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The primary indicated use for the SafePro* Plus Safety Syringe is for general purpose use in aspirating and injecting fluid.

The secondary indicated use for the SafePro* Plus Safety Syringe is for needlestick protection; the device may aid in the reduction of needlestick injuries.

The SafePro* Plus Safety Syringe consists of a syringe assembly and a needle assembly. The device has a built-in safety feature to reduce the risk of accidental needlestick injuries.

Acceptance Criteria and Study for SafePro* Plus Safety Syringe

Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 500 SafePro* Plus Safety Syringes were evaluated.
• Data Provenance: The study was a "simulated use study," implying it was a prospective study conducted specifically for this submission. The text does not specify the country of origin of the participants.

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

The provided text does not mention experts being used to establish a "ground truth" for the simulated use study. Instead, the study involved "50 participants" who evaluated the syringes and provided "positive responses." It also reported that "no sharps injuries or failures of the safety mechanism occurred." This suggests that the "ground truth" was based on direct observation of safety mechanism functionality and user feedback, rather than expert judgment on complex cases.

4. Adjudication Method for the Test Set

The text does not describe an adjudication method. Since there's no mention of multiple experts establishing ground truth, a formal adjudication process (like 2+1 or 3+1) would not be applicable here. The outcomes (no injuries, no failures, positive responses) appear to be directly observed and collected.

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

No, an MRMC comparative effectiveness study was not done. The study described is a simulated use study focusing on the device's functionality and safety, not a comparison of human reader performance with and without AI assistance.

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

N/A (Not Applicable). The SafePro* Plus Safety Syringe is a physical medical device, not an AI algorithm. Therefore, the concept of "standalone (algorithm only)" performance does not apply.

7. The Type of Ground Truth Used

The ground truth used in this study was based on:

• Direct observation of device performance and safety: "No sharps injuries or failures of the safety mechanism occurred."
• User feedback/satisfaction: "Positive responses from the Evaluators regarding functional and performance aspects."

This is not a traditional "expert consensus," "pathology," or "outcomes data" in the typical diagnostic sense, but rather a direct assessment of device functionality and user experience.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable here as the SafePro* Plus Safety Syringe is a physical device, not an AI/ML model. Therefore, there is no training set.

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

As there is no training set, this question is not applicable.

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