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The Q.Cap™ Needle-Free Reconstitution 13mm Vial Adapter is intended to allow needle-free withdrawal, reconstitution and transfer of Repronex® (menotropins for injection, USP) and/or Bravelle® (urofollitropin for injection, purified) and diluent from vials into an injection syringe for administration.

The device which is the subject of this Notification is a sterile, injection molded component, which will be included into Ferring Pharmaceutical's Repronex® and Bravelle® drug kits to assist in needle-free reconstitution of these lyophilized drugs for injection. The Vial Adapter component's physical design, description and performance are identical to that of a previously cleared device, Bioject Reconstitution Kit & Vial Connector (K010623). Packaging and sterilization of the Vial Adapter are identical to that of a previously cleared devices, Bioject Needle-Free Vial Adapter, (13mm); K963012.

This 510(k) summary describes a medical device, the Q.Cap™ Needle-Free Reconstitution 13mm Vial Adapter, and references its performance by comparing it to predicate devices. It does not contain a study report with specific acceptance criteria and reported device performance in the format of a table as requested, nor does it detail a standalone algorithm performance study or an MRMC study.

However, based on the provided text, here's an attempt to extract the relevant information, with some sections marked as "Not Applicable" or "Not Provided" due to the nature of the document.

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary primarily relies on the equivalency to predicate devices rather than presenting explicit performance metrics against predefined acceptance criteria for the new device. The performance is assessed by stating that the device is "identical" or that certain aspects "support product safety."

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

• Sample size for test set: Not explicitly provided. The document relies on equivalence to previously cleared devices rather than new extensive testing for this 510(k) application.
• Data provenance: Not explicitly provided for new testing. The reference to predicate devices implies that past testing data from these devices (Bioject Reconstitution Kit & Vial Connector (K010623) and Bioject Needle-Free Vial Adapter (K963012)) would be the primary provenance. The document indicates that biocompatibility was "demonstrated" and that "testing support(s) product safety," implying some form of testing was performed, but details on sample size or provenance are absent.

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

• Not Applicable. This device is a medical accessory, and the regulatory submission focuses on physical and biological safety/performance equivalence, not diagnostic accuracy requiring expert ground truth establishment in the traditional sense of image analysis or diagnostic algorithms.

4. Adjudication method for the test set

• Not Applicable. See point 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

• No. This is a medical device (vial adapter) and not an AI/software as a medical device (SaMD). Therefore, MRMC studies are not applicable.

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

• No. This is a physical medical device, not an algorithm.

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

• Not Applicable. For this type of device, "ground truth" relates more to material specifications, sterility, absence of extractables, and functionality (e.g., proper fit, ease of use, no leakage) as demonstrated by engineering and biological testing, rather than a diagnostic 'truth'. The document states that "biocompatibility...is demonstrated" and "testing support additional product safety," implying laboratory-based testing results served as the "ground truth" for these safety aspects.

8. The sample size for the training set

• Not Applicable. This is not an AI/machine learning device; hence, there is no "training set."

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

• Not Applicable. See point 8.

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