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SafeR® is an automatically Retractable Safety Syringe, it is intended to provide a safe, accurate and reliable method for the aspiration of fluids and for the injection of fluids immediately after filling. It is intended to be used for the administration of medications (intramuscular (IM), intradermal (ID) and subcutaneous (SC)). SafeR® system is provided in 2 separate parts: SafeR Syringe and the needle group SafeR Sting, Before use, the end user needs to assemble syringe and needle group. The syringe, once assembled with his needle, incorporates a passive safety mechanism which retracts and contains the contaminated needle after use, aiding in prevention of possible infection due to needlestick injuries and syringe re-use. Needle retraction is activated by the syringe user with one hand. SafeR Sting blunt fill needle is designed only for drug preparation and it is not in contact with human body. SafeR Syringe with SafeR Sting maintain standard injection techniques.

SafeR® (SafeR Syringe and SafeR Sting) is an automatically retractable safety syringe, it is intended to provide a safe, accurate and reliable method for the aspiration of fluids or for the injection of fluids immediately after filling. SafeR® system is composed by a body syringe (SafeR Syringe) and a needle group (SafeR Sting). SafeR Syringe and SafeR Sting are 2 (two) products, packaged and sold separately, but designed to be coupled for use. Before use, the end user needs to assemble the body syringe and needle group through a clockwise rotation. Body syringe and needle group are connected by means of a threaded connection and conical mating surfaces between Screw Connector and Barrel. Geometry of the threaded connection was designed to ensure appropriate coupling only between SafeR Sting screw connector and SafeR Syringe barrel. Once assembled with its needle (SafeR Sting), incorporates a passive safety mechanism which retracts and contains the contaminated needle into a hollow stem of the plunger after use, aiding in the prevention of possible infections due to needle stick injuries and syringe reuse. Needle retraction is activated by the syringe user with one hand. Its intended condition is sterile, single use, for hospital or home use.

The furnished text is a 510(k) summary for the SafeR Syringe and SafeR Sting, a medical device. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance data for a new AI/Machine Learning diagnostic device. Therefore, a direct answer to your request for acceptance criteria and study data proving the device meets acceptance criteria for an AI/ML device cannot be fully extracted from this document.

However, I can extract the acceptance criteria related to the performance of this specific medical device (a syringe and needle) and how it was proven to meet these.

Here's an analysis based on the provided text, reinterpreting your request in the context of this device:

Acceptance Criteria and Device Performance (based on Non-Clinical Performance Testing):

The "acceptance criteria" for this device are defined by its conformity to various international ISO standards for syringes, needles, and safety features. The core of the performance testing is to demonstrate that the SafeR Syringe and SafeR Sting meet these established standards, thus proving its safety and effectiveness relative to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a typical "acceptance criteria" table with numerical thresholds and exact measured performance values for each. Instead, it refers to compliance with established industry standards. The "Reported Device Performance" is consistently stated as "Conformity to [ISO Standard]" or "Meets requirements."

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

The document does not explicitly state the sample sizes used for each specific non-clinical test. It generally refers to "Performance tests (bench)" and "test results." The provenance of the data is not mentioned in terms of country of origin or whether it was retrospective or prospective, as these terms are more relevant for clinical studies than bench testing of a physical device. All tests appear to be conducted in a laboratory/bench setting.

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

Not applicable. The "ground truth" for the performance of a physical medical device (syringe and needle) is established through objective, quantifiable measurements against engineering specifications and international standards (e.g., ISO, ASTM), rather than expert consensus on subjective interpretations (as would be the case for AI/ML diagnostic imaging).

4. Adjudication Method for the Test Set:

Not applicable. This concept is relevant for studies where human expert disagreement needs to be resolved (e.g., in medical image interpretation for AI ground truth). For bench testing of a physical product against standards, the measurements are objective.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size:

No. This type of study is specifically designed to evaluate the performance of diagnostic systems (often AI-assisted) where human readers interpret cases. The SafeR Syringe and SafeR Sting is a physical medical device, not a diagnostic imaging AI/ML product.

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

Not applicable. This device is a physical product, not an algorithm. Its performance is inherent in its design and manufacturing, tested through objective bench testing.

7. The Type of Ground Truth Used:

The ground truth is based on objective measurements against established engineering specifications and international standards (ISO, ASTM). For example, for "Lubricant amount," the ground truth is "

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