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The CentriMag™ Blood Pump for use with CentriMag™ Acute Circulatory Support System (Motor, Monitor, Console, and Flow Probes) is indicated for controlling blood flow as part of an extracorporeal membrane oxygenation (ECMO) circuit. ECMO is intended to provide assisted extracorporeal circulation and physiologic gas exchange of the patients' blood for adult patients with acute respiratory failure and/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 CentriMag™ Blood pump for use with CentriMag™ Acute Circulatory Support System (hereafter referred to as the CentriMag System) is designed to provide assisted extracorporeal circulation and physiologic gas exchange of patients' blood for adult patients with acute respiratory and/or acute cardiopulmonary failure. The CentriMag System was designed to provide temporary mechanical circulatory support. The CentriMag System provides circulatory assistance for patients in acute hemodynamic compromise, a population whose treatment options are limited. The system includes: CentriMag 2nd Generation Primary Console, CentriMag Motor, CentriMag Blood Pump, Flow Probe, and Mag Monitor (optional). The CentriMag System features a centrifugal flow pump with inflow and outflow ports that are at right angles to one another, and a magnetically levitated impeller (Full MagLev™ technology). The CentriMag Motor is a reusable, non-sterile component of the CentriMag Acute Circulatory Support System. The CentriMag Motor holds the blood pump and drives the impeller inside the blood pump. When the pump is inserted into the motor and activated, the internal impeller is electromagnetically levitated and centered, eliminating the need for shafts, seals, and bearings in the pump. Utilizing magnetic levitation technology (Full MagLev™ technology) to suspend and spin the impeller eliminates bearing and seal friction, resulting in minimal heat generation and wear of the pump components. the console is used to control pump speed, the resultant blood flow, and monitor the operation of the system. A cable connects the console to the motor, allowing flexibility in the pump motor and pump positioning.

The provided text describes the CentriMag™ Blood Pump for use with the CentriMag™ Acute Circulatory Support System. While it details extensive performance testing and claims substantial equivalence, it does not present acceptance criteria in terms of specific quantitative metrics (e.g., sensitivity, specificity, accuracy) that would apply to an AI/ML device, nor does it provide a study that explicitly demonstrates the device meets these types of criteria using methods common for AI/ML performance evaluation (like those involving expert consensus for ground truth).

Instead, the document focuses on the engineering and clinical performance of a mechanical circulatory support system. The "acceptance criteria" appear to be implicit in meeting the special controls outlined in 21 CFR 870.4100(b) and demonstrating substantial equivalence to a predicate device through various non-clinical and clinical evaluations.

Here's a breakdown of the information that is present, interpreted in the context of the prompt, and highlighting what is not present but would be typical for AI/ML device evaluation:

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

The document does not provide a table with explicit acceptance criteria (e.g., target percentages for accuracy, sensitivity, specificity) and corresponding reported device performance for an AI/ML component. The "acceptance criteria" for this device seem to be implicitly tied to meeting regulatory requirements for extracorporeal circuits and accessories, and demonstrating performance comparable to a predicate device through a range of engineering and clinical tests.

Reported Device Performance (based on the provided text):

The performance of the CentriMag System was demonstrated through a comprehensive set of tests:

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

• Sample Size for Test Set: Not explicitly stated as a test set in the traditional AI/ML sense. The "clinical summary" refers to a "pre-specified statistical analysis plan from the ELSO Registry," which is a real-world clinical data source. The number of patients included in this propensity-matched analysis is not provided.
• Data Provenance: The data comes from the ELSO Registry, which is a registry for Extracorporeal Life Support Organization, suggesting a multi-center, international scope. The analysis was retrospective (utilizing existing registry data).

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

Not applicable in the typical AI/ML context. The clinical study used the ELSO Registry, which records actual clinical outcomes and complications. The "ground truth" here is the aggregated, documented patient outcomes from the registry, not an expert-annotated dataset for an algorithm.

4. Adjudication method for the test set

Not applicable. As the "ground truth" is derived from a clinical registry of patient outcomes, there's no mention of an adjudication method used by experts for a test set. The registry likely has its own data entry and validation protocols.

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 such study was conducted or mentioned, as the device is a mechanical circulatory support system, not an AI-assisted diagnostic or decision support tool for human readers.

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

This question is not applicable to the CentriMag Blood Pump, as it is a mechanical device, not an algorithm.

7. The type of ground truth used

For the clinical evaluation, the "ground truth" consists of outcomes data from the ELSO Registry, specifically ECMO-related clinical complications and other patient outcomes.

8. The sample size for the training set

Not applicable. The CentriMag Blood Pump is a hardware device; it does not involve a training set for an AI/ML algorithm.

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

Not applicable. There is no training set mentioned for this device.

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

The CentriMag™ Circulatory Support System, hereafter referred to as the CentriMag System, was designed to provide temporary mechanical circulatory support. The CentriMag system in the United States (US) is indicated as a component of an extracorporeal bypass circulatory support circuit for use during cardiopulmonary bypass (CPB) surgery (up to 6 hours). The CentriMag System provides circulatory assistance for patients in acute hemodynamic compromise, a population whose treatment options are limited.

The CentriMag System is composed of:

• CentriMag Primary Console
• CentriMag Motor
• CentriMag Blood Pump
• CentriMag Flow Probe
• Mag Monitor (optional)

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.

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, single use, disposable devices. The cannula kit is designed for use with the Thoratec CentriMag® Extracorporeal Blood Pumping System.

The provided text is a 510(k) summary for a medical device (CentriMag Acute Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, and CentriMag Drainage (Venous) Cannula Kit).

Based on the content of the document, the device did not undergo a study to prove its performance against acceptance criteria in the typical sense of a new or modified device requiring such evidence. This 510(k) submission is a "Special 510(k)" which implies that the changes being made are minor and do not affect the device's fundamental performance, design, or intended use. Specifically, the document states:

• "The technological characteristics of the CentriMag Acute Circulatory Support System, CentriMag Return (Arterial) Cannula Kit and CentriMag Drainage (Venous) Cannula Kit have not changed from the predicate devices."
• "Components of the CentriMag Acute Circulatory Support System, CentriMag Return (Arterial) Cannula Kit and CentriMag Drainage (Venous) Cannula Kit are not affected by the labeling changes proposed in this Special 510(k) premarket notification. The labeling changes make the contraindications consistent among all labeling, add and/or strengthen warnings and precautions, and generally align and update the content for consistency."
• "The performance characteristics of the CentriMag Acute Circulatory Support System, CentriMag Return (Arterial) Cannula Kit and CentriMag Drainage (Venous) Cannula Kit have not changed. The labeling changes included in this 510(k) are for the Thoratec (now Abbott's) devices (predicates listed above) and do not require performance data to evaluate the change."
• "Clinical testing was not necessary for the labeling changes stated herein since the changes do not impact the design and performance of the devices."

Therefore, I cannot provide a table of acceptance criteria, reported device performance, or details of a study with sample sizes, expert ground truth, adjudication methods, or MRMC studies, as these types of studies were explicitly stated as not necessary for this specific 510(k) submission.

The document argues for substantial equivalence primarily based on the lack of change in technological characteristics and performance from legally marketed predicate devices (K191557, K152161, and K152190).

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The CentriMag 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 support 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 CentriMag™ Circulatory Support System, hereafter referred to as the CentriMag System, was designed to provide temporary mechanical circulatory support. To date, the CentriMag system in the United States (US) is indicated as a component of an extracorporeal bypass circulatory support circuit for use during cardiopulmonary bypass (CPB) surgery (up to 6 hours). The CentriMag System provides circulatory assistance for patients in acute hemodynamic compromise, a population whose treatment options are limited.

The CentriMag System is composed of:

• CentriMag Primary Console
• CentriMag Motor
• CentriMag Blood Pump
• CentriMag Flow Probe
• Mag Monitor (optional, not shown)

The CentriMag Motor is a reusable, non-sterile component of the CentriMag Acute Circulatory Support System. The CentriMag Motor holds the blood pump and drives the impeller inside the blood pump. The motor turns the magnet (and impeller) within the blood pump (Full MagLev™ technology) at a speed that is set on the console by the user. When the impeller is rotated, a pressure gradient develops between the center and outside edge of the pump, causing blood to flow from the inflow to the outflow port of the pump. The amount of flow through the pump depends on the speed of the impeller, and the difference between the inlet and outlet pressures.

The provided text describes a 510(k) premarket notification for a design modification to the CentriMag™ Acute Circulatory Support System, specifically a redesigned motor cable with enhanced bend protection. This is a medical device, and the submission focuses on proving the substantial equivalence of the modified device to its predicate, rather than establishing clinical effectiveness for a new-to-market device or an AI algorithm.

Therefore, the typical metrics and study designs used for AI/algorithm performance (e.g., sensitivity, specificity, MRMC studies, expert consensus for ground truth of an AI algorithm) do not apply in this context. The acceptance criteria and "study" are focused on mechanical and electrical performance to ensure the modified cable is at least as safe and effective as the original, and does not introduce new safety concerns.

Here's a breakdown of the requested information based solely on the provided text, recognizing its limited scope for AI-specific metrics:

Acceptance Criteria and Device Performance (for a Medical Device Component Modification)

The acceptance criteria for this device modification are focused on maintaining or improving the mechanical and electrical integrity of the motor cable compared to the predicate device.

Table of Acceptance Criteria and Reported Device Performance

Study Details (Bench Testing for a Device Component Modification):

1. Sample sizes used for the test set and data provenance:

   • Sample Size: The text states "Comparison bench testing was performed" and refers to "both designs" (redesigned and current/original cable designs). It does not specify the number of individual cables or test repetitions for each test (Endurance and Kink test).
   • Data Provenance: The testing was carried out by Thoratec (now part of Abbott) as part of their 510(k) submission, implied to be internal company testing. The country of origin of the data is not explicitly stated beyond the company's US address (Pleasanton, CA). This was not a human clinical study, but rather laboratory bench testing. The term "retrospective or prospective" doesn't directly apply here; it's a controlled bench test evaluating a manufactured component.

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

   • Not Applicable (N/A) / None specified: For these types of mechanical and electrical bench tests, "ground truth" is established by direct measurement and observation of physical parameters, not by expert interpretation in the way it is for diagnostic imaging or clinical outcomes. Engineering specifications and industry standards (like IEC 60601-1) serve as the "truth" against which performance is measured.
   • Qualifications of personnel conducting the tests are not provided, but would typically be engineers or technicians trained in relevant mechanical and electrical testing protocols.

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

   • Not Applicable (N/A): Adjudication methods like 2+1 or 3+1 refer to consensus-building among human readers for subjective data interpretation (e.g., reading medical images). This was a series of objective bench tests with pass/fail criteria based on physical performance and visual inspection. Any "adjudication" would be part of standard quality control and engineering verification processes, not a multi-reader review.

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

   • No, Not Applicable (N/A): This was a 510(k) for a physical medical device component (motor cable) and not an AI algorithm. Therefore, an MRMC study comparing human reader performance with or without AI assistance was not conducted, nor would it be relevant.

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

   • No, Not Applicable (N/A): This is a physical device, not an algorithm.

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

   • Engineering Specifications and Industry Standards: The "ground truth" for these tests consisted of predefined pass/fail criteria derived from engineering design specifications and compliance with recognized international standards (e.g., IEC 60601-1). Performance data (e.g., integrity of cable after specified bends, absence of short circuits) formed the direct evidence.

7. The sample size for the training set:

   • Not Applicable (N/A): This device modification did not involve machine learning or AI, so there was no "training set."

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

   • Not Applicable (N/A): As there was no training set, this question is not applicable.

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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 2nd Generation CentriMag Primary Console and Mag Monitor are indicated for use with the CentriMag Extracorporeal Blood Pumping System. The CentriMag 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 support 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 2nd Generation CentriMag Primary Console is a microprocessor based device. The microprocessor generates the primary motor control signal, monitors system sensors, generates display outputs, interprets the inputs through the front keypad, provides alarm functions and handles the Mag Monitor interface. The Console is intended to be operated on single phase AC power; however, it also has a built-in rechargeable battery with a battery charger. The rechargeable battery is field replaceable. In addition, an optional external modular battery (UPS) can be used to power the CentriMag Primary Console. The human interface of the CentriMag Primary Console consists of a graphical screen to display data and system options and touch pads to change the system status. The 2nd Generation CentriMag Primary Console is intended to be used together with the Mag Monitor: however it can be also operated as a stand-alone unit.

The Mag Monitor provides a redundant user interface containing a display and touch pads. The Mag Monitor is a non-sterile, reusable device that is designed to work only with the 2nd Generation CentriMag Primary Console. The Mag Monitor is a 12V DC-powered device and receives its power directly from 200 Generation CentriMag Primary Console via a power connector that mates with a connector on the back-panel of 2nd Generation CentriMag Primary Console. Based on the design of its power connector, the Mag Monitor cannot be plugged into a hospital AC power outlet. The Mag Monitor's core function is to provide multi-color alphanumerical and graphical displays of information it receives from the 200 Generation CentriMag Primary Console.

The Mag Monitor is a processor based device, with a flat color screen (e.g. LCD). In addition, it is equipped with touch pad to allow the user to enter commands. In the hospital-setting configuration, the user is able to operate and monitor the performance of the CentriMag System through the Monitor. The Monitor can control the functions of the 2nd Generation CentriMag Primary Console, and therefore, of the CentriMag System. The Monitor only displays data and stores user commands without interacting directly with the primary motor control which is managed by the 2nd Generation CentriMag Primary Console. The Mag Monitor is connected to the 200 Generation CentriMag Primary Console through one cable, which includes data and power lines. Power is provided by the 200 Generation CentriMag Primary Console.

The redesigned Mag Monitor is compatible with both the current 200 Generation Console and the redesigned 2nd Generation Console. However, when plugged into the current Console, the redesigned Mag Monitor will only operate when the Console is connected to AC power. It will not operate when the current Console is run on Battery power

The provided text describes a 510(k) summary for the Thoratec 2nd Generation CentriMag Primary Console and Mag Monitor. This documentation focuses on demonstrating substantial equivalence to predicate devices for regulatory approval, rather than detailing a clinical study with specific acceptance criteria and performance metrics for an AI-powered diagnostic device.

Therefore, the information required to answer your prompt, particularly regarding AI device performance, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment, is not present in the provided 510(k) summary.

This document focuses on the device itself (a cardiopulmonary bypass pump console and monitor), its design, intended use, and a comparison of its technological characteristics and performance (functional testing, safety, environmental, etc.) against existing predicate devices. It explicitly states: "Clinical testing was not performed." (Section I. Clinical Performance).

As such, I cannot create the requested table or provide details about AI device performance from this document. If you have a different document describing an AI-powered diagnostic device, please provide it.

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