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The Safety Pen Needle for Single Use is intended for use with pen injector devices for the subcutaneous injection of insulin.

The Insulin Pen Needle is intended for use with pen injector devices for the subcutaneous injection of insulin.

The devices are provided in two types of configurations: Safety Pen Needle for Single Use and Insulin Pen Needle.

The Safety Pen Needle for Single Use is intended for use with pen injector devices for the subcutaneous injection of insulin. It consists of a needle cap, needle hub, safety protective cover, self-destruction seat and sealed paper. The safety protective cover is manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.

The Insulin Pen Needle is intended for use with pen injector devices for the subcutaneous injection of insulin. It consists of protective cap, needle tube, needle protective cover and sealed paper.

The provided document describes a 510(k) premarket notification for a medical device, specifically Safety Pen Needles for Single Use and Insulin Pen Needles. It focuses on demonstrating substantial equivalence to a predicate device (K181447) rather than presenting a study for general acceptance criteria alone.

Therefore, the response will be structured to address the acceptance criteria as derived from the comparative and standalone testing performed to establish substantial equivalence.

Here's an analysis based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document lists numerous non-clinical tests and standards that the proposed device was tested against. The acceptance criteria are implicit in compliance with these standards and the comparisons to the predicate device. The performance is stated as "complied with" or "met the requirements".

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

The document does not specify the exact sample sizes for each test in the acceptance criteria. It broadly states "Non-clinical tests were conducted..." and "Physical, Mechanical, and Chemical testing listed in following table were performed on the proposed device."
Regarding data provenance, the manufacturer is Berpu Medical Technology Co., Ltd. in Wenzhou, Zhejiang, China. Therefore, the data provenance is China, and the data is prospective as it involves direct testing of the proposed devices.

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

This section is not applicable as the document describes non-clinical laboratory and performance testing for a medical device (pen needles), not a diagnostic algorithm requiring expert ground truth for interpretation of images or other data. The "ground truth" here is defined by compliance with established international and ASTM standards.

4. Adjudication method for the test set

This section is not applicable for the same reasons as point 3. The evaluation is based on objective measurements against specified standard criteria, not subjective expert judgment requiring 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

This section is not applicable. The device is a physical medical device (pen needle), not an AI-powered diagnostic tool, and therefore, no MRMC study or AI assistance evaluation was performed or is relevant.

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

This section is not applicable as the device is a physical medical instrument, not an algorithm or software. The non-clinical tests described are "standalone" in the sense that they evaluate the device's intrinsic properties against standards, without human interaction influencing the core performance metrics being measured (e.g., flow rate, bond strength).

7. The type of ground truth used

The "ground truth" for the non-clinical tests and the product's performance is established by international and national standards (e.g., ISO, ASTM, USP) and the specifications derived from these standards. For example, the criteria for cytotoxicity or sterility assurance level (SAL) are defined by the respective ISO and USP standards. The "pre-established criteria" mentioned for the simulated clinical study and safety feature test would also fall under this category, likely derived from the relevant standards (ISO 23908:2011) and FDA guidance.

8. The sample size for the training set

This section is not applicable. The document describes the testing of a physical medical device. There is no "training set" in the context of an AI/ML algorithm. The training in device manufacturing typically refers to process validation and quality control, not data training.

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

This section is not applicable for the same reason as point 8; there is no training set mentioned in the context of this device's approval process.

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