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Vials Adapters Ø20 mm and Ø13mm are indicated for the transfer and mixing of drugs contained in vials.

The vial Adapters (VA) Ø20mm and Ø13mm are sterile polycarbonated devices which allows easy transfer of fluids into and out of drug vials. It incorporates a siliconized hollow spike for puncturing the stopper in the neck of a vial and a luer fitting that allows connection of a syringe on opposite side. After puncturing the hollow spike seats securely around the ferrule of drug vial utilizing the "legs" of the vial adapter. The opposite side of the vial adapter contains a Luer fitting for the connection of a standard Luer Lock syringe for the reconstitution and removal of the contents of the drug vial. The proposed VA is available in two Ø20 mm and Ø13mm diameter to accommodate respective size of drug vials and is available in 3 configurations, no filter, in-line 5-micron or 15-micron disc filter sub- assembly for particulate filtration.

The provided text is a 510(k) Premarket Notification from the FDA for a medical device called "Vial Adapter Ø20 mm, Vial Adapter Ø13 mm". It describes the device, its intended use, and the testing conducted to demonstrate its substantial equivalence to a predicate device.

However, the request asks for information relevant to the acceptance criteria and study proving a device meets those criteria for an AI/ML-enabled medical device. The document provided pertains to a traditional physical medical device (Vial Adapter) and, as explicitly stated in section "10. Clinical Testing", no clinical testing was required or performed, and the device is not an AI/ML-enabled device.

Therefore, most of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/ML performance (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth) is not applicable to this document.

The document focuses on non-clinical performance testing (mechanical, flow, packaging, filtration, Luer Lock) and biocompatibility for a physical device.

N.B.: Since the core premise of the request (AI/ML device testing) is not met by the provided document, I cannot fulfill most of the specific numbered points. The below response will address only what is present in the document related to acceptance criteria and testing for this physical device.

Acceptance Criteria and Study for Vial Adapter (Physical Device)

The document describes non-clinical performance testing for the Vial Adapter to demonstrate substantial equivalence to a predicate device, rather than an AI/ML system's performance. The acceptance criteria for these tests are implicitly that the device performs as expected according to the specified standards or internal performance criteria.

1. A table of acceptance criteria and the reported device performance

The document provides a "Non-Clinical/Performance testing Summary" table listing various tests and the testing standards used. It then states in section "9. Summary of Non-Clinical Testing" and "Performance Testing Summary" that:

• "All testing met the required acceptance criteria."
• "The performance testing of the filters met required acceptable criteria."

The specific quantitative acceptance criteria values (e.g., minimum snapping force, maximum leak rate) and the reported device performance values (e.g., actual snapping force measured, actual leak rate) are not detailed in this summary document. Only the statement that they "met the required acceptance criteria" is provided.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified in the provided summary for any of the non-clinical tests.
• Data Provenance: Not applicable in the context of this physical device's non-clinical performance testing. The tests are laboratory-based. The submitter is Avenir Performance Européenne Medical (APEM), located in France, suggesting the testing likely occurred in France or a European testing facility.

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. This device is a physical product, not an AI/ML system requiring expert interpretation for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. Ground truth and adjudication methods are not relevant for these non-clinical performance tests.

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 physical device, and no AI/ML component is involved.

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

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

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

• Not applicable. The "ground truth" for a physical device's performance tests would be the established scientific/engineering standard for what constitutes acceptable performance (e.g., maximum allowable leak rate, minimum force for a secure connection). These are determined by regulatory standards (e.g., ISO) or internal specifications.

8. The sample size for the training set

• Not applicable. There is no training set as this is not an AI/ML device.

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

• Not applicable. There is no training set.

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