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Elcam Stopcocks and Manifolds are indicated for fluid flow directional control and for providing access port(s) for administration of solutions. Typical uses include pressure monitoring, intravenous fluid administration and transfusion.

Elcam Stopcocks and Manifolds (*including MRVLS, Closed Stopcock and S2R)

I am sorry, but the provided text from the FDA 510(k) clearance letter for "Elcam Stopcocks and Manifolds" (K190489) does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any details related to AI/MRMC studies.

The document is a standard FDA clearance letter, primarily confirming substantial equivalence to a predicate device and outlining regulatory information. It describes the device's indications for use but does not delve into the specific technical studies or performance data typically associated with software-as-a-medical-device (SaMD) or AI-powered devices.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC study details or effect size.
6. Standalone performance.
7. Type of ground truth used.
8. Training set sample size.
9. Method for establishing training set ground truth.

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Elcam Stopcocks and Manifolds with Safe2 Rotator are indicated for fluid flow directional control and for providing access port(s) for administration of solutions. Typical uses include pressure monitoring, intravenous fluid administration and transfusion.

Elcam Stopcocks and Manifolds with Safe2 Rotator are an additional variation in the Elcam's Stopcocks and Manifolds product-family. The Safe2 Rotator component is male luer with a mounted and internally threaded rotator that is fixed on the stopcocks body with a modified male connector. Both components create a uniform straight fluid path. The device uniqueness is that the Safe2 Rotator can freely rotate on the stopcock male connector axis preventing the formation of kinks and twists in the IV sets during or following manipulations. In addition, the rotation ability of the Safe2 Rotator provides health care providers with a convenient access to a stopcock side (vertical) port during injection and aspiration.

The provided document describes a 510(k) submission for Elcam Medical Stopcocks and Manifolds with Safe2 Rotator. This is a medical device, not an AI/ML-driven diagnostic or prognostic tool. Therefore, the questions related to AI/ML specific criteria (such as sample sizes for test/training sets, experts for ground truth, MRMC studies, standalone performance, etc.) are not applicable to this document.

The document discusses performance data in the context of the device's physical functionality and substantial equivalence to a predicate device.

Here's the relevant information extracted from the document:

1. Table of acceptance criteria and the reported device performance:

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

• The document states that "non-clinical tests" were conducted.
• It does not specify the sample sizes used for each test.
• The data provenance (country of origin, retrospective/prospective) is not detailed. However, the manufacturer, Elcam Medical, is based in Israel, so it can be inferred that testing was conducted either internally or by a contracted lab, adhering to international standards.

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

• This question is not applicable as the document describes physical device testing for functionality, not diagnostic/prognostic algorithm performance requiring expert-established ground truth. The "ground truth" here is objective physical measurements against established engineering standards (ISO 594-2).

4. Adjudication method for the test set:

• This question is not applicable for the same reasons as #3.

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:

• This question is not applicable as this is not an AI/ML device.

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

• This question is not applicable as this is not an AI/ML device.

7. The type of ground truth used:

• The "ground truth" for this device's performance testing is defined by established engineering standards (specifically ISO 594-2 for various mechanical properties like twisting force, liquid pressure resistance, and disconnection force). These are objective, measurable criteria.

8. The sample size for the training set:

• This question is not applicable as this is not an AI/ML device, and therefore there is no "training set."

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

• This question is not applicable as this is not an AI/ML device, and therefore there is no "training set."

Summary of what the study did prove:

The study conducted for the Elcam Medical Stopcocks and Manifolds with Safe2 Rotator involved a series of non-clinical bench tests. These tests were designed to evaluate the physical functionality and safety of the modified device, particularly the new Safe2 Rotator component. The tests demonstrated that the device meets its specifications and complies with the functional requirements outlined in ISO 594-2 for lock fitting (initial twisting force, secondary twisting force, liquid pressure resistance, and disconnection force). Based on these results, the manufacturer concluded that the "modified device is as safe and effective as its predicate."

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Elcam Stopcocks and Manifolds are indicated for fluid flow directional control and for providing access port(s) for administration of solutions. Typical uses include pressure monitoring, intravenous fluid administration and transfusion.

Elcam Stopcocks and Manifolds are composed of a body with two or three ports and a handle. Each port has either a male or female connector. Male connectors also include a nut for locking over the female connector of another component. A small amount of lubricant is applied between the stopcock body and handle. Elcam Stopcocks and Manifolds will be available in a wide variety of configurations for use according to the particular situation and the clinician's preference.

This document is a 510(k) summary for Elcam Stopcocks and Manifolds, a medical device. It describes the device, its intended use, and its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Device Performance

The provided document does not explicitly state specific quantitative acceptance criteria for the Elcam Stopcocks and Manifolds device. Instead, it relies on demonstrating substantial equivalence to a predicate device and satisfactory results from standard performance and biocompatibility testing. Since no explicit numerical criteria are offered, a table cannot be constructed with "reported device performance" against those criteria.

However, we can infer the general acceptance conditions from the information provided:

Study Details

Based on the provided text, the following information can be extracted regarding any "study" conducted:

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

   • Sample size: Not specified. The document uses phrases like "Standard testing" and "A biocompatibility assessment was performed," but does not provide any numerical sample sizes for these tests (e.g., number of stopcocks tested, number of material samples).
   • Data provenance: Not explicitly stated. The manufacturer is Elcam Plastic Kibbutz BarAm Merom Hagalil 13860 Israel. The testing was conducted as part of their submission to the US FDA. The nature of the testing (bench, in-vitro, etc.) is implied rather than explicitly detailed as retrospective or prospective clinical data.

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

   • Not applicable/Not specified. For mechanical devices like stopcocks and manifolds, "ground truth" is typically established by engineering specifications, validated test methods, and industry standards, rather than expert clinical consensus in the way it would be for diagnostic algorithms. The "satisfactory results" mentioned for performance and biocompatibility testing imply that the results met predefined engineering and safety standards, but no expert panel is detailed.

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

   • Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or for establishing ground truth for diagnostic imaging algorithms where there's subjectivity. For performance and biocompatibility testing of a simple medical device, results are usually objectively measured against predefined criteria.

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, an MRMC study was not done. This type of study is relevant for diagnostic imaging or AI-assisted interpretation, which is not the nature of this device (stopcocks and manifolds for fluid control).

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

   • Not applicable. This device is a manual, mechanical component. There is no algorithm involved.

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

   • For performance testing: Ground truth would be defined by engineering specifications, established industry standards (e.g., for luer fittings, pressure resistance, flow rates), and regulatory requirements for fluid administration devices.
   • For biocompatibility: Ground truth would be established by validated toxicology and material safety standards (e.g., ISO 10993 series).

7. The sample size for the training set:

   • Not applicable. This is a mechanical device, not an AI/machine learning algorithm, so there is no "training set."

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

   • Not applicable, as there is no training set for this type of device.

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