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The UNIQSAFE Rotatable, Retractable Safety Syringe (1ml , 3ml , 5ml , 10ml ) is designed as an anti-stick syringe to reduce the risk of sharps injuries and the potential for syringe reuse and is a single use, disposable and manual retractable safety syringe which is intended for injection of medical fluids into the body.

The UNIQSAFE Rotatable, Retractable Safety Syringe is sterile, single-use, disposable , Non-reusable, Manual , Retractable, Piston Syringe, provided with needle attached in place., which is used for injection of fluids into the body. The UNIQSAFE Rotatable, Retractable Safety Syringe consist of the following major components. m Plunger , n Piston , h adaptor , i O-Ring , r Barrel, w Hub, i Needle a Cap. It is manufactured in size of 1ml ,3ml ,5ml and 10ml volume.

This document describes the UNIQSAFE Rotatable, Ret retractable Safety Syringe. Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions "bench testing & simulated use study" but does not specify the sample size for these tests. The data provenance is not explicitly stated as country of origin, nor is it explicitly labeled as retrospective or prospective, beyond indicating they were part of the submission for clearance.

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

This information is not provided in the document.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This document describes a medical device (a safety syringe), not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not done.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This document describes a manual medical device. Therefore, a standalone algorithm performance study is not applicable and was not done.

7. The Type of Ground Truth Used

The document implies that the ground truth for performance was established through adherence to specified standards (ISO, USP) for physical, chemical, biological, and sterilization properties, and through bench testing and simulated use studies to demonstrate equivalence to predicate devices regarding safety and effectiveness. There is no mention of pathology, expert consensus (beyond the assumption that standards are based on expert knowledge), or outcomes data in this context.

8. The Sample Size for the Training Set

This document describes the premarket notification for a physical medical device. The concept of a "training set" is typically relevant for machine learning algorithms. Therefore, a training set is not applicable and was not used in the context of this device's submission.

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

As a training set is not applicable, the ground truth establishment for it is also not applicable.

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