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The CentriMag Return (Arterial) Cannula is indicated for use as an arterial return cannula with an extracorporeal bypass circuit for extracorporeal circulatory support for periods up to six hours.

The Thoratec CentriMag Return (Arterial) Cannula Kit consists of the return (arterial) cannula and several accessories used in the surgical placement procedure. The cannula and all kit accessories are sterile, single-use, disposable devices. The cannula kit is designed for use with the Thoratec CentriMag® Extracorporeal Blood Pumping System (K020271).

The Cannula Kit includes the following accessories:

This document describes a 510(k) premarket notification for the "Thoratec CentriMag Return (Arterial) Cannula Kit." This is a medical device and not an AI/ML algorithm, so many of the requested fields are not applicable. I will provide information relevant to device testing as presented in the document.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size for each performance test. It only mentions that "All testing employed devices that were exposed to 2x sterilized, accelerated-aging to simulate a real-time equivalent of 1-year, and heated saline soak for 30 days."

Data Provenance: Not specified, but generally, device performance testing data comes from the manufacturer's internal testing labs. It is a prospective study in the sense that the tests were designed and executed to evaluate the new device.

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

Not applicable. This device is evaluated through engineering and biocompatibility testing, not expert interpretation of outputs.

4. Adjudication Method for the Test Set

Not applicable. This is not an AI/ML algorithm or a diagnostic test requiring human adjudication. Device performance is determined by meeting physical and chemical specifications.

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

No, an MRMC comparative effectiveness study was not done. This is a medical device, not an AI/ML diagnostic tool.

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. The performance tests are inherently "standalone" in that they assess the device itself.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance testing is based on:

• Engineering specifications and design requirements (e.g., specific tensile strength values, pressure limits, dimensional tolerances).
• Material science standards (e.g., chemical composition analysis, biocompatibility standards).
• Sterility standards (microbiological performance).

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device undergoing performance and material testing, not an AI/ML model that requires a training set.

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

Not applicable, as there is no training set for a physical medical device.

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The CentriMag Drainage (Venous) Cannula is indicated for use with an extracorporeal bypass circuit for extracorporeal circulatory support for periods up to six hours.

The Thoratec CentriMag® Drainage (Venous) Cannula Kit consists of the drainage (venous) cannula and several accessories used in the surgical placement procedure. The cannula and all kit its accessories are sterile, singleuse, disposable devices. The cannula kit is designed for use with the Thoratec CentriMag® Extracorporeal Blood Pumping System (K020271).

The Drainage Cannula Kit includes the following accessories:
QTY Kit Component
1 Drainage (Venous) Cannula Body
1 Connector, 3/8-inch, barbed
1 Apical Sewing Ring with Umbilical Tape
1 Apical Sewing Ring Handle
1 Cap (with Umbilical Tape)
1 Apical Support Cuff
4 Suture Rings (large)
4 Suture Rings (medium)

This document is a 510(k) premarket notification for a medical device, specifically the Thoratec CentriMag Drainage (Venous) Cannula Kit. It describes the device, its intended use, and provides a summary of performance data to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the provided text in relation to your request about acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly state quantitative "acceptance criteria" against which specific numerical performance metrics are compared. Instead, it lists various "performance and functional verification tests" that were successfully conducted. The implicit acceptance criterion for each test is "successful results," indicating compliance with the design requirements for that particular 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 specify the sample size used for the test set for any of the listed performance tests. It also does not explicitly state the data provenance (country of origin, retrospective/prospective). However, the general context of a 510(k) submission typically implies that such testing is conducted by the device manufacturer (Thoratec Corporation, based in Pleasanton, CA) as part of their design verification and validation process, which would be prospective for the purpose of the submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not provided in the document. The performance tests described (Flex, Tensile Strength, Chemical Resistance, etc.) are typically engineering and material science tests, not clinical evaluations requiring expert interpretation of medical images or patient outcomes. Therefore, "ground truth" in this context would likely be established by engineering specifications and objective measurements, rather than expert consensus in a medical sense.

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

This information is not provided and is not applicable to the types of performance tests described. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of data by multiple experts. The tests mentioned are objective engineering and material 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:

No, an MRMC comparative effectiveness study was not done. This document is for a physical medical device (a cannula kit), not an AI-powered diagnostic or assistive tool. Clinical testing was explicitly stated as "not performed."

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

This question is not applicable. The device is a physical medical device (cannula kit), not an algorithm or AI system.

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

The "ground truth" for the performance tests listed would be based on engineering specifications, material science standards, and predefined acceptance limits for each test (e.g., a specific tensile strength value, a certain pressure resistance, dimensional tolerances, chemical inertness). It is not based on expert consensus, pathology, or outcomes data, as these are non-clinical (bench and material) tests.

8. The sample size for the training set:

This information is not applicable. The document describes a physical medical device, not an AI algorithm that requires a "training set."

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

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

In summary, the provided document focuses on demonstrating the substantial equivalence of a physical medical device (a cannula kit) through non-clinical performance and functional verification tests. It does not involve AI development, clinical trials, or expert-based ground truth establishment in the way typically seen for diagnostic algorithms.

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The TandemHeart pump is intended 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 TandemHeart System consists of two major components, the Escort Controller (K061369), and the TandemHeart Blood Pump (K991783), along with a number of accessory components required to setup and utilize the Pump. The system is intended for extracorporeal circulatory support using an extracorporeal bypass circuit.

The provided document is a 510(k) summary for the TandemHeart System, a non-roller type cardiopulmonary bypass blood pump. This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. As such, it focuses on comparing the new device to existing ones rather than presenting a standalone study with detailed acceptance criteria and performance metrics in the way one might expect for a novel AI/software medical device.

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

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

   • Acceptance Criteria (Implicit): The primary acceptance criterion for a 510(k) submission is "substantial equivalence" to a predicate device. For the specific performance test mentioned, the implicit acceptance criterion was that the TandemHeart System demonstrate "adequate flow performance with the inclusion of an Oxygenator in the extracorporeal circuit, and that the flows were substantially equivalent to those provided by the predicate AB-180 XC System."
   • Reported Device Performance:
     • "The HQ testing results demonstrated adequate flow performance with the inclusion of an Oxygenator in the extracorporeal circuit, and that the flows were substantially equivalent to those provided by the predicate AB-180 XC System."

   Table:

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. The document mentions "subsequent testing of the TandemHeart System" for "flow vs. pressure drop (HQ)," but does not provide details on the number of units tested, the duration of tests, or any patient data sample sizes.
   • Data Provenance: Not specified. As the testing was to verify performance, it's likely internal lab testing, but specific country or retrospective/prospective nature regarding patient data is not applicable/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. This device is a mechanical blood pump, not an AI/diagnostic imaging device. "Ground truth" in the context of expert review or clinical outcomes is not pertinent to the "flow vs. pressure drop" testing described.

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

   • Not applicable. This is not a study involving expert adjudication for diagnostic accuracy. The performance testing described (flow vs. pressure drop) would likely involve objective measurements against engineering specifications or comparative measurements with a predicate, not 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 is not an AI-assisted diagnostic device.

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

   • Not applicable. This is a mechanical device.

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

   • For the "flow vs. pressure drop (HQ)" testing, the ground truth would be based on physical measurements and engineering principles, likely comparing the device's performance against established specifications or the performance of the predicate device. It's not based on expert consensus, pathology, or outcomes data.

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. As above, this is a mechanical device, not an AI system.

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The PediMag Blood Pump is indicated for use with the CentriMag Console and Motor to pump blood through a complete extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours) for surgical procedures such as a mitral valve reoperation. It is also indicated for use in extracorporeal support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g. valvuloplasty, surgery of the vena cava or aorta, liver transplants etc.).

The PediMag Pump can generate a maximum pump flow equal to 1.5 liters per minute, limiting its use to pediatric patients.

The Levitronix PediMag Blood Pump is indicated for use only with the Levitronix CentriMag Console and Motor.

The PediMag Blood Pump is a sterile, single-use, disposable, non-coated, polycarbonate centrifuqal blood pump. The pump has a 14 ml priming volume. The pump inlet is on the rotational axis of the impeller whereas the pump outlet is perpendicular to the inlet and tangent to the outer diameter. Both the inlet and outlet ports include standard 1/4 inch barbed connectors for easy mating to standard medical grade 1/4 inch tubing. The Pump is designed to move blood by centrifuqal force created by the magnetically suspended rotating impeller.

The acceptance criteria and study details for the Levitronix PediMag Blood Pump are as follows:

The provided document is a 510(k) summary for a medical device, which typically focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance acceptance criteria in the way one might for a novel diagnostic algorithm. The primary "acceptance criteria" here are that the device performs functionally as expected and is substantially equivalent to existing predicate devices regarding safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance:

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

No specific "test set" or patient data is mentioned. The submission relies entirely on functional testing of the device itself and comparison to predicate devices, without clinical data.

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

Not applicable. No clinical test set or expert ground truth was established as the submission relies on functional testing and substantial equivalence, not clinical performance data.

4. Adjudication Method for the Test Set:

Not applicable. No clinical test set requiring adjudication was used.

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

No. Clinical testing was explicitly not performed on this system: "Clinical testing was not performed on this system." (Section I. Clinical Performance). Therefore, an MRMC study comparing human readers with and without AI assistance was not conducted.

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

Not applicable. This device is a blood pump, not an AI algorithm. Its performance is intrinsic to the device's mechanical and fluid dynamics, not algorithmic output.

7. The Type of Ground Truth Used:

For the functional testing, the "ground truth" would implicitly be engineering specifications and established performance characteristics of the predicate devices. For example, a flow rate measurement would be compared against a target flow rate or the known performance range of predicate devices.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device, not an AI algorithm requiring a training set.

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

Not applicable. No training set was used.

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The Orqis Extracorporeal Blood Pumping system is indicated to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours). It is also indicated for use in extracorporeal circulatory systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g., valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants, etc).

The Orqis Pump Tubing is indicated for use in extracorporeal circuits for circulatory support lasting six-hours or less.

The Orqis Extracorporeal Blood Pumping System consists of a pump, independent motor unit, a controller, a flow sensor, and some pump tubing. The system also has two accessories: a holster for the pump and motor, and a controller stand.
The Orqis Blood Pump is a sterile, single-use, disposable, non-pulsatile, non-roller pump that utilizes a rotor to impart energy to the blood in an extracorporeal circuit through centrifugal forces. The inlet of the pump runs concentric with the axis of the rotor.
The Orqis Motor is a small, compact, reusable unit that holds the disposable blood pump and drives the rotor inside the blood pump. The Motor turns a magnet that is hermetically sealed in the pump's rotor at a speed that is set by the controller. The outer shell of the motor is built from aluminum and polycarbonate. The motor is provided non-sterile.
The Orqis Controller is a microprocessor-based device, which drives and controls the blood pump, through the motor. The Controller also provides monitoring of motor speed, fluid flow, and pressure through the use of alphanumeric display and audible and visual alarms.
The Orqis Flow Sensor is an ultrasonic flow meter that measures fluid flow through standard 3/8" tubing.
The Orqis Pump Tubing is medical grade PVC tubing used to connect the Blood Pump to external devices. The Pump Tubing is provided sterile.

This document describes the Orqis Extracorporeal Blood Pumping System, a non-roller type blood pump intended for use in extracorporeal circulation for cardiac support for up to six hours.

1. Acceptance Criteria and Reported Device Performance

The provided text indicates that the device underwent "Functional Testing" and was deemed "as safe and effective as the predicate device for its intended use." However, specific quantitative acceptance criteria or detailed performance metrics are not provided in the excerpt. Therefore, I cannot construct a table with specific acceptance criteria and reported performance values. The summary only states:

2. Sample Size for Test Set and Data Provenance

The provided text does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The study is described as "Functional Testing," which implies laboratory or in-vitro testing rather than a clinical study with human subjects.

3. Number of Experts and Qualifications for Ground Truth Establishment

Not applicable. The "Functional Testing" described is likely engineering or laboratory-based and would not involve experts establishing ground truth in the way a clinical image analysis study or diagnostic device study would.

4. Adjudication Method for Test Set

Not applicable. As the "Functional Testing" appears to be an engineering or laboratory assessment, a clinical adjudication method like 2+1 or 3+1 is not relevant.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The provided text describes "Functional Testing" to demonstrate equivalence to a predicate device, focusing on the device's intrinsic operation rather than its impact on human reader performance.

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

Yes, a standalone performance assessment was conducted. The "Functional Testing" described appears to assess the device's operational capabilities (e.g., pumping blood, controlling speed, measuring flow and pressure) independently. The conclusion states "The Orqis Extracorporeal Blood Pumping System has successfully undergone functional testing demonstrating equivalence to the predicate device," which directly indicates an assessment of the device's inherent performance.

7. Type of Ground Truth Used

The ground truth for the "Functional Testing" would likely be established based on:

• Engineering specifications and design requirements: The device's operation would be tested against pre-defined performance characteristics.
• Performance of the predicate device: The benchmark for "equivalence" would be the known and established performance of the Levitronix CentriMag® Extracorporeal Blood Pumping System (K020271), Cardiac Assist TandemHeart Escort Controller (K061369), and Olsen Medical Sales Plastron Pump Tubing (K013578).
• Standardized test methods and equipment: The "functional testing" would involve using calibrated instruments and established protocols to measure parameters like flow rate, pressure, speed, and potentially hemolysis or other blood-related effects.

8. Sample Size for the Training Set

Not applicable. This device is a mechanical blood pumping system, not an AI/ML algorithm that requires a training set of data. The "Functional Testing" described focuses on the physical and operational performance of the device.

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

Not applicable. As the device is not an AI/ML algorithm, there is no training set or associated ground truth establishment process in that context.

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