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Sterile Blunt for Single Use includes two models, which are blunt fill needle and blunt plastic cannula.

The blunt fill needle is used in conjunction with a syringe to penetrate the vial/ampoules stopper intended for injection or aspiration of fluid.

The blunt plastic cannula is used in conjunction with a syringe to access the pre-slit septum covering injection sites on I.V. System intended for injection or aspiration of fluid.

The proposed device, Sterile Blunt for Single Use, includes two models, which are blunt fill needle and blunt plastic cannula.

The blunt fill needle consists of a stainless steel needle tube, a hub and a sheath. It is used to penetrate the vial and/or ampoules stopper intended for injection or drawl fluid. It is not intended to access the injection site on I.V. System.

The blunt plastic cannula consists of molded plastic blunt tipped cannula, a hub and a sheath. It is used to replace hypodermic needles to prevent from the unintended injury by metal needle.

Both two models are available in either EO sterilized to achieve a Sterilized to achieve a Sterility Assurance Level (SAL) of 106. The proposed device is sealed in a sterility maintenance package to maintain its sterility during its shelf life of three (3) years.

This is a 510(k) premarket notification for a medical device, not a study evaluating a device's performance against specific acceptance criteria in a clinical setting. Therefore, many of the requested categories (like sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, or specific effect sizes for human readers with and without AI) are not applicable to this type of document.

The document focuses on demonstrating Substantial Equivalence (SE) to a legally marketed predicate device, rather than proving performance against predefined acceptance criteria from a clinical study. The "acceptance criteria" here refer to compliance with recognized consensus standards and general safety/performance attributes.

Here's an interpretation based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k), the "acceptance criteria" are compliance with various ISO and ASTM standards, as well as general performance attributes related to safety and effectiveness compared to the predicate device. The device "performance" is reported as meeting these standards and being substantially equivalent.

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

• Sample Size: Not specified in the document. The text refers to "bench tests" and "test results" but does not provide specific sample quantities for these tests.
• Data Provenance: The tests were conducted by the manufacturer, Shanghai Double-Dove Industry Co, Ltd., in China. The data would be considered prospective for the purpose of this 510(k) submission, as it was generated to support the review.

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

• Not Applicable. For a medical device 510(k) submission focused on mechanical, physical, and biological bench testing, there isn't a "ground truth" derived from expert consensus in the way it's used for diagnostic algorithms. Ground truth here refers to the validated methods and results of the specified international standards.

4. Adjudication method for the test set:

• Not Applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for diagnostic accuracy to resolve discrepancies between readers. This submission relies on standardized test methods where the outcome (pass/fail against a standard's criteria) is objectively measured.

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 sterile blunt needle/cannula, a physical medical device, not an AI-powered diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are irrelevant to this submission.

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

• Not Applicable. This is a physical medical device, not an algorithm, so "standalone performance" in that context is not relevant. The performance evaluated here is the device's compliance with established safety and performance standards.

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

• For the physical and biological tests: The "ground truth" is defined by the acceptance criteria specified within the referenced ISO and ASTM standards (e.g., specific force limits, chemical concentrations, sterility levels, etc.). Compliance with these standards indicates the device meets established safety and performance benchmarks.

8. The sample size for the training set:

• Not Applicable. This is a physical medical device, not an algorithm that requires a "training set."

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

• Not Applicable. (See point 8).

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The Sterile Hypodermic Syringe for Single Use is intended for dispensing/ administering fluids, and collecting/ sampling of fluid in medical practice. Their function is mechanical.

The sterile Insulin Syringe for single use with fixed needle is a device is a device intended for medical purposes for the manual aspiration of insulin, and for the injection 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.

Not Found

The provided text is a 510(k) Summary for medical devices (syringes and needles) and does not contain information typically found in a study proving a device meets acceptance criteria for complex AI/ML-driven diagnostic devices. Specifically, this document is a premarket notification for general medical devices, not a study report. Therefore, most of the requested information regarding AI/ML device performance evaluation methods (such as sample size for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) is not applicable or present in this document.

However, I can extract the device acceptance criteria implicitly mentioned and the general conclusion regarding meeting those criteria.

Acceptance Criteria and Reported Device Performance

• Sterile Hypodermic Syringe: dispensing/administering fluids, collecting/sampling of fluid.
• Sterile Insulin Syringe: manual aspiration of insulin, injection of insulin.
• Sterile Hypodermic Needle: use with syringes for fluid injection/aspiration. | The successful substantial equivalence determination implies that the devices are expected to perform their stated intended uses as safely and effectively as their predicate devices. |

Study Details (Based on available information and understanding of 510(k) for these types of devices)

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not specified. For physical medical devices like syringes and needles, testing typically involves a sufficient number of units to demonstrate statistical confidence in meeting specific physical and chemical standards (e.g., sterility, fluid tightness, material compatibility, needle sharpness, break force, etc.).
   • Data Provenance: Not specified, but generally, such testing is performed in accredited laboratories. Given the sponsor's location (Shanghai, China), the testing would likely have been conducted in China, potentially at their own facilities or a contract research organization. The document indicates "Laboratory testing was conducted."

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

   • Not Applicable. For these types of devices, "ground truth" is established through engineering and quality control tests comparing performance against defined standards (e.g., ISO standards, ASTM standards) and predicate device specifications, rather than expert interpretation of diagnostic images or clinical observations.

3. Adjudication method for the test set:

   • Not Applicable. Adjudication methods like 2+1 or 3+1 are used in diagnostic studies (especially for AI/ML) where there is ambiguity in human interpretation. For physical device testing, the results are typically quantitative measurements against objective pass/fail criteria.

4. 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 premarket notification for physical medical devices (syringes and needles), not an AI-assisted diagnostic device. Therefore, no MRMC study or AI assistance is relevant.

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

   • Not Applicable. This is not an algorithm or software device.

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

   • Objective Standards and Predicate Device Performance: The "ground truth" here would be established by:
     • International and national standards for sterile medical devices (e.g., ISO, ASTM).
     • Performance specifications based on predicate devices.
     • Measured physical, chemical, and biological properties (e.g., sterility, dimensional accuracy, mechanical strength, material safety).

7. The sample size for the training set:

   • Not Applicable. There is no "training set" as this is not an AI/ML device.

8. How the ground truth for the training set was established:

   • Not Applicable. No training set is involved.

In summary: The document confirms that laboratory testing was conducted to verify that the Double-Dove Syringes and Needles met all design specifications and were substantially equivalent to the predicate devices. This type of regulatory submission for general medical devices relies on objective physical and chemical testing against established standards and predicate device performance, rather than the complex clinical study paradigms used for AI/ML diagnostic tools.

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