(280 days)
The Mix2Vial® Transfer Device is intended for transferring drugs contained in two vials.
The subject device, Mix2Vial® Transfer Device (M2V), is a single-use, gamma sterilized, nonpyrogenic device intended for the transfer of drugs contained in two vials. The M2V consists of two vial adapter bodies with piercing spike and wings, connected back-to-back via a Luer connection, with an in-line filter.
The female vial adapter (clear) connects to the drug vial and the male vial adapter (blue) connects to the diluent vial. The vacuum present in the lyophilized drug vial draws in the contents of the diluent vial.
The female Luer connection interfaces to a syringe and has an in-line 5um filter that strains the drug or solution when aspirated out of the vial. The male connection has a "Tight Grip" that provides a secure connection to the diluent vial having a 20mm neck diameter.
Puncturing the elastomeric closure or "stopper" of a drug or diluent vial is achieved by means of an integral polycarbonate cannulated spike located in the center of each Vial Adapter (VA) body of the M2V. Each side of the device (diluent vial side and drug vial side) is a polycarbonate molded part containing a Luer port.
After reconstitution, the drug can be administered by disconnecting the diluent vial and connecting a needleless syringe to the female Luer Lock of the female Vial Adapter. The device does not contain any medicinal substances and can be used with drug vials/diluent vials with a neck diameter of 20mm.
I am sorry, but the provided text describes a 510(k) premarket notification for a medical device (Mix2Vial® Transfer Device) and does not contain any information about a study involving an AI/Machine Learning device or its acceptance criteria within the context of AI performance metrics like sensitivity, specificity, or AUC.
The document focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway for non-AI medical devices. The performance data discussed relates to physical and chemical properties of the device (e.g., fragmentation, particulate, Luer stability, sterility, biocompatibility, force measurements), not the performance of an AI algorithm.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance related to AI.
- Sample sizes used for a test set (in the context of AI).
- Data provenance for an AI test set.
- Number of experts establishing ground truth for AI.
- Adjudication method for an AI test set.
- MRMC comparative effectiveness study results.
- Standalone AI performance.
- Type of ground truth (for AI).
- Training set sample size (for AI).
- Ground truth establishment for a training set (for AI).
The document explicitly states: "Clinical trials were not performed for the Mix2Vial® Transfer Device." This further confirms that there are no clinical performance studies, let alone AI performance studies, described in this regulatory submission.
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.