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The Sterile Hypodermic Syringe for Single Use with/without needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body.

The sterile insulin syringe for single use with needle, with the calibration 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 calibration unit of 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.

The proposed devices are Sterile Hypodermic Syringe for single use with/without Needle, Sterile Insulin Syringe for single use with Needle, and Sterile Hypodermic Needle for single use. The hypodermic syringes are available in Luer slip and Luer lock nozzles with volumes from 1ml to 50ml, made of PP, and can be with or without a needle. The insulin syringes have a fixed needle, are available in 0.3ml, 0.5ml, and 1ml volumes, made of PP, and come with a fixed needle. The hypodermic needles are available in Luer slip and Luer lock nozzles with gauges from 18G to 30G, made of Stainless Steel.

Here's a breakdown of the acceptance criteria and study information for the medical devices, based on the provided text:

Important Note: The provided text is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed, standalone clinical study with strict acceptance criteria for a novel AI device. Therefore, the information related to AI-specific elements (like MRMC studies, human reader improvement with AI, standalone algorithm performance, training set details) is not present in this document. The "device" in this context refers to physical medical devices (syringes and needles), not an AI algorithm.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for these devices are defined by compliance with established international standards. The study demonstrates that the proposed devices comply with these standards, thereby meeting the acceptance criteria.

• ISO 594:1986 (Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment -- Part 1: General requirements)
• ISO 594:1998 (Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment -- Part 2: Lock fittings) | Device complies with these standards, demonstrating it meets design specifications and is substantially equivalent to predicate devices. |
  | Sterile Insulin Syringe for single use (with needle) | - ISO 8537:2007 (Sterile single-use syringes, with or without needle, for insulin)
• ISO 594:1986 (Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment -- Part 1: General requirements)
• ISO 594:1998 (Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment -- Part 2: Lock fittings) | Device complies with these standards, demonstrating it meets design specifications and is substantially equivalent to predicate devices. |
  | Sterile Hypodermic Needle for single use | - ISO 7864:1993 (Sterile hypodermic needles for single use)
• ISO 9626:1991 / Amendment: 2001 (Stainless steel needle tubing for the manufacture of medical devices)
• ISO 594:1986 (Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment -- Part 1: General requirements)
• ISO 594:1998 (Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment -- Part 2: Lock fittings) | Device complies with these standards, demonstrating it meets design specifications and is substantially equivalent to predicate devices. |

Study Details

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

   • The document states that "Bench tests were conducted." It does not specify the sample size for these bench tests.
   • Data Provenance: Not explicitly stated, but the manufacturer is based in Shanghai, China, and the standards are international (ISO), suggesting tests were conducted to meet these international standards. The nature of bench tests implies controlled laboratory conditions rather than patient data from a specific country. The study is non-clinical.

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

   • Not applicable as this is a non-clinical bench testing for physical medical devices against engineering standards, not a study requiring expert clinical ground truth for an AI algorithm.

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

   • Not applicable for non-clinical bench testing against engineering standards. Compliance is typically determined by measurement against the specified limits within the standard.

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:

   • No. This is a 510(k) submission for physical medical devices (syringes and needles), not an AI-powered device. Therefore, no MRMC study or AI assistance evaluation was performed.

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

   • No. This is not an AI algorithm. The device is a physical medical instrument.

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

   • The "ground truth" for these tests is defined by the technical specifications and performance requirements outlined in the referenced ISO standards (e.g., specific force required to activate a plunger, leakage rates, needle sharpness, etc.).

7. The sample size for the training set:

   • Not applicable. This is a physical non-AI device.

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

   • Not applicable. This is a physical non-AI device.

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