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These disposable sterile Insulin pen needles are intended for subcutaneous injection of insulin in the treatment of diabetes.

Fine Ject insulin pen needle consists of a Sterile Cap, needle hub, which can be fixed with needle and blister paper. The sterile cap has function to sustain sterilization of 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 with pen. The needle cap covers intended to provide physical protection to the needle tube.

Fine Ject insulin pen needles are single use, sterile, medical devices designed to be used in conjunction with pen injectors and pen cartridges. Pen needles are used by consumers, caregivers and health care professionals. They are offered in variougauge sizes (29G, 30 G, 31G and 32G) and lengths (4mm, 5mm, 8mm and 12.7mm). Fine Ject insulin pen needles are sterile (gamma irradiation sterilization), non-toxic and non-pyrogenic.

The hub has internal threads, which allows it to be screwed onto the pen-injector device. This allows the Non Patient (NP) end of the cannula to penetrate through the rubber septum of the cartridge.

This document describes the premarket notification (510(k)) for the Fine Ject Insulin Pen Needle. It details the device's characteristics, comparison to predicate devices, and non-clinical testing performed to establish substantial equivalence.

Here's an analysis of the provided information, focusing on the requested categories. It's important to note that this 510(k) summary is for a medical device (insulin pen needle), not an AI/ML powered device, so many of the requested categories related to AI performance, ground truth, and expert evaluation are not directly applicable. I will address each point as best as the provided text allows.

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the exact sample sizes used for each non-clinical performance test (e.g., for ISO standards compliance, biocompatibility, sterilization, shelf-life). These are typically determined by the testing protocols for each standard.

The data provenance is from non-clinical testing conducted by Twobiens Co., Ltd. in Korea. The document doesn't explicitly state "retrospective" or "prospective" for these tests, but non-clinical laboratory testing is typically conducted prospectively to meet specific requirements.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable to this type of medical device submission. Ground truth established by medical experts (like radiologists) is relevant for diagnostic AI/ML products, not for physical medical devices like insulin pen needles. The "ground truth" here is compliance with established international standards for device design, materials, and performance, which is verified through laboratory testing.

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

Not applicable. Adjudication methods like "2+1" or "3+1" are used in studies involving human readers or evaluators for diagnostic agreement, which is not relevant for the non-clinical testing of a physical device.

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 is not an AI-powered device, and no MRMC comparative effectiveness study was conducted or is relevant.

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

Not applicable. This is a physical medical device, not an algorithm.

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

The "ground truth" in this context is the compliance with recognized international standards (ISO 7864, ISO 9626, ISO 11608-2, ISO 10993-1). This is established through specific laboratory tests and measurements designed to verify that the device meets the defined performance and safety criteria outlined in these standards.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set with established ground truth.

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The Henke-Sass Wolf, Disposable Hypodermic Single Lumen Needle is Intended to be used for the purpose of injecting fluids into, or withdrawing fluids from parts of the body below the surface of the skin.

The HENKE -SASS , WOLF FINE-JECT® Disposable Needles are sterile hypodermic Single Lumen Needles, packaged individually for single patient use. The HENKE SASS WOLF Needles have the same operating principals and intended uses as the predicate devices already in commercial distribution

Below is the information regarding the acceptance criteria and the study for the submitted device, a Hypodermic Single Lumen Needle.

Device Name: Hypodermic Single Lumen Needle (Proprietary Name: FINE-JECT®)
Classification Name: Hypodermic Needle
Product Code: FMI
Regulation Number: 880.5570
Classification: Class II

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) submission for the Hypodermic Single Lumen Needle (FINE-JECT®) relies on demonstrating substantial equivalence to already marketed predicate devices rather than presenting specific quantitative performance data against predefined acceptance criteria for novel safety/efficacy endpoints. The "acceptance criteria" here are therefore generally understood as compliance with established manufacturing and quality standards, and the "reported device performance" is its adherence to these standards and functional equivalency to predicate devices.

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

This submission is a 510(k) Premarket Notification for a Class II medical device (Hypodermic Single Lumen Needle). For such submissions, especially for devices like hypodermic needles that rely on well-established technology, the primary evidence of "safety and efficacy" (or substantial equivalence) often comes from bench testing, material conformity, and adherence to recognized standards, rather than clinical trials with patient test sets.

• Sample Size for Test Set: Not explicitly stated in terms of a "test set" from a patient population. The safety and efficacy information presented is based on material composition, manufacturing processes, sterilization validation, and comparison to predicate devices. Performance is assessed against industry standards and the characteristics of existing devices.
• Data Provenance: The data provenance is primarily from bench testing, material certifications, and regulatory standards compliance documents. This type of data is generated during the manufacturing and quality assurance processes, not typically from a clinical patient population. The country of origin for manufacturing is Germany (HENKE-SASS, WOLF GmbH, D-78532 Tuttlingen Germany). The data is retrospective in the sense that it refers to established manufacturing practices, material specifications, and standardized testing procedures, rather than a prospective clinical trial.

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

Given the nature of a 510(k) for a hypodermic needle, "ground truth" is established through:

• Material Science Experts: To certify the quality and properties of the stainless steel (ISO 5832/1 and ASTM 899) and plastics.
• Sterilization Experts: To validate the ethylene oxide sterilization process against ISO 11135-1194 and EN 550.
• Quality Management/Regulatory Experts: To ensure compliance with cGMP, ISO 9001/EN 46001, AAMI, and ASTM standards.

The specific "number of experts" and their detailed qualifications (e.g., "radiologist with 10 years of experience") are not provided nor typically required for this type of 510(k) submission. Instead, the submission relies on the certification of the manufacturing facility (ISO Approved Facility) and adherence to international standards, which implicitly involve expert-validated methodologies and practices.

4. Adjudication Method for the Test Set

Adjudication methods like 2+1 or 3+1 are typical for studies involving human interpretation (e.g., medical imaging) to resolve discrepancies in expert opinions. For this device, which relies on physical characteristics and performance against objective standards:

• Adjudication Method: None in the context of expert review of subjective data.
• Instead, performance is determined by objective measurements, material specifications, and validation reports (e.g., sterilization cycle reports, material certificates of conformity) that meet predefined quantitative and qualitative standards. Deviations from these standards would constitute a failure to meet acceptance criteria, not a matter for expert adjudication.

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

• MRMC Study: No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is designed for evaluating diagnostic devices where human readers interpret medical data, often with and without AI assistance. This type of study is not applicable to a basic medical device like a hypodermic needle.
• The device's effectiveness is established by its functional equivalence to predicate devices and compliance with safety and performance standards relevant to its physical properties and intended use.

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

• Standalone Performance Study: Not applicable in the context of an algorithm.
• For a hypodermic needle, the "standalone performance" refers to the device's ability to function as intended (injecting/withdrawing fluids) and its associated safety aspects (sterility, material integrity, sharpness, break resistance, etc.). These performances are assessed through bench testing and compliance with specific ASTM/ISO standards relevant to needles, ensuring that the device itself performs its mechanical and biological functions without requiring human "interpretation" of data generated by the device itself.

7. The Type of Ground Truth Used

The "ground truth" for a device like a hypodermic needle is based on:

• Objective Standards and Specifications: Adherence to defined material compositions (e.g., AISI SUS 304, ISO 5832/1, ASTM 899 for stainless steel), manufacturing tolerances, and physical properties (e.g., needle sharpness, hub attachment strength).
• Validated Processes: Successful validation of sterilization processes according to ISO 11135-1194 and EN 550.
• Functional Equivalence: Confirmation that the device's operating principles and intended uses are the same as legally marketed predicate devices, implying comparable safety and efficacy profiles that have been historically accepted.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device does not involve an AI algorithm or machine learning components that require a "training set" of data.

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

• Training Set Ground Truth: Not applicable. As there is no AI/ML component, there's no training set or associated ground truth for a training set.

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