Search Results

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 needle shield is intended to provide physical protection to the needle with the hub. Blister paper covers 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 text describes a 510(k) premarket notification for the Medifine Pen Needle 3 Bevel and Medifine Pen Needle Quinta 5 Bevel. This submission aims to demonstrate substantial equivalence to previously cleared predicate devices, specifically the Medifine Pen Needle 3 Bevel & Medifine Pen Needle Quinta 5 Bevel (K171144) and the CareFine Pen Needle by Facet Technologies, LLC (K140568) for an Over-the-Counter (OTC) claim.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Medifine Pen Needles are based on compliance with various ISO and ASTM standards. The document states that the "test results show that the subject device is substantially equivalent to the predicate devices in the market," implying the device performance met these criteria. However, specific numerical performance results for each test item are not provided in this document. The table below lists the test items and the relevant standards used as acceptance criteria.

2. Sample Size for the Test Set and Data Provenance

The document does not specify the exact sample sizes used for each test item. It only states that "The following tests were performed on the Medifine Pen Needle 3 Bevel and Medifine Pen Needle Quinta 5 Bevel." The data provenance is not explicitly mentioned (e.g., country of origin or retrospective/prospective). However, the testing is performed to satisfy international standards (ISO, ASTM), implying a standardized testing environment rather than a clinical data collection.

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

This document describes a submission for a medical device (pen needles) based on engineering performance testing and substantial equivalence to existing devices, not on diagnostic accuracy requiring expert interpretation of medical images or data. Therefore, the concept of "ground truth" and "experts" in the context of clinical interpretation, as typically applied to AI/ML medical devices, is not applicable to this type of submission. The ground truth for the performance tests would be defined by the specifications and measurement techniques within the cited ISO and ASTM standards.

4. Adjudication Method for the Test Set

As explained above, this submission is for a medical device that relies on engineering and material performance criteria. Therefore, an adjudication method for a test set, in the sense of resolving discrepancies between expert interpretations, is not applicable. The results of the performance tests would be objective measurements against predefined criteria in the standards.

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

No. This document does not describe an MRMC comparative effectiveness study. This type of study is typically conducted for AI/ML diagnostic or prognostic devices to assess the impact of AI assistance on human reader performance. The Medifine Pen Needle is a physical medical device.

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

No. This document describes the performance testing of a physical medical device, not an algorithm, so a standalone algorithm performance study is not applicable.

7. The Type of Ground Truth Used

The "ground truth" for the acceptance criteria and performance testing of the Medifine Pen Needle is based on established engineering and safety standards (ISO, ASTM). These standards define acceptable dimensions, flow rates, bond strengths, material properties, sterility, and other physical and safety features. It is not based on expert consensus for clinical diagnosis, pathology, or outcomes data.

8. The Sample Size for the Training Set

This document describes a 510(k) submission for a physical medical device. It does not involve any artificial intelligence or machine learning algorithms that would require a "training set." Therefore, the concept of a training set sample size is not applicable.

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

As there is no training set for an AI/ML algorithm involved in this device, the question of how its ground truth was established is not applicable.

Ask a specific question about this device

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.

Ask a specific question about this device