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The SMARxT Tubing and Connectors, a part of the Heart/Lung Perfusion Pack, are intended to be used in surgical procedures requiring extracorporeal support for periods of up to six hours.

The SMARxT Tubing and Connectors, subjects of this application are part of the Heart/Lung Perfusion Pack (K881330), a customized system of tubing and other devices built to user specifications designed for use during surgery requiring cardiopulmonary bypass.

This is a 510(k) summary for the SMARxT Tubing and Connectors, a medical device used in cardiopulmonary bypass. The document states that the modified device, which uses a different surface treatment material (Tegomer additive material is changing from Tegomer H-Si6441 P), is substantially equivalent to its predicate device. This determination is based on non-clinical testing.

Here's the detailed breakdown:

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: The document does not specify the exact sample sizes (number of units tested) for each of the in vitro tests. It only states that "in vitro testing was performed."
• Data Provenance: The data provenance is retrospective in the sense that it's a submission for regulatory clearance based on testing already completed. The tests were performed by Livanova USA Inc., presumably in a controlled laboratory environment. The country of origin of the data is not explicitly stated but can be inferred to be from the manufacturer's testing facilities, likely in the US or Europe given Livanova's global presence.

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

This section is not applicable as the evaluation was based on non-clinical (in vitro) testing against established standards and internal performance specifications, not human expert interpretation of data.

4. Adjudication Method for the Test Set

This section is not applicable as the evaluation was based on non-clinical (in vitro) testing against established standards and internal performance specifications. There was no need for human adjudication of test results in the way it might apply to image-based diagnostic AI.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is hardware (tubing and connectors) and does not involve AI or human readers for its function.

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

No, a standalone (algorithm only) performance study was not conducted. This device is hardware and does not involve an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device, in the context of its substantial equivalence determination, was established through adherence to recognized medical device standards and rigorous in vitro performance testing. This includes:

• International Standard ISO 10993-1: "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process."
• FDA Guidance Document: "Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process of September 4, 2020."
• Internal performance specifications/requirements: The specific acceptance criteria for "Blood pathway integrity and coverage," "Surface Modification Integrity," "Connection testing," "Life to failure testing," and "Spallation" would have been defined by the manufacturer based on the predicate device's performance and clinical requirements for cardiopulmonary bypass tubing.

Essentially, the ground truth is that the device must perform equivalently to its predicate and meet established safety and performance benchmarks for its intended use.

8. The Sample Size for the Training Set

Not Applicable. This device is hardware and does not involve machine learning or an AI algorithm, therefore, there is no "training set."

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

Not Applicable. As there is no training set.

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Quantum SuperPAC Tubing set is a set of tubing intended for use during cardiopulmonary bypass for a duration up to 6 hours.
Quantum SuperPAC Cardioplegia Set is a tubing set used for the infusion of cardioplegia solutions and physiological fluids during cardiac surgery procedures on the heart and great vessels for up to six hours.

Quantum SuperPAC Tubing set devices are designed to connect different devices that are not provided in the Quantum SuperPAC tubing set such as oxygenators, pumps, reservoirs, filters, and other cardiopulmonary bypass components into circuits used in surgical procedures requiring extracorporeal support, for a maximum duration of 6 hours.
Quantum SuperPAC Cardioplegia set devices are designed to connect different devices that are not provided in the Quantum SuperPAC tubing set for the infusion of cardioplegia solutions and physiological fluids during cardiac surgery procedures on the heart and great vessels for up to six hours.
Quantum SuperPAC devices (all variants) are non-toxic, non-pyrogenic, and sterilized by ethylene oxide. Devices are intended for single use only and are not to be resterilized by the user.
All the device surfaces in contact with blood are treated with a phosphorylcholine-based coating.
Quantum SuperPAC devices (all variants) are mainly constituted of polyvinyl chloride (PVC) DOP free tubing and additional components composing the set; different variants are available, varying for tubing dimension and set configuration in order to address customer and surgical procedure specifications.

This document is a 510(k) summary for the Quantum SuperPAC Tubing Set and Quantum SuperPAC Cardioplegia Set. It details the device's intended use, comparison to predicate devices, and performance testing. However, it does not contain information regarding studies that establish acceptance criteria for device performance in the manner of an AI/ML algorithm's effectiveness in diagnostic tasks, nor does it provide details on sample sizes, ground truth establishment, or expert adjudication typical for such studies.

Instead, this document focuses on demonstrating substantial equivalence to existing medical devices through non-clinical performance and biocompatibility testing for a medical device (tubing sets) rather than a diagnostic AI system.

Therefore, many of the requested categories are not applicable to the information provided in this 510(k) summary, as it pertains to a physical medical device.

Here's the breakdown based on the provided text:

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

The document does not explicitly present a table of acceptance criteria alongside reported device performance in the context of an AI/ML diagnostic system. Instead, it states that "All testing passed by meeting the established requirements set for the devices." The performance tests conducted are listed as:

• Operating Parameters
• Mechanical Integrity
• Device pressure drop
• Spallation and Tubing Life
• Connection strength

These tests were mainly performed according to ISO 15676. Additional tests included:

• Evaluation of product shelf life (according to EP/UPS requirements)
• Validation of EtO Sterilization process (according to ISO 11135:2014)
• Packaging Validation tests (according to ISO 11607-1:2019, ASTM F1886/F1886M-16, EN 868-5 and ASTM F1929-15)
• Biocompatibility (according to ISO 10993-1:2018 and FDA Guidance)

The document asserts that the devices met these established requirements, implying that the acceptance criteria were defined by these standards and the device's performance aligned with them.

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

This information is not applicable as the document describes non-clinical performance testing for a physical medical device, not a diagnostic AI/ML system requiring 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)

This information is not applicable as the document describes non-clinical performance testing for a physical medical device, not a diagnostic AI/ML system requiring expert-established ground truth.

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

This information is not applicable as the document describes non-clinical performance testing for a physical medical 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

This information is not applicable as the document describes non-clinical performance testing for a physical medical device, not a diagnostic AI/ML system.

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

This information is not applicable as the document describes a physical medical device, not an algorithm.

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

This information is not applicable for the type of device described. The "ground truth" for this device would be its adherence to performance specifications and safety standards as determined by the listed non-clinical tests (e.g., mechanical integrity tests, biocompatibility tests).

8. The sample size for the training set

This information is not applicable as the document describes a physical medical device, not a machine learning model.

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

This information is not applicable as the document describes a physical medical device, not a machine learning model.

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The AngioVac Circuit is indicated for use in procedures requiring extracorporeal circulatory support for periods of up to six hours.

The AngioVac Circuit is an extracorporeal perfusion set that includes four subassemblies including a main perfusion circuit (manufactured of 0.375" non-DEHP PVC coextruded tubing with Y-connector, tubing quick-connects and priming line), waste line, tuohy adapter and reinfusion cannula connector. An extra reinfusion cannula connector and tuohy adapter are provided in a sealed pouch with the circuit.

The provided text is a 510(k) summary for the AngioVac Circuit, a medical device. It describes design modifications to an existing device, and its intended use, but it does not contain information about a study that assesses the performance of an AI/ML device against specific acceptance criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the document pertains to a medical device where performance is evaluated through bench testing and biocompatibility rather than AI/ML model performance.

Specifically, the document states:

• "G. Performance Data: Bench testing, including physical integrity and performance testing, was performed to support substantial equivalence of the AngioVac Circuit. The AngioVac Circuit met all specified design and performance requirements."
• "H. Clinical Testing: Not applicable"

This confirms that the evaluation performed for this device was based on bench testing (physical and performance characteristics) and biocompatibility, not on a study measuring the diagnostic or predictive performance of an AI/ML algorithm against a test set with established ground truth.

If you have a different document related to an AI/ML medical device, please provide it, and I will be happy to assist with your request.

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Indicated for use in procedures requiring extracorporeal circulatory support for periods of up to six hours.

The Vortex Medical AngioVac Cardiopulmonary Bypass Circuit and Accessories consists of: Tuohy Borst Adapter, Non-Vented Spike, Vented Cap, PVC tubing .375"ID, PVC tubing .500" ID, PVC tubing .250" ID, Y Connectors, Colder MPX Series Coupling Body (In-Line Hose Barb with Lock - Male), Colder MPX Series Coupling Insert (In-Line Hose Barb - Female), Reducers, Adhesive backed tubing holder, Pinch Clamps ("Roberts").

The provided text [K092486](https://510k.innolitics.com/search/K092486) describes a device for "Cardiopulmonary Bypass Tubing and Accessories." This is a mechanical device, not an AI/ML-driven software device. Therefore, the questions about acceptance criteria for AI models, sample sizes for test sets, expert adjudication, MRMC studies, standalone performance, ground truth definitions, and training set information are not applicable.

The document indicates that substantial equivalence was determined based on non-clinical performance data and no clinical tests were performed. The non-clinical tests focused on connection strength and system integrity to verify the integrity of the fittings and the assembled system.

Here's the information that can be extracted relevant to acceptance criteria and performance for this type of medical device:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document only broadly states "Connection strength and system integrity testing was performed to verify the integrity of the fittings and the assembled system." It does not specify quantitative acceptance thresholds (e.g., minimum burst pressure, tensile strength limits) or detailed reported values, only that the tests were performed and the integrity verified.

2. Sample sized used for the test set and the data provenance: Not applicable. This is a non-clinical evaluation of a physical device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical device testing typically involves engineering specifications and direct measurement, not expert clinical consensus in the way an AI model would be evaluated.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For this physical medical device, the "ground truth" for the non-clinical tests would be established engineering specifications and performance benchmarks for connection strength and system integrity of similar predicate devices.

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: Not applicable.

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

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

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

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

1. Acceptance Criteria and Reported Device Performance

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

2. Sample Size for Test Set and Data Provenance

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

3. Number of Experts and Qualifications for Ground Truth Establishment

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

4. Adjudication Method for Test Set

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

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

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

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

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

7. Type of Ground Truth Used

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

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

8. Sample Size for the Training Set

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

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

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

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The Cardiopulmonary Bypass Pump Tubing with X-Coating is intended to provide a conduit for extracorporeal blood flow through a roller pump during cardiopulmonary bypass procedures. The tubing is intended for use in procedures lasting up to 6-hours in duration.

Each size of the Pump Tubing with X-Coating that is included in this submission is comprised of polyvinyl chloride (PVC). Each tubing size is coated with a biocompatible polymer coating (X-Coating) that is intended to reduce the adhesion of platelets to the internal surface of the tubes as blood flows through the circuit.

The provided text describes a 510(k) summary for the "Pump Tubing with X-Coating" and its substantial equivalence to an uncoated pump tubing. The performance evaluation presented is primarily a comparison with the predicate device, rather than a study establishing standalone performance against specific acceptance criteria.

Here's an analysis based on your request, highlighting what is provided and what is not:

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

The document does not explicitly present quantitative acceptance criteria in a table format with corresponding reported device performance values. Instead, it states that the performance of the Pump Tubing with X-Coating was evaluated against the uncoated pump tubing to demonstrate equivalence.

The "performance evaluations" section lists the types of tests conducted:

• Dimensional/Visual Analysis
• Leakage and Mechanical Integrity Testing
• Pull Force Testing
• 6-hour Circulation Testing
  • Flow Rate
  • Durability/Spallation
  • Thrombus Formation (Visual)
  • Effects Upon Cellular Components (Hemolysis)

The "Substantial Equivalence Comparison" and "Substantial Equivalence Summary" sections state:

• "The comparisons demonstrated that there were no clinically significant performance differences between the two devices."
• "Any noted differences between the two devices do not raise new issues of safety and effectiveness."

Without specific numerical acceptance criteria or quantitative performance data, a direct table cannot be constructed from the provided text. The criteria are implied to be "no clinically significant differences" compared to the predicate device.

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 does not specify the sample sizes used for any of the performance evaluations (e.g., how many pump tubing samples were tested for durability, hemolysis, etc.). It also does not mention the data provenance beyond indicating that Terumo Cardiovascular Systems Corporation conducted the studies.

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 submitted document. The performance evaluations described are physical and chemical tests (e.g., flow rate, durability, hemolysis, visual thrombus formation), not diagnostic or interpretative tasks requiring expert annotation for ground truth.

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.

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 is not applicable. The device is pump tubing, not an AI-assisted diagnostic tool.

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

This is not applicable. The device is pump tubing, not an AI algorithm.

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

The "ground truth" for the performance evaluations would be the results of the physical, chemical, and biological tests performed. For example:

• Dimensional/Visual Analysis: Measured dimensions and visual inspection standards.
• Leakage and Mechanical Integrity Testing: Pre-defined leakage rates or structural failure points.
• Pull Force Testing: Defined maximum or minimum pull force thresholds.
• 6-hour Circulation Testing:
  • Flow Rate: Measured flow rate compared to a control or specification.
  • Durability/Spallation: Visual inspection for material degradation, particle generation, or functional failure.
  • Thrombus Formation (Visual): Visual assessment for the presence and extent of thrombus formation against a defined scale or absence.
  • Effects Upon Cellular Components (Hemolysis): Lab measurements of hemolysis levels compared to established safety limits or predicate performance.

For the biocompatibility studies, the "ground truth" was established by adhering to ISO 10993 guidelines and conducting an in-vivo animal study, where the absence of adverse conditions reflected acceptable biocompatibility.

8. The sample size for the training set

This is not applicable as the device is not an AI/machine learning model that requires a training set.

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

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

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The Pump Tubing is intended to provide a conduit for extracorporeal blood flow through a roller pump during cardiopulmonary bypass procedures. The tubing is also intended to provide a conduit for extracorporeal blood flow when interconnecting components of the bypass circuit.

The tubing is intended for use in procedures lasting up to 6-hours in duration.

Each of the three sizes of the Pump Tubing that is included in this submission is Each of the tires child of the (PVC). The tubing ranges in size from a ¼" inside diameter to ½" in diameter. The durometer measurement is Shore A-68.

Acceptance Criteria and Device Performance Study

This document describes the acceptance criteria and the study performed to demonstrate the substantial equivalence of the Plastron Pump Tubing to its predicate device, Pexco PVC pump tubing. The provided text is a 510(k) summary, which focuses on demonstrating equivalence rather than establishing novel performance metrics or conducting a comprehensive clinical study.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Plastron Pump Tubing were based on demonstrating equivalence to the predicate Pexco PVC pump tubing across several performance categories. The "acceptance criteria" here implicitly means that the Plastron tubing's performance in these areas should not be "clinically significantly different" from the predicate.

Summary of Performance: The document explicitly states: "The comparisons demonstrated that there were no clinically significant performance differences between the two devices."

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

• Sample Size: The document does not specify the exact sample sizes used for each individual test (Dimensional Analysis, Leakage, Hemolysis, etc.). It only mentions that "The following tests were conducted to demonstrate equivalence in performance."
• Data Provenance: The origin of the data is not explicitly stated in terms of country or specific institution. Given the context of a 510(k) summary submitted to the FDA by Olson Medical Sales, Inc. (Ashland, MA), it is highly likely that the testing was conducted in the United States or by accredited laboratories adhering to US standards. The study appears to be retrospective in the sense that existing predicate device performance (which presumably has a history of safe use) is used as a benchmark for the new device. The testing of the Plastron Pump Tubing itself would have been prospective to demonstrate its equivalence.

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

This document describes an engineering and materials equivalence study, not a study requiring expert clinical interpretation to establish ground truth in the traditional sense. Therefore:

• Number of Experts: Not applicable.
• Qualifications of Experts: Not applicable.

The "ground truth" for this type of submission is largely defined by the established performance and safety record of the predicate device and the objective results from standardized engineering and biocompatibility tests.

4. Adjudication Method

Not applicable, as this was not a study requiring human interpretation or adjudication for establishing ground truth. The tests conducted are objective measurements (e.g., dimensions, flow rates, chemical residues) or standardized evaluations (e.g., hemolysis, biocompatibility per ISO 10993).

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices where human readers interpret medical images or data, and the AI's impact on their performance is evaluated. This submission is for medical tubing, which does not involve human interpretation in this manner.

6. Standalone Performance Study

Yes, implicitly, a standalone performance study of the Plastron Pump Tubing was performed. The "Performance Evaluations" section lists several tests (Dimensional Analysis, Leakage Testing, Hemolysis, Flow Rate, Durability, Spallation, Thrombus Formation) conducted on the Plastron Pump Tubing. The results of these tests were then compared to the performance of the predicate Pexco PVC pump tubing to establish substantial equivalence.

7. Type of Ground Truth Used

The ground truth used for this equivalence study primarily relies on:

• Predicate Device Performance: The established, legally marketed performance and safety profile of the Pexco PVC tubing serves as the primary "ground truth" for comparison.
• Engineering Standards and Specifications: Objective measurements and adherence to specified ranges (e.g., durometer Shore A-68, ID ¼" to ½").
• Biocompatibility Standards: Adherence to recognized international standards like ISO 10993 (e.g., "blood contacting materials were found to be biocompatible").
• Sterilization Standards: Validated in accordance with AAMI guidelines for SAL.
• Regulatory Limits: Compliance with FDA regulations for Ethylene Oxide residues.

8. Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a "training set." The device is a physical medical component, and the testing involves laboratory evaluation, not data-driven model training.

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

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

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The Cardiopulmonary Bypass Pump Tubing is intended to provide a conduit for extracorporeal blood flow through a roller pump during cardiopulmonary bypass procedures. The tubing is intended for use in procedures lasting up to 6-hours in duration.

Cardiopulmonary Bypass Pump Tubing

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, results of a study, sample sizes, expert qualifications, or ground truth establishment. The document is a 510(k) clearance letter from the FDA for a Cardiopulmonary Bypass Pump Tubing, detailing its classification, regulatory compliance, and indications for use. It does not include the specifics of performance testing or clinical studies.

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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 Better-Tubing™ is designed for use as a blood compatible conduit for pumping blood in a roller pump during cardiopulmonary bypass or other extracorporeal applications of up to 6 hours.

The Better-Tubing™ (BT) is a 6 ft. length of ¼' ID tubing for use in an extracorporeal cardiopulmonary bypass circuit. It is biocompatible, has high tensile strength, and has many advantages over standard tubing made from polyvinyl chloride (PVC).

Here's a breakdown of the acceptance criteria and study information for the Better-Tubing™ device, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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