Sorin CP5 is intended for use as a component part of or optional accessory for the Sorin heart lung machine consoles and with the Stöckert Air Purge (APC) the Borin heads they System. The Sorin CP5 consists of the drive unit, a mounting receptacle for the Dystein. The Cretaining key, splash protection, and a 3-joint mast holder with fast clamp connector. It integrates the functional capabilities of the SCP, the SCP Plus, and the Sorin Pulse Mode Control within a single device.

The Sorin CP5 consists of hardware, firmware, and electronics that are used to drive the centrifugal pump for surgical procedures requiring cardiopulmonary bypass for typical durations of six (6) hours or less. The SCP drive unit uses magnetic coupling with the disposable centrifugal pump.

The Sorin CP5 with the loaded centrifugal pump recirculates the contents of the extracorporeal circuit during cardiopulmonary bypass.

The design, materials, and physical properties of the CP5 are essentially unchanged from that of the parent/predicate devices already reviewed and cleared by the FDA.

The provided text describes a 510(k) summary for the Sorin Centrifugal Pump (CP5). However, it explicitly states that no clinical testing and no comparative nonclinical testing served as the basis for substantial equivalence. The summary focuses on technological characteristics compared to predicate devices and internal validation.

Therefore, the requested information regarding an acceptance criteria table, detailed study parameters, ground truth establishment, expert involvement, and MRMC studies cannot be extracted from the provided text, as such studies were not performed or are not reported.

Here's what can be extracted based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "Testing of the Sorin Centrifugal Pump (CPS) demonstrates that the CP5 fulfills prospectively defined performance criteria and meets user needs." However, the specific quantitative or qualitative acceptance criteria and the corresponding reported device performance values are not detailed in this summary.

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

Not applicable. The document states: "No comparative nonclinical testing served as the basis for substantial equivalence." and "No clinical testing served as the basis for substantial equivalence." The testing performed involved "integration testing of hardware and firmware, functional testing, testing of organized (IEC 60601-1 including deviations for the US) and associated tooling, success (IEC 60601-1-2), and validation testing (simulated use and in use)." This describes internal validation, not a test set based on patient data.

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

Not applicable, as no external test set with ground truth established by experts is described.

4. Adjudication method for the test set:

Not applicable, as no external test set requiring adjudication is described.

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 cardiopulmonary bypass centrifugal pump, not an AI-assisted diagnostic tool for human readers. No MRMC study was performed or is mentioned.

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

The device is a hardware component (centrifugal pump) with firmware, not a standalone algorithm. Performance testing was internal validation of the hardware and firmware.

7. The type of ground truth used:

Not applicable in the context of clinical or diagnostic performance. The "ground truth" for the internal validation would be the design specifications and expected functional behavior.

8. The sample size for the training set:

Not applicable, as this is not an AI/machine learning device with a training set.

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

Not applicable, as this is not an AI/machine learning device with a training set.

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In general, these devices are intended for use during cardiopulmonary bypass surgery for up to 6 hours. No changes were made to the intended use of the individual devices.

The Affinity CP Centrifugal Blood Pump with Carmeda BioActive Surface is used to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to 6 hours). It is also indicated for use in extracorporeal support systems (for periods up to 6 hours) not requiring complete cardiopulmonary bypass (eg, valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants).

The MYOtherm XP is a device intended for the mixing, warming/ cooling and delivery of oxygenated blood/cardioplegia solution in a predetermined ratio.

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

The Affinity NT Hollow Fiber Oxygenator with Plasma Resistant Fiber 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 NT Integrated CVR Membrane Oxygenator (Plasma Resistant Fiber [PRF] Oxygenator) 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.

This product, MVR Collapsible Venous Reservoir Bag, is indicated for use during cardiopulmonary bypass surgery in an extracorporeal circuit utilizing a membrane oxygenator. The MVR Holder (Model MVR-SH) is indicated for use with the MVR Collapsible Venous Reservoir Bag.

Medtronic Coated Accessories (Flow Probes) is indicated for use in the extracorporeal circuit during cardiopulmonary bypass surgery.

Medtronic Coated Accessories (Tri-Optic Measurement Cells) is indicated for use in the extracorporeal circuit during cardiopulmonary bypass surgery.

Medtronic Packs and Accessories (Tubing and Connectors) is indicated for use in the extracorporeal circuit during cardiopulmonary bypass surgery.

The Medtronic Resting Heart Module is indicated for use in surgical procedures requiring extracorporeal circulatory support, gas exchange, and thermal regulation. The device is indicated for use in procedures requiring blood flow rate of 1-6 lpm and lasting up to six hours. The system is indicated for use only with the Bio-Console. The VARD is indicated for use only with the AAR1000. The Bio-Pump+ Blood Pump in the Medtronic Resting Heart Module is indicated for use only with the Bio-Console. The Carmeda AFFINITY NT Oxygenator and Carmeda AFFINITY Arterial Filter in the Medtronic Resting Heart Module have the same indications for use as a Carmeda AFFINITY NT Oxygenator and Carmeda AFFINITY Arterial Filter used in other extracorporeal circuits.

Medtronic DLP "Y" Adapter - Coronary Perfusion is intended for use in conjunction with the delivery of cardioplegia solution.

Medtronic DLP Aortic Root Cannula is intended for use in conjunction with cardiopulmonary bypass surgery for delivering cardioplegia solution. The cannula may also be used to aspirate air from the aorta at the conclusion of the bypass procedure. The #23009 cannula may also be used to monitor pressure in the aorta.

Medtronic EOPA 3D Arterial Cannula are intended for use in perfusion of the ascending aorta during short term (6 hours or less) cardiopulmonary bypass.

Medtronic DLP Single Stage Venous Cannula are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery up to six hours or less.

Medtronic DLP Femoral Arterial and Venous Cannula is intended for rapid femoral venous and arterial access for short term cardiopulmonary bypass.

No changes to the devices are being made. An additional source of the raw material used to make USP heparin used in Carmeda and Trillium coatings is being added.

The provided text does NOT include details about a study evaluating a device's performance against acceptance criteria using AI or machine learning. Instead, it is a 510(k) summary for various Medtronic cardiopulmonary bypass devices, focusing on demonstrating substantial equivalence to predicate devices, primarily due to an additional source of raw material for heparin used in coatings.

Therefore, many of the requested sections (sample sizes for test and training sets, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth types) cannot be fulfilled from the provided document as they relate to AI/ML device performance studies, which are not described here.

However, based on the text, I can infer the acceptance criteria and how the device (specifically, the modified heparin coating) meets them.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified. The document refers to "bench testing" but does not quantify the number of units or batches tested.
• Data Provenance: The testing appears to be internal Medtronic bench testing, likely conducted at their facilities in Minneapolis, MN, USA. It is prospective testing designed to evaluate the new raw material source.

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

• Not applicable/Not specified. The "ground truth" for this type of performance testing (coating, chemistry, potency) would typically be established by established laboratory methods and validated instrumentation, overseen by qualified laboratory personnel and engineers, rather than expert consensus on clinical data.

4. Adjudication method for the test set:

• Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 typically apply to clinical studies where reviewers (e.g., radiologists) are assessing images or clinical outcomes. For bench testing of material properties, performance is determined by adherence to pre-defined physical and chemical specifications.

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. This is not an AI/ML device, and no MRMC study was conducted or mentioned.

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

• Not applicable. This is not an AI/ML algorithm. The performance described is for physical medical devices and their material properties.

7. The type of ground truth used:

• The "ground truth" would be the physical and chemical specifications and performance characteristics of the existing, predicate devices' heparin-coated components. The new raw material's performance was compared against these established benchmarks. This is essentially a comparison to a known standard/predicate device performance.

8. The sample size for the training set:

• Not applicable. There is no AI/ML training set. The "training" for this context would be the historical data and manufacturing processes of the existing heparin-coated devices.

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

• Not applicable. There is no AI/ML training set. The "ground truth" for the predicate devices' performance would have been established through their initial regulatory clearances, involving a combination of bench testing, biocompatibility studies, and potentially clinical data (though not explicitly detailed for the specific heparin coating formulation in this summary).

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The Stockert Centrifugal Pump System is a cardiopulmonary bypass speed control device (21CFR 870.4380) that is indicated for use with the Cobe Revolution® Pump Head/Dideco Synergy™/ECC.OTM for for speed controlled pumping through a cardiopulmonary bypass circuit for typical durations of six hours or less. The SCP Plus is intended for use as a component part of or optional accessory to the S3 and S5 System (or any compatible system using the SS firmware versions of 3.0. or greater) and the Stöckert Air Purge Control (APC) System.

The SCP Plus has been qualified only for typical durations of six hours or less, appropriate to cardiopulmonary bypass procedures and has not been qualified through in vitro, in vivo, or clinical studies for long-term use as a bridge to transplant, pending recovery of the natural heart, or extracorporeal membrane oxygenation (ECMO) procedures.

The SCP Plus System is intended for use as a component part of or optional accessory to the S3 and S5 System (or any compatible system using the S5 firmware versions of 3.0. or greater) and with the Stöckert Air Purge (APC) System. The System consists of the drive unit, a mounting receptacle for the pump head, a retaining key, splash protection, and a 3-joint mast holder with fast clamp connector.

The Stöckert Centrifugal Pump (SCP) Plus System consists of hardware, firmware, and electronics that are used to drive the centrifugal pump for surgical procedures requiring cardiopulmonary bypass for typical durations of six (6) hours or less. The SCP drive unit uses magnetic coupling with the centrifugal pump.

This document describes the acceptance criteria and accompanying study for the Sorin Group Deutschland GmbH Stöckert Centrifugal Pump (SCP) Plus System.

No information regarding a multi-reader multi-case (MRMC) comparative effectiveness study, standalone algorithm performance, or training set details is available in the provided text, as this is a traditional 510(k) for a medical device (a pump), not an AI/ML-driven device.

1. Acceptance Criteria and Reported Device Performance

The SCP Plus System was evaluated against prospectively defined performance criteria. The document states that the device's performance characteristics remain unchanged from its predicate device (K091008). Therefore, the acceptance criteria are implicitly tied to maintaining the established performance and safety standards of the predicate device.

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

The provided document does not specify a "test set" in the context of diagnostic performance evaluation with a defined sample size for images or patient data. This is a submission for a physical medical device (a pump), not a diagnostic algorithm.

The testing conducted was primarily non-clinical performance testing (safety, EMC, functional acceptance tests) of the physical device and its components. The document does not describe any studies involving human subjects or data derived from patients.

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

This section is not applicable as the document does not describe a "test set" requiring ground truth established by experts (e.g., radiologists, pathologists). The evaluation focused on engineering and performance criteria for a physical pump.

4. Adjudication Method for the Test Set

This section is not applicable as there was no test set requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The provided text describes a 510(k) submission for a physical medical device (a centrifugal pump), not an AI/ML-driven diagnostic or assistive tool. Therefore, there is no mention of human readers improving with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone performance study (in the context of an algorithm) was not done. The device is a physical pump designed to operate within a cardiopulmonary bypass circuit, and its performance is assessed through engineering and functional tests, not as an "algorithm only."

7. The Type of Ground Truth Used

For the non-clinical performance testing, the "ground truth" was established by:

• Compliance with international and national standards (IEC60601-1 for safety, IEC60601-1-2 for EMC).
• Adherence to formal prospectively defined functional acceptance test specifications.
• Meeting user needs and performance identical to the predicate device.

There was no "ground truth" derived from expert consensus, pathology, or outcomes data in the context of diagnostic accuracy, as this is not a diagnostic device.

8. The Sample Size for the Training Set

This section is not applicable. The SCP Plus System is a hardware device with firmware, not a machine learning model, so there is no concept of a "training set" for an algorithm.

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

This section is not applicable for the same reasons as above.

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The RotaFlow Centrifugal Pump is indicated as a component of the extracorporeal circuit for pumping liquid matter e.g. blood and can be used in conjunction with the RotaFlow Console. The utilization period of this device is restricted to six hours. The device is not designed or intended for use except as indicated.

The RotaFlow Centrifugal Pump is a non-occlusive pump. The pump has a spinning rotor with flow channels which imparts rotary motion to incoming liquid, directing it through a spiral housing to the outflow port.

This submission (K090515) is for a medical device called the MAQUET RotaFlow Centrifugal Pump with Softline Coating. It's important to note that this 510(k) summary does not contain acceptance criteria or a study proving the device meets those criteria in the way you've outlined for AI/software-driven devices.

This is a premarket notification for a Class III physical medical device (a centrifugal pump for cardiopulmonary bypass). The submission focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, not on showing performance against specific, quantifiable acceptance criteria typically associated with software or AI performance.

Therefore, many of your specific questions are not applicable to the information provided in this 510(k) summary. I will address the relevant sections and explain why others cannot be answered from the provided text.

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

This information is not provided in the 510(k) summary for K090515. For physical devices like this, the "performance" demonstrated for substantial equivalence typically involves engineering tests (e.g., flow rates, pressure handling, durability, biocompatibility) rather than quantifiable metrics like sensitivity or specificity seen in diagnostic AI. The summary states that "Performance" was evaluated, but it does not present specific criteria or results in a table.

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

This information is not provided. As this is a physical device, "test sets" in the context of data points for algorithm evaluation are not relevant here. The evaluation would involve physical prototypes or manufactured units of the pump.

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 and is not applicable to a physical medical device submission like this. Ground truth, in the context of expert consensus, is typically for diagnostic interpretation, not for evaluating the mechanical function of a pump.

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

This information is not provided and is not applicable.

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

This information is not provided and is not applicable. This type of study relates to the performance of diagnostic AI with human readers, not a physical pump.

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

This information is not provided and is not applicable. There is no algorithm discussed for diagnostic or interpretative purposes in this submission.

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

This information is not provided and is not applicable in the way you've described. For a physical pump, "ground truth" might refer to engineering specifications, validated test methods for flow, pressure, material integrity, and biocompatibility standards. The submission highlights that "Integrity", "Performance", "Biocompatibility", and "Sterility" were evaluated, implying various testing methodologies were used, but details are not given.

8. The sample size for the training set

This information is not provided and is not applicable. There is no training set for an AI/ML algorithm in this submission.

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

This information is not provided and is not applicable.

Summary of Relevant Information from the K090515 Submission:

• Device Name: RotaFlow Centrifugal Pump with Softline Coating
• Submission Type: 510(k) Premarket Notification
• Purpose of Study/Evaluation: To demonstrate substantial equivalence to legally marketed predicate devices.
• Predicate Devices:
  • RotaFlow Centrifugal Pump with BIOLINE Coating (K080470) - for the pump design and function.
  • QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with Softline Coating (K082117) - for the Softline Coating material.
• Key Differences from Predicate: The only stated difference from the primary predicate is the coating (Softline instead of BIOLINE). The Softline coating itself is identical to a coating already approved in another predicate device.
• Evaluated Areas (for demonstrating substantial equivalence):
  • Integrity
  • Performance
  • Biocompatibility
  • Sterility
• Conclusion: The data demonstrated that the RotaFlow Centrifugal Pump with Softline Coating is substantially equivalent to the named predicate devices.

In essence, this 510(k) is for a manufacturing change (a new coating) on an already cleared device, leveraging the prior approval of both the pump design and the specific coating material on other devices. It does not involve AI or software development that would require the kind of performance metrics and study designs you've detailed.

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The Stöckert Centrifugal Pump Plus System (SCP Plus) is a cardiopulmonary bypass speed control device (21 CFR 870.4380) that is indicated for use with the COBE Revolution Pump Head/Dideco Synergy/ECC.O for speed-controlled pumping through a cardiopulmonary bypass circuit for typical durations of six hours or less. The SCP Plus is intended to be used with the S3 or S5 System and the Stöckert Air Purge Control (APC) System.

The SCP Plus has been qualified only for typical durations of six hours or less, appropriate to cardiopulmonary bypass procedures and has not been qualified through in vitro, in vivo, or clinical studies for long-term use as a bridge to transplant, pending recovery of the natural heart, or extracorporeal membrane oxygenation (ECMO) procedures.

The modified Stöckert Centrifugal Pump System (referred to as the SCP Plus) is an optional accessory to the S3 or S5 System, a modular system consisting of a console, various pumps, monitors, displays, controls, and user interfaces.

This is a 510(k) summary for a medical device called the "Stöckert Centrifugal Pump Plus System (SCP Plus)". This document describes a medical device and its intended use, but it does not contain the kind of detailed information about acceptance criteria and a study proving those criteria that you've requested.

Specifically, the document states:

• "Testing of the Stöckert Centrifugal Pump Plus System has demonstrated that the System continues to fulfill prospectively defined performance criteria and that the modified System meets user needs."

However, it does not provide:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets, data provenance, number/qualifications of experts, or adjudication methods for establishing ground truth.
3. Details on an MRMC comparative effectiveness study or any effect size.
4. Information on a standalone (algorithm only) study.
5. Type of ground truth used.
6. Sample size for the training set.
7. How ground truth for the training set was established.

This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device ("Stöckert Centrifugal Pump System") rather than providing a detailed performance study with specific acceptance criteria and results. For such detailed information, one would typically need to refer to the full 510(k) submission, which is not publicly available in this summarized form.

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The Rotaflow Centrifygal Pump is a device that uses a method other to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:

· Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels: or

· Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.

The RotaFlow Centrifugal Pump is is a prescription device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:

(i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or

(ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.

The Bioline Coating improves the physical surface properties of products for the extracorporeal circulation system.

This document is a 510(k) premarket notification summary for the RotaFlow Centrifugal Pump with Bioline Coating. It focuses on demonstrating substantial equivalence to pre-existing devices. This type of regulatory submission does not contain the detailed study results and acceptance criteria typically used to prove a device meets specific performance metrics in the way a clinical study for a novel diagnostic or treatment would.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document in the manner you've requested for a device that involved clinical performance testing with metrics like sensitivity, specificity, or AUC. The "acceptance criteria" here are based on demonstrating that the new device (with Bioline coating) performs similarly to the predicate devices and meets relevant safety standards (integrity, performance, biocompatibility, sterility) for a medical device of its class.

Here's an attempt to answer your questions based on the provided text, recognizing the limitations:

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

As explained above, this document describes a special 510(k) for a coating modification. The "acceptance criteria" are implied to be substantial equivalence to predicate devices regarding safety and effectiveness, demonstrated through evaluation of integrity, performance, biocompatibility, and sterility. The document does not provide quantitative performance metrics or a detailed acceptance criteria table as might be found in a clinical trial report.

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

The document does not specify a "test set" sample size in the context of clinical or diagnostic performance. The evaluations mentioned (integrity, performance, biocompatibility, sterility) would typically involve laboratory testing. The provenance of this data (e.g., country of origin, retrospective/prospective) is not provided in this summary.

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

This type of information is not relevant to a 510(k) submission for a device change related to a coating, particularly when the submission focuses on substantial equivalence through non-clinical testing (integrity, performance, biocompatibility, sterility). There isn't a "ground truth" established by human experts in the context of a diagnostic test set described here.

4. Adjudication method for the test set

Not applicable for this type of 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 medical pump, not an AI-assisted diagnostic or imaging device.

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

Not applicable. This is a mechanical pump, not an algorithm.

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

For the evaluations of integrity, performance, biocompatibility, and sterility, the "ground truth" would be established by validated scientific methodologies and standards relevant to each of these areas (e.g., ISO standards for biocompatibility, engineering specifications for integrity and performance, validated sterilization methods). It does not involve expert consensus, pathology, or outcomes data in the way a diagnostic device would.

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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