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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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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 offered in one gage - 31 G and in two lengths: 6mm and 8 mm. 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 slides into the shield. While the slider glides into the shield, the safety feature is activated. Following injection, the slider glides back into its initial position, completely covering the needle where it remains locked.

The red safety lock indicator tells the user that 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 a 510(k) premarket notification for a medical device called "DropSafe Safety Pen Needles." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel safety and effectiveness through extensive clinical trials. Therefore, the information provided primarily addresses design verification and validation testing of the device's physical properties and safety features, and not a study proving the device meets high-level acceptance criteria through, for instance, a multi-reader multi-case clinical study or algorithm-only performance.

Based on the provided text, here's a breakdown of the requested information, highlighting what is present and what is not applicable or not detailed for this type of submission:

1. A table of acceptance criteria and the reported device performance:

The document lists "Non-Clinical Performance Data" and "Clinical Performance Data" which serve as acceptance criteria based on established standards and guidance.

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

• Test Set Sample Size: The document does not specify the numerical sample sizes for the non-clinical performance tests (e.g., number of needles tested for flow rate, bond strength, etc.) nor for the "Simulated Use Study" involving clinical and non-clinical users. It merely states that "Testing was performed" and "All testing met the applicable requirements."
• Data Provenance: The tests are described as being conducted in compliance with ISO standards and FDA guidance. The manufacturer, HTL-Strefa S.A., is located in Poland. The text doesn't explicitly state the location of the testing, but it can be inferred to have been conducted by or for the manufacturer. The studies described are likely prospective tests performed specifically for this 510(k) submission.

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

This information is not applicable and not provided. For this type of device (a hypodermic needle), "ground truth" is established through engineering and performance testing against objective standards (ISO 11608-2:2012) and simulated user studies. Expert consensus or ground truth derived from a panel of medical specialists (like radiologists) is not relevant for this device's validation. The "Simulated Use Study" involved "clinical and non-clinical users," but their number or specific qualifications (beyond being "clinical users") are not detailed.

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

Not applicable. Adjudication methods are typically used in studies where human readers are interpreting images or data, and their disagreements need to be resolved to establish ground truth. For the physical and functional tests of a pen needle, objective measurements against established standards are the norm, not adjudication.

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 device is a mechanical medical device (a safety pen needle), not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or performed for this product.

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

Not applicable. This device is not an algorithm or AI system. Its performance is inherent to its physical design, manufacturing, and user interaction.

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

The "ground truth" for this device's performance is established by:

• Compliance with international standards (ISO 11608-2:2012) for physical and functional properties (e.g., materials, dimensions, flow rate, bond strength, lubrication, compatibility).
• Compliance with FDA guidance for sharps injury prevention features, validated through a "Simulated Use Study" to confirm the safety feature's function and IFU effectiveness with users.
• The primary ground truth is the ability of the device to meet specified engineering and performance requirements for safe and effective use, rather than a clinical diagnosis.

8. The sample size for the training set:

Not applicable. This is a mechanical device, not an AI model requiring a training set.

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

Not applicable, as there is no training set for a mechanical device.

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