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The EasyTouch™ Safety Pen Needle is intended for use with pen injection of drugs, including insulin and exenatide. Additionally, the attached safety shield automatically locks in place and reduces the occurrence of accidental needle sticks from the patient end of the shield also serves to hide the needle before and after injection.

EasyTouch™ Safety Pen Needle is designed to be used with pen injectors for subcutaneous injections of a desired dose of drugs approved for delivery using a pen needle. The EasyTouch™ Safety Pen Needle is sterile (Ethylene Oxide sterilization procedure), and non-pyrogenic. It is a disposable, single use device. Additionally, the EasyTouch™ Safety Pen Needle is designed to reduce the occurrence of accidental needle sticks by providing a sheath that locks of the needle after use. Prior to injection, the end user will attach the EasyTouch™ Safety Pen Needle to an injector pen. The protective sheath will hide the needle from the user prior to use. Upon application of the needle to the sheath will retract to allow for the needle to enter the body. After the injection is complete, and the needle is removed from the skin, the protective sheath will automatically extend over the needle and lock into place. The EasyTouch™ Safety Pen Needle should be removed from the pen and discarded properly.

The provided text describes the 510(k) premarket notification for the EasyTouch™ Safety Pen Needle (K163578). This document primarily establishes substantial equivalence to a predicate device (BD Autoshield™ Pen Needle, K060007) based on technical characteristics and non-clinical testing. It does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of a typical AI/ML medical device submission.

However, I can extract the information related to the device's performance based on the non-clinical testing performed, which serves as evidence for its safety and effectiveness, and thus acts as a form of "acceptance criteria" for the 510(k) submission.

Here's the breakdown of the information requested, based on the provided text:

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

The document doesn't explicitly state "acceptance criteria" in a quantitative, pass/fail table for a specific performance metric like sensitivity or specificity. Instead, the "acceptance criteria" are implied by the requirements of the standards and regulations the device needs to comply with. The "reported device performance" is that the device "passed" these tests or "complies" with the standards.

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

The document details non-clinical bench testing. It does not specify "sample sizes" for individual tests in the way an AI/ML study would for a test set of images. For mechanical testing of the safety feature, it states "utilizing both professional health care workers and non-clinician pen users using gloved hands." The exact number of users or devices tested is not provided.

• Test Set Sample Size: Not explicitly stated for specific tests (e.g., number of devices for mechanical testing, number of runs for sterility).
• Data Provenance: Not applicable in the context of clinical patient data. The tests are bench tests performed in a lab setting, likely at the manufacturer's facility or a contract testing lab.

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

This is not applicable as the study described is a non-clinical device performance and safety study, not a study involving expert annotation or ground truth establishment for AI/ML algorithms. The "ground truth" for the tests is defined by the objective pass/fail criteria of the specified international standards (ISO) and FDA guidance documents.

4. Adjudication method for the test set

Not applicable. The performance is determined by objective measurement against established standards, not by expert adjudication of classifications.

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 is a 510(k) submission for a physical medical device (safety pen needle), not an AI/ML software device. Therefore, MRMC studies and AI-assisted human reader performance are not relevant or discussed.

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

No. This is a physical medical device. The concept of "standalone algorithm performance" is not applicable.

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

The "ground truth" for the non-clinical tests is based on objective, measurable criteria defined by international standards (ISO) and FDA guidance documents for device performance, safety, and biocompatibility. For instance, a sterility test's ground truth is a quantified sterility assurance level, and biocompatibility tests have established biological endpoints.

8. The sample size for the training set

Not applicable. This is not an AI/ML algorithm.

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

Not applicable. This is not an AI/ML algorithm.

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These disposable sterile insulin pen needles are intended for subcutaneous injection of insulin in the treatment of diabetes

The Pen Needle consists of a sterile cap, needle cap needle hub, which can be fixed with needle and protected by blister paper. The sterile cap functions to maintain the sterility of the needle because sterile cap covers the needle hub and needle cap with blister paper sealed on the opening hole of sterile cap. The needle hub can be connected to the pen. The needle cap cover is intended to provide physical protection to the needle tube. They are supplied with a sterile fluid path, (EO), nontoxic, and non pyrogenic, for single use only, disposable. The devices operate on the principles of common piston syringes.

The Easy.Touch Pen Needle (K112789) is a relabeled version of the Feel Fine insulin pen needle (K080904) and is claimed to be substantially equivalent to it and Becton Dickenson Pen Needles (K100005, K051899). The submission provided a summary of performance testing to support this claim of substantial equivalence.

Here's an breakdown of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "Bench testing included biocompatibility, compatibility with ISO Type A pens, mechanical testing, sterility testing including EO residues. The tests demonstrated that the device is as effective, and performs in a substantially equivalent manner to the previous predicate devices."
However, specific acceptance criteria values (e.g., minimum tensile strength, maximum leakage rate) and the precise reported device performance values are not detailed in the provided text. The claim is general, stating that the device "is as effective, and performs in a substantially equivalent manner."

2. Sample Sizes and Data Provenance:

• Test Set Sample Size: Not specified. The document states "Bench tests were performed," but does not provide the number of units tested for each type of bench test.
• Data Provenance: Not explicitly stated, but assumed to be internal laboratory testing by MHC Medical Products or its contracted labs, likely performed in the USA given the company's address. The data is retrospective in the sense that it's based on completed bench tests submitted for regulatory review.

3. Number of Experts and Qualifications for Ground Truth:

• This information is not applicable as the provided documentation describes a medical device, specifically a pen needle. The "ground truth" for such a device is established through objective physical, chemical, and biological performance testing (bench tests) against recognized standards and predicate device performance, not through expert consensus on interpretations like with diagnostic imaging.

4. Adjudication Method for the Test Set:

• Not applicable. See point 3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, an MRMC study was not done. This type of study is typically performed for AI-powered diagnostic systems or decision support tools where human interpretation is involved. The Easy.Touch Pen Needle is a mechanical device, not a diagnostic or AI-assisted tool.

6. Standalone (Algorithm Only) Performance Study:

• No, a standalone algorithm study was not done. This is not an AI/algorithm-driven device. The performance refers to the physical and biological characteristics of the pen needle itself.

7. Type of Ground Truth Used:

• The ground truth used for evaluating the device's performance was based on objective bench test results against established engineering specifications, ISO standards (e.g., for ISO Type A pens), and the performance characteristics of legally marketed predicate devices. This includes measurements for mechanical integrity, material biocompatibility, and sterility.

8. Sample Size for the Training Set:

• Not applicable. This device does not involve a "training set" in the context of machine learning or AI. Its design and manufacturing are based on established engineering principles and standards, not data training.

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

• Not applicable. See point 8.

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