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Connecta® Plus 1 and Connecta® Plus 3 2-way and 3-way Stopcocks are control valves for use in I.V. therapy and hemodynamic pressure monitoring. They are added to IV cannula or extension tubing sets for simultaneous or alternate administration of IV drugs, fluids, and blood, or for blood sampling. They can also be used in areas in which solution flow requires control. Alternatively, they are used for hemodynamic monitoring via an arterial cannula and a central venous catheter.

The disposable Connecta® Plus 1 and Plus 3 2-way and 3-way Stopcocks consist of:

• · a smoke colored housing with three connectors: two female Luer fittings, and one male Luer fitting;
• · a color coded (white, blue, or red) rotating tap with eight (8) closed and open position indicators (snap on-off);
• · a smoke colored collar nut assembled to the male Luer fitting in the housing. The rotating nut is used to secure the stopcock's connection with the product it is connected with.
• · two white plugs attached to the two female Luer fittings in the housing;
• · a white protection cap attached to the male Luer cone; and
• · optional color-coded (blue or red) pegs used for line identification: blue for venous lines, and red for arterial lines.

The provided document is a 510(k) summary for a medical device (Connecta® Plus 1 and Connecta® Plus 3 2-way and 3-way Stopcocks). This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Therefore, much of the requested information (acceptance criteria table, sample sizes for test/training sets, expert qualifications, MRMC study, standalone performance, etc.) is not typically found or required in a 510(k) submission for a Class II device like a stopcock. These submissions primarily rely on bench testing and comparison to an existing device.

Here's an analysis of the available information in relation to your request:

Acceptance Criteria and Device Performance

The document states that "Bench tests have been conducted to assess the effects of changes. All results are satisfactory." This is a general statement indicating the device met internal performance benchmarks for the specified improvements. However, no specific quantitative acceptance criteria or detailed performance metrics are provided in this summary.

Study Details

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

   • Sample Size: Not specified in the document. The study described is "Bench tests," which typically involve a limited number of device units.
   • Data Provenance: The tests were conducted internally by Ohmeda Inc., Medical Devices Division. There is no information on external or country-of-origin data. The tests are prospective in the sense that they evaluate changes to the device.

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

   • Not applicable. As this involves bench testing of a mechanical device (stopcock), the "ground truth" would be established by objective measurements and engineering standards, not expert consensus on medical images or diagnoses.

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

   • Not applicable. Adjudication methods like 2+1 or 3+1 are used for human interpretation of data, typically in diagnostic or clinical studies. Bench tests are assessed based on objective measurements against engineering 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:

   • No. This is a submission for a mechanical medical device (stopcock), not an AI-powered diagnostic or interpretive system. Therefore, an MRMC study is not relevant.

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

   • No. This is not an algorithm or AI system.

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

   • The "ground truth" for the bench tests would be defined by engineering specifications, material science properties, and fluid dynamics principles. For example, flow rate would be measured against a standard, cracking resistance against material strength tests, and air bubble entrapment assessed through visual observation or specialized imaging under controlled flow conditions.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device that requires a training set.

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

   • Not applicable (see above).

In summary: The document describes a 510(k) submission for a mechanical medical device, where equivalence to a predicate device is demonstrated through bench testing and assertions of improved design features. The type of detailed clinical study information (like MRMC, AI performance metrics, expert adjudication, etc.) requested in the prompt is not relevant to this specific device or type of regulatory submission.

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