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The MiniGuard™ Arterial Safety Valve is intended to be used in an Extracorporeal Circuit during cardiopulmonary bypass procedures for the prevention of retrograde flow.

The MiniGuard Arterial Safety Valve ensures unidirectional flow in a blood filled line by means of a duckbill check valve located in the valve housing. If the line becomes pressurized, the check valve would automatically close and prevent flow in the reverse direction. A directional arrow as shown in Figure 12.1 below is printed on the valve to provide the user with a visual indication of blood flow. The MiniGuard Arterial Safety Valve consists of a an inlet and outlet housing made from Terlux 2802 HD ABS and a duckbill made from GLP-38L6 Off White Silicone rubber. The MiniGuard is sold with a cap made from PVC, 6811G-05. The cap is removed before use and has no patient contact. No colorants or adhesives are used on the valve.

The provided text describes the MiniGuard™ Arterial Safety Valve, outlining its intended use, technological characteristics, and performance data to support its substantial equivalence to a predicate device (RetroGuard Arterial Safety Valve, K922356). However, the document does NOT contain explicit acceptance criteria defined by specific numerical thresholds for each test, nor a detailed study that directly "proves" the device meets these criteria in the typical sense of a clinical trial or a statistically powered performance study against pre-defined metrics.

Instead, the document states: "Results of the performance testing demonstrates that the device meets all established specifications necessary for consistent performance." This implies that internal specifications were met, but these specifications are not explicitly detailed for each test.

Therefore, the following information is extracted or inferred based on the provided text. Many fields cannot be directly answered due to the nature of the available document, which is a 510(k) summary focused on substantial equivalence rather than a full study report with detailed acceptance criteria and performance data.

Acceptance Criteria and Reported Device Performance

Note: The document only states that the device "meets all established specifications necessary for consistent performance." It does not provide the specific numerical values for these specifications (e.g., "Opening pressure < X mmHg") nor the exact reported performance values (e.g., "Opening pressure was Y mmHg").

Additional Study Information:

1. Sample size used for the test set and the data provenance: Not specified. The document mentions "performance testing" but does not detail the number of units tested for each parameter or the origin of any data (e.g., country, retrospective/prospective).
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable / Not specified. This device is a mechanical valve, so "ground truth" as typically applied to diagnostic AI algorithms involving human expert interpretation is not relevant here. The ground truth for its performance would be determined by direct physical measurement and engineering testing.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. See point 2.
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 a mechanical valve; it is not an AI-based diagnostic tool that assists human readers.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a mechanical device, not an algorithm. Its performance is inherently "standalone" in the sense that it operates without human intervention once installed in the circuit.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is based on direct physical measurement and engineering testing against predefined industrial/performance specifications (e.g., flow rates, pressure, leak integrity).
7. The sample size for the training set: Not applicable. This is a mechanical device, not an AI model that requires a training set.
8. How the ground truth for the training set was established: Not applicable. See point 7.

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The One Way Soft Valve is intended to be used for the prevention of retrograde flow in ¼/' or smaller lines subject to arterial pressure during cardiopulmonary bypass procedures for use up to six hours.

The One Way Soft Valve is a transparent one-way valve with ¼" inlet and outlet ports. The One Way Soft Valve prevents retrograde flow. A directional arrow is printed on the valve to provide the user with a visual indication of the allowable flow direction within the valve is constructed entirely of PVC and is to be used in lines subject to arterial pressures.

The provided document is a 510(k) premarket notification for the "One Way Soft Valve" and outlines the device's technical specifications and a summary of performance evaluations conducted to demonstrate its substantial equivalence to a predicate device. It is not a study report that details acceptance criteria and device performance in the format requested.

Therefore, I cannot extract the specific information about:

1. A table of acceptance criteria and the reported device performance: The document lists "Performance Evaluations" that were conducted, such as "Tubing Connection (Bond) Strength Evaluation," "Mechanical/Structural Integrity/Burst Strength Evaluation," "Opening Pressure Evaluation," "Negative Pressures and Retrograde Flow Evaluation," and "Circulation and Hemolysis Evaluation." It states that "Performance testing was conducted with substantially equivalent results" to the predicate device. However, it does not provide specific numerical acceptance criteria or the reported performance data for these evaluations.

As a result, the following points cannot be answered from the provided text as they pertain to a detailed study report that is not included:

2. Sample sizes used for the test set and the data provenance: Not provided.
3. 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 in-vitro device testing.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable as this is not an interpretive diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical medical device, not an algorithm.
7. The type of ground truth used: For in-vitro performance evaluations, the "ground truth" would be established by validated test methods and established engineering and medical standards, not expert consensus or pathology in the typical sense for diagnostic devices. The document implies that the "substantial equivalence" of the results to the predicate device is the key ground truth.
8. The sample size for the training set: Not applicable as this is a physical medical device, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the document states that performance evaluations were conducted to demonstrate substantial equivalence, but it does not provide the detailed acceptance criteria or the specific performance results in a tabular format as requested. It also does not reference a study that would include the other requested details because the document is a 510(k) summary, not a full study report.

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The IBC FloGard is indicated for use for the prevention of retrograde flow when used with centrifugal pumps during cardiopulmonary bypass surgery (up to six hours).

The IBC FloGard is a single-use, disposable, check valve intended for use for the prevention of retrograde flow in the arterial line when used with centrifugal pumps during open-heart surgery. The device is designed for use in the main arterial line when centrifugal pumps are used. The fully assembled IBC FloGard Valve is geometrically similar to the Quest RetroGuard valve, which is the predicate device for purposes of this 510(k) submission. The operating principles of the two devices are identical.

The differences between the IBC VRV and the predicate device are found in the material selection, specific dimensions of the component parts and the type of check valve used. The first of these differences is the choice of polymer for molding the plastic components. The main flow through body of the IBC VRV is made of polycarbonate and the Quest RetroGuard is made of clear ABS. The polycarbonate is clearer, has higher impact resistance, greater tensile and compression strength and superior chemical resistance. Secondly, the straight duck bill check valve in the predicate device, Quest RetroGuard, required an oversized body to accommodate clinical flow rates without a substantial resistance to flow. The bi-leaflet design of the check valve in the IBC FloGard valve substantially reduces the size of the flow through housing without increasing resistance to flow. This geometry substantially lowered prime volume and hemolysis.

This looks like a submission for a medical device (IBC FloGard) seeking 510(k) clearance, which means the manufacturer is trying to demonstrate that their new device is "substantially equivalent" to a legally marketed predicate device (Quest RetroGuard). The analysis primarily involves comparing performance characteristics rather than establishing de novo clinical efficacy through large-scale trials.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are implicitly substantial equivalence to the predicate device, Quest RetroGuard, particularly in key performance metrics relevant to its intended use in cardiopulmonary bypass. The document provides comparison results directly.

Note: For many metrics, the specific numerical values for current and predicate devices are not provided in the executive summary, only qualitative comparisons. The implicit acceptance criterion is that the IBC FloGard performs as well as or better than the Quest RetroGuard in these critical areas, demonstrating substantial equivalence.

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

• Sample Size:
  • The study involved comparing "the IBC FloGard (sterile, 6 month aged, environmentally conditioned)" against the "Quest RetroGuard." It's not explicitly stated how many units of each device were tested for each metric (e.g., how many FloGard valves for pressure drop, how many RetroGuard valves for hemolysis). It refers to "the IBC FloGard Valve" and "the Quest RetroGuard valve" implying a representative sample, but specific numbers are absent.
• Data Provenance: The study was conducted by IBC, the manufacturer, as part of their 510(k) submission. This is retrospective in the context of device development (i.e., tests were run on finished devices to support the submission). The data is generated internally by the company for regulatory purposes. Country of origin for data generation is not specified but assumed to be the US given the submission to the FDA.

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

• This type of device clearance (510(k) for a physical medical device like a check valve) primarily relies on engineering and laboratory performance testing, not expert-established "ground truth" on diagnostic images or clinical outcomes.
• Therefore, no experts were explicitly described as establishing ground truth in the way a radiologist might for an AI diagnostic algorithm. The "ground truth" for this device's performance is derived from standardized laboratory measurements (e.g., flow rates, pressure, hemolysis assays). The "experts" involved would be the biomedical engineers and lab technicians conducting the tests, whose qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods like 2+1 or 3+1 reconciliation are typically used for establishing ground truth in clinical data (e.g., imaging studies where multiple readers interpret cases to reach a consensus).
• For this device, the "adjudication" is inherent in the reproducibility and standardization of the laboratory tests and comparison against established physical principles and the predicate device's measured performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. An MRMC study is not relevant for this type of device (a mechanical check valve). MRMC studies evaluate the diagnostic performance of human readers, often with and without AI assistance, especially in radiology or pathology. This device is a component in a cardiopulmonary bypass circuit, not a diagnostic tool requiring human interpretation.

6. If a Standalone Performance Study was done

• Yes, a standalone performance characterization was done for the IBC FloGard, and importantly, it was conducted side-by-side with the predicate device (Quest RetroGuard). This is crucial for demonstrating substantial equivalence.
• The description details various tests:
  • Pressure drop measured at 4 L.P.M.
  • Hemolysis measured at 7 L.P.M. for 6 hours.
  • Reverse-flow measured at 100 mm Hg back-pressure.
  • Pressure required to close the valves.
  • Biocompatibility, bioburden, and sterilization.

7. The Type of Ground Truth Used

• The "ground truth" for this submission is established through:
  • Direct physical measurements and laboratory assays: Pressure, flow rate, hemolysis, reverse flow, prime volume measurements.
  • Compliance with recognized standards: Biocompatibility tested against "tripartite biocompatible ISO standards and the FDA modified matrix of 1995."
  • Comparison to a legally marketed predicate device: The performance metrics are held against the measured performance of the Quest RetroGuard.

8. The Sample Size for the Training Set

• Not applicable. This device is a mechanical component, not an AI/ML algorithm that requires a "training set." The engineering design and material selection process are not "trained" on data in the same way an algorithm is.

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

• Not applicable, as there is no training set for a mechanical device. The design and validation are based on engineering principles, material science, and performance testing against specified requirements and predicate device characteristics.

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The COBE® Vacuum Relief Check Valve is indicated for use during cardiopulmonary bypass surgery to help prevent the buildup of excessive vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent flow of air into the heart.

The COBE® Vacuum Relief Check Valve is a sterile device with a non-pyrogenic fluid pathway. It is for single use only and is not to be resterilized by the user. The device consists of a housing with a 1/4" inlet port and a combination 1/4" and 3/8" outlet port (to accommodate either 1/4" or 3/8" ID tubing on the outlet side). It contains a unidirectional valve which prevents retrograde flow and an umbrella valve that opens under excessive vacuum, allowing air in to relieve the excessive vacuum pressure in the line. In addition, the device contains an over-pressure relief band which opens under excess positive pressure, allowing blood to escape. Arrows molded into the housing indicate the direction of flow through the device.

The COBE® Vacuum Relief Check Valve is intended for use during cardiopulmonary bypass surgery to prevent excessive vacuum pressure during suctioning from the heart or surgical field and to prevent accidental air flow into the heart.

Here's an analysis of the provided information regarding the acceptance criteria and study for the COBE® Vacuum Relief Check Valve:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a general statement that "Performance testing was conducted to demonstrate substantial equivalence of the COBE® Vacuum Relief Check Valve to the predicate devices." It then lists the types of performance testing, but does not explicitly state specific numerical acceptance criteria (e.g., "vacuum pressure relief must occur within X mmHg") nor the precise quantitative results ("device relieved vacuum at Y mmHg") for the COBE device or the predicate devices.

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

The document states that "Performance testing was conducted," but does not specify the sample size used for the test set for any of the listed tests. Furthermore, there is no information provided about the data provenance (e.g., country of origin, retrospective or prospective nature). Given the nature of a 510(k) submission for a device, it's highly probable these were prospective laboratory tests.

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

This information is not applicable to this type of device and study. The testing described involves objective physical and mechanical measurements (e.g., pressure, flow, leaks, material integrity), not subjective interpretation requiring expert consensus on a "ground truth" like in imaging studies.

4. Adjudication Method for the Test Set

This is not applicable as the tests are objective physical measurements and not subject to expert adjudication.

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 typically used for diagnostic imaging devices where human readers interpret results, and an AI's impact on their performance is being evaluated. The COBE® Vacuum Relief Check Valve is a mechanical device, and its performance is evaluated through engineering and biological testing, not human interpretation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable as the device is a mechanical component and does not involve an algorithm or AI. The performance discussed is inherent to the device's physical function.

7. The Type of Ground Truth Used

For the performance tests conducted, the "ground truth" would be established by objective physical measurements and engineering standards. For example:

• Vacuum Pressure Relief: Measured pressure at which the valve opens.
• Positive Pressure Relief: Measured pressure at which the relief band opens.
• Retrograde Flow Prevention: Observation and measurement of any backward flow.
• Hemolysis: Laboratory analysis of blood samples for signs of red blood cell damage.
• Leak Testing: Observation or measurement of any fluid leakage.
• Connection Bond Strength: Measurement of the force required to dislodge connections.

This is a form of objective measurement against defined physical parameters or established ASTM/ISO standards often used in medical device testing.

8. The Sample Size for the Training Set

This is not applicable. As a mechanical device, there is no "training set" in the context of machine learning or AI development. The device's design is based on engineering principles and prototypes are tested.

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

This is not applicable. Since there is no training set, there is no ground truth establishment process for it.

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The RDI Suction Safety Device is intended to be used during open heart surgery and placed in a suction line to permit flow only away from the heart, prevent buildup of line pressure, and limit line vacuum.

The RDI Suction Safety Device is a three function assembly that is positioned in a suction line. The Suction Safety Device contains to valves. The first valve is a check valve that insures unidirectional flow. The second valve is a combination valve that relieves excess pressure and relieves excess vacuum.

Here's an analysis of the provided information regarding the RDI Suction Safety Device, focusing on acceptance criteria and supporting studies, formatted as requested.

RDI SUCTION SAFETY DEVICE - K960937

This device is not an AI/ML powered device, therefore some of the requested information (e.g., sample sizes for training/test sets, expert adjudication methods, MRMC studies, standalone performance, etc.) is not applicable. The documentation primarily focuses on demonstrating substantial equivalence to a predicate device and basic functional and safety testing.

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not provided in the summary for the functional, material, or packaging tests. As this is not an AI/ML device, the concept of a "test set" in the context of clinical data or image analysis is not relevant. The testing described is laboratory-based functional and physical testing of the device itself.

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

This information is not applicable/not provided. The "ground truth" for this device's performance is established through direct physical and functional testing against defined standards and specifications, or by direct comparison to a predicate device's measured performance, rather than through expert review of clinical data.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. Adjudication methods are typically associated with clinical studies or expert review processes, which are not described for this device.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human reader performance is being evaluated, especially with and without AI assistance. The RDI Suction Safety Device is a physical medical device, not a diagnostic tool utilizing AI.

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

Not applicable. This device does not involve an algorithm or AI component.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance evaluation relies on:

• Standardized Test Methods: Adherence to established industry standards like ASTM F1140-88, NSTA Project 1A, AAMI/ISO for sterilization, and Tripartite Biocompatibility Guidance.
• Predicate Device Performance: Direct comparison of observed performance (pressure relief, one-way flow, vacuum relief) to the measured functional characteristics of the Delta Vacuum Relief Valve (K760894). The predicate device's performance serves as the benchmark.

8. The Sample Size for the Training Set

Not applicable. This device does not utilize machine learning or AI, and therefore does not have a "training set" in that context.

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

Not applicable. As there is no training set, there is no ground truth established for it.

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