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This device is intended for aspiration and injection of fluids. The needle protection device covers the needle after use to help prevent needle sticks.

The Hypodermic Needle-Pro® Safety Allergy Tray contains 25 graduated hypodermic syringes with permanently affixed needles and integral needle safety sheaths. The safety sheath rotates so it can be adjusted to the desired position relative to the needle bevel and syringe graduations. Each syringe within the tray has a shield over the needle and an end cap covering the end of the plunger. The trav is sterilized using irradiation and the syringe fluid path remains sterile until the shield or end cap is removed. The syringe is used to inject fluids into the body. After the procedure is completed, the needle is pressed into the sheath using a one-handed technique. The needle enters the protective sheath and is contained within the sheath. The device is then discarded into a sharps container.

This document is a 510(k) Pre-market Notification for the Hypodermic Needle-Pro® Safety Allergy Tray. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel acceptance criteria with detailed performance study results against those criteria. Therefore, several requested categories of information are not explicitly present in the provided text.

Here is an attempt to address your request based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of Table: The document explicitly states "similar performance specifications" and "could be used effectively," implying these are the acceptance criteria that were met. The specific quantitative metrics for these "specifications" or "effectiveness" are not enumerated in this summary.

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

The document mentions "Bench testing" and "Simulated clinical use studies."

• Sample Size: Not specified for either the bench testing or the simulated clinical use studies.
• Data Provenance: Not explicitly stated, but given it's a 510(k) submission from "Smiths Medical ASD, Inc. 10 Bowman Drive Keene NH 03431 USA," the studies were likely conducted in the USA by or for the manufacturer. The studies are by nature prospective as they were specifically conducted to support this 510(k) submission.

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

• Experts: Not specified.
• Qualifications: Not specified.

The "simulated clinical use studies" would likely involve users (e.g., healthcare professionals) to assess effectiveness, but the quantity and qualifications of these individuals are not detailed in this summary.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. Given the nature of a 510(k) for a safety syringe, the "simulated clinical use" likely involved observing successful deployment of the safety mechanism and effectiveness of the device for its intended use, rather than a complex diagnostic ground truth adjudication.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done or described in this document. This submission relies on demonstrating substantial equivalence through bench testing and simulated use, not a comparison of human reader performance with and without AI assistance (as this is a physical medical device, not an AI diagnostic tool).

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

• Standalone Performance: Not applicable. This device is a physical hypodermic syringe with a safety feature, not an algorithm.

7. The Type of Ground Truth Used

• For Bench Testing: The ground truth would have been established by comparing the device's performance against applicable standards and FDA guidance for devices with sharps injury prevention features, as well as against the performance specifications of the predicate device. This is based on objective, measurable physical properties and functional tests.
• For Simulated Clinical Use Studies: The ground truth was likely based on observational assessment of the device's functional integrity and successful deployment of the safety mechanism according to its design intent. This would involve criteria such as ease of use, successful needle shielding, and effective prevention of needle sticks in a simulated environment.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This document describes a physical medical device, not a machine learning model, so there is no "training set."

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this type of device submission.

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