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Churchill Medical Systems Stopcock is a valve for use in I.V. therapy and pressure monitoring to direct and control the flow of medical fluids.

The Churchill Medical Systems 4 way stopcock consist of a housing with two one male luer with rotating lock ring. The diversion handle opens or closes each port.

The provided text describes a 510(k) summary for the Churchill Medical Systems 4 Way Stopcock. This document is a premarket notification for a medical device and does not detail a study proving specific acceptance criteria in the way a clinical trial or performance study for an AI/ML medical device would. Instead, it focuses on demonstrating substantial equivalence to a predicate device through physical, chemical, and biological specifications and internal performance testing, rather than an AI model's performance.

Therefore, many of the requested sections about AI/ML device performance, such as sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable to this type of device submission.

However, I can extract the relevant information from the provided text regarding the closest equivalents to "acceptance criteria" and "device performance" as presented in this 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is the sum of various tests conducted by Churchill Medical Systems, Inc. in accordance with established international and national standards and internal protocols.

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

• Sample Size for Test Set: Not specified in the provided text. The submission mentions "testing summary results" and conformance to various standards, implying that samples were tested to demonstrate compliance, but specific quantities are not provided.
• Data Provenance: Not specified. The testing was conducted internally by Churchill Medical Systems, Inc.

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

• Not Applicable. This is a physical medical device (stopcock), not an AI/ML algorithm requiring expert ground truth for image or data interpretation. The "ground truth" here is the adherence to the specified physical, chemical, and biological performance parameters as defined by the standards (ISO, USP) and internal requirements.

4. Adjudication method for the test set:

• Not Applicable. As above, this is for a physical device, not an AI/ML algorithm interpretation. Performance is assessed against quantitative and qualitative standards.

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

• No. This is a physical medical device (stopcock), not an AI-assisted diagnostic tool. Therefore, an MRMC study is not applicable.

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

• Not Applicable. This is a physical medical device. It does not involve an algorithm.

7. The type of ground truth used:

• The "ground truth" for this device's performance is compliance with established international standards (ISO), national pharmacopeia (USP), and internal validated specifications for physical properties, chemical compatibility, biological safety (e.g., cytotoxicity, sensitization, pyrogenicity), and sterility. The device is also compared to the performance characteristics of a predicate device to demonstrate substantial equivalence.

8. The sample size for the training set:

• Not Applicable. This is a physical medical device, not an AI/ML algorithm that requires a "training set."

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

• Not Applicable. As above, a training set is not applicable for this type of device.

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