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The proposed device is indicated for the transfer and mixing of drugs contained in a vial.

The proposed device, Vial Connector 13 mm Closed Collar, is intended for use in healthcare facilities or in home environment by the patient or care-giver to aid and support prescribed treatment and therapy. The proposed device consists of two integrated parts, the first part is the 13mm vial connector body intended to be attached to a standard 13 mm drug vial neck and a male luer connection. The vial connector body contains the single lumen piercing spike and an assembled 5μm fluid path filter (Versapor® Hydrophilic membrane on a HDPE disc). The second part of the device is the closed collar which restricts the connection of the vial connector to standard 13 mm vials with a body diameter of up to 15 mm. The two integrated parts are injection molded as one single device. The proposed device does not contain any medicinal substances.

This looks like a 510(k) summary for a medical device. Based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria.

The document primarily focuses on establishing substantial equivalence to a predicate device, which is a common pathway for medical device clearance in the US. This type of submission relies on demonstrating that the new device has the same indications for use and principle of operation as a legally marketed device, rather than requiring new clinical trials or performance studies against predefined acceptance criteria for a novel device.

Here's why each point in your request cannot be fulfilled based on the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document describes the device, its intended use, and argues for its similarity to a predicate. It does not contain performance metrics or acceptance criteria as would be found in a study report.

2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): No test set, sample size, or data provenance is mentioned because no performance study for this specific device is referenced.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable, as no test set or ground truth establishment is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no test set or adjudication process is mentioned.

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: Not applicable. This device is a mechanical "Vial Connector," not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a non-AI, mechanical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no ground truth is established for this type of device submission.

8. The sample size for the training set: Not applicable, as this is a mechanical device and does not involve AI model training.

9. How the ground truth for the training set was established: Not applicable, same reason as above.

In summary, the provided text is a 510(k) summary demonstrating substantial equivalence for a medical device, which typically does not include detailed performance studies with acceptance criteria in the way a novel technology or an AI/software device often would. The clearance is based on its similarity to an already approved predicate device.

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