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Single-use non-sterile device intended to aid in the insertion of a commercially available syringe. The Safety feature prevents needle reuse.

This device is used in conjunction with a commercially available syringe to aid in the insertion of the syringe needle. The device is constructed of thick walled rigid polycarbonate injection molded components, and a spring, that are permanently assembled within a housing. The devices are provided bulk non-sterile to the user. The user fills a standard syringe and places it in the device. The user positions the device against the injection site. The safety feature is unlocked by rotating the moving carrier. The insertion spring is activated by pressing the device against the skin at the injection site. This spring advances the syringe such that the needle penetrates the skin. The user dispenses the medication by depressing the syringe plunger. Two 'legs' snap over the plunger at the end of the injection stroke to capture the syringe plunger. The device is disposed of in appropriate sharps containers according to local, state, and Federal regulations.

The document provided is a 510(k) premarket notification for a medical device (MedSafe™ System Inserter) and primarily focuses on establishing substantial equivalence to a predicate device. It does not contain information about a study proving the device meets specific acceptance criteria in the manner requested (e.g., performance metrics like sensitivity, specificity, or reader improvement with AI).

Instead, the submission demonstrates compliance with voluntary standards and compares the device's features to a predicate device to argue for substantial equivalence.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative "acceptance criteria" for device performance in terms of metrics like accuracy, sensitivity, or specificity. Instead, the "acceptance criteria" are implied to be compliance with voluntary standards and demonstrating substantial equivalence to a predicate device.

2. Sample sized used for the test set and the data provenance:

• The document does not describe a test set or data provenance because it's a 510(k) submission focused on substantial equivalence based on design and function comparison, not a performance study involving a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable as no such test set or ground truth establishment is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable as no test set is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No. This document describes a mechanical syringe inserter, not an AI-assisted diagnostic or therapeutic device. Therefore, an MRMC study related to AI assistance is not applicable.

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

• No. This description is for a mechanical device; there is no algorithm involved.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Not applicable as no specific ground truth for performance evaluation (in the medical imaging/AI sense) is discussed. The "ground truth" for this device's acceptance is its compliance with manufacturing standards and its functional equivalence to a legally marketed predicate.

8. The sample size for the training set:

• Not applicable as this is a mechanical device, not a machine learning model requiring a training set.

9. How the ground truth for the training set was established:

• Not applicable as no training set is relevant for this device.

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