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The Insulin Pen Needle is intended for use with pen injector devices for the subcutaneous injection of insulin.

The proposed device, Insulin Pen Needle, is a single-use device, which is designed for use with a pen injector for the subcutaneous injection of insulin. It consists of needle tube, hub, tube sheath and sealed paper. The hub can be connected screwed onto the insulin pen. The Insulin Pen Needle is offered in various gauge sized and length. They are provided sterilized with Sterility Assurance Level (SAL) of 10-6.

The provided text describes a 510(k) summary for an Insulin Pen Needle, focusing on its substantial equivalence to a predicate device rather than a study proving performance against specific acceptance criteria. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed device, primarily through non-clinical testing and comparison to existing standards.

Therefore, many of the requested elements for describing an acceptance criteria study (such as sample sizes for test sets, expert-established ground truth, adjudication methods, MRMC studies, and standalone performance) are not applicable or detailed in this document.

Here's an breakdown based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance results in the typical sense of a clinical or performance study. Instead, it states that the device 'complies with' various ISO and ASTM standards, which inherently define performance requirements. The performance specification for the proposed device is listed as "Comply with ISO 7864, ISO 9626, and ISO 11608-2."

Implicit Acceptance Criteria and Reported Performance (derived from compliance with standards and comparison table):

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

The document indicates "Non clinical tests were conducted to verify that the proposed device met all design specifications," but it does not specify the sample sizes used for these tests. The data provenance is not explicitly stated in terms of country of origin for specific test results, but the sponsor is located in China. The tests are non-clinical (laboratory-based) rather than retrospective or prospective human clinical data.

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

Not applicable. This document describes non-clinical performance testing against established engineering standards (ISO, ASTM, USP). There is no "ground truth" in the clinical sense established by human experts for a test set. The standards themselves define the "ground truth" for performance.

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

Not applicable. As the tests are non-clinical, there is no need for expert 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 is a medical device (Insulin Pen Needle), not an AI-powered diagnostic or interpretive system. Therefore, an MRMC study related to AI assistance is not 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. There is no "algorithm only" performance to evaluate.

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

For the non-clinical tests described, the "ground truth" is defined by the specifications and requirements set forth in the referenced international standards (ISO 7864, ISO 9626, ISO 11608-2, ISO 10993-7, ASTM F88/F88M-09, ISO 11737-2, USP 35-NF30:2012). The device's performance is compared against these engineering and manufacturing benchmarks.

8. The sample size for the training set

Not applicable. This pertains to non-clinical device testing and manufacturing compliance, not a machine learning model that requires a training set.

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

Not applicable. There is no training set mentioned in the context of this device submission.

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Disposable insulin syringe is a device intended for medical purpose for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin.

Disposable insulin syringe is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin.

The proposed device of Disposable Insulin Syringe is a syringe with needle, consisting of a calibrated hollow barrel, a movable plunger, the needle cover and end cap. The needle is fixed on the syringe. The syringe is designed for manual use.

The proposed device of Disposable Insulin Syringe is available in 0.3ml (U-100), 0.5ml (U-40, U-100), 1ml (U-40, U-100) volumes.

The proposed device is provided sterilized.

The provided document describes a 510(k) premarket notification for a Disposable Insulin Syringe (K110421). This is a medical device and not an AI/ML software device, therefore, many of the requested criteria (like ground truth, expert adjudication, MRMC studies, standalone performance, training sets, etc.) are not applicable.

The acceptance criteria and the study that proves the device meets them are based on bench tests against established international standards for such devices.

Here's a breakdown of the requested information, adapted for a medical device rather than an AI/ML product:

Acceptance Criteria and Device Performance for Disposable Insulin Syringe (K110421)

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample sizes used for the bench tests. It refers generally to "Bench tests." As this is a physical medical device, not an AI model, "data provenance" in the typical AI sense (country of origin, retrospective/prospective) is not directly applicable. The "tests" are likely physical tests conducted on a sufficient number of manufactured units to ensure compliance with the specified ISO standards.

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

This is Not Applicable (N/A). For medical devices like insulin syringes, "ground truth" is established through adherence to internationally recognized performance and safety standards (e.g., ISO standards) and regulatory requirements, not through expert consensus on medical images or patient outcomes. The "experts" involved are typically engineers, quality assurance personnel, and regulatory specialists who interpret and apply these standards.

4. Adjudication Method for the Test Set:

This is Not Applicable (N/A). Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation or subjective assessments, typically for AI/ML performance evaluation. For bench testing of a physical medical device, the results are objective measurements against defined criteria in the standards.

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

No, an MRMC comparative effectiveness study was Not Applicable (N/A). This type of study is relevant for evaluating the impact of an AI diagnostic aid on human reader performance, which is not the nature of this physical medical device.

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

No, a standalone study was Not Applicable (N/A). This concept applies to AI algorithms. The "standalone performance" of this device is its ability to meet the physical and functional requirements of the ISO standards when tested in a laboratory setting.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance is defined by the specifications within the cited ISO international standards (ISO 8537:2007, ISO 9626:1991/Amendment 1:2001, ISO 7864:1993). These standards define physical properties, dimensional tolerances, material requirements, sterility, and functional performance (e.g., fluid delivery accuracy, needle sharpness, leak-proof integrity). Compliance with these standards serves as the "ground truth" for device safety and effectiveness.

8. The Sample Size for the Training Set:

This is Not Applicable (N/A). This device is a physical product, not an AI model requiring a training set.

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

This is Not Applicable (N/A). As there is no training set for a physical medical device like this, no ground truth needed to be established for it.

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