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Top Fine® Pen Needle is intended for use with pen injector device for the subcutaneous injection of insulin.

Top Fine® 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 various gauge sizes (29G, 30G, 31G, 32G, 33G and 34G) and lengths (4mm, 5mm, 6mm, 8mm, 12mm). Top Fine® Pen Needles are sterile (EO gas sterilization), non-toxic and non-pyrogenic.

Top Fine® Pen Needle assembly consists of hub, needle cap, sterile cap and sterile paper.

The document provided describes the Top Fine® Pen Needle and its equivalence to a predicate device (Feel Fine Insulin Pen Needle). The acceptance criteria are based on bench testing to demonstrate equivalent performance to the predicate device.

Here's a breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance

Notes:

• The document explicitly states that the "principal device demonstrated equivalent performance to the predicate devices during bench testing" and that "The bench tests of Needles with 32G, 33G, 34G demonstrated conformances to ISO 11608-2 and ISO 7864." The general conclusion statement also implies compliance for other aspects.
• For several criteria, specific numerical acceptance limits are not provided in the document, but compliance with the standards (ISO 11608-2, ISO 7864, ISO 11135, USP 39, KP 11) serves as the acceptance criteria.

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

• Sample size for the test set: The document does not specify the exact sample sizes for each bench test conducted. It generally refers to "bench tests" being conducted.
• Data provenance: The tests were conducted by MedExel Co., Ltd. in Korea (company address listed as "252, Geumgwangosan-ro, Geumgwang-myeon, Anseong-si, Gyeonggi-do, Korea"). The nature of bench testing implies the data would be prospective for the device being tested.

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

Not applicable. The "ground truth" for a medical device like a pen needle typically refers to its physical and functional performance against established engineering and medical standards, not expert opinions or diagnoses. The "bench tests" are designed to objectively measure these parameters.

4. Adjudication method for the test set

Not applicable. As described above, the evaluation relies on objective measurements against engineering and medical standards, not subjective expert judgment requiring 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

Not applicable. This device is a hypodermic single lumen needle, not an AI-powered diagnostic tool. Therefore, MRMC effectiveness studies with human readers and AI assistance are not relevant to its evaluation.

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

Not applicable. This device is a physical medical instrument, not an algorithm. Its performance is evaluated through physical and functional bench tests.

7. The type of ground truth used

The ground truth used is based on established engineering and medical device standards and objective physical and functional performance measurements. Specifically, the document mentions:

• ISO 11608-2:2012 (Needle systems for medical use - Part 2: Needles for pen injectors)
• ISO 7864:1993 (Sterile hypodermic needles for single use)
• ISO 11135: 2007 (Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices)
• USP 39: Bacterial Endotoxin test
• KP 11: Endotoxin Test Method

8. The sample size for the training set

Not applicable. This device is a physical medical instrument, not an AI model requiring 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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The Top Fine® disposable sterile insulin pen needles are intended for subcutaneous injection of insulin in the treatment of diabetes.

Top Fine® insulin pen needle consists of a sterile cap, a needle cap, and a needle hub which holds the needle. Blister papers the cap. The sterile cap maintains sterility the 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 screwed onto the pen. The needle cap cover is intended to provide physical protection to the needle tube. The device is for single patient single time use. The pens come in three sizes, 29 gauge, 30 gauge, and 31 gauge. They are ETO sterilized, non toxic and nonpyrogenic.

The provided text is a 510(k) summary for the Top Fine® Insulin Pen. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a comprehensive study report for novel performance. As such, some of the requested information (e.g., specific performance metrics, sample sizes for training/test sets, expert details for ground truth) is not explicitly present in the document.

However, based on the available information, here's an attempt to structure the response:

Device: Top Fine® Insulin Pen (Insulin syringe)

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: The document does not specify the exact sample size for the bench or clinical tests. It generally states that "Both bench and clinical tests were performed."
• Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. Given the manufacturer is based in Korea, it's plausible the studies were conducted there, but this is not confirmed.

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

• The document does not provide details on the number of experts or their qualifications used to establish ground truth. The evaluation likely relied on standard industry practices and regulatory guidelines for medical device testing.

4. Adjudication Method for the Test Set

• The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none). The "satisfactory" outcomes imply a straightforward assessment against pre-defined benchmarks, usually without complex expert adjudication in this type of submission.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging or interpretative AI systems, which is not applicable to an insulin pen needle. The comparison was primarily for substantial equivalence of physical and functional characteristics against predicate devices.

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

• This question is not applicable. The device is a physical medical device (insulin pen needle), not an algorithm or AI system. Its performance is evaluated through physical and biological testing, not computational analysis.

7. The Type of Ground Truth Used

• For this type of device, "ground truth" would be established by:
  • Validated laboratory methods: For biocompatibility (e.g., ISO standards), sterility (e.g., USP methods), and EO residue testing.
  • Mechanical testing standards: For needle integrity, strength, and flow rates.
  • Clinical observation and qualitative assessment: For adequacy of instructions for use, patient population range, and general reliability in a clinical setting (though the extent of "clinical testing" here appears to be focused on usage and general performance rather than specific clinical outcomes).
  • Comparison to predicate devices: The "ground truth" for substantial equivalence is often the performance profile of the legally marketed predicate devices.

8. The Sample Size for the Training Set

• This question is not applicable. The device is a physical medical device, not an AI/ML algorithm that requires a "training set."

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

• This question is not applicable, as there is no "training set" for this type of device.

Summary of the Study:

The study described is a submission for substantial equivalence for the Top Fine® Insulin Pen needles to existing legally marketed predicate devices (B.Braun "one.click™ needle", Terumo® Micro tapered Pen Needle, BD Pen Needles).

The study involved:

• Bench testing: Covered biocompatibility, mechanical testing, sterility testing (including EO residues).
• Clinical testing: Focused on determining the adequacy of instructions for use, the range of patient population, general performance characteristics, and reliability.

The results of both bench and clinical tests were reported as "satisfactory" and indicated "no concerns over safety and effectiveness as compared to predicate devices." The conclusion was that the device is "as safe, as effective, and performs in a substantially equivalent manner to the predicate device."

It is important to note that a 510(k) summary provides a high-level overview and does not typically delve into the granular details of study protocols, specific performance metrics with numerical thresholds, or detailed statistical analysis that would be found in a full study report or PMA submission.

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For the subcutaneous injection of insulin.

The Top Fine® disposable sterile insulin syringes are intended for subcutaneous injection of insulin.

Top Fine® insulin syringe consists of a calibrated hollow barrel which can contain the medication and the distal end of barrel is fixed with needle . The needle cannot be exchanged after assembling because needle is fixed in the barrel nozzle lumen. The plunger and gasket are the same shape as the conventional insulin syringes. The needle cap cover is intended to provide physical protection to the needle tube. The cap is color coded orange, same as equivalent insulin syringes. The syringes are available in 0.3 ml/cc, 0.5 ml/cc and 1 ml/cc sizes. They are supplied with a sterile fluid path, (EO), non-toxic, and non pyrogenic, for single use only, disposable. Rx only. The devices operate on the principles of common piston syringes.

The provided text describes the 510(k) summary for the "Top Fine® Insulin Syringe" (K063348), comparing it to a predicate device (BD Insulin Syringe K024112). It focuses on demonstrating substantial equivalence rather than presenting detailed acceptance criteria and a specific study proving the device meets them quantitatively in the way one might expect for a complex AI/software device.

However, based on the provided text, I can infer the "acceptance criteria" were related to safety and effectiveness, and the general "study" information is about these aspects.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions "bench and clinical tests were performed," but does not specify the sample sizes for either the bench or clinical tests. The data provenance (country of origin, retrospective/prospective) is also not mentioned.

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

This information is not provided in the document. For a physical device like an insulin syringe, "ground truth" is typically established through direct measurements, laboratory assays, and user performance observations rather than expert review of data.

4. Adjudication Method for the Test Set

This information is not provided as it's not relevant for this type of device and testing.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or AI interpretation devices, not for a physical medical device like an insulin syringe. The "clinical testing" mentioned was likely focused on user experience and function.

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

No, this is not applicable to an insulin syringe, which is a physical device, not an algorithm.

7. The Type of Ground Truth Used

For the bench tests, the "ground truth" would have been established by standardized laboratory measurement methods and industry standards for biocompatibility, mechanical properties (e.g., fluid delivery accuracy, needle integrity, plunger force), and sterility.

For the clinical tests (focusing on "adequacy of instructions for use, the range of patient population, performance characteristics, and reliability"), the "ground truth" would likely be based on direct observation of use, user feedback, and comparison to predefined performance metrics.

8. The Sample Size for the Training Set

This concept is not applicable as this is a physical medical device, not an AI/software device that would have a "training set."

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

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

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