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Vial access devices with SmartSite™ are standalone, single-vial use, disposable devices which provide access to a medication vial without the use of a needle during medication preparation. BD standalone vial access devices are not intended to be used on a patient.

Vial access devices with SmartSite™ are standalone, single-vial use, disposable devices which permit access to a medication vial without the use of a needle during medication preparation. Vial access devices with needle-free connectors are available in two configurations: 13 mm or 20 mm.

The provided text describes a 510(k) premarket notification for a medical device, the "BD SmartSite™ 13mm Vial Access Device" and "BD SmartSite™ 20mm Vial Access Device." This document focuses on demonstrating substantial equivalence to a predicate device rather than outright performance against specific acceptance criteria for a novel device or AI algorithm.

Therefore, the typical structure for acceptance criteria and human-in-the-loop studies for AI algorithms is not applicable to this document. This submission details the safety and performance testing to show that a new version of a device (subject device) is comparable to an already cleared device (predicate device).

Here's an analysis of the provided information, framed within the context of demonstrating substantial equivalence, and noting where the requested AI-specific information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Instead of a specific table for acceptance criteria vs. device performance for a novel AI device, this document lists various bench and non-clinical tests performed according to recognized consensus standards. The "acceptance criteria" here implicitly refer to meeting the specifications of these standards to demonstrate safe and effective performance, thus supporting substantial equivalence.

The document states: "All test results met their acceptance criteria and support that the BD SmartSite™ Vial Access Device is substantially equivalent to the predicate SmartSite Access Pin."

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify exact sample sizes for each non-clinical test. It lists the standards followed (e.g., ISO, ASTM, USP), which inherently define the methodologies and often the sample sizes for such tests.

Data provenance isn't described in terms of "country of origin" or "retrospective/prospective" as typical for clinical data or AI training data. Instead, the tests were conducted according to recognized international standards and FDA guidance documents.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the device is not an AI algorithm requiring expert ground truth for image interpretation or similar tasks. The "ground truth" for these tests are the objective measurements against the specified performance parameters in the standards (e.g., proper fitting, no leaks, meeting particulate limits, etc.).

4. Adjudication Method for the Test Set

This is not applicable for the same reasons as point 3. Testing involves objective measurements and adherence to specified standard protocols, not subjective expert adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The device is an intravenous administration set component, not an AI algorithm, and therefore no MRMC study or AI assistance evaluation was performed or required.

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

This is not applicable as the device is not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical and bench testing presented in this submission is based on objective measurements defined by the referenced national and international consensus standards (e.g., ISO, ASTM, USP). Examples include:

• Measurement of luer taper conformance.
• Detection of leaks using specific pressure tests.
• Counting particulate matter within specified limits.
• Assessment of biological responses in accordance with biocompatibility standards (e.g., cytotoxicity, sensitization).
• Validation of sterilization efficacy.

8. The Sample Size for the Training Set

This is not applicable as the device is not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

This is not applicable for the same reasons as point 8.

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