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The product is intended for subcutaneous injection of U-40 insulin in the treatment of diabetes.
The product is intended for subcutaneous injection of U-40 and U-100 insulin in the treatment of diabetes.

The Disposable Insulin Syringe is designed for subcutaneous injection of a desired dose of U-100 and U-40 insulin and has capacity of 0.3mL, 0.5mL, and 1.0mL. The product is a single use, sterile, non-toxic, non-pyrogenic, disposable syringe that consists of a needle, barrel, needle cap, plunger, piston, and plunger cap(only type A). The needle is a single ended lubricated stainless-steel cannula. The needle is covered by a polypropylene needle cap which is placed on the barrel. The barrel is molded from polypropylene with the exterior permanently marked with the proper scale markings. The piston is attached to the plunger and a Polypropylene plunger cap is placed over the plunger rod(only type A). All products are EO sterilized. The subject device operates on the principle of a piston syringe and has a shelf life of 5 years.

The provided submission is for a medical device (Disposable Insulin Syringe), not an AI/ML powered device. Therefore, a table of acceptance criteria and the study that proves the device meets the acceptance criteria in the context of AI/ML is not applicable. The information requested (multi reader multi case study, standalone performance, ground truth establishment, training set sample size, etc.) pertains to AI/ML device evaluations and cannot be extracted from this document, which describes the testing and comparison of a traditional medical device against a predicate device.

The document discusses various performance data, including biocompatibility, sterilization, shelf life, and physical performance testing according to ISO and ASTM standards. These tests demonstrate the device's safety and effectiveness as a disposable insulin syringe, but not as an AI/ML system.

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The disposable insulin syringe is intended for medical purposes for the manual aspiration of U-100 insulin, and for the injection of insulin into parts of the body below the surface skin.

The proposed device is a syringe with fixed needle tube which is intended for injection the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin. The insulin is injected to subcutaneous tissue by pushing force generated through pushing plunger rod of the insulin syringe. The proposed devices are provided sterile, single use.

The proposed device is available in 0.3ml, 0.5ml and 1ml volumes.

This document describes the premarket notification (510(k)) for the Disposable Insulin Syringe (K162180) by Berpu Medical Technology Co., Ltd. The submission aims to demonstrate substantial equivalence to a predicate device (K072739).

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The device performance is demonstrated by compliance with various international standards for medical devices and specific tests. The table below summarizes these, acting as both acceptance criteria and reported performance (as the tests were performed to verify compliance).

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

The document does not specify the exact sample sizes for each of the physical, mechanical, chemical, packaging, sterilization, or biocompatibility tests. It broadly states that "Non clinical tests were conducted to verify that the proposed device met all design specifications." The data provenance is implied to be from internal testing conducted by Berpu Medical Technology Co., Ltd in China, as they are the sponsor. The studies are prospective in the sense that they are conducted on the device being submitted for approval.

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

This information is not provided. The ground truth for these types of device performance tests is typically established by compliance with international standards and validated testing methodologies, rather than expert consensus on individual cases.

4. Adjudication method for the test set

This information is not provided, as the studies are device performance tests against pre-defined standards, not typically involving adjudication of subjective outcomes by experts.

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

A MRMC comparative effectiveness study was not done. This device is a disposable insulin syringe, not an AI-powered diagnostic or assistive tool for human readers.

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

This is not applicable to a disposable insulin syringe, which is a physical medical device and not an algorithm. Therefore, no standalone algorithm performance study was conducted.

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

The ground truth for the performance of the Disposable Insulin Syringe is largely based on compliance with established international and national standards (ISO 9626, ISO 7864, ISO 8537, ISO 11135, ISO 10993-7, ISO 10993-11, USP 38-NF 33 <85>, ASTM F88/F88-09, ASTM F1140/F1140M-13, ASTM F1929-12). These standards define acceptable ranges, limits, and methodologies for evaluating the physical, mechanical, chemical, and sterility properties of such devices.

8. The sample size for the training set

This is not applicable. The device is a physical medical instrument, not an AI model, and therefore does not have a "training set" in the context of machine learning.

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

This is not applicable, as there is no training set for this device.

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The disposable insulin syringe is 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 Disposable Insulin Syringes are provided sterile, single use.

For the Disposable Insulin Syringes, they consist of six components: (1) orange needle cap (2) needle (3) piston (4) plunger (5) barrel (6) orange protective end cap. The materials for all components are listed in Table 1 Component material list.

The Disposable Insulin Syringes are available in different combination of syringe volumes and needle sizes. The range of syringe volume, needle gauge and needle length are listed in Table 2 syringe and needle specification.

This document describes the premarket notification for a Disposable Insulin Syringe (K151949). It does not contain information about an AI/ML powered device. Instead, it details the substantial equivalence to a predicate device, focusing on non-clinical performance and biocompatibility.

Therefore, many of the requested categories for AI/ML device studies are not applicable. I will extract the relevant information for the device's acceptance criteria and the studies conducted to meet them.

Here's the breakdown of the information that can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated for each test. The document generally refers to "non clinical tests" being conducted.
• Data Provenance: The device manufacturer is Jiangyin Caina Technology Company Incorporated, located in Jiangyin, Jiangsu, China. The testing was conducted as part of their submission without specifying the exact location of the testing laboratories, but it would presumably be in China or by accredited labs. The data is retrospective in the sense that it's submitted to demonstrate compliance for a device manufactured by the company.

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

• Not Applicable: This is a submission for a non-AI/ML medical device. "Ground truth" in the context of expert consensus is not relevant here. Compliance is assessed against established international and ASTM standards for physical, chemical, and biological properties.

4. Adjudication Method for the Test Set

• Not Applicable: As this is not an AI/ML diagnostic or image interpretation device, adjudication methods by experts are not relevant. Compliance is measured against objective standards.

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 disposable insulin syringe, not an AI/ML powered diagnostic or clinical support tool.

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

• Not Applicable: This device is not an algorithm.

7. The Type of Ground Truth Used

• Standards-based Compliance: The "ground truth" for this device's performance is adherence to recognized international and national standards (ISO, ASTM, USP) for medical devices. For biocompatibility, reliance was also placed on prior clearance (K113091) for materials with the same intended use.

8. The Sample Size for the Training Set

• Not Applicable: This device does not involve a "training set" in the context of AI/ML. Manufacturing processes are validated through established quality control and testing protocols.

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

• Not Applicable: Not an AI/ML device.

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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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