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Elcam's High and Medium Pressure Stopcocks and High and Premium High Pressure Manifolds are intended to serve as flow control and delivery devices for I.V fluids injection to the patient's vascular system. The devices are indicated for medium and high pressure injection of fluids such as, but not limited to, fluids used during angiography and angioplasty and during interventional radiology and cardiology procedures. Devices indication for medium and high pressure does not preclude its use for low pressure procedures. The High and Medium Pressure Stopcocks and High and Premium High Pressure Manifolds are intended for single use only.

Stopcocks and Manifolds are generally used for administration of fluids into the human. body. There is a wide use of Stopcocks as flow controls and sampling sites in I.V sets, critical care applications and monitoring kits. Stopcocks are used individually or in the form of Manifolds, units comprised of several Stopcocks joined together ("gang"). High pressure Stopcocks and Manifolds are used in cardiac angiography and angioplasty procedures in which fluids are administered under pressure. These procedures require stopcocks and manifolds which are robust under high pressures. The line of pressure resistant Stopcocks and Manifolds presented in this file includes four (4) products: i. High Pressure (HP) Stopcocks ii. Medium Pressure (MP) Stopcocks High Pressure (HP) Manifolds iii. Premium High Pressure (PHP) Manifolds iv.

The provided document is a 510(k) summary for medical devices (stopcocks and manifolds), not an AI/ML device study. Therefore, most of the requested information (sample sizes, expert ground truth, MRMC study, standalone performance, training set details) is not applicable or present in this type of regulatory submission.

However, I can extract the acceptance criteria and the stated performance relative to those criteria from the document.

1. Table of Acceptance Criteria and Reported Device Performance:

The document establishes substantial equivalence by comparing the proposed devices to legally marketed predicate devices, and by performing specific tests to demonstrate that the new devices, particularly in handling higher pressures, meet relevant safety and performance standards. The acceptance criteria are largely defined by adherence to specific ISO standards and the ability to withstand stated pressure ratings.

2. Sample size used for the test set and the data provenance:
Not applicable. This is a review of a 510(k) submission for physical medical devices, not a study involving a test set with patient data for an AI/ML algorithm. The "tests" mentioned are engineering and performance validation tests on the devices themselves.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth as typically defined in AI/ML studies is not relevant here. The "truth" is established by physical measurements and compliance with international standards.

4. Adjudication method for the test set:
Not applicable.

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:
Not applicable. This is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/ML device.

7. The type of ground truth used:
The "ground truth" for the device's performance is established through physical testing and adherence to recognized international standards (e.g., ISO 8536-10, ISO 10993, ISO 11135-1, ISO 11607-1/2, ISO 594-1, ISO 594-2). These standards define the expected performance and safety characteristics.

8. The sample size for the training set:
Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established:
Not applicable.

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This device provides additional access ports into a standard angiographic fluid delivery system and can be used in conjunction with syringes and other accessories where angiographic injection is indicated. This product's medium/high nressure designation does not preclude its use for low pressure modalities.

The SDM Angiographic Manifold consist of one or more stopcocks, where the multiple stopcock configurations are connected in line to form a manifold, with some models of each also having a high pressure extension line attached. These devices have bodies made of nolvearbonate and handle plugs made of polyethylene. The plugs are lightlv siliconized for smooth rotation. Each of the devices will be supplied single packaged and sterile. Packaging will consist of a standard Tyvek/Poly pouch.

This document describes a 510(k) premarket notification for the "SDM Angiographic Manifold with Extension Lines," a medical device. As such, it does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria in the context of AI/ML or diagnostic performance.

510(k) submissions typically demonstrate substantial equivalence to a legally marketed predicate device rather than conducting de novo clinical trials to establish acceptance criteria for performance metrics in the way often associated with AI/ML devices (e.g., sensitivity, specificity).

Therefore, I cannot provide the requested information for the following reasons:

The document does not:

• Define "acceptance criteria" related to device performance in a quantified way (e.g., sensitivity, specificity, accuracy).
• Describe a "study that proves the device meets the acceptance criteria" in terms of clinical outcomes or diagnostic performance.
• Mention any AI or machine learning components.
• Discuss sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details.

Instead, the document focuses on:

• Substantial Equivalence: Comparing the device to existing predicate devices in terms of intended use, materials, and design.
• Biocompatibility Evaluation: Stating that materials are generically the same as predicate devices and that testing showed biocompatibility per ISO Standard 10993, Part I.

Conclusion:

The provided document is a 510(k) summary for a physical medical device (angiographic manifold) seeking to demonstrate substantial equivalence, not a performance study for an AI-powered diagnostic tool. Therefore, the requested information elements (acceptance criteria table, sample sizes, expert details, etc.) are not applicable or present in this context.

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