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The CentriMag Return 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 Return Cannula Kit consists of a sterile, single-use, disposable, noncoated, Polyvinyl Chloride (PVC) Cannula and the following accessories:
A) One Obturator (or Introducer)
B) One Hemostasis Seal
C) One Cap
D) One Porous Plug
E) One Needle with Sheath
F) One Guidewire Assembly
G) Two Stabilizer Rings Medium
H) Two Stabilizer Rings Small
I) Two Tip Stabilizers

The provided text describes a medical device, the Levitronix CentriMag Return Cannula Kit, and its 510(k) summary for FDA clearance. However, it does not contain information about a study proving the device meets acceptance criteria in the context of AI/ML performance evaluation. The document focuses on demonstrating substantial equivalence to a predicate device through functional testing, not through AI/ML performance metrics.

Therefore, for aspects related to AI/ML studies, ground truth, sample sizes for training/test sets, expert adjudication, or MRMC studies, the requested information cannot be extracted from the provided text.

Here's a breakdown of what can be extracted based on the provided text, primarily regarding the device's functional performance:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that functional testing was performed and "All met pre-established acceptance criteria." However, the specific acceptance criteria and the quantified reported device performance values are not provided in the text. It only lists the categories of tests performed.

The following questions cannot be answered from the provided text, as they pertain to AI/ML performance studies, which were not conducted for this device clearance.

2. Sample Size Used for the Test Set and the Data Provenance (e.g., country of origin of the data, retrospective or prospective)

• Not applicable / Not provided. The device is a physical medical device (cannula kit), and its clearance relied on functional and bench testing, not an AI/ML model evaluated on a test set of data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts (e.g., radiologist with 10 years of experience)

• Not applicable / Not provided. No ground truth for a test set was established as there was no AI/ML model being evaluated.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

• Not applicable / Not provided. No test set or expert adjudication for an AI/ML model was involved.

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 / Not provided. This is not an AI/ML device.

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

• Not applicable / Not provided. This is not an AI/ML device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Not applicable / Not provided. Ground truth, in the context of AI/ML, was not established for this device. The "truth" for this device's performance was determined by established engineering specifications and biological safety standards (e.g., for hemolysis, biocompatibility).

8. The Sample Size for the Training Set

• Not applicable / Not provided. There was no AI/ML model needing a training set.

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

• Not applicable / Not provided. There was no AI/ML model or training set with associated ground truth.

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The Levitronix 2nd Generation CentriMag Primary Console and Levitronix Monitor are indicated for use with the Levitronix CentriMag Extracorporeal Blood Pumping System. The Levitronix 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 Levitronix 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 Levitronix Monitor; however it can be also operated as a stand-alone unit.

The Levitronix Monitor provides a redundant user interface containing a display and touch pads. The Primary and Back-Up Consoles also provide a fullyfunctional user interface containing a display and touch pads. The Levitronix Monitor is a non-sterile, reusable device that is designed to work only with the 2nd Generation CentriMag Primary Console; therefore, it does not support the 1st Generation CentriMag Primary Console or the CentriMag Back-Up Console. The Levitronix Monitor is a 12V DC-powered device and receives its power directly from 2nd 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 Levitronix Monitor cannot be plugged into a hospital AC power outlet. The Levitronix Monitor's core function is to provide multi-color alpha-numerical and graphical displays of information it receives from the 2nd Generation CentriMag Primary Console. The Levitronix Monitor is intended for use as a hospital-based unit (OR and bed-side) and is not intended for use during patient transport from one hospital to another.

The Levitronix 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 Levitronix Monitor. The Levitronix Monitor can control the functions of the 2nd Generation CentriMag Primary Console, and therefore, of the CentriMag System. The Levitronix 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 Levitronix Monitor is connected to the 2nd Generation Primary Console through one cable, which includes data and power lines. Power is provided by the 2nd Generation CentriMag Primary Console.

Here's an analysis of the provided text regarding device acceptance criteria and study information:

Device Acceptance Criteria and Study Analysis for Levitronix 2nd Generation CentriMag Primary Console and Levitronix Monitor

Based on the provided 510(k) summary, the Levitronix 2nd Generation CentriMag Primary Console and Levitronix Monitor did not undergo a clinical study with specific acceptance criteria and performance metrics in the traditional sense for this submission. Instead, the submission relies on demonstrating substantial equivalence to predicate devices through functional testing and risk management.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Sample Size: Not applicable in the context of a clinical test set with human subjects. The "test set" here refers to the functional tests performed on the physical devices.
• Data Provenance: The document does not specify the exact location or details of where the functional testing was conducted. It mentions that the devices were CE Mark approved on February 5, 2010, and have been successfully used clinically in Europe in the commercial market, implying that some performance data may have been gathered during that commercial use, but this is not presented as formal clinical study data for this 510(k) submission. The functional testing would have been conducted by the manufacturer, Levitronix LLC.

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

• Not applicable. As no clinical study with a "test set" requiring expert ground truth was performed for this 510(k) submission, this information is not provided.

4. Adjudication Method for the Test Set:

• Not applicable. No clinical study requiring subject-level adjudication was performed.

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

• No, an MRMC comparative effectiveness study was not done. The submission states: "Clinical testing was not performed."
• There is no information regarding the effect size of human readers improving with or without AI assistance, as AI is not mentioned as a component of this device, and no human reader study was conducted.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• This concept is not directly applicable to this device. The Levitronix 2nd Generation CentriMag Primary Console and Monitor are hardware devices for managing a cardiopulmonary bypass system. There isn't an "algorithm-only" performance to evaluate separately from the device's integrated function. The "functional testing" mentioned is essentially the standalone performance of the physical device.

7. Type of Ground Truth Used:

• For the functional testing, the "ground truth" would be the engineering specifications and established performance parameters of the predicate devices. The new devices were tested to ensure their performance matched or exceeded these established benchmarks, thereby demonstrating substantial equivalence. There's no mention of pathology, outcomes data, or expert consensus in this context.

8. Sample Size for the Training Set:

• Not applicable. This submission does not describe a machine learning algorithm or AI model that would require a training set. The device is a hardware system.

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

• Not applicable. No training set was used.

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The Levitronix CentriMag Primary and Back-Up Consoles are indicated for use with the Levitronix CentriMag Extracorporeal Blood Pumping System. The Levitronix 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 Primary Console is a microprocessor-based device. The microprocessor generates the primary Motor control signal, monitors system sensors, generates front display outputs, and provides alarm functions. The microprocessor acquires the sensor data for use in generating operator displays and alarms. An alphanumeric screen is used to display monitored data, system options, and menus. Operator adjustable alarms and parameters are accessible via the system menus.

The CentriMag Back-Up Console is a microprocessor-based device. The microprocessor generates the primary Motor control signal, monitors system sensors, generates front display outputs, and provides alarm functions. The microprocessor acquires the sensor data for use in generating operator displays and alarms. An alphanumeric screen is used to display monitored data.

This document pertains to a 510(k) submission for the Levitronix CentriMag Primary Console and Back-Up Console. It specifically states that the submission is for a "labeling change" and that this change "did not require any performance characteristics testing."

Therefore, the document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria as typically understood for new device submissions or modifications requiring performance validation.

Here's why the requested information cannot be extracted from this document:

1. No Acceptance Criteria or Performance Data: The document explicitly states: "The proposed labeling change did not require any performance characteristics testing." This means no new tests were conducted to establish performance or acceptance criteria for this particular submission.
2. Substantial Equivalence to Predicate Device: The entire premise of this 510(k) is based on demonstrating substantial equivalence to previously cleared predicate devices (K083340 and K090004). This implies that the performance characteristics (and thus, presumably, acceptance criteria met by those predicate devices) are considered already established.
3. No Study Conducted: Since no performance testing was required or conducted for this submission, there is no study to describe in terms of sample size, data provenance, ground truth, expert involvement, or MRMC analysis.

In summary, the provided document does not contain the information requested because the 510(k) submission described is for a labeling change that did not necessitate new performance testing or the establishment of new acceptance criteria.

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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 Levitronix CentriMag Back-Up Console is indicated for use with the Levitronix CentriMag Extracorporeal Blood Pumping System. The Levitronix 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 Back-Up Console is a microprocessor-based device. The microprocessor generates the primary Motor control signal, monitors system sensors, generates front display outputs, and provides alarm functions. The microprocessor acquires the sensor data for use in generating operator displays and alarms. An alphanumeric screen is used to display monitored data.

The provided document is a 510(k) summary for the Levitronix CentriMag Back-Up Console. It describes the device, its intended use, and its comparison to a predicate device. However, it does not contain the detailed information necessary to answer all parts of your request regarding acceptance criteria and a study proving those criteria are met. This document is a regulatory submission for premarket notification, not a clinical trial report or a performance validation study report.

Here's what information can be extracted and what is missing:

Information Present:

• Device Name: Levitronix CentriMag Back-Up Console
• Intended Use: To pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods up to six hours, both for complete cardiopulmonary bypass and other circulatory support systems.
• Comparison to Predicate Device: The document states that the device has "technological characteristics similar to the predicate device," "indications for use which is substantially equivalent," "is composed of the same or equivalent materials," "has equivalent design features," and "has functional characteristics which are the same or equivalent to those of the predicate device." It concludes that "Due to the equivalency of indications for use, materials of composition, design features, and functional characteristics, the device raises no new safety or effectiveness issues."
• Summary of Performance Data: The document briefly mentions: "The performance characteristics of the Levitronix CentriMag Back-Up Console were tested and compared with Levitronix performance specifications established for the device and with the commercially available predicate device."

Information NOT Present (and likely not found in a 510(k) summary of this type):

The document does not provide the following:

1. A table of specific acceptance criteria and the reported device performance against those criteria.
2. Sample sizes used for any test set or the data provenance (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method for a test set.
5. Details of a multi-reader multi-case (MRMC) comparative effectiveness study, or effect size of human readers with/without AI assistance. (This is a medical device, not an AI diagnostic tool).
6. Details of a standalone (algorithm only) performance study. (Again, this is a hardware console, not an AI algorithm).
7. Type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for a training set.
9. How ground truth for a training set was established.

Based on the provided text, I cannot complete the requested tables and sections related to specific acceptance criteria, study sizes, expert involvement, and AI performance metrics. The document focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance validations with quantitative acceptance criteria.

The "Summary of Performance Data" section (H) only states that tests were performed "compared with Levitronix performance specifications established for the device and with the commercially available predicate device." It doesn't present those specifications or the detailed test results.

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The Levitronix CentriMag Primary Console is indicated for use with the Levitronix CentriMag Extracorporeal Blood Pumping System. The Levitronix 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 Primary Console is a microprocessor-based device. The microprocessor generates the primary Motor control signal, monitors system sensors, generates front display outputs, and provides alarm functions. The microprocessor acquires the sensor data for use in generating operator displays and alarms. An alphanumeric screen is used to display monitored data, system options, and menus. Operator adjustable alarms and parameters are accessible via the system menus.

This document is a 510(k) summary for a medical device called the "Levitronix CentriMag Primary Console". It describes the device, its intended use, and its comparison to a predicate device to demonstrate substantial equivalence. However, it does not contain acceptance criteria for device performance or a study demonstrating the device meets those criteria in the way typically expected for an AI/software device that makes diagnostic or interpretive claims.

This device is a cardiopulmonary bypass pump console, which is hardware that controls a blood pumping system. The 510(k) is primarily focused on demonstrating that a new version of the console, specifically with "Software Version 3.00", is substantially equivalent to a previously cleared version (Software Version 2.02).

Therefore, I cannot extract the requested information as it is not present in the provided text. The questions posed relate to the evaluation of AI or diagnostic software, which this device is not.

Here's why the requested information isn't applicable or available in this document:

• Acceptance Criteria for Performance: For a mechanical device like this, acceptance criteria would typically involve engineering specifications (e.g., flow rate accuracy, pressure monitoring accuracy, alarm response times, battery life). These are not detailed in a way that can be presented in a performance table as if it were a diagnostic AI. The document only generally states: "The performance characteristics of the Levitronix CentriMag Primary Console were tested and compared with Levitronix performance specifications established for the device and with the commercially available predicate device." No specific performance metrics or their achieved values are reported in this summary.
• Study Proving Acceptance Criteria: The "study" mentioned is a comparison to a predicate device and internal performance specifications. This is not a study in the sense of a clinical trial or performance evaluation using a test set with ground truth as would be done for an AI algorithm.
• Sample Size for Test Set/Data Provenance/Experts/Adjudication/MRMC/Standalone/Ground Truth (for test set)/Training Set/Ground Truth (for training set): These are all concepts related to the validation of AI or diagnostic algorithms using clinical data. This document describes a medical device (a pump console) that does not make diagnostic interpretations or use AI in the way implied by these questions. The software mentioned (V3.00 Application Software) is for controlling the pump, monitoring sensors, and displaying data, not for making diagnostic decisions based on patient data.

In summary, the provided text is a regulatory submission for a hardware medical device with embedded software for control, not a diagnostic or AI-driven system. Therefore, the questions are largely not applicable to the content provided.

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The Levitronix CentriMag Primary Console is indicated for use with the Levitronix CentriMag Extracorporeal Blood Pumping System. The Levitronix 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 Primary Console is a microprocessor-based device. The microprocessor generates the primary Motor control signal, monitors system sensors, generates front display outputs, and provides alarm functions. The microprocessor acquires the sensor data for use in generating operator displays and alarms. An alphanumeric screen is used to display monitored data, system options, and menus. Operator adjustable alarms and parameters are accessible via the system menus.

Here's a breakdown of the acceptance criteria and study information for the Levitronix CentriMag Primary Console, based on the provided text:

It's important to note that the provided text is a 510(k) summary for a medical device and not a detailed clinical study report. Therefore, some information, particularly regarding specific statistical metrics and study designs common in AI/diagnostic device evaluations, is not present. This submission focuses on substantial equivalence to a predicate device for regulatory clearance.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated. The document refers to "performance characteristics... were tested," but doesn't provide the number of tests, units, or specific data points.
• Data Provenance: Not explicitly stated. Given the nature of a 510(k) for a hardware console, the testing likely involved in-house engineering and laboratory validation, rather than patient data in the typical sense of a diagnostic or therapeutic device. The "comparison with the commercially available predicate device" suggests comparative bench testing.

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

• This information is not provided and is generally not applicable in the context of a 510(k) for a medical device console like the CentriMag, which is a hardware system for pumping blood rather than an AI/diagnostic tool requiring expert labeling of data. The "ground truth" would be the expected functional output and safety parameters confirmed by engineering specifications and testing.

4. Adjudication Method for the Test Set

• Not applicable. This typically refers to resolving discrepancies in expert labeling for ground truth in diagnostic tests. For a device like the CentriMag Console, "adjudication" would refer to engineering and quality control procedures for discrepancy resolution during testing, which are part of standard quality management systems but not detailed in this 510(k) summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• No. An MRMC study is not applicable here. The Levitronix CentriMag Primary Console is a cardiopulmonary bypass pump console, not an AI or diagnostic imaging device that assists human readers.

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

• No. This question is not applicable as the device is a hardware console for extracorporeal blood pumping, not an algorithm. Its operation inherently involves human interaction for setup, monitoring, and control. The "microprocessor-based" nature implies internal algorithmic control, but not as a standalone algorithm in the context of typical AI device evaluation.

7. The Type of Ground Truth Used

• Engineering Specifications and Predicate Device Performance: The "ground truth" for this device's performance would be against established engineering performance specifications (e.g., flow rate accuracy, alarm functionality, motor control stability) and the known, acceptable performance of the predicate CentriMag Console. Safety and functional reliability are key "truths" established through testing against these benchmarks.

8. The Sample Size for the Training Set

• Not applicable. The CentriMag Primary Console is a hardware device (with embedded software) for blood pumping, not a machine learning or AI model that requires a "training set" in the conventional sense. Its "training" would be analogous to the design, development, and validation of its hardware and software components.

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

• Not applicable. As established in point 8, there isn't a "training set" in the context of an AI model for this device. The "ground truth" for its development would be derived from medical and engineering requirements for safely and effectively performing cardiopulmonary bypass, informed by existing medical practice and the performance of previous or similar devices.

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The Levitronix CentriMag Primary Console is indicated for use with the Levitronix CentriMag Extracorporeal Blood Pumping System. The Levitronix 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 Primary Console is a microprocessor-based device. The microprocessor generates the primary Motor control signal, monitors system sensors, generates front display outputs, and provides alarm functions. The microprocessor acquires the sensor data for use in generating operator displays and alarms. An alphanumeric screen is used to display monitored data, system options, and menus. Oneator adjustable alarms and parameters are accessible via the system menus.

The provided text is a 510(k) Summary for the Levitronix CentriMag Primary Console. This document focuses on demonstrating substantial equivalence to a predicate device for regulatory approval, rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics typically associated with AI/software-as-a-medical-device (SaMD) clearances.

Therefore, much of the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, training set details) cannot be found in the provided text because the device is a hardware medical device (a cardiopulmonary bypass pump console), not an AI/SaMD product.

However, I can extract the relevant information from the document regarding its "performance data" in the context of a hardware device submission.

Here's a breakdown based on the provided text, indicating what is present and what is absent:

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

The document does not provide a formal table of acceptance criteria and reported device performance in the manner typically seen for SaMD or diagnostic devices (e.g., sensitivity, specificity, AUC). Instead, it makes a general statement about performance testing against established specifications.

• Acceptance Criteria (Implied): "Levitronix performance specifications established for the device" (Section H). These are not detailed in the summary.
• Reported Device Performance: "The performance characteristics of the Levitronix CentriMag Primary Console were tested and compared with Levitronix performance specifications established for the device and with the commercially available predicate device." (Section H). No specific quantitative performance metrics are provided in this summary document. The comparison confirms functional equivalency rather than specific diagnostic accuracy metrics.

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. Performance testing in this context typically refers to engineering bench testing and verification/validation activities of a hardware system, not a clinical test set with patient data.
• Data Provenance: Not applicable, as this refers to hardware performance testing, not patient data.

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 hardware pump console, and its "performance" would be assessed against engineering specifications and predicate device behavior, not by expert interpretation of clinical data.

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

• Not applicable. This is not a clinical study involving human readers or interpretation.

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 a hardware device; no MRMC study involving human readers and AI assistance was conducted or is relevant for this type of device.

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

• Not applicable. This is a hardware device, not an algorithm. Its "standalone" performance would refer to its operational characteristics without external human intervention, which would be part of standard engineering testing.

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

• Ground Truth: For a hardware device like this, the "ground truth" would be established engineering specifications, design requirements, and the known performance/characteristics of the predicate device. It is not clinical "ground truth" like pathology or expert consensus.

8. The sample size for the training set

• Not applicable. This is a hardware device, not a machine learning model.

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

• Not applicable. This is a hardware device, not a machine learning model.

Summary of the Study that Proves the Device Meets Acceptance Criteria (based on the provided text):

The document states under "H. Summary of Performance Data":

"The performance characteristics of the Levitronix CentriMag Primary Console were tested and compared with Levitronix performance specifications established for the device and with the commercially available predicate device."

This indicates that:

• Study Type: This was a performance testing and comparison study (likely involving bench testing, verification, and validation activities common for hardware medical devices).
• Objective: To demonstrate that the new CentriMag Primary Console performs according to its internal Levitronix performance specifications and is functionally equivalent to the predicate device (Levitronix CentriMag Console, K020271).
• Key Finding: The submission implies that these tests confirmed the device meets its specifications and is substantially equivalent, raising "no new safety or effectiveness issues" (Section G).

However, specific details of these tests (e.g., number of test cycles, specific parameters measured, quantitative results, pass/fail criteria) are not included in this 510(k) summary document. These details would typically be found in the full 510(k) submission attachments, but not in the publicly available summary.

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The Levitronix CentriMag Back-Up Console is indicated for use with the Levitronix CentriMag Extracorporeal Blood Pumping System and as a back-up to the CentriMag Primary Console. The 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 unloading of the ventricle during surgery of the vena cava or aorta, liver transplants etc).

The Levitronix CentriMag Back-Up Console is a microprocessor-based device. The microprocessor generates the primary Motor control signal, monitors system sensors, generates front display outputs, and provides alarm functions. The microprocessor acquires the sensor data for use in calculations and alarms. An alphanumeric screen is used to display monitored data. The CentriMag Back-Up Console uses single phase AC power and is capable of a flow rate of up to one of eld replaceable internal battery. In addition, each Back-Up Console contains a non-rechargeable, field replaceable internal battery that is capable of maintaining Back-Up Console functionality in the event of a loss of AC Power.

Here's an analysis of the provided text regarding the Levitronix CentriMag Back-Up Console, focusing on the requested aspects of acceptance criteria and study details.

Important Note: The provided text is a 510(k) summary for a medical device. These summaries are designed to establish "substantial equivalence" to a predicate device, not necessarily to provide detailed clinical trial data. Therefore, many of the requested data points (like specific sample sizes for test/training sets, number of experts, adjudication methods, MRMC studies, effect sizes, and detailed ground truth establishment for training) are not present in this type of document. The focus here is on demonstrating that the device performs similarly to a previously cleared device.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the acceptance criteria are implicitly met by demonstrating "substantial equivalence" to the predicate device in terms of functional characteristics. The "reported device performance" is a general statement of equivalency rather than specific metrics.

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

• Sample Size for Test Set: Not specified in the provided document. The summary only states that "The performance characteristics... were tested and compared with the... predicate device."
• Data Provenance: Not explicitly stated. Given it's a 510(k) for a device like a pump console, testing would typically involve bench testing and possibly animal or in-vitro models to compare performance characteristics. Clinical human data is not generally required for a 510(k) unless there are significant differences that raise new safety or effectiveness concerns. The summary does not mention any human or clinical data.

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

• This information is not provided in the 510(k) summary. For device performance testing of this nature (comparing functional characteristics), "ground truth" would likely refer to established engineering specifications, performance standards for the predicate device, or measurements obtained from gold-standard testing equipment, rather than expert consensus on interpretive data.

4. Adjudication Method for the Test Set

• This information is not provided as the type of study described (comparison of device performance characteristics) does not typically involve expert adjudication in the way medical imaging or diagnosis studies do.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret output (e.g., radiology images). The Levitronix CentriMag Back-Up Console is a cardiopulmonary bypass pump console, not a diagnostic imaging device.

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

• Yes, in spirit, standalone performance was assessed. The testing described is intrinsic device performance ("performance characteristics... were tested and compared"). While the device assists human clinicians, its core function is automated (microprocessor control, sensor monitoring, alarm generation). The "standalone" testing here refers to the device operating according to its design specifications, not necessarily an AI algorithm. There is no mention of a human-in-the-loop study to evaluate its effectiveness.

7. The Type of Ground Truth Used

• Engineering Specifications / Established Performance of Predicate Device: The ground truth for this type of device comparison would be the independently verified performance specifications of the predicate device and the engineering requirements established for the new device. For example, if the predicate device has a specified flow rate accuracy, the new device would be tested against that established accuracy. The summary states, "The performance characteristics of the Levitronix CentriMag Back-Up Console were tested and compared with the commercially available predicate device." This implies the predicate's performance serves as the "ground truth" or benchmark.

8. The Sample Size for the Training Set

• This information is not applicable/not provided. The device described is a hardware medical device with microprocessor control, not a machine learning or AI-driven system that would typically have a "training set" in the computational sense. Its functionality is based on programmed logic and physics, not trained on data.

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

• This information is not applicable/not provided for the same reasons as #8.

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The Levitronix 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.q., valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants etc).

System - The Levitronix CentriMag® Extracorporeal Blood Pumping System is a fault-tolerant system comprised of four (4) main assemblies which are available separately:

• Blood Pump
• Remote Motor Drive Unit
• Control Console
• Ultrasonic Flow Sensor

Blood Pump - The Levitronix CentriMag® Extracorporeal 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 to the pump runs concentric with the axis of the rotor. The outlet of the pump is perpendicular to the inlet and tangent to the outer diameter. Blood enters the pump housing via the pump's inlet port where it makes contact with the rotor. As the rotor turns, energy in the form of pressure and velocity is transferred from the rotor to the blood. The CentriMag® Extracorporeal Blood Pump moves the blood through the circuit at a desired pressure and flow rate by increasing or decreasing the speed of the rotor. This is accomplished by adjusting the The pump operates from the Levitronix Remote Motor Drive Unit and microprocessor-based console, located outside the sterile field.

Remote Motor Drive Unit - The CentriMag® Motor Drive Unit is positionable on an IV pole/mast or adjacent to the console using an optional utility post. The Motor Drive Unit holds the disposable blood pump and drives the rotor inside the blood pump.

Control Console - The Levitronix CentriMag Console is a microprocessorbased device, which drives and controls the speed of the blood pump in the extracorporeal circuit. The console also provides monitoring of motor speed, fluid flow, and pressure through the use of alphanumeric display, audible alarms and visible alarms.

Ultrasonic Flow Sensor - The Levitronix CentriMag® Extracorporeal Blood Pumping System includes an ultrasonic flow meter.

The provided text outlines the safety and effectiveness of the Levitronix CentriMag® Extracorporeal Blood Pumping System, focusing on its substantial equivalence to predicate devices rather than establishing specific acceptance criteria for a novel device performance. Therefore, a direct table of "acceptance criteria and reported device performance" as typically seen for AI/ML device evaluations is not explicitly present.

However, based on the narrative, the device's performance was evaluated through in-vitro bench testing and compared against established internal performance specifications and the performance of predicate devices. The primary goal was to demonstrate substantial equivalence to existing legally marketed devices.

Here's an attempt to structure the information based on your request, with an understanding that the original document is a traditional 510(k) summary for a non-AI/ML device, focusing on equivalence rather than detailed performance metrics against quantitative acceptance criteria for a new clinical claim:

Acceptance Criteria and Study Details for Levitronix CentriMag® Extracorporeal Blood Pumping System

The Levitronix CentriMag® Extracorporeal Blood Pumping System's acceptance criteria and performance were primarily established through substantial equivalence to predicate devices and adherence to relevant standards and internal specifications, as detailed in the K020271 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for a non-AI/ML device demonstrating substantial equivalence, explicit quantitative acceptance criteria with corresponding reported performance metrics are not detailed in the same manner as for novel performance claims. Instead, the "acceptance criteria" are implied by the demonstration of:

• Technological Characteristics similar to predicate devices.
• Functional Characteristics the same or equivalent to predicate devices.
• Safety and Effectiveness not significantly affected compared to predicate devices.
• Compliance with relevant standards and guidance documents (e.g., software validation, biocompatibility, sterilization).

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

• Test Set Description: The primary "test set" was the Levitronix CentriMag® Extracorporeal Blood Pumping System itself, and its performance was evaluated through in-vitro bench testing.
• Sample Size: The document does not specify the number of devices or experimental replicates used in the in-vitro bench testing.
• Data Provenance: The testing was conducted internally by Levitronix, LLC. The provenance of the predicate device performance data used for comparison is not specified (e.g., publicly available specifications, internal testing of predicate devices). The data is retrospective in the sense that it evaluates the manufactured device against existing standards and predicate devices. No human patient data (prospective or retrospective) was used for performance evaluation as "Clinical testing was not performed on this system."

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

• Ground Truth Establishment: This concept is not applicable in the context of this 510(k) submission. The "ground truth" for device performance (e.g., flow rate accuracy, pressure resistance, biocompatibility) is established by physically testing the device against defined engineering specifications, industry standards (e.g., ISO, USP, FDA guidance), and the known performance of predicate devices. It does not involve expert consensus on medical findings.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Performance testing for this type of device (e.g., durability, flow rates, pressure resistance, biocompatibility) is measured objectively and quantitatively against specifications, not through expert review and 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

• MRMC Study: No. This study is not relevant as the device is a medical pump system, not an AI-based diagnostic or assistive technology for human readers.

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

• Standalone Performance: Not applicable in the context of AI/ML algorithms. The "standalone performance" of the device refers to its physical and functional operation (e.g., pumping blood, monitoring flow, maintaining pressure) as an electromechanical system, which was evaluated through in-vitro bench testing. The console itself is microprocessor-based and governs the pump's operation.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for the various performance aspects (e.g., safety, effectiveness, biocompatibility, sterilization, functional ranges) consists of:
  • Engineering Specifications: Internal performance specifications established by Levitronix.
  • Regulatory Standards: Compliance with FDA guidance (e.g., software validation, biocompatibility), international and national standards (e.g., ISO 10993-1, ISO 11135-1994, ISO 10993-7, ANSI/AIMI, USP XXIII), and FDA guidelines for residuals and pyrogens.
  • Predicate Device Performance: The established operating characteristics and safety profiles of the legally marketed predicate devices (Medtronic Bio-Pump, Model BPX-80 and Medtronic Bio-Console, Model 550) serve as a benchmark for equivalence.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device is not an AI/ML system that requires a "training set" in the computational sense. Its design and operational parameters are based on established engineering principles, fluid dynamics, and medical device regulations.

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

• Ground Truth for Training Set Establishment: Not applicable, as there is no training set for an AI/ML algorithm involved. The "ground truth" for the device's design and manufacturing (analogous to a training process for an AI) is implicitly established through decades of engineering best practices for similar medical devices, adherence to quality systems (e.g., 21 CFR Part 820 Good Manufacturing Practice requirements), and the foundational knowledge of cardiovascular support systems.

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