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The DropSafe Safety Pen Needles are sterile, single-use safety needles intended for use with pen injector devices for the injection of drugs.

DropSafe Safety Pen Needles are sterile, single-use safety needles intended for use with pen injector devices for the injection of drugs. DropSafe Safety Pen Needles are OTC devices intended to be used by clinical and non-clinical users. DropSafe Safety Pen Needles are already offered in one gage - 31 G and in two lengths: 6mm and 8 mm. This submission covers the addition of a new length: 5 mm with the same gage - 31G. DropSafe Safety Pen Needles are gamma sterilized, non-toxic single use devices.

The device is designed to minimize the risk from accidental needle sticks with a used needle by application of a sharps injury prevention feature. Following use, the needle is locked out preventing reuse. The shield also serves to hide the needle before and after injection. Each DropSafe safety pen needle is individually packaged in a sealed container. The DropSafe safety pen needle is used by removing the seal and attaching it to the pen injector device to administer a drug subcutaneously. While inserting the needle into the skin at a 90° angle, the slider glides into the shield. While the slider glides into the shield, the safety feature is activated. Following injection, the slides back into its initial position, completely covering the needle where it remains locked. The red safety lock indicator tells the safety lock has been activated. Once the safety pen needle is in the locked mode, it cannot be reused. The safety pen needle is detached from the pen injector device and disposed of into a sharps container.

The pen needle assembly consists of a double-ended cannula that is assembled into an injection molded hub using an adhesive. The hub has internal threads which allows it to be screwed onto the pen injector device. This allows the cartridge end of the needle to penetrate through the rubber septum of the cartridge. The patient-end and the cartridge end of the cannula are lubricated using a silicone-based lubricant for ease of injection and rubber septum penetration.

An injection molded inner shield is assembled over the patient end of the cannula to prevent needle point damage and accidental needle-sticks. This needle assembly is inserted into a protective injection molded container and sealed with a peel away medical grade paper tab which provides a sterility barrier and tamper evident seal.

The provided text describes the 510(k) summary for the DropSafe Safety Pen Needles, specifically focusing on the addition of a new 5mm length. While it details non-clinical performance data and mentions a simulated use study for clinical performance, the structured format of an AI device's acceptance criteria and proven performance based on specific metrics (like sensitivity, specificity, AUC) is not directly present.

The document primarily demonstrates substantial equivalence to a predicate device (DropSafe Safety Pen Needle K170988) by showing that the new device's technical characteristics, intended use, operation principle, and materials are same, with the only difference being the needle length (5mm vs. 6mm and 8mm for the predicate). The "performance data" presented is largely a compliance check against ISO 11608-2:2012, which covers physical and functional requirements for pen needles.

Therefore, I cannot extract the information required for a typical AI device's acceptance criteria and study proving its performance in the requested format, as this submission pertains to a mechanical medical device (a safety pen needle) and not an AI/ML powered device.

However, I can describe the acceptance criteria and proven device performance as they relate to the information provided for this specific device:

Device Type: Mechanical medical device (Safety Pen Needle), not an AI/ML medical device.

1. Table of Acceptance Criteria and Reported Device Performance (as per ISO 11608-2:2012 for a mechanical device):

As the device is not an AI/ML medical device, the following points are not applicable in their typical sense for an AI/ML context:

2. Sample size used for the test set and data provenance:
* The document does not specify a numerical sample size for each performance test listed in the table, nor does it detail data provenance in terms of country of origin or if it's retrospective/prospective outside of the "simulated clinical environment" for the simulated use study. The tests are in vitro compliance tests.

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
* Not applicable for this type of device and testing. Ground truth for these criteria is based on international standards (ISO 11608-2:2012) and engineering measurements/observations, not expert consensus on medical images or diagnoses.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
* Not applicable. Test results are objective measurements against specified standard requirements.

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:
* Not applicable. This is not an AI-powered device, and no human reader comparative study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Not applicable. This is a mechanical device, not an algorithm. Its "standalone" performance is measured by its physical compliance to standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* The "ground truth" for this device's performance is compliance with established international standards (ISO 11608-2:2012) and engineering specifications, along with functional testing for elements like the safety feature. For the 'Simulated Use Study', the ground truth is functional validation and user experience.

8. The sample size for the training set:
* Not applicable. There is no "training set" as this is not an AI/ML device.

9. How the ground truth for the training set was established:
* Not applicable. There is no "training set."

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