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Single Use Sterile Syringe with Needle inject fluids into or withdraw fluid from, parts of the bady below the surface of the skin.

The Single Use Sterile Syringe with Needle belongs to standard piston. And there are eight models - 1ml,2ml,2.5ml,5ml,10ml,20ml,30ml and 50ml within the device, which enjoy the same stucture, that is, all of the eight models consists of a piston syringe comprised of a movable plunger, piston and a calibrated hollow barrel, at one end of which there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle, and a matching hypodermic single lumen needle which consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designated to mate with a male connector (nozzle) of a piston syringe.

The provided document is a 510(k) summary for a Single Use Sterile Syringe with Needle. It details the device's characteristics and its substantial equivalence to a predicate device, focusing on non-clinical performance and biocompatibility testing. It is important to note that this document is for a medical device (syringe) and not for an AI/ML powered device, therefore, many of the requested categories are not applicable.

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

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

The document does not explicitly present acceptance criteria in a quantitative table with reported device performance values. Instead, it states that the subject device "comply[s] with" or "accord[s] with" specific ISO standards, which inherently contain the acceptance criteria for those tests. The reported performance is generally implied to have met these standards.

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

The document does not specify exact sample sizes for each test. It refers to compliance with ISO standards, which define the testing methodologies and potentially the sample sizes required.
The data provenance is from the manufacturer, Jiangxi Kelun Medical Devices Manufacturing Co.,Ltd. in China. The tests were performed as part of a premarket notification, implying prospective testing for the purpose of demonstrating substantial equivalence.

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 information is not applicable. The device is a physical sterile syringe, and the testing involves non-clinical performance and biocompatibility evaluations against established international standards (ISO). It does not involve expert interpretation or subjective assessments that would require establishing a "ground truth" through expert consensus.

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

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, particularly for subjective assessments by multiple readers (e.g., radiologists, pathologists) to resolve discrepancies and establish a ground truth. Since this product is a physical device and its performance is assessed against objective engineering and biological standards, such adjudication methods are not relevant.

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 information is not applicable. This document pertains to a physical medical device (syringe) and its non-clinical testing. It is not an AI/ML powered device, and therefore, an MRMC study or AI assistance is not relevant.

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

This information is not applicable as the device is not algorithm-based.

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

This information is not applicable in the typical sense for an AI/ML device. For this physical medical device, the "ground truth" for its performance and safety is defined by:

• International Standards: ISO 7886-1, ISO 594/1, ISO 7864, ISO 9626, ISO 10993 (parts 4, 5, 10, 11), ISO 11135-1, ISO 10993-7. These standards provide objective, measurable criteria and test methods.
• Predicate Device Comparison: The subject device is compared to a legally marketed predicate device (K111841 - Shifeng Disposable Syringe with or without needle), and differences are verified against relevant FDA recognized standards to ensure no new safety or effectiveness concerns.

8. The sample size for the training set

This information is not applicable. This is not an AI/ML device, and therefore, there is no "training set."

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

This information is not applicable as there is no training set for this physical medical device.

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