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The Unifine Pentips range of pen needles are intended for use with pen injector devices for the subcutaneous injection of drugs, including insulin.

Unifine® Pentips® and Unifine® Pentips® Plus are sterile, non-toxic, non-pyrogenic, single use pen needles for the subcutaneous injection of drugs from pen injectors. The pen needles are used by consumers, caregivers, and healthcare professionals. They are available in a variety of lengths (4mm, 5mm, 6mm, 8mm and12mm) and gauges (29G, 31G and 32G).

The pen needle assembly consists of a double-ended cannula, a needle hub, a needle shield, primary container and sterility seal that covers the assembly inside the primary container.

The hub has internal threads, which allows the pen needle to be screwed onto a pen injector device. The Non Patient (NP) end of the cannula (inside the hub) penetrates the rubber septum of the cartridge in the pen injector device. The Patient end and NP end of the cannula are lubricated using a silicone based lubricant to aid in injection and penetration into the rubber septum. The inner needle shield is injection molded and assembled over the Patient end of the needle to protect the needle from damage and accidental needle-sticks. The pen needle assembly is then inserted into an iniection molded outer container and sealed with a protective peel-away label to ensure a sterility barrier and tamper evidence. The outer container can be used to remove the hub with cannula from the pen injector device after the injection is completed. The peel-away label is pre-printed with information, which includes the lot number, expiry date, and size (length) and gauge of the needle. The individual needle assemblies are then packaged in bags and/or cartons, and placed into shippers with appropriate labeling. The shipper cases are then placed on pallets for sterilization.

Unifine Pentips Plus pen needles differ from Unifine Pentips pen needles because the primary container consists of two 'chamber contains a new, unused pen needle and the second chamber is empty. The empty chamber serves as a built-in pen needle remover, and may prevent accidental needlesticks. Users can insert their used needle into the chamber, then unscrew from the injection pen. The primary container is designed to hold the used pen needle until it can be disposed of in a suitable sharps container. The actual pen needle is identical between Unifine Pentips and Unifine Pentips Plus in both the physical appearance and functionality.

This document is a 510(k) Premarket Notification for medical devices, specifically pen needles. It is not a study proving an AI/ML medical device meets acceptance criteria. Therefore, most of the requested information regarding AI/ML device performance, ground truth establishment, sample sizes for training/test sets, expert adjudication, and MRMC studies, cannot be extracted from this document.

This document focuses on demonstrating substantial equivalence of the Unifine® Pentips® and Unifine® Pentips® Plus pen needles to legally marketed predicate devices, primarily K973899 (Unifine® Pentips®). This is a regulatory pathway for Class II medical devices in the US, where the manufacturer needs to show that their new device is as safe and effective as an already cleared device.

Here's what can be extracted based on the provided text, and where the requested information is not applicable or not present:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for these pen needles are primarily defined by adherence to ISO standards and internal performance tests. The document states that the devices meet these standards/criteria.

Note: The document states "The devices comply with the acceptance criteria established based on the specifications of the devices" for internal tests, but does not provide the specific numerical criteria for these tests.

Regarding the study that proves the device meets acceptance criteria (for an AI/ML context):

This document describes a regulatory submission for a physical medical device (pen needles), not an AI/ML software device. Therefore, the concepts of "test set," "training set," "ground truth," "experts for ground truth," "adjudication," and "MRMC studies" as they apply to AI/ML performance evaluation are not relevant here. The "study" described is a series of non-clinical performance (bench) tests and biocompatibility tests to demonstrate substantial equivalence to existing devices.

Here's why the specific questions are not applicable or cannot be answered from this document:

2. Sample sized used for the test set and the data provenance:

• Not Applicable in AI/ML context: This is a physical device. "Test set" refers to samples tested during bench testing.
• Sample Size: The document does not specify the number of pen needles tested for each performance test. It only states that the tests were performed and results "meet standard" or "meet acceptance criteria."
• Data Provenance: Not applicable in the AI/ML sense. Data is from laboratory bench testing of manufactured pen needles. The manufacturing locations mentioned are the UK (Owen Mumford) and Italy (Artsana S.p.A.).

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

• Not Applicable: There is no "ground truth" in the AI/ML sense (e.g., expert-annotated images) for a physical device like a pen needle. The "ground truth" is defined by the objective physical and mechanical properties measured against established ISO standards and internal specifications. Bench testing is typically performed by trained technicians.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not Applicable: No expert adjudication process as would be used for clinical image interpretation or AI model validation. Bench tests have objective, measurable outcomes.

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 type of study (MRMC, human readers, AI assistance) is for clinical decision support or diagnostic AI devices. This document is for a mechanical device.

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

• Not Applicable: This is not an algorithm or software device.

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

• Not Applicable in AI/ML context: The "ground truth" for these pen needles is defined by objective physical and mechanical measurements against established ISO standards (e.g., dimensions, flow rate, bond strength) and internal engineering specifications. Biocompatibility is assessed through standardized biological tests.

8. The sample size for the training set:

• Not Applicable: This is not an AI/ML device, so there is no "training set."

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

• Not Applicable: As above, no training set or AI/ML ground truth. The "ground truth" for manufacturing and quality control of pen needles is based on engineering specifications and adherence to international standards for medical devices.

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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.

This document describes a 510(k) submission for the Comfort EZ Pen Needle, a Class II medical device. The submission primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study of AI-based diagnostic performance. Therefore, many of the requested elements for describing a study proving a device meets acceptance criteria related to AI or diagnostic accuracy are not applicable.

Based on the provided text, the device in question is a Comfort EZ Pen Needle, which is a medical device for drug delivery (insulin) and not a diagnostic AI system. Therefore, the typical acceptance criteria and study designs relevant to AI/diagnostic performance (such as sensitivity, specificity, MRMC studies, ground truth establishment by experts, etc.) are not applicable to this document.

The "study" described in this 510(k) summary is a set of bench tests and demonstrations of substantial equivalence to existing predicate devices, as is standard for many medical devices, particularly those for which equivalence can be shown based on design and performance characteristics rather than complex diagnostic interpretation.

Here's an attempt to address the points based on the provided text, noting where the requested information is not relevant to a pen needle:

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

Since this is a non-AI, non-diagnostic device, the acceptance criteria are based on physical and functional properties, and the performance is reported against these.

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

• Sample Size: Not explicitly stated for each bench test. Bench tests typically involve a specific number of units to ensure statistical significance for the particular test being conducted (e.g., a certain number of needles for mechanical force testing, or samples for sterility testing). The document does not provide these specifics.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This is standard for internal product development and testing of a device rather than a clinical study with patient data. The tests would be performed in a controlled laboratory environment.

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

• Not Applicable. This device does not involve diagnostic interpretation or "ground truth" established by human experts in the way an AI diagnostic device would. Bench tests follow established laboratory protocols and standards (e.g., ISO standards for pen compatibility, AAMI standards for sterility). Compliance with these standards serves as the "ground truth" for device performance.

4. Adjudication method for the test set:

• Not Applicable. There's no human interpretation or subjective assessment that would require 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:

• No. This is not an AI or diagnostic device, so an MRMC study is not relevant.

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

• Not Applicable. This is not an algorithm or AI device. The "performance" described is the physical and functional performance of the pen needle itself.

7. The type of ground truth used:

• The "ground truth" for this device's performance is established by international standards (e.g., ISO "Type A" for pen compatibility), manufacturing specifications, and industry best practices for medical device safety and efficacy (e.g., biocompatibility standards, sterility assurance levels). It's not based on expert consensus, pathology, or outcomes data in the way a diagnostic device's ground truth would be.

8. The sample size for the training set:

• Not Applicable. This device does not involve machine learning or a "training set."

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

• Not Applicable. There is no training set for this type of device.

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