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The Additive Port Cap is indicated for use on the medication port of Baxter VIAFLEX, Baxter AVIVA, and Baxter ALL-IN-ONE EVA containers to provide both visual evidence that medication has been added and tamper evidence once the device is closed.

The Additive Port Cap (APC) is a polypropylene, single use device designed to snap over the outside of the medication port of compatible Baxter IV container (Baxter VIAFLEX, Baxter INTRAVIA, Baxter AVIVA, and Baxter ALL-IN-ONE EVA) after the addition of medication. Once closed, the device prevents the port from being accessed without causing visible damage to the IV container. The bright red coloration serves as a clear indicator that medication has been added. The APC device is non-fluid path and non-sterile. The APC device is marketed as a stand-alone device and packaged in bulk.

Here's an analysis of the provided text regarding the acceptance criteria and study for the "Additive Port Cap" (APC) device:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It primarily details performance testing for engineering characteristics rather than clinical performance or AI/human reader studies. Therefore, many of the requested points related to AI, human readers, and ground truth for clinical outcomes will not be present in this type of document.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes performance testing that was conducted, and states that "All pre-determined acceptance criteria were met." However, the specific quantitative acceptance criteria and the exact reported performance values are not explicitly provided in detail within this summary. Instead, it lists the types of tests performed.

Here's a table based on the information available, indicating where details are missing:

Information Not Found / Not Applicable Given the Device Type:

The device, an "Additive Port Cap," is a physical medical device (plastic cap) designed for tamper evidence and visual indication. It is not an AI/software device or diagnostic imaging device. Therefore, many of the requested points related to AI/ML study design are not applicable to this submission.

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

• Sample Size: The document does not specify the exact sample sizes used for each of the performance tests. It merely states that "Performance testing to demonstrate tamper evidence was conducted" and lists various tests.
• Data Provenance: Not applicable in the context of clinical data. The tests are engineering and benchtop tests of a physical product.

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

• Not applicable. This is a physical device. "Ground truth" in the sense of expert medical interpretation for a diagnostic AI is not relevant here. The "ground truth" for the performance tests would be the measurement results from the engineering tests themselves (e.g., force required to open, presence of leakage).

4. Adjudication Method for the Test Set

• Not applicable. There's no clinical "test set" requiring adjudication by multiple experts. The tests are physical measurements and observations against engineering specifications.

5. If a Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. This type of study is typically done for diagnostic imaging devices or AI-assisted solutions to compare human performance with and without AI. It is not relevant for a physical device like an IV port cap.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. There is no algorithm or AI component in this device.

7. The Type of Ground Truth Used

• Engineering Specifications and Physical Measurements: The ground truth for this device's performance would be derived from the mechanical properties, dimensional tolerances, and functional performance (e.g., ability to indicate tamper, withstand certain forces, prevent leakage) as defined by its design and intended use. This is established via physical testing.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/ML device; therefore, there is no "training set."

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

• Not applicable. There is no AI/ML device or training set.

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Additive Cap is indicated for use on the medication port of VIAFLEX and AVIVA containers to provide visual evidence that medication has been added.

The subject of this submission is an Additive Cap which will be indicated for use on the medication port of VIAFLEX and AVIVA containers to provide visual evidence that medication has been added. The material and design of the cap are not changing. The proposed Additive Cap will continue to be non-fluid path and non-sterile. The only change is a label modification to expand the indications for use statement to identify compatibility with an additional I.V. container (AVIVA). The device is marketed as a stand-alone device and is packaged in bulk.

This document describes a 510(k) submission for a medical device called an "Additive Cap." The submission is for a modification to an existing device, specifically a label change to expand its indications for use. As such, the "study" conducted is a performance test to ensure the modified device still functions as intended.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text only explicitly mentions one specific performance test.

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

• Sample Size: Not explicitly stated for the "force to remove" test.
• Data Provenance: The study was conducted internally by Baxter Healthcare Corporation. It is a prospective test conducted for this 510(k) submission to evaluate the modified device. The country of origin for the data is implied to be the United States, given Baxter's location and the FDA submission.

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

This type of information is generally not applicable to a performance test for a mechanical device like an "Additive Cap," especially when the change is a label modification. The "ground truth" for such a device is its mechanical function and material properties, which are assessed through engineering and biocompatibility testing, not through expert clinical consensus.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert review and consensus, typically in diagnostic imaging studies or clinical trials, not for mechanical performance tests.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not applicable to a non-fluid path, non-sterile Additive Cap whose only change is a label modification.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone performance study in the context of an algorithm or AI was not done. This device is a passive mechanical component, not an algorithm.

7. Type of Ground Truth Used

For the "force to remove" test, the "ground truth" is the measured mechanical force required, compared against predefined engineering specifications or performance benchmarks for the device's functionality. For biocompatibility, the ground truth is established by biocompatibility testing standards (ISO 10993-5 in this case) and the pass/fail criteria defined by those standards.

8. Sample Size for the Training Set

Not applicable. This device is a mechanical component, not an AI or algorithm that requires a "training set."

9. 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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