Search Results

The Arisure™ Closed Vial Adapter is intended for use by healthcare professionals in a wide variety of healthcare environments including hospitals, healthcare facilities, and pharmacies for reconstitution or dispensing of medication. The Arisure™ Closed Vial Adapter is indicated for use with rubber-stopper medication vials for reconstitution or dispensing of medications, including chemotherapy agents.

The Arisure Closed Vial Adapter is intended for use by healthcare professionals in a wide variety of healthcare environments including hospitals, healthcare facilities, and pharmacies for reconstitution or dispensing of medication. The Arisure Closed Vial Adapter is indicated for use with rubber-stopper medication vials for reconstitution or dispensing of medications, including chemotherapy agents.

The Arisure Closed Vial Adapter is a mechanically closed device, designed to retain vapors produced from medications in the attached vial.

The Arisure™ Closed Vial Adapter's acceptance criteria and the study proving it meets these criteria are described below:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes used for each individual performance test (e.g., how many devices were tested for "Misuse Test" or "Flow Rate"). It generally states that "The following tests were conducted on the Arisure Closed Vial Adapter device to demonstrate equivalency of the performance characteristics to the predicate device(s)."

The data provenance is not specified in terms of country of origin or whether it was retrospective or prospective. It is implied that these are lab-based performance tests related to the device itself.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable. The device is a medical accessory (vial adapter), and the tests described are physical, chemical, and biological performance tests, not clinical evaluations requiring human expert interpretation for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable, as the tests are objective performance metrics rather than assessments requiring human adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human readers interpret results, and the Arisure™ Closed Vial Adapter is a medical accessory.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable to the Arisure™ Closed Vial Adapter. It is a physical medical device, not a software algorithm that operates without human intervention. The performance tests evaluate the device's physical and functional properties.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests described are the established scientific and engineering standards and specifications relevant to medical device performance, such as ISO 10993 for biocompatibility and internal specifications for parameters like detachment force, flow rate, trapped air volume, etc.

8. The Sample Size for the Training Set

This information is not applicable. The Arisure™ Closed Vial Adapter is a physical medical device, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable, as there is no training set for this device.

Ask a specific question about this device