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SureFine Pen Needle is intended for use with a pen injector for the subcutaneous injection of insulin.

SureFine Pen Needle is 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 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.

SureFine Pen Needle is offered in 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 SureFine Pen Needle device, K250658, is a Class II hypodermic single lumen needle intended for use with a pen injector for the subcutaneous injection of insulin. The information provided is from an FDA 510(k) Clearance Letter.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the SureFine Pen Needle are based on compliance with international standards ISO 9626, ISO 11608-2, and ISO 10993-1, 10993-4, 10993-5, 10993-7, 10993-10, and 10993-11 for biocompatibility and sterilization validation according to ISO 11135.

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

The document does not explicitly state the specific sample sizes for each test mentioned (ISO 9626, ISO 11608-2, Biocompatibility). However, it indicates that "Bench tests for the device's performance were conducted" and "Biocompatibility of the SureFine Pen Needle was evaluated". The testing was conducted by Shina Med Corporation, a company based in the Republic of Korea. The nature of these tests (bench testing, lab-based biocompatibility) suggests they are prospective tests performed on manufactured samples of the device. The data provenance is primarily from internal testing and validation by the manufacturer, following international standards.

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

The document does not specify the number or qualifications of experts used to establish ground truth for the "test set" in the context of device performance. The testing performed is against established international standards (ISO 9626, ISO 11608-2, ISO 10993 series), which themselves represent a form of "ground truth" for device safety and performance criteria. The evaluation results are reported as "Pass" or "Met," implying adherence to these predefined standards rather than an expert panel establishing a de novo ground truth for each specific test.

4. Adjudication Method for the Test Set

No information is provided regarding an adjudication method (such as 2+1, 3+1, none). The evaluation is based on objective measurements and established criteria set forth by the ISO standards. For instance, a flow rate test would have a pass/fail threshold, not require expert adjudication in the traditional sense.

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

No. The document describes bench tests and biocompatibility evaluations for a medical device (pen needle), not a diagnostic or AI-assisted system that would typically undergo an MRMC comparative effectiveness study involving human readers. Therefore, there is no mention of an effect size of human readers improving with or without AI assistance.

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

No. This device is a physical medical instrument (a pen needle), not a software algorithm or AI system. Therefore, the concept of "standalone performance" in the context of algorithms is not applicable here.

7. The Type of Ground Truth Used

The ground truth used for demonstrating the device's performance is adherence to established international standards and regulatory requirements:

• ISO 9626: Specifies requirements for stainless steel needle tubing for the manufacture of hypodermic needles.
• ISO 11608-2: Specifies requirements and test methods for single-use needles used with pen-injectors.
• ISO 10993 series: Biological evaluation of medical devices, covering various aspects of biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity, hemocompatibility, pyrogenicity).
• ISO 11135: Specifies requirements for the development, validation, and routine control of an ethylene oxide sterilization process for medical devices.
• ISO 10993-7: EtO residual limits.
• LAL testing: To ensure absence of bacterial endotoxins.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning or AI algorithm, so there is no "training set."

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

Not applicable, as there is no training set for a physical medical device.

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SureFine Pen Needle is intended for use with a pen injector for the subcutaneous injection of insulin.

The SureFine Pen Needle is 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 of the needle because primary container covers the hub and the needle tube with blister paper sealed on the opening hole of primary container.

The needle hub can be connected with the pen. The hub has internal threads, which allows it to be screwed onto the pen. The needle shield is intended to provide physical protection to the needle tube.

The SureFine Pen Needle is offered in various gauges sizes (29G, 30G, 32G) and Lengths (4mm, 6mm, 8mm, 12.7mm). These are sterile (Eo gas sterilization) and non-pyrogenic. The pen needles are disposable, single use devices.

The provided document is a 510(k) premarket notification for the SureFine Pen Needle, a medical device. It does not describe a study proving the device meets acceptance criteria but rather demonstrates substantial equivalence to a predicate device.

Here's an analysis of the provided information in the context of your request:

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

The document provides a comparative table between the SureFine Pen Needle (Subject Device) and its predicate device (ShinaPen® K113186). The acceptance criteria are implied by the performance specifications of the predicate device, and the "reported device performance" is essentially the subject device's matching of these characteristics.

Beyond this comparative table, the document states that the SureFine Pen Needle was "designed and successfully tested to meet the applicable requirements outlined in ISO 7864:1993, ISO 9626:1991 and ISO 11608-2:2012." The specific clauses listed for each ISO standard represent the acceptance criteria for those performance aspects.

For example, for ISO 7864:1993, acceptance criteria would be:

• Clause 4: Cleanliness requirements met.
• Clause 5: Limits for acidity or alkalinity met.
• Clause 6: Limits for extractable metals met.
• Clause 7: Size designation accurate.
• Clause 11.3: Freedom from defects.
• Clause 11.4: Lubricant requirements met.
• Clause 12: Needle point specifications met.
• Clause 13.1: Bond between hub and needle tube specifications met.
• Clause 13.2 a): Patency of lumen demonstrated.

Similar detailed acceptance criteria are implied for the other ISO standards and biocompatibility tests mentioned.

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 broadly mentions "Performance Testing", "Biocompatibility Testing", and "Sterilization and Shelf-life Testing" without specifying the exact sample sizes for each test. These were non-clinical tests.

• Test Type: Non-clinical (bench testing, biocompatibility, sterilization validation).
• Data Provenance: The manufacturer is SHINA MED CORPORATION, located in the Republic of Korea. The testing was conducted to international standards (ISO).
• Retrospective/Prospective: These are prospective tests on the SureFine Pen Needle device design.

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 information is not applicable/provided in the context of this 510(k) submission. This type of submission relies on non-clinical performance and substantial equivalence to a predicate device, not expert-derived ground truth as would be relevant for diagnostic AI/imaging devices. The "ground truth" here is the adherence to established engineering standards (ISO) and the characteristics of the predicate device.

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

This information is not applicable/provided. Adjudication methods are typically used in clinical studies, particularly for diagnostic devices where multiple readers interpret images or data, and discrepancies need resolution. This document describes bench testing and demonstrates substantial equivalence, not clinical evaluation with human readers.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices, which is not what the SureFine Pen Needle is. The document explicitly states: "No prospective clinical trials were conducted in support of this Traditional 510(k)."

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

A standalone performance evaluation was done in the sense that the device itself (the pen needle) was tested against technical specifications and international standards (ISO). However, this is not an "algorithm-only" standalone performance study as described for AI devices. The device's performance was evaluated inherently by its physical and material properties and its function when used with compatible pen injectors.

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

The "ground truth" for this device's evaluation is primarily engineering specifications, material science standards, and established international performance standards (ISO standards). For biocompatibility, the ground truth is defined by the results of specific biological evaluations (e.g., cytotoxicity, irritation, sensitization, systemic toxicity, pyrogenicity tests). For functional compatibility, the ground truth is simply successful operation with specified insulin injectors.

8. The sample size for the training set

This information is not applicable/provided. The SureFine Pen Needle is a mechanical medical device, not an AI or machine learning model. Therefore, there is no "training set" in the context of machine learning.

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

This information is not applicable/provided. As explained above, there is no training set.

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