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The Small (4") and Large (6") Roller Pumps for the Terumo® Advanced Perfusion System 1 are indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.

The Small (4") and Large (6") Roller Pumps of the Terumo® Advanced Perfusion System 1 (System 1) are peristalic pumps with 4 inch and 6 inch diameter raceways. The pumps can be mounted on the base of the System 1 console or can be positioned in an optimal location in the perfusion circuit by mounting to the system poles. Operation of the pumps can be configured using the System 1 Central Control Monitor (CCM). Local user interface displays and control panels are also located on the front of the large and small roller pumps. The small roller pump can accommodate applications requiring flow rates up to 4 L/min including pediatric arterial, adult and pediatric cardioplegia, vent and suction pumping, whereas the large roller pump can accommodate applications requiring flow rates up to 10 L/min including adult and pediatric arterial, cardioplegia, vent and suction pumping. The small and large roller pumps both have variable tube clamp mechanisms that accommodate a variety of tubing sizes, including dual tube sets.

This document, K162843, is a 510(k) premarket notification for updates to the Terumo Advanced Perfusion System 1 Roller Pumps. The main change described is the inclusion of medical grade silicone tubing as a compatible tubing option for both the Small (4") and Large (6") Roller Pumps. Since the device is substantially equivalent to a previously cleared predicate device (K153376), it primarily relies on demonstrating that the new tubing material does not adversely affect the device's safety and effectiveness.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative table format with corresponding "reported device performance" values for all functionality. Instead, it leverages the substantial equivalence to a predicate device and focuses on confirming that the new medical grade silicone tubing does not compromise the established performance.

However, based on the Functional Summary and Flow Range Accuracy sections, we can infer some performance characteristics and the implicit "acceptance criteria" that the subject device (with silicone tubing) must meet by being "Identical to predicate device."

The "Reported Device Performance" column essentially states "met" or "identical to predicate device" because the core of this 510(k) is to demonstrate that the addition of silicone tubing compatibility maintains the performance characteristics of the already cleared predicate device. The conclusion explicitly states: "Performance testing has confirmed that the design input requirements were met demonstrating that medical grade silicone tubing can be used with the Small and Large System 1 Roller Pumps."

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

The document states: "Performance testing of medical grade silicone tubing with the Small and Large System 1 Roller Pumps has been completed successfully." However, it does not specify the sample size (e.g., number of pumps, number of tests, duration of tests) used for this performance testing.

Regarding data provenance, the document does not explicitly state the country of origin or if the study was retrospective or prospective. It implies the testing was conducted by Terumo Cardiovascular Systems Corporation as part of their 510(k) submission, suggesting it was likely prospective testing specifically for this change.

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

The document does not mention the use of human experts to establish ground truth for performance testing in the context of device function for roller pumps. Performance criteria for such devices (flow rate accuracy, speed accuracy, tubing compatibility, etc.) are typically established through engineering specifications and objective measurements, not subjective expert assessment. Therefore, this question is not directly applicable to the type of device and testing described.

4. Adjudication Method for the Test Set

The document does not mention an adjudication method. As noted above, the performance testing for this device is based on objective measurements against engineering specifications, not on subjective assessments that would require adjudication.

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

No, an MRMC comparative effectiveness study was not done for this device. This type of study is typically used for diagnostic devices where human interpretation of images or data is involved, and the goal is to evaluate the effectiveness of AI assistance on human reader performance. The Terumo roller pumps are mechanical devices, and their performance is evaluated through objective measurements and engineering tests.

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

While the term "standalone" typically refers to AI algorithm performance without human intervention, in the context of this mechanical device, the "performance testing" described can be considered analogous to "standalone" in that it evaluates the device's function (with the new tubing) based on its intrinsic capabilities against predefined criteria, without an explicit "human-in-the-loop" interaction as part of the primary performance assessment. The device is designed to operate mechanically, and the performance tests verify its mechanical and fluid dynamics properties.

7. The Type of Ground Truth Used

The ground truth used for this device's performance testing consists of:

• Engineering Specifications: Predefined quantitative thresholds for parameters like flow rate accuracy, speed accuracy, and dimensions.
• Functional Equivalence: The expectation that the subject device, with the new tubing, performs identically or equivalently to the predicate device in terms of all functional aspects (e.g., pump configurations, controls, safety).
• Biocompatibility (implied): The "medical grade silicone tubing" implies that material properties and safety (e.g., non-toxicity, durability) were assessed, although specific details are not provided in this summary.

8. The Sample Size for the Training Set

The concept of a "training set" is relevant to machine learning/AI devices. Since the Terumo roller pump is a mechanical device, there is no training set in the AI/ML sense. Its design and performance are based on engineering principles and physical testing, not data-driven learning.

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

As there is no training set for this mechanical device, this question is not applicable.

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The Large (6") Roller Pump for the Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.

The Large (6") Roller Pump for the Terumo Advanced Perfusion System 1 is a component of the Terumo Advanced Perfusion System 1. It is a large roller pump with a 6" race that can accommodate applications requiring flow rates up to 10 L/min including adult and pediatric arterial, cardioplegia, vent and suction pumping. It uses commercially available medical grade PVC tubing with 11/16" OD (max) and 1/16" - 3/32" wall thickness. It has a front panel for user interface controls, functional displays, and alarm conditions. The pump can be configured using the System 1 Central Control Monitor (CCM) as an Arterial pump or Cardioplegia pump. The Arterial pump can be run in Continuous, Pulse, Servo, or Master/Follower mode. The pump continuously monitors its own performance and reports status information and problems to the user via the pump display panel alarms and to the CCM. Pump responses to detected problems can include Stop, Pause, Reduce Speed, or Message Only. The pump can be mounted on System 1 base or pole.

The Terumo Cardiovascular Systems Corporation Large (6") Roller Pump K131618 is substantially equivalent to the predicate device K112587. The modification made to the device involved software updates.

Here's a breakdown of the acceptance criteria and study information:

1. Acceptance Criteria and Reported Device Performance

The submission states that the modified device has the "same intended use, substantially equivalent indications for use, and the same or substantially equivalent operating principles and technical specifications" as the predicate device. The performance specifications are identical to the predicate device, K112587.

The study supporting the acceptance criteria explicitly states: "Software and system testing have confirmed that the modifications improve device performance."

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

The submission does not specify a distinct "test set" in the context of clinical data or patient samples. The performance testing described relates to software verification and validation testing at unit, integration, and system levels. Therefore, there is no mention of data provenance (e.g., country of origin, retrospective/prospective) typically associated with clinical studies.

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

Not applicable. The performance testing was for software verification and validation, not for establishing clinical ground truth on patient data.

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

Not applicable. The testing was for software and system performance, not for clinical assessment requiring expert adjudication.

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

Not applicable. This device is a medical pump, not an AI-assisted diagnostic or interpretive system that would involve human readers.

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

The performance testing focused on the software modifications to the device, confirming improved device performance through unit, integration, and system level testing. This implies a "standalone" evaluation of the software's functionality and its impact on the device's overall operation, without direct human interaction as part of the performance measurement.

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

For software verification and validation, the "ground truth" would be established specifications, requirements, and expected operational parameters of the device. The software was tested against these predefined functional and performance requirements.

8. The sample size for the training set

Not applicable. This device is a medical pump with software modifications; there is no indication of a machine learning or AI model that would require a "training set" in the context of image analysis or similar applications. The software was developed and then verified/validated.

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

Not applicable, as there is no "training set." The software's correct functioning is validated against engineering specifications and expected device behavior.

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The Large (6") Roller Pump for the Terumo® Advanced Perfusion System 1 is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.

The image shows a device description and indications for use of the APS 1 Large (6") Roller Pump. The device is a peristaltic pump with a 6 inch diameter race that can be mounted on the base of the Advanced Perfusion System 1 (APS1) console or positioned in an optimal location in the perfusion circuit by mounting on the pole. The large roller pump can accommodate applications requiring flow rates up to 10 L/min.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

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 numerical sample size used for the test set in the performance studies. It mentions "new and aged parts" but no specific quantity.

The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. Given the nature of a 510(k) submission for a design change, the testing would generally be prospective, conducted in a laboratory setting by the manufacturer.

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

This information is not provided in the document. The performance tests appear to be engineering-based (strength, reliability/durability) rather than requiring expert clinical interpretation for ground truth.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the tests (Pass/Fail based on engineering criteria), formal adjudication by clinical experts is unlikely.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a mechanical pump, not an AI-powered diagnostic or interpretive tool that would involve human readers.

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

Yes, the performance tests described (Strength, Reliability/Durability) are standalone tests of the device's mechanical integrity and function. The device itself (a roller pump) is a standalone piece of equipment. The assessment of its performance did not involve a "human-in-the-loop" component for interpretation of results, but rather its mechanical operation and ability to withstand stress.

7. Type of Ground Truth Used

The ground truth used for these performance tests appears to be engineering specifications and pre-defined acceptance criteria. For "Strength," the ground truth is defined by the "Knob/Cam Follower Impact Strength Verification" protocol. For "Reliability/Durability," the ground truth is established by "Simulated use testing... under worst-case conditions." The "Pass" result indicates that the device met these engineering and design validation targets.

8. Sample Size for the Training Set

This information is not applicable and therefore not provided. The device is a mechanical pump, not an AI/ML-based system that requires a "training set" in the context of machine learning. The design and manufacturing process would involve internal testing and validation, but not a "training set" in the computational sense.

9. How Ground Truth for the Training Set Was Established

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

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The Medtronic Trillium™ BioPump Plus is indicated for use only with the Medtronic Bio-Console to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary byrass (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 vena cava or aorta, liver transplants, etc.)

The Trillium® BioPump Plus is a centrifugal blood pump which is a single use, disposable, non-pvrogenic device designed to move blood through the extracorporeal circuit by centrifugal forces created by smooth rotating cones. It is the disposable portion of the pumping system and is electromechanically coupled to the BioConsole which is the instrument that monitors and displays the flow and pressure of the blood flow. Venous blood enters the inlet port of the Bio-Pump. The smooth cones rotate in the polycarbonate housing. As the cones rotate, energy in the form of pressure and velocity is transferred from the cones to the blood. The blood is gently accelerated towards the outlet of the pump. The Bio-Pump moves the blood through the circuit at a desired pressure and flow rate by increasing or decreasing the speed of the rotating cones. This is accomplished by adjusting the BioConsole's RPM (revolutions per minute). The arterial blood is returned to the patient from the extracorporeal circuit.

The provided text describes a "SPECIAL 510(k)" submission for a medical device called the Trillium® BioPump Plus. This submission aims to demonstrate that a modified version of an already marketed centrifugal pump is substantially equivalent to existing devices, primarily due to the addition of a Trillium coating to blood-contacting surfaces.

Here's an analysis based on the provided text, addressing your specific points:

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

The document does not explicitly state "acceptance criteria" in a quantified, numerical table format, nor does it provide a direct "reported device performance" in terms of specific metrics. Instead, it relies on a comparative approach, stating that the Trillium® BioPump Plus should perform comparably to predicate devices.

The core "acceptance criteria" can be inferred as:

• Safety and Effectiveness Equivalence: The Trillium® BioPump Plus does not significantly affect safety and effectiveness when compared to the predicate devices.
• No New Safety/Effectiveness Questions: The technological characteristic (Trillium coating) does not raise new types of safety or effectiveness questions.
• Acceptable Scientific Methods: Acceptable scientific methods exist for assessing the effects of this new technological characteristic.

The reported device performance is qualitative: "The biocompatibility and in vitro bench testing demonstrated that when compared to the predicate devices, the Trillium®BioPump Plus does not significantly affect safety and effectiveness and is substantially equivalent to other commercially distributed extracorporeal cardiopulmonary devices."

Table of Inferred Acceptance Criteria and Reported Performance

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

The document mentions "biocompatibility and in vitro bench testing," which implies a test set was used. However, it does not specify the sample size for these tests (e.g., number of devices tested, number of in vitro samples).

The data provenance is not explicitly stated regarding country of origin, retrospective/prospective nature, or whether it involved human or animal subjects (though "biocompatibility" often involves in vitro and sometimes in vivo studies). Given it's a "SPECIAL 510(k)" for a modification to an existing device, the testing would likely be focused on the impact of the coating.

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 section is not applicable to the provided document. The Trillium® BioPump Plus is a mechanical medical device (a centrifugal blood pump), not an AI or diagnostic imaging device that would typically involve human expert interpretation to establish a ground truth for a test set. The validation relies on engineering performance parameters, biocompatibility, and material equivalence rather than expert consensus on diagnostic interpretations.

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

This section is not applicable for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are used in studies where a "ground truth" needs to be established from subjective expert opinions, typically in diagnostic tasks like image interpretation. This device's testing would involve objective measurements against engineering specifications and biocompatibility standards.

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

This section is not applicable. An MRMC study is relevant for diagnostic devices (especially those involving AI for interpretation) where the performance of human readers, with and without AI assistance, is compared across multiple cases. The Trillium® BioPump Plus is a therapeutic/support device, not a diagnostic one involving human "readers."

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

This section is not applicable. The device is a physical, mechanical blood pump, not an algorithm. The concept of "standalone" performance without human-in-the-loop is relevant for AI algorithms. The device functions as part of a human-controlled extracorporeal circuit.

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

Given the nature of the device, the "ground truth" would be established through objective scientific and engineering principles:

• Biocompatibility Standards: Compliance with recognized biocompatibility standards (e.g., ISO 10993 series) for materials in blood contact.
• In Vitro Bench Testing Parameters: Specific performance metrics like flow rates, pressure generation, hemolysis indices, thrombogenicity, and durability under simulated physiological conditions.
• Material Equivalence: Verification that the Trillium coating behaves as expected and is comparable to existing applications (e.g., AFFINITY® Hollow Fiber Oxygenator with Trillium® BioSurface) in terms of blood compatibility.

The document implicitly states that "acceptable scientific methods exist for assessing effects of these new technological characteristics," which refers to these types of objective tests and standards.

8. The sample size for the training set

This section is not applicable. The Trillium® BioPump Plus is a physical device, not an AI model that requires a "training set."

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

This section is not applicable for the same reasons as point 8.

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The Stöckert Compact System is an integrated heart-lung machine consisting of pumps, monitoring, and control elements on a single chassis. It is indicated for speed controlled pumping through the cardiopulmonary bypass circuit for typical durations of six hours or less, left ventricular venting, cardiotomy suction, administration of cardioplegia solution, when used by a qualified perfusionist who is experienced in the operation of the SC System.

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

The Stöckert Compact System is a modification of the Stöckert S3 System, which integrates its components into a single chassis. There is no change to the indications for use or the fundamental technological characteristics.

The provided document, K982014, describes a Special 510(k) for a device modification of the Stöckert Compact System (SC System). A Special 510(k) is used when a modification to a legally marketed device does not alter the fundamental technology or intended use, and therefore the determination of substantial equivalence relies heavily on the equivalence to the predicate device and the validation of the modifications according to design control procedures. This type of submission typically does not involve a traditional "study" in the sense of a clinical trial or performance study with acceptance criteria being met by reported device performance against a ground truth.

Instead, the "acceptance criteria" for a Special 510(k) are typically the demonstration that the modified device remains substantially equivalent to the predicate device in terms of intended use, technological characteristics, safety, and effectiveness. The "study" proving this usually involves design validation and verification activities.

Based on the provided text, here's an analysis against your requested information:

1. Table of acceptance criteria and the reported device performance

The document does not present a formal table of acceptance criteria with reported device performance in the manner requested for a new device submission. Instead, the "acceptance criteria" are implied by the nature of a Special 510(k) and the claim of substantial equivalence.

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

The document does not mention a "test set" in the context of a performance study with a specific sample size. The validation performed focused on the modifications to the existing S3 system. There is no information about data provenance like country of origin or retrospective/prospective nature because it's not a performance study on a new clinical dataset.

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

Not applicable. No "test set" or "ground truth" was established by experts in the context of a new performance study. The validation relates to engineering and design control processes.

4. Adjudication method for the test set

Not applicable. There was no test set requiring adjudication in the context of a performance study.

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

Not applicable. This device is a heart-lung machine, not an AI-powered diagnostic or assistive technology for human readers.

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

Not applicable. This device is a heart-lung machine, not an algorithm.

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

Not applicable. The "ground truth" for this submission is the established safety and effectiveness of the predicate S3 System, and the demonstration that the modifications to create the SC System do not alter this. This is validated through design, engineering, and quality system procedures, not comparison to a clinical "ground truth" dataset.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, and therefore does not have a "training set."

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

Not applicable. As above, this is not an AI/ML device.

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The Medtronic CSS™ Cardioplegia Safety System is intended for use as a cardioplegia delivery system which controls, monitors, and delivers oxygenated blood and/or asanguineous solutions during cardiopulmonary bypass procedures.

The Medtronic CSS Cardioplegia Safety System Model 990 consists of an electro-mechanical instrument and disposable Cardioplegia Sets. The instrument delivers cardioplegia solution through dual peristaltic independently operated pumps (one for blood, one for crystalloid). It monitors volume delivered, flow rate (adjustable from 0 - 990 ml/min), and pressure (line and external). It also includes temperature monitoring capabilities, gross air detection using ultrasonic technology, and two independent elapsed timers. The instrument has a color central information display and a two-stage alert-alarm process. It has battery backup for 60 minutes of "On" time and 15 minutes of pumping time. The disposable sets are single use, sterile, and nonpyrogenic, designed to mix arterial blood and asanguineous cardioplegia solution at various ratios. The sets include silicone tubing and polycarbonate connectors and are available in four configurations, with or without a heat exchanger and with standard or dual lumen patient lines.

The Medtronic CSS Cardioplegia Safety System Model 990 is intended for use as a cardioplegia delivery system which controls, monitors, and delivers oxygenated blood and/or asanguineous solutions during cardiopulmonary bypass procedures. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than fully detailing a study against specific acceptance criteria for novel performance claims. However, it does present performance data for various features of the device as part of the substantial equivalence argument, which can be interpreted as meeting certain "acceptance criteria" by comparing them to predicate devices or manufacturer's specifications.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a comparative table where the Medtronic CSS's features and performance specifications are listed alongside those of predicate devices (Sorin BCC, Quest MPS, Sarns 9000). While it doesn't explicitly state "acceptance criteria" as pass/fail thresholds for clinical claims, the comparison table implicitly defines the acceptable performance range by demonstrating equivalence to already cleared devices or meeting internal specifications.

* "Based on customer input this accuracy is sufficient for this application"

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

The document describes "In-Vitro Bench Testing" and "Biocompatibility Testing."

• Test Set Sample Size: Not explicitly stated for any of the individual bench tests. The document only lists the types of tests conducted. For biocompatibility, it states "these devices were tested," implying a sample was used but no number is provided.
• Data Provenance: The tests described are "In-Vitro Bench Testing" and "Biocompatibility Testing." This indicates the data is from retrospective laboratory experiments conducted by the manufacturer, Medtronic Bio-Medicus, Inc. There is no mention of human subject data or data from specific countries of origin beyond the company's location in Eden Prairie, MN, USA.

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

Not applicable. This device is a cardioplegia delivery system, and the studies performed are bench tests and biocompatibility tests. There is no diagnostic component requiring human expert ground truth for interpretation of medical images or patient conditions. The "ground truth" for these tests would be the established engineering specifications, chemical/biological standards, and physical measurements.

4. Adjudication Method for the Test Set

Not applicable, as expert adjudication is not relevant for bench or biocompatibility testing. The "adjudication" would involve comparing test results against predefined engineering specifications and regulatory standards.

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

No, a Multi-Reader Multi-Case comparative effectiveness study was not done. This type of study is typically performed for diagnostic or screening devices where human readers (e.g., radiologists) interpret images or data, and their performance with and without AI assistance is compared. The Medtronic CSS Cardioplegia Safety System is a therapeutic delivery system with monitoring capabilities, so an MRMC study is not relevant to its function and claims.

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

Yes, the "In-Vitro Bench Testing" and "Biocompatibility Testing" can be considered standalone performance evaluations. These tests assess the device's intrinsic mechanical, electrical, and material properties and performance against specifications without direct human-in-the-loop interaction for the specific performance endpoint being measured (e.g., pump flow accuracy, pressure detection, air bubble detection). The control system (microprocessor, software) within the instrument operates autonomously during these tests to fulfill its functions.

7. Type of Ground Truth Used

The ground truth for the various tests appears to be:

• Engineering Specifications: For parameters like flow accuracy, pressure accuracy, temperature accuracy, timer accuracy, and constant pressure mode performance, the ground truth is the device's designed operational specifications and performance limits. These are then compared to the measured performance.
• Physical Measurements: Directly measured flow rates, pressures, temperatures, and times.
• Biological/Chemical Standards: For biocompatibility, the ground truth is established by recognized international standards (ISO 10993-1, USP XXIII) and FDA guidelines. For EtO residuals, it's ANSI/AAMI/ISO 10993-7:1995. For pyrogen testing, it's FDA guidelines.
• Visual/Physical Detection: For gross air detection, the ground truth would be the presence of a known air bubble of a specified size.

8. Sample Size for the Training Set

Not explicitly stated. As this is a 510(k) for a hardware device with embedded software (not a machine learning/AI diagnostic system generating models from data), the concept of a "training set" in the context of statistical modeling or AI development is not directly applicable in the way it is for imaging algorithms. Any "training" or calibration would likely refer to internal iterative development and testing against specifications, rather than data-driven model training.

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

Not applicable in the typical AI/ML sense. For hardware and embedded software development, the "ground truth" during development (if we were to loosely interpret "training set" as development data) would be established by engineering design specifications, safety standards, and performance targets derived from clinical requirements and predicate device performance. This would involve rigorous internal testing, debugging, and verification to ensure the device performs as designed.

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The Stockert S3 Mast Pump is a modular component of the Stockert S3 Perfusion System. The S3 Mast Pump is intended to provide speed controlled pumping of blood through the cardiopulmonary bypass circuit for durations of normally six hours or less, left ventricular venting, cardiotomy suction, or the administration of cardioplegia solution, when used by a qualified perfusionsist who is experienced in the operation of the S3 System.

The Stockert S3 (cardiopulmonary bypass) Mast Pump Module is intended for use during cardiopulmonary bypass surgery. The S3 Mast Pump Module is a component of the Stockert S3 Perfusion System, and is intended to provide speed controlled pumping of fluid through the cardiopulmonary bypass circuit, left ventricular venting, cardiotomy suction, or the administration of cardioplegia solution. The predicate and predecessor device to the S3 Mast Pump Module is the S3 Double Head Pump Module. The S3 Mast Pump has the same double head pump design and intended use as the S3 Double Head Pump Module(K955038). The basic difference between these two double head pumps is that for the Mast Pump, the pump heads are mounted on the mast of an S3 Mast Pump Extension Unit, and the control/operating unit is placed on a swivel plate on the console, whereas for the standard 69 double head pump module, the control unit is mounted directly over the pump theads and the entire module is installed on the S3 Console Base. The Mast Pump configuration enables the perfusionist to position the pump heads in close proximity to the patient, thus reducing the length of tubing required for the extracorporeal blood circuit and the associated priming volume required. This option is useful in clinical situations where it is important to minimize the amount of tubing in the circuit, e.g. infant perfusion.

The provided 510(k) summary for the Stöckert S3 Perfusion System Mast Pump Module does not include acceptance criteria or a study demonstrating device performance against such criteria.

The document primarily focuses on establishing substantial equivalence to a predicate device (S3 Double Head Pump Module) and outlines the device's description, intended use, and conformity to general safety standards (IEC 601, IEC 62a, and UL 544).

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving device performance from the provided text.

Here's why the requested information isn't present:

• No Acceptance Criteria: The document does not define specific performance metrics, thresholds, or pass/fail criteria for the device.
• No Performance Study Details: While it mentions "extensive testing results characterizing device performance and software verification and validation," it does not provide any details about these studies, such as:
  • The specific tests performed.
  • The results of those tests.
  • The methodologies used.
  • Any comparison to acceptance criteria.
  • Sample sizes, ground truth establishment, or expert involvement.

In summary, the provided text describes the device and its regulatory status, but lacks the detailed performance study information required to answer your specific questions.

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The Stöckert S3 Cyclic RPM Control Module is an accessory to the S3 Cardiopulmonary Bypass System Console which allows for the cyclicapm control offan;S3:pump.

The Stöckert S3 Cyclic RPM Control Module is an accessory module to the Stöckert S3 (cardiopulmonary bypass) Perfusion System, and is intended to allow the roller pump or double head pump to operate in the pulsed flow mode. The predicate and predecessor device to the S3 Cyclic RPM Control Module is the Stöckert-Shiley CAPS PFC 100 S Control unit (K883456). Similar devices have been used for many years for this same intended purpose. The new S3 Cyclic RPM Control Module is a simple upgrade of the technological aspects of the predicate device, e.g., the software controls and have been updated and the control and display panels have been updated for user convenience in operating the system.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Stöckert S3 Cyclic RPM Control Module:

Limitations of the Provided Information:

It's important to note that the provided document is a 510(k) summary, which is a high-level overview. It describes the device, its intended use, and states that testing was performed to support substantial equivalence. However, it does not provide detailed acceptance criteria, specific reported performance data, or the methodologies of the studies in the granularity typically requested.

Therefore, many sections of your request will be answered by stating that the information is either not provided or not applicable based on the context of this specific document.

Description of Acceptance Criteria and Study for Stöckert S3 Cyclic RPM Control Module

The Stöckert S3 Cyclic RPM Control Module is an accessory to the Stöckert S3 Perfusion System, designed to enable pulsed flow operation for the roller pump or double head pump during cardiopulmonary bypass. The device is a technological upgrade of a predicate device, the Stöckert-Shiley CAPS PFC 100 S Control unit (K883456).

The provided 510(k) summary indicates that the device underwent testing to demonstrate substantial equivalence to its predicate. The testing conducted included:

• Electrical testing: To ensure compliance with electrical safety standards.
• Functional acceptance testing: To verify that the device performs its intended functions correctly.
• Software verification and validation testing: To ensure the software controls operate as designed and meet specified requirements.

The device also conforms to applicable international standards: IEC 601 and IEC 62a.

1. Table of Acceptance Criteria and the Reported Device Performance

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

This information is not provided in the 510(k) summary. The document states "extensive testing results characterizing device performance" but does not detail the sample sizes for any test sets or the provenance (e.g., country of origin, retrospective/prospective nature) of data. Given that this is a hardware and software control module, the "test set" would typically refer to the number of units tested or specific scenarios run, rather than patient data.

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

This information is not provided and is largely not applicable in the context of this type of device (a control module for a perfusion system). Ground truth, in this case, would be established by engineering specifications and objective measurements, not expert consensus on medical images or clinical outcomes.

4. Adjudication Method for the Test Set

This information is not provided and is generally not applicable for the type of testing described (electrical, functional, software V&V for a control module). Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image review where subjective interpretation is 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

An MRMC study was not done and is not applicable for this device. This device is a control module for a perfusion system, not an AI-assisted diagnostic or clinical decision support system that involves human readers interpreting cases.

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

The device itself (the Cyclic RPM Control Module) is essentially a standalone control algorithm that modulates the pump's RPM. The "standalone" performance testing would be categorized under the "functional acceptance testing" and "software verification and validation testing" mentioned. The document states these tests were performed, but does not provide details on the specific performance metrics or results of these standalone tests.

7. The Type of Ground Truth Used

The ground truth for the testing of this device would be based on:

• Engineering specifications and design requirements: For electrical performance, functional parameters like RPM control accuracy, and software logic.
• Established international standards: IEC 601 and IEC 62a.

It would not involve expert consensus, pathology, or outcomes data in the typical sense for a medical device.

8. The Sample Size for the Training Set

This information is not provided and is not applicable in the context of this device. The Stöckert S3 Cyclic RPM Control Module is described as possessing updated software controls, implying traditional software engineering and validation rather than a machine learning model that requires a "training set."

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

This is not applicable as there is no indication that a "training set" for a machine learning model was used. The software controls would have been developed and validated against engineering specifications and functional requirements.

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The Affinity™ Blood Pump System is intended to be used in an extracorporeal perfusion circuit to pump blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.

The AVECOR Cardiovascular Affinity Pump System consists of the Model 2000 Affinity Pump Console, Affinity Pump Rotor, Affinity Pump Holder, Affinity Pump Chamber, 5/8" Connecting Tube and an AVECOR venous reservoir with 5/8" outlet. The AVECOR Affinity Blood Pump Console and components' shall conform with all the applicable requirements of IEC 601, UL 544 and will display the European Community CE marking. The Affinity Pump Console, Model 2000 provides a system for controlling a variable speed pump motor and additional systems for monitoring flow rate, pump speed (RPM), pressure, timed events and battery status. The AVECOR Affinity Pump has been designed to operate on the principles of a peristaltic pump for extracorporeal use. The pump consists of a polyurethane chamber incorporating polycarbonate inlet and outlet connectors, which fills passively due to the filling pressure exhibited by the fluid height in a reservoir. The peristaltic action of the rollers against the filled pump chamber results in forward flow. Flow rate is affected by the combination of reservoir volume, RPM's of the pump rotor and the total circuit resistance.

This document describes the premarket notification (510(k)) for the AVECOR Affinity Blood Pump System, establishing its substantial equivalence to the Stockert Instrumente (Sorin) Pump System.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criterion for the Affinity Blood Pump System was substantial equivalence in performance to the Stockert Instrumente (Sorin) Pump System. This was assessed across various aspects, particularly focusing on blood trauma.

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

The document does not specify the sample sizes for the various tests (In Vitro Operating Characteristics, In Vitro Cellular Damage, etc.) used to establish equivalence. It refers to these details being in other sections/appendices of the 510(k) application.

The data provenance is retrospective, as the tests were conducted by AVECOR to compare their new device against an existing, already marketed predicate device. The country of origin of the data is implicitly the USA, as AVECOR Cardiovascular Inc. is based in Minnesota, and the application is to the US FDA.

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

This type of information is not applicable in this context. The "ground truth" for a medical device's performance in a 510(k) submission for substantial equivalence is typically established by comparing its performance to a predicate device, as opposed to expert consensus on clinical outcomes or diagnoses. The "truth" is whether the new device performs acceptably and similarly to the predicate. The FDA acts as the ultimate arbiter by reviewing the provided data.

4. Adjudication Method for the Test Set

This type of information is not applicable. Adjudication methods (like 2+1, 3+1) are common in clinical trials involving expert interpretation of medical images or diagnoses. In this 510(k) submission, the "adjudication" is essentially the review process by the FDA based on the technical and performance data submitted by AVECOR, comparing it against the predicate device.

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 device is a blood pump system, not an AI-assisted diagnostic tool.

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

This concept is not applicable to a mechanical blood pump system. The device itself operates, and its performance is measured directly, not as an algorithm's output for human interpretation.

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

The "ground truth" for this substantial equivalence determination is the established performance characteristics of the predicate device (Stockert Instrumente (Sorin) Pump System). The new device's performance (e.g., blood trauma, operating characteristics) was tested and compared against the known performance of the predicate. This is a direct comparative performance evaluation against an already approved device.

8. The Sample Size for the Training Set

This information is not applicable. This is not a machine learning or AI-based device that would require training data. The "training" for such a mechanical device involves engineering design, material selection, and iterative physical testing and refinement, not data-driven model training.

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

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

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The Stockert S3 Cardioplegia Control Module is an accessory module to the Stockert S3 (cardiopulmonary bypass) Perfusion System, and is intended to control and monitor the use of cardioplegia solutions during the bypass procedure.

The Stockert S3 Cardioplegia Control Module is an accessory module to the Stockert S3 (cardiopulmonary bypass) Perfusion System, and is intended to control and monitor the use of cardioplegia solutions during the bypass procedure. The predicate and predecessor device to the S3 Cardioplegia Control Module is the Stockert CAPS Cardioplegia Control unit. Similar devices have been used for many years for this same intended purpose. The newly modified Cardioplegia Control Module from Stockert (the S3 Cardioplegia Control Module) is a simple upgrade of the technological aspects of the device, e.g., the software controls have been updated and the control and display panels have been updated for user convenience in operating the system.

This K963300 submission for the Stöckert S3 Perfusion System Cardioplegia Control Module does not contain the requested information regarding acceptance criteria and a study proving the device meets those criteria.

The provided text only includes:

• A 510(k) summary for the device.
• Device description and comparison to predicate products.
• A general statement about "extensive testing results characterizing device performance, including electrical testing, functional testing, and software verification and validation testing."
• Mention of conformance to IEC 601, IEC 62a, and UL 544, and holding the CE mark.

There is no detailed information provided on:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for any testing.
3. Number or qualifications of experts for ground truth.
4. Adjudication methods.
5. MRMC comparative effectiveness studies.
6. Standalone performance studies.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This submission is from 1997, and the level of detail regarding testing and validation, especially for software-controlled medical devices, was generally less extensive in public summaries compared to what might be expected from more recent submissions or detailed technical documentation.

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