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The Medifine Pen Needle 3 Bevel and the Medifine Pen Needle Quinta 5 Bevel are indicated for use with a pen injector device for the subcutaneous injection of insulin.

The Medifine Pen Needle consists of a needle with hub, and shield assembly. The need to provide physical protection to the needle with the hub. Blister paper covers the primary container. The primary container maintains sterility of the needle covering the hub and the shield with the blister paper. The needle hub can be connected onto the pen injector device for the subcutaneous injection of insulin. The device offers two compatible types of needle (patient contact point) as below. The user can choose the needle as per their preference.

The provided document is a 510(k) Premarket Notification for the Medifine Pen Needle 3 Bevel and Medifine Pen Needle Quinta 5 Bevel. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than explicit acceptance criteria and effectiveness studies as would be seen for higher-risk devices or novel technologies.

Therefore, the information you've requested regarding acceptance criteria and performance studies, particularly in the context of AI/algorithm performance and expert adjudication, is largely not applicable to this document as it describes a medical device (hypodermic pen needles), not an AI/software as a medical device (SaMD).

However, I can extract the closest information available from the document that aligns with your request, interpreting "acceptance criteria" as the performance standards met by the device through testing.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission for a physical medical device (pen needles), the "acceptance criteria" are the performance specifications defined by international standards (ISO standards) for hypodermic needles. The document states that the device met these criteria through testing. It does not provide specific numerical thresholds for acceptance or numerical results for each test item. Instead, it indicates that the device conforms to the standards.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated in the document. The tests performed are typically batch-release or design verification tests, which would involve a statistically significant sample size based on the specific ISO standards, but the exact number is not detailed here.
• Data Provenance: Not specified. Standard medical device testing is typically conducted by the manufacturer or accredited testing laboratories. The country of origin of the data is not mentioned. It is assumed to be part of the manufacturer's quality system which adheres to international standards. The study is prospective in the sense that the new device was tested against established standards and specifications.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• This question is not applicable as the device is a physical pen needle, not an AI/software device requiring expert interpretation of diagnostic images or data. Performance is assessed against physical and mechanical standards using laboratory testing, not human expert "ground truth."

4. Adjudication Method for the Test Set

• This question is not applicable for the same reason as point 3. Testing involves objective measurements and adherence to engineering and material specifications, not subjective expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• This question is not applicable. MRMC studies are used for diagnostic imaging devices or SaMD where human readers interpret cases. This document concerns a physical device (pen needle).

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

• This question is not applicable. This device is not an algorithm or software. It is a physical medical device.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is established by international standards (ISO standards) for hypodermic needles and pen needles (e.g., ISO 11608-2, ISO 9626, ISO 7864) and manufacturer's internal specifications derived from these standards. These standards define the acceptable physical properties, mechanisms, and safety characteristics.

8. The Sample Size for the Training Set

• This question is not applicable. "Training set" refers to data used to train an AI model. This device is not an AI/software device.

9. How the Ground Truth for the Training Set was Established

• This question is not applicable for the same reason as point 8.

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