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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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