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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 Sterile Hypodermic Syringe for Single Use with/without need for medical purposes to inject fluid into or withdraw fluid from body.

The sterile insulin syringe for single use with needle, with the callbration unit of insulin for U-100, 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 sterile insulin syringe for single use with needle, with the callbration unit of insulin for U-40 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 Sterile Hypodermic Needle for single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.

• Disposable Sterile Syringe, with/without needle; luer/luer-lock: Piston, Plunger, Barrel. EO Sterilized. Prescription use. Single use. The plunger of syringe can be pulled and pushed along inside the barrel, allowing the syringe to take in and expel the fluids through the connector to the patient. Length 83-152mm, Diameter 50-31mm, Tip type luer/luer-lock, Needle tip configuration long bevel angle, Nozzle type Luer / Lock, 6% conical, 1,2 mm, Barrel marking specs 0.01ml-0.5ml, Graduation legibility Legible, Needle cover color Transparent, Lubricant composition Dimethicone, Barrel transparency Transparent/ UV resistant, Needle cover strength 15N (min. 2N max. 15N), Hub/needle bond strength min. 22-69 N. Complied with ISO 7886-1, ISO 7864, ISO 9626. Volume 1mL, 2mL, 2.5mL, 3mL, 5mL, 10mL, 20mL, 25mL, 30mL, 50mL. Sizes 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G. Needle Lengths 13-38 mm. Piston material Isoprene Rubber, Barrel material PP, Plunger material PP, Needle material PP, SUS304. SAL 10-6. Endotoxin Limit 20 EU per device. Biocompatibility Complied with ISO 10993-4/5/10/11 (Cytotoxicity, Irritation, Sensitization Acute Systemic Toxicity, Hemolytical effect).

• Sterile Insulin Syringe for Single use, with needle: Needle Cap, Needle, Piston, Plunger, Barrel, End Cap. EO Sterilized. Prescription use. Single use. The plunger of syringe can be pulled and pushed along inside the barrel, allowing the syringe to take in and expel the fluids through the connector to the patient. Complied with ISO 8537. Volume 0.5ml, 1ml volumes with fixed needle. Needle Lengths 8mm. Piston material Isoprene Rubber, Barrel material PP, Plunger material PP, Needle material SUS304, Needle Cap material PE, End Cap material PE. SAL 10-6. Endotoxin Limit 20 EU per device. Biocompatibility ISO 10993-4/5/10/11 (Cytotoxicity, Irritation, Sensitization Acute Systemic Toxicity, Subchronic Toxicity, Hemolytical effect).

• Sterile Hypodermic needle for Single use: Protective cap, Needle, Adhesives, Needle hub. EO Sterilized. Prescription use. Medical professionals and trained care givers. Protective cap, Needle, Adhesives, Needle hub. Single use. For Manual Use Only, For Single Use only. Complied with: ISO 7864, ISO 9626. Sizes 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 30G. Needle Lengths 13-38 mm. Protective cap materials PP, Adhesive Epoxy resin, Needle Hub materials PP, Needle material SUS304. SAL 10-6. Endotoxin Limit 20 EU per device. Biocompatibility Complied with ISO 10993-4/5/10/11 (Cytotoxicity, Irritation, Sensitization Acute Systemic Toxicity, Hemolytical effect).

The provided text is a 510(k) summary for medical devices (syringes and needles). It does not describe a study involving an AI model or a device that uses AI. Instead, it focuses on demonstrating substantial equivalence of the submitted devices to a predicate device through performance testing against established international standards for medical devices.

Therefore, the requested information regarding acceptance criteria and a study proving an AI device meets those criteria cannot be extracted from this document. The document primarily details the physical and performance specifications of the syringes and needles themselves.

To directly answer your request based on the provided document, I must state that the information related to AI model acceptance criteria, test sets, ground truth establishment, expert adjudication, MRMC studies, and training set details are not present in the provided text. The document describes a traditional medical device submission, not an AI/ML-enabled medical device.

However, I can extract the acceptance criteria and performance data for the physical medical devices described:

Acceptance Criteria and Device Performance for Physical Medical Devices

The acceptance criteria for these devices are defined by compliance with a series of international ISO standards and USP guidelines. The "device performance" is reported as having "complied with" these standards. No specific quantitative performance metrics (e.g., accuracy, precision, etc.) are provided in a numerical table format for an AI algorithm, as this is not an AI device.

Table of Acceptance Criteria and Reported Device Performance

Regarding an AI-enabled device and its study, the following information is NOT available in the provided document:

• 1. Table of acceptance criteria and reported device performance for an AI model: Not applicable, as this is not an AI device.
• 2. Sample size used for the test set and data provenance: No test set for an AI model is mentioned. The performance testing refers to physical tests on the medical devices themselves.
• 3. Number of experts used to establish ground truth & qualifications: Not applicable for an AI model's ground truth. The ground truth for the physical devices' performance is established by the specifications and test methods within the referenced ISO standards.
• 4. Adjudication method for the test set: Not applicable.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done: "No prospective clinical trials were conducted in support of this 510(K)."
• 6. If a standalone (algorithm only) performance was done: Not applicable, as there is no algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the physical devices, the "ground truth" is adherence to established engineering and material standards for safety and performance (e.g., fluid aspiration/injection, material biocompatibility, sterility).
• 8. The sample size for the training set: Not applicable, as there is no AI model.
• 9. How the ground truth for the training set was established: Not applicable, as there is no AI model.

In summary, the provided document details a 510(k) submission for conventional medical devices (syringes and needles) and their compliance with relevant international standards, not an AI-enabled medical device. Therefore, the specific criteria requested for AI devices are not found within this text.

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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 , 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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Safelock Disposable Insulin Syringe is intended to inject U-100 insulin into the human body and aid in the prevention of accidental needle stick injuries.

Safelock Disposable Insulin Syringes are provided sterile, single use, which consist of five pieces components: (1) a syringe barrel calibrated in units of insulin (U-100) with a permanently attached single lumen needle on it, (2) a needle cap, (3) plunger and (4) protective end cap and (5) an additional safety mechanism installed at the needle end of the syringe. The devices are available in different combination of syringe volumes and needle sizes.

Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them, structured as requested:

Device: Safelock Disposable Insulin Syringe

1. Table of Acceptance Criteria and Reported Device Performance

The provided summary details various non-clinical tests performed according to recognized ISO and ASTM standards. The reported performance is generally stated as "met all design specifications" or "met the pre-established criteria." Specific quantitative acceptance criteria or performance metrics are largely absent from this summary but are implied by adherence to the referenced standards.

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

The provided text does not specify the sample size for any of the non-clinical tests (e.g., number of syringes tested for each ISO standard criterion, number of packages for ASTM, number of devices for safety feature testing).

The provenance of the data is that it was generated through non-clinical bench testing performed by the manufacturer, Jiangyin Caina Technology Co., Ltd. (located in China). The summary reports on tests performed on the "proposed device." It does not indicate retrospective or prospective in the typical sense of clinical studies, as these are lab-based evaluations.

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

This section is not applicable as the evaluation relies on direct measurement and adherence to objective standards (ISO, ASTM, USP) rather than expert interpretation of a ground truth in a clinical or image-based context. The "ground truth" is defined by the parameters and limits set forth in the referenced standards.

4. Adjudication Method for the Test Set

This section is not applicable. The tests are objective measurements against established standard criteria, not subjective assessments requiring adjudication among multiple reviewers.

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

This is not applicable as the device is a medical syringe with a safety feature, not an AI-powered diagnostic or assistive technology for human readers. There is no mention of AI in this submission.

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

This is not applicable for the same reason as point 5. The device does not involve an algorithm.

7. The Type of Ground Truth Used

The ground truth for most tests is based on objective, internationally recognized performance standards (ISO, ASTM, USP) which define acceptable limits for physical, mechanical, chemical, and sterility properties. For the simulated clinical study and safety feature testing, the "ground truth" was derived from "pre-established criteria" and FDA guidance for sharps injury prevention devices, which likely includes defined force thresholds or functional performance checks.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical medical device and does not involve AI or machine learning models that require a training set.

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

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

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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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The STERIPACK Sterile Disposable Syringe is intended to be used for injecting fluids into, or withdraw fluids from, the body. The STERIPACK Sterile Disposable Insulin Syringe is intended to be used for the subcutaneous injection of insulin.

The STERIPACK Sterile Disposable Syringe, with or without a hypodermic needle, is a sterile, single use, piston syringe, designed for manual use. The STERIPACK Sterile Disposable Syringe is available in 3, 5, 10 and 50 ml volume sizes with luer lock, slip tip, and eccentric configurations.

The STERIPACK Sterile Disposable Insulin Syringe with permanently affixed hypodermic needle, is a sterile, single use, insulin syringe, designed for manual use. The STERIPACK Sterile Disposable Insulin Syringe is available in 0.5 and 1.0 ml volume sizes, color coded with markings for delivery of 100 units of insulin/ml (U-100).

The provided text describes the STERIPACK™ Sterile Disposable Syringes and STERIPACK™ Sterile Disposable Insulin Syringes. This device is a medical device, and the information given is part of a 510(k) summary for premarket notification to the FDA. Such submissions typically focus on demonstrating substantial equivalence to a legally marketed predicate device rather than providing detailed clinical study results with specific acceptance criteria and performance metrics in the way a diagnostic AI device study would.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set details) are not applicable to this type of device and submission.

Here's the information that can be extracted or inferred based on the provided document:

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)

• Not Applicable. This document summarizes a 510(k) application for sterile disposable syringes. The "test set" and "data provenance" as applied to a diagnostic AI algorithm's performance are not relevant here. The "performance characteristics" describe compliance with international standards, which would typically involve laboratory testing of manufactured samples to these standards, not a clinical "test set" with patient data.

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)

• Not Applicable. Ground truth, in the context of diagnostic performance evaluation, is not relevant for this device. The standards themselves define the test methodologies and acceptance criteria for physical properties and sterility.

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

• Not Applicable. Adjudication methods are typically used in studies involving human interpretation or subjective assessments, often in diagnostic imaging. This is not relevant to the compliance testing of a sterile disposable syringe.

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. An MRMC study is relevant for evaluating the impact of AI on human readers (e.g., radiologists). This device is a mechanical medical instrument, not an AI diagnostic tool.

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

• Not Applicable. This device is a sterile disposable syringe, not an algorithm.

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

• For this type of device, the "ground truth" would be defined by the specifications and test methodologies outlined in the referenced ISO standards. For example, dimensions, fluid leakage, sterility, and material compatibility are verified against the requirements of these standards. The standards themselves set the benchmarks for "truth" regarding the device's physical and functional properties.

8. The sample size for the training set

• Not Applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

• Not Applicable. As there is no training set for an AI algorithm, this question is not relevant.

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