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Sterile Syringe with Safety needle for Single Use in the aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety mechanism can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks.

Sterile Syringe for Single Use is a sterile luer lock syringe which is intended to be used with a hypodermic needle for the aspiration and injection of fluids for medical purpose.

Sterile Safety Needle for Single Use is intended to be used with a luer lock syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety mechanism can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks.

Sterile Syringe with Safety needle for Single Use is intended for manual and single use only to aspirate and inject of fluids for medical purpose, which consists of syringe (piston, barrel, plunger) and hypodermic needle with a safety mechanism. The proposed device is available in a variety combination of syringe volume and needle size.

The Sterile Syringe for Single Use is intended for manual and single use only, which consists of piston, barrel and plunger. The proposed device is available in a variety syringe volume. The syringe is available in luer lock, which is intended to be connected with a hypodermic needle.

Sterile Safety Needle for Single Use is intended for manual and single use only to aspirate and inject of fluids for medical purpose, which consists of needle tube, retractable cartridge, jointing medium and needle hub. The proposed device is available in variety of needle gauge and needle length. According to the needle length, the safety mechanism is available in 2-part cartridge (outer retractable cartridge and inner retractable cartridge) and 3-part cartridge (outer retractable cartridge, middle retractable cartridge and inner retractable cartridge). The proposed device is compatible for use with a luer lock syringe. After withdrawal of the needle from the body, the attached needle safety mechanism can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks.

The provided text describes a submission for K192679 (Sterile Syringe with Safety Needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use) to the FDA, asserting substantial equivalence to predicate device K170651.

The document discusses acceptance criteria for various tests and confirms that the proposed device met these criteria through non-clinical testing and a simulated clinical study.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the numerical sample sizes for each test set. It mentions tests were performed on the "proposed device" and "aging samples" for shelf-life. In the Safety Feature Test, tests were performed on "both proposed device and predicate device".

The data provenance is from non-clinical tests conducted by Gemtier Medical (Shanghai) Inc. in China (manufacturer location). The nature of these tests (bench testing, simulated clinical study) implies they are prospective in execution, meaning they were designed and performed for the purpose of this submission.

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)

This section is not applicable as the document describes non-clinical and simulated clinical studies for a medical device (syringes and needles), not studies involving human subjects or expert assessment of medical images/data for ground truth. The acceptance criteria are based on compliance with international standards and internal design specifications, not expert consensus on medical conditions.

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

This section is not applicable. Adjudication methods are typically used in clinical studies or studies where subjective interpretations need to be resolved. The tests described here are objective performance measurements against established 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

This is not applicable. The device is a sterile syringe and needle system, not an AI-powered diagnostic or assistive technology that would involve human readers or AI assistance.

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

This is not applicable. The device is a physical medical instrument, not an algorithm.

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

The "ground truth" for the device's performance is established by the international standards (e.g., ISO 7886-1, ISO 7864, ISO 9626, ISO 10993-7, ISO 23908, ISO 80369-7) and internal design specifications against which the device was tested. For biocompatibility, the lack of "negative impacts" is the ground truth. For the safety mechanism, meeting "pre-established criteria" of relevant guidance documents serves as the ground truth.

8. The sample size for the training set

This is not applicable. The document describes the testing and comparison of a physical medical device. There is no training set mentioned, as this is not an AI/ML device.

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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