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Hypodermic Safety Needle with Syringe: The Hypodermic Safety Needle with Syringe is intended for use in the aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.

Hypodermic Safety Needle: The Hypodermic Safety Needle 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 shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.

The device is used for subcutaneous injection, intramuscular injection, intravenous injection of blood, and preparation of liquid medicine. The needle tube will be pushed into the safety cap after use. It is designed to aid in the prevention of needlestick injuries.

The device is a disposable anti-needle stick syringe made of the following components: Needle cap, Needle tube, Safety shield, Needle hub, Barrel, Plunger, Plunger stopper.

This document describes the premarket notification (510(k)) for the Hypodermic Safety Needle and Hypodermic Safety Needle with Syringe. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study that proves the device meets specific acceptance criteria in the way an AI/ML device would.

However, I can extract the information you've requested based on the regulatory submission's approach to performance and safety, interpreting the "acceptance criteria" as compliance with relevant international standards and the "study" as the non-clinical performance testing.

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)

The document does not explicitly state the sample sizes for the performance testing. The "data provenance" for non-clinical performance testing would typically be from in-house or contracted laboratory testing conducted by the manufacturer (Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. in China). These are prospective tests designed to show compliance with the standards.

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 is not applicable to this type of device submission. The "ground truth" for these tests are the objective technical requirements and measurement methods defined by the international ISO standards. Compliance is determined by whether the device's measured performance falls within the specified limits of these standards, not by expert consensus on clinical interpretation.

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

Not applicable. This type of device performance testing does not involve human adjudication in the way clinical diagnostic studies do. Compliance against standards is an objective measurement.

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 is a conventional medical device (safety needle/syringe), not an AI/ML diagnostic or assistive device. No MRMC study was performed.

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

Not applicable. This is a conventional physical medical device, not an algorithm or software. No standalone performance testing in this context was performed.

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

The "ground truth" for this submission are the objective technical requirements and test methods defined by recognized international standards (ISO standards). Device performance is measured against these established, quantitative benchmarks.

8. The sample size for the training set

Not applicable. This is a conventional medical device, not an AI/ML device that requires a training set.

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

Not applicable. This is a conventional medical device, not an AI/ML device.

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Hypodermic Safety Needle with Syringe: The Hypodermic Safety Needle with Syringe is intended for use in the aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.
Hypodermic Safety Needle: The Hypodermic Safety Needle 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 shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.

The device is used for subcutaneous injection, intravenous injection of blood and preparation of liquid medicine. The needle tube will be pushed into safety cap after use. It is designed to aid in the prevention of needle stick injuries. This device is a single use device, which is delievered sterile. The device is a disposable anti-needle stick syringe made of the following components: Needle cap, Needle tube, Safety shield, Needle hub, Barrel, Plunger, Plunger stopper.

The provided document describes the acceptance criteria and the studies conducted for the Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.'s Hypodermic Safety Needle and Hypodermic Safety Needle with Syringe.

Here's a breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance

The document states that "All of the pre-determined acceptance criteria were met" for each of the performance tests, biocompatibility tests, and sterility information tests. Specific numerical acceptance criteria are generally not explicitly detailed in this type of summary report but are implied by adherence to the referenced standards.

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

The document does not explicitly state the specific sample sizes used for each test set. It mentions a "simulated clinical study" but does not provide details on the number of devices tested.
The data provenance is implied to be from internal testing conducted by the manufacturer, Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd., likely in China (Anhui Province China is listed as the manufacturer's location). The studies are retrospective as they were conducted to support a premarket notification.

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 in the document. The document describes bench testing, simulated clinical studies, biocompatibility, sterility, and packaging tests, which typically rely on standardized methods and laboratory results rather than expert consensus on ground truth in the way a clinical imaging study might.

4. Adjudication method for the test set

This information is not applicable and is not provided. The testing described does not involve expert adjudication or interpretation for ground truth.

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 to the device described. The device is a medical hardware product (safety needle/syringe), not an AI diagnostic or assistive tool.

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

This is not applicable to the device described as it is not an algorithm or AI product. The "simulated clinical study" refers to testing the physical safety feature of the needle/syringe.

7. The type of ground truth used

For the performance testing, biocompatibility, sterility, and package/shelf life, the "ground truth" is defined by adherence to specific international and national standards (ISO, ASTM, USP, AAMI, ANSI). For example, for sharps injury prevention, the ground truth is whether the safety feature prevents accidental needle sticks as per ISO 23908 requirements. For biocompatibility, the ground truth is that the materials do not elicit adverse biological responses as per ISO 10993.

8. The sample size for the training set

This is not applicable as the device is not an AI/ML algorithm that requires a training set.

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

This is not applicable as the device is not an AI/ML algorithm.

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