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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/or Menopur® (menotropins for injection, USP) and diluent from vials into an injection syringe for administration.

The Vial Adapter component's physical design, description and performance are identical to that of the previously cleared predicate device, Q-Cap ™ Reconstitution 13mm Vial Adapter: K041654 Ko4166 H. Packaging and sterilization of the Vial Adapter are identical to that of the previously cleared predicate device, Q•Cap™ Needle-Free Reconstitution 13mm Vial Adapter: K044654 Ko41564. The clear polycarbonate component is General Electric Lexan® 144R. No color additives are present in this component. Ethylene oxide sterilization, ETO residual testing, and LAL Pyrogen testing support additional product safety.

Here's a summary of the acceptance criteria and the study details for the Q-Cap™ Needle-Free Reconstitution 13mm Vial Adapter, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

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

   • The test set involved comparing the biological activity of Menopur® (FSH and LH) when prepared with the Q-Cap™ Vial Adapter versus a standard needle and syringe.
   • The exact sample size (number of vials, number of tests performed) for this specific biological activity comparison is not explicitly stated in the provided text.
   • The data provenance is not specified regarding country of origin or whether it was retrospective or prospective. It is implied to be a prospective laboratory study conducted by the manufacturer or a contracted lab to generate data for this submission.

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

   • This was a laboratory assay for biological activity of a drug, not a diagnostic device requiring expert interpretation of images or patient data. Therefore, the concept of "experts establishing ground truth" in the typical sense (e.g., radiologists) does not apply.
   • The ground truth was established by the quantifiable results of the Menopur® Assay, performed in a lab environment. The qualifications of the personnel conducting the assay are not provided but would typically involve trained laboratory scientists.

3. Adjudication method for the test set:

   • Not applicable, as this was a quantitative biochemical assay, not a case-based interpretation requiring adjudication.

4. 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a medical accessory for drug reconstitution, not an AI-powered diagnostic tool, and therefore does not involve human readers interpreting data or AI assistance.

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

   • No, this device is a physical vial adapter, not an algorithm.

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

   • The ground truth used was quantitative laboratory assay results for the Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) biological activities of Menopur®.

7. The sample size for the training set:

   • Not applicable. This device is a physical product, not an AI algorithm requiring a training set. The "design and performance" were established based on the predicate device and physical/chemical testing.

8. 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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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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