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ShinaPen® is intended for use with pen injector devices for the subcutaneous injection of insulin.

The ShinaPen® are designed for use with a pen injector for the subcutaneous injection of insulin. The pen needle consists of a needle, hub, and shield assembly. Blister paper covers primary container. The primary container maintains sterility the of the needle because primary container covers the hub and needle cap with blister paper sealed on the opening hole of primary container. The needle hub can be connected screwed onto the pen. The needle shield is intended to provide physical protection to the needle tube. The ShinaPen® are offered various gauges sizes (29G, 30G, 31G, 32G) and Lengths (4mm, 6mm, 8mm, 12.7mm). These are sterile (Eo gas sterilization), non-toxic, and non-pyrogenic. The pen needles are disposable, single use devices.

The provided text describes a 510(k) premarket notification for the ShinaPen®, an insulin pen needle. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a study with detailed performance metrics. Therefore, many of the requested elements (e.g., acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC study, training set details) are not applicable or cannot be extracted from this document.

Here's an analysis based on the information available:

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

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

• Sample sizes: Not explicitly stated for any of the performance tests. The document only mentions "performance testing" and "biocompatibility testing" without providing the number of units tested.
• Data provenance: Not explicitly stated. However, the manufacturer is SHINA CORPORATION from Korea. The testing would presumably have been conducted by or for the manufacturer. It is non-clinical safety and performance testing, not data derived from human subjects.

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

• Not applicable. This document describes non-clinical engineering and laboratory tests (e.g., meeting ISO standards, material biocompatibility, sterilization validation). These types of tests do not typically involve human experts establishing "ground truth" in the way clinical studies or diagnostic algorithm validations do. The "truth" is defined by the passing criteria of the standards themselves (e.g., a certain force to remove a needle shield, a concentration limit for residues).

4. Adjudication method for the test set

• Not applicable. See point 3.

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 an insulin pen needle, a physical medical device. It is not an AI-powered diagnostic or assistive tool, and therefore, MRMC studies or AI assistance are not relevant.

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

• Not applicable. See point 5.

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

• Standard-defined criteria/specifications: For the performance tests (ISO standards, internal standards, biocompatibility, sterilization, shelf-life), the "ground truth" or acceptance criteria are defined by the specific requirements and limits set forth in the referenced international standards (e.g., ISO7864, ISO9626, ISO11608-2, ISO10993-1, ISO11135, ISO10993-7) and the manufacturer's own internal specifications for needle shield assembly force and sharpness.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Not applicable. See point 8.

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