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Safeport Manifold is indicated to serve as a flow control and a conduit device for I.V fluids delivery to the patient's vascular system. The product is intended for delivering 1.V drugs or fluids, allowing gravity feed, sampling, bolus injection and elimination of reflux of fluids during operation

Modified SafePort Manifold (or Stopcock) is a redesign of Induction & Sampling Manifold (or Stopcock). It has the same appearance and intended use while several design modifications were introduced in order to contribute to the device's convenience of use and robustness. The device will be available in two (2) versions swabable or standard ports configurations. The first version, standard port configuration is similar to the predicate device but with more robust design. The second version, besides of the design changes have an additional feature. The feature is the swabable valves which can be incorporated into the female side ports and function as a closed luer activate valve. The swabable valve enables the female port (luer) to be closed when it is not in use and saves the need to close it with a cap in order to avoid leakage and/ or port's contamination and serves as a needleless injection site integrated in the stopcock. Devices having the swabable valves have been demonstrated in a 510(k) submission for Elcam's Closed Stopcock.

SafePort Manifold or Stopcock is composed of the following components:

• -One piece injected body having a side female ports. (with or without swabable valves according to the end user request)
• Handles assembled into the female side ports. ー
• -Elastomer placed between each handle and side female port body, which is placed to function as a pressure activated valve activated valve.
• Rotor assembled to the male port (connected toward the patient ) for . " connection locking.
• -Check valve assembled to the male port which is connected toward the patient in order to enable connection locking. (this part will not be included, unless otherwise requested by the end user)
• Port covers and colored buttons. (if requested by an end user) -

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the SafePort Manifold (or Stopcock).

It's important to note that the provided document is a 510(k) summary for a medical device, which generally focuses on demonstrating "substantial equivalence" to a predicate device rather than presenting detailed performance acceptance criteria and study results in the same way one might for a novel, higher-risk device or a more comprehensive clinical trial report.

Based on the information given:

Acceptance Criteria and Reported Device Performance

The document states that a series of non-clinical tests were conducted to address the functionality of the SafePort Manifold's different variations. The general acceptance criterion implied is that the modified device is as safe and as effective as its predicate.

Study Details

The document refers to "non-clinical tests" as the primary evidence.

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

   • Sample Size: Not explicitly stated. The document mentions "a series of non-clinical tests" but doesn't quantify the number of devices or iterations tested.
   • Data Provenance: Not explicitly stated as country of origin, but the applicant is Elcam Medical ACAL, located in Kibbutz BarAm, Israel. The tests would likely have been conducted by them or a contracted lab. It's a retrospective summary of tests conducted for the submission.

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

   • This concept of "ground truth" established by experts is typically associated with clinical studies or performance assessments where human interpretation (e.g., of images or patient conditions) is involved. For non-clinical, functional testing of a physical device like a manifold, the "ground truth" is typically defined by engineering specifications, validated test methods, and industry standards. Therefore, the document does not mention experts establishing ground truth in this context.

3. Adjudication method for the test set:

   • Not applicable/Not mentioned. Adjudication methods (like 2+1, 3+1) are relevant when multiple human readers or evaluators are making subjective assessments that need reconciliation, which is not the nature of non-clinical device testing described here.

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 physical medical device (intravascular manifold/stopcock), not an AI diagnostic tool. Therefore, an MRMC study related to AI assistance is not applicable and was not performed.

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

   • Not applicable. This is a physical medical device, not an algorithm.

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

   • For the non-clinical tests, the "ground truth" would be objective engineering standards, performance specifications, and established test methods designed to verify mechanical integrity, fluid flow properties, resistance to pressure, sterilization efficacy, and other functional aspects. These are typically defined by engineering and quality control departments.

7. The sample size for the training set:

   • Not applicable. This is a 510(k) for a physical device, not an AI/machine learning model that requires a "training set."

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

   • Not applicable, as there is no training set for a physical device in this context.

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