Search Results

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.

Ask a specific question about this device

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

The Terumo® Pump Tubing is comprised of a commonly used polyvinyl chloride resin (PVC) that includes a plasticizer recognized as Di-(2-ethylhexyhl) phthalate (DEHP). The PVC tubing that is the subject of this application is 68 durometer pump tubing (Shore A Hardness nominal measurement). It has a nominal inside diameter of 3/32" and a nominal wall thickness of 1/16". The outside diameter measures 7/32" (nominal). The 68D PVC Pump Tubing will have a Shore A nominal durometer of 68D while the predicate device, the 70D PVC Pump Tubing, has a Shore A nominal durometer of 70D. The durometer dictates the hardness of the tubing. There are no internal markings on the subject tubing. Outside markings consist of the Terumo symbol, followed by inner diameter (in inches) x wall thickness (in inches), durometer, and TCVS part number.

The acceptance criteria and the study that proves the device meets the acceptance criteria are not explicitly detailed in the provided text in the typical format of a device's performance metrics against predefined thresholds. This document is a 510(k) premarket notification letter, which focuses on demonstrating "substantial equivalence" to a predicate device rather than presenting a performance study with detailed acceptance criteria for a new, novel device.

However, based on the information provided, we can infer the acceptance criteria and the nature of the study conducted to demonstrate equivalence for the Terumo® Pump Tubing (68D PVC Pump Tubing) to its predicate (70D PVC Pump Tubing).

Here's an interpretation based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide a table of quantitative acceptance criteria with corresponding performance metrics in a pass/fail format. Instead, it lists the performance evaluations conducted to demonstrate "functional equivalence" to the predicate device. The implied acceptance criterion for each test is that the 68D PVC Pump Tubing performs equivalently to or within acceptable limits of the 70D PVC Pump Tubing, without raising new issues of safety or effectiveness.

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

• Sample Size: The document does not specify the sample sizes used for each of the performance evaluations (e.g., number of tubing samples tested for durability, connection strength, etc.).
• Data Provenance: The studies were conducted by Terumo Cardiovascular Systems Corporation as "in-vitro performance evaluations." The country of origin of the data is implied to be within the US, where Terumo Cardiovascular Systems Corporation is located (Elkton, MD and Ashland, MA). The studies are "premarket notification" tests, which are inherently prospective for the purpose of this submission (i.e., conducted specifically to support this 510(k)).

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

This information is not applicable to this type of device and study. The testing described (e.g., dimensional analysis, connection strength, durability) relies on objective physical and chemical measurements rather than expert interpretation of complex data (like medical images). Therefore, "ground truth" in the traditional sense of expert consensus (e.g., for diagnostic accuracy) is not established.

4. Adjudication Method for the Test Set

Not applicable. As described above, the tests are objective physical/chemical measurements, not requiring expert adjudication in the manner of medical imaging or clinical trial outcomes.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or screening devices where human readers interpret patient data (e.g., images), and the AI's impact on reader performance is measured. The Terumo Pump Tubing is a component for cardiopulmonary bypass and does not involve human readers interpreting "cases."

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

Not applicable. "Standalone performance" refers to the accuracy of an AI algorithm operating independently. The Terumo Pump Tubing is a physical medical device, not an algorithm. The performance evaluations conducted are intrinsic to the device's physical and mechanical properties.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluations (e.g., connection strength, durability, dimensions) is established by the specifications and performance characteristics of the predicate device (70D PVC Pump Tubing), as well as relevant industry standards and internal quality control specifications for medical devices of this type. The objective is to demonstrate that the new device's performance aligns with these established benchmarks, ensuring it is at least as safe and effective as the legally marketed predicate.

8. The Sample Size for the Training Set

Not applicable. This device is a physical product, not an AI algorithm, and therefore does not have a "training set" in the machine learning context.

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

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

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

The HLM Tubing Sets with Bioline Coating are designed to be used in extracorporeal circulation during cardiopulmonary bypass procedures lasting six hours or less.

The HLM Tubing Sets with Bioline Coating are for single use only. They may be sold sterile, non-sterile, and bulk packed. Tubing sets that are sold sterile are not to be re-sterilized by the user. In open heart surgery the HLM Tubing Sets with Bioline Coating are used in combination with the heart-lung machine for the oxygenation of blood and removal of carbon dioxide. The main purpose of the HLM Tubing Sets with Bioline Coating is to connect the patient to the heart-lung machine and it's components. The HLM Tubing Sets with Bioline Coating are therefore a component in the extracorporeal perfusion circulation system. The utilization period of the use of the tubing sets is restricted to six hours. The Bioline Coating improves the physical surface properties of products for the extracorporeal circulation system.

This document is a 510(k) summary for a medical device called "HLM Tubing Sets with Bioline Coating." It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a novel device. Therefore, many of the requested categories for a study proving device meets acceptance criteria are not directly applicable or explicitly detailed in this type of submission.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

The submission states that "Evaluation on safety and effectiveness was executed to demonstrate that the HLM-Tubing Set with Bioline Coating described in this submission is substantially equivalent to the Jostra HLM-Tubing Set as a custom tubing pack and to the Quadrox D Diffusion Membrane Oxygenator with Bioline Coating with regards to the Bioline Coating."

The areas evaluated were: Integrity, Performance, Biocompatibility, and Sterility.

The document does not provide a specific table of numerical acceptance criteria or detailed reported performance values. Instead, it concludes that the device is "substantially equivalent" to predicate devices, implying it meets the same implicit performance and safety standards as those already cleared.

Missing Information: Numerical performance metrics, specific pass/fail thresholds, and detailed results of the evaluations are not included in this summary.

Study Details

Given this is a 510(k) summary for substantial equivalence, a traditional "study" in the sense of a large-scale clinical trial with specific acceptance criteria and detailed statistical analysis is not typically presented in this format. The evaluations are likely bench tests and material science assessments.

1. Sample size used for the test set and the data provenance: Not specified in the summary. The studies would likely involve multiple tubing sets and connectors for integrity, performance (e.g., flow rates, pressure resistance), biocompatibility (e.g., in vitro or in vivo tests), and sterility tests. Data provenance is not mentioned, but given the manufacturer is in Germany, a portion of the testing might have occurred in Germany.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For this type of device and submission, ground truth would be established by scientific and engineering standards (e.g., ISO, ASTM, internal specifications) for material properties and device function, rather than expert consensus on diagnostic imaging.
3. Adjudication method for the test set: Not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., medical imaging). For device integrity and performance, results are typically determined by measurement against predefined specifications.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is not an AI-powered diagnostic tool, so MRMC studies or AI assistance are irrelevant.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device (tubing set), not an algorithm or software.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for this device would be based on established engineering principles, material science specifications, validated test methods (e.g., for biocompatibility and sterility), and performance standards relevant to cardiopulmonary bypass equipment. For example, sterility would be confirmed by validated sterilization processes and sterility testing, biocompatibility by cytotoxicity, sensitization, and irritation tests according to ISO 10993.
7. The sample size for the training set: Not applicable. This is a physical device, not an AI model requiring a training set.
8. How the ground truth for the training set was established: Not applicable.

Conclusion from the document:

The submission concludes that "The data given demonstrate that the HLM-Tubing Set with Bioline Coating is substantially equivalent to the named predicate devices which hold currently market clearance." This means the conducted evaluations confirmed that the modified device (with Bioline coating) performs as safely and effectively as the existing, legally marketed predicate devices, with no new questions of safety or effectiveness raised.

Ask a specific question about this device

The Jostra HLM Tubing Sets are designed to be used in extracorporeal circulation during cardiopulmonary bypass procedures lasting six hours or less.
The Jostra HLM Tubing Set is indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours.

The Jostra HLM Tubing Set is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user. The product consists of tubing and connectors with connected oxygenators, reservoirs, fifters, and other cardiopulmonary bypass components assembled into user specified circuits for procedures requiring extracorporeal support up to six hours.
Tubing with a 3/32 inch wall thickness may also be used in a roller type displacement blood pump to propel the blood/fluid through the circuit.
The Maquet tubing is made of polyvinyl chloride (PVC) and ranges in size from 1/8" diameter to 1/2" diameter.
The following generic types of barbed connectors will be used: straight with or without luer locks, reducer with or without luer port, Y with or without luer port, male or female luer locks. Connectors may range in size from 1/8 to 1/2 inch.

The Maquet Cardiopulmonary AG Jostra HLM Tubing Set is a sterile, non-pyrogenic device intended for single use in extracorporeal circulation during cardiopulmonary bypass procedures lasting up to six hours. This summary outlines the acceptance criteria and the study that demonstrates the device meets these criteria.

The acceptance criteria for the Jostra HLM Tubing Set revolved around demonstrating that its components (tubing and connectors) are safe and effective for their intended use and are substantially equivalent to currently marketed devices.

1. Table of Acceptance Criteria and Reported Device Performance

1. Bond strength: Performed on the tubing and connectors.
2. Burst pressure: Performed on the tubing and connectors.
3. Effects upon cellular components (hemolysis): Performed on the tubing and connectors, indicating a measure of blood compatibility.
4. Spallation: Performed on the tubing and connectors, assessing resistance to shedding particles.
   The non-clinical tests' overall conclusion was that the materials "are safe and effective for their intended use." Additionally, the data supported that "Maquet tubing and connectors are substantially equivalent to the tubing and connectors that currently hold market clearance." This also extended to the complete "Jostra HLM Tubing Sets," which were deemed "substantially equivalent to the Custom Tubing Packs that currently hold market clearance." |
   | Intended Use | The device is suitable for extracorporeal circulation during cardiopulmonary bypass procedures lasting six hours or less. The "Indications for Use" explicitly state: "The Jostra HLM Tubing Sets are designed to be used in extracorporeal circulation during cardiopulmonary bypass procedures lasting six hours or less." |
   | Sterility | The device is provided sterile. The device description states, "The Jostra HLM Tubing Set is a sterile, non-pyrogenic device for single use only." |
   | Non-pyrogenicity | The device is non-pyrogenic. The device description states, "The Jostra HLM Tubing Set is a sterile, non-pyrogenic device for single use only." |
   | Single Use Only | The device is designed for single use and not to be re-sterilized. The device description states, "The Jostra HLM Tubing Set is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user." |

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

The provided document does not specify the exact sample size for each performance or biocompatibility test performed (e.g., number of tubing segments for burst pressure, number of samples for hemolysis). The data provenance is also not explicitly stated in terms of country of origin or whether the studies were retrospective or prospective. Given the nature of a 510(k) submission for a physical medical device, these tests would typically be laboratory-based and conducted in a controlled environment, likely by the manufacturer or a contract testing lab.

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

This information is not applicable to the type of device and study described. The ground truth for this device is established through objective, standardized engineering and biological tests (e.g., measuring bond strength, burst pressure, hemolysis rates) against predefined criteria or comparison to predicate devices, rather than expert interpretation of data.

4. Adjudication Method

Not applicable. The "adjudication method" usually refers to a process of resolving discrepancies in expert interpretations, which is not relevant for objective laboratory and physical performance tests of a device.

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

Not applicable. This device is not an AI-powered diagnostic tool or a device that involves human interpretation of output. Therefore, an MRMC study and the concept of human readers improving with AI assistance are not relevant.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a physical medical device (tubing set) and does not involve an algorithm or AI.

7. Type of Ground Truth Used

The ground truth used for this device's evaluation is primarily objective, quantifiable laboratory measurements and performance metrics according to standardized protocols. This includes:

• Engineering specifications (e.g., bond strength and burst pressure measurements).
• Biological responses (e.g., hemolysis and spallation tests).
• Comparison to established performance characteristics of predicate devices.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML device that requires a training set.

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

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

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

The chest drainage tubing is intended to serve as a conduit for the flow of body fluids that are removed from the patient, via vacuum, and delivered to a reservoir during cardiopulmonary bypass procedures.

The chest drainage tube is piece of flexible polyvinylchloride tubing that is used as a conduit for body fluids suctioned from the chest cavity and moved into a reservoir following cardiopulmonary bypass procedures. The tubing is a 40 durometer tube with an inside diameter of 0.375" and an outside diameter of 0.562".

The provided text describes a 510(k) submission for "Chest Drainage Tubing" and establishes its substantial equivalence to a predicate device. This type of submission relies on demonstrating similarity to an already cleared device, rather than conducting new clinical trials with acceptance criteria based on performance metrics like sensitivity or specificity.

Therefore, many of the requested points regarding acceptance criteria, study design, and ground truth are not applicable in this context. The "acceptance criteria" here are that the new device is "substantially equivalent" to the predicate device in terms of intended use, design, technology/principle of operation, materials, and performance, and that it raises no new issues of safety and effectiveness.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The "study" here is not a typical clinical trial but rather a demonstration of substantial equivalence through comparison to a predicate device.

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

Not applicable. There is no "test set" in the traditional sense of a clinical or analytical performance study with a specific number of samples. The demonstration of equivalence relies on comparing the device's characteristics and performance to those of a predicate device.

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

Not applicable. Ground truth, in the sense of expert consensus on diagnostic accuracy or clinical outcomes, is not established for this type of 510(k) submission. The "truth" is established by showing that the characteristics of the new device are sufficiently similar to a legally marketed predicate device.

4. Adjudication Method for the Test Set

Not applicable. There is no adjudication method described as there isn't a test set requiring adjudication of findings.

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

Not applicable. This is not an AI-assisted diagnostic device, and no MRMC study was conducted.

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

Not applicable. This is not an algorithmic device.

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

The "ground truth" for this submission is established by the known characteristics, safety, and effectiveness of the predicate device (Gish Biomedical Tubing, K870792). The new device is compared against this established benchmark.

8. The sample size for the training set

Not applicable. There is no training set mentioned, as this is not a machine learning device.

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

Not applicable. There is no training set.

Ask a specific question about this device