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The ICU Medical Universal Vial Access Device is a single use - universally adaptable and needleless drug container access disposable. The proprietary technology of the Clave enables the device to have a needleless port for withdrawal of medications or other IV fluids as directed by the physician.

AI/ML Overview

This document (K080989) is a 510(k) premarket notification for the ICU Medical Universal Vial Access Device. It is a submission to demonstrate substantial equivalence to legally marketed predicate devices, not a study presenting specific performance data or a statistical analysis with detailed acceptance criteria.

Therefore, the requested information regarding acceptance criteria, reported performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details cannot be fully extracted from the provided text. The document focuses on regulatory compliance and substantial equivalence, not a detailed technical performance study report.

Here's a breakdown of what can be inferred from the provided text, and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated as quantifiable metrics with pass/fail thresholds in the provided text. The document refers to conforming to "requirements of published international standards as well as those FDA recognized standards and/or published guidelines." This is a general statement of compliance, not a specific set of acceptance criteria with numerical targets.
Reported Device Performance: While the document states the device "conform[s] to the requirements" and has an "established and validated history of meeting the 10⁻⁶ level" for Sterility Assurance Level (SAL), it does not provide specific test results comparing the new device's performance against numerical acceptance criteria.

Acceptance Criteria (Implied)	Reported Device Performance (Inferred)
Conformance to international and FDA-recognized standards/guidelines	Conforms to requirements of published international standards and FDA recognized standards/guidelines.
Sterility Assurance Level (SAL)	Established and validated history of meeting the 10⁻⁶ level (for ICU Medical's products, implying the new device meets this established standard).
Hydrophobic filter efficacy	Ensures airborne contaminates larger than 0.2µm are excluded. (No specific test data or efficacy percentage reported, only a functional statement).
Functionality (vial access, needleless access)	"No functional differences between any of the predicate devices or the proposed devices in terms of use." (Implies meeting the functional performance of predicates, but no specific metrics are given). The device enables "needleless port for withdrawal of medications or other IV fluids."
Adaptability to vial sizes	"Improved clip that can adapt to all sizes of drug vials." (A qualitative statement of improvement, without specific range or fit criteria.)
Manufacturing Quality	"Manufactured in a quality environment that is certified independently and complies with cGMPs."
Safety and Effectiveness for Intended Use	"Materials, performance, and operational features... are substantially equivalent and safe and effective for their intended use." (This is a conclusion of the 510(k) submission, not a detailed performance report). Note: This section indicates that "Safety and Performance" will conform to requirements, but doesn't report the tested performance.

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

Sample Size: Not mentioned. No information is provided about specific test sets, their size, or the number of units tested.
Data Provenance: Not mentioned. There is no information about country of origin, or whether any data used for internal verification was retrospective or prospective.

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

Number of Experts: Not applicable. The document does not describe a study involving expert-established ground truth for a test set. This is a regulatory submission for substantial equivalence based on engineering and design considerations, not an AI/diagnostic device performance study.
Qualifications of Experts: Not applicable.

4. Adjudication method for the test set:

Not applicable. There is no mention of a test set requiring adjudication in the context of this 510(k) submission.

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:

MRMC Study: No. This is not an AI-assisted diagnostic device, but a medical accessory (vial access device). Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described.
Effect Size: Not applicable.

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

Standalone Performance: Not applicable. This is a physical medical device, not an algorithm, so "standalone (algorithm only)" performance is not a relevant concept for this submission.

7. The type of ground truth used:

Not applicable in the context of a diagnostic performance study. The 510(k) submission relies on demonstrating substantial equivalence to predicate devices, compliance with established standards, and internal verification processes to ensure the device's functional and safety characteristics. The "ground truth" here would be established engineering and biological safety standards, along with the proven performance of the predicate devices.

8. The sample size for the training set:

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

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

Not applicable, as there is no training set.

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