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The Sterile Disposable Syringe with Safety Needle is intended for use in the aspiration 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.

The Sterile Disposable Syringe with Needle is intended for use in the aspiration of fluids for medical purpose.

The Sterile Disposable Safety Needle is intended to be used with a luer slip or luer lock syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.

The Sterile Disposable Needle is intended to be used with a luer lock syringe for aspiration and injection of fluids for medical purpose.

The Sterile Disposable Safety Needle is intended for manual and single use only to aspirate and inject of fluids for medical purpose, which consists of needle tube, needle hub and safety mechanism. The proposed device is available in variety of needle gauges and lengths. The safety needle is compatible for use with a luer slip and 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. Needle specification is same as the needle size of Sterile Disposable Syringe with Safety Needle.

Compared with Sterile Disposable Safety Needle, Sterile Disposable Needle has the same components and specifications except without safety mechanism.

The Sterile Disposable Syringe with Safety Needle is intended for manual and single use only to aspirate and inject of fluids for medical purpose. There are two kinds of sterile disposable syringe with safety needle: syringe with fixed needles and syringe without fixed needles. Sterile disposable syringe with safety needle of 0.5ml and 1ml are available syringe with fixed needles. Syringe without fixing needle are 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.

Compared with Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle has the same components and specifications except without safety mechanism. The Sterile Disposable Syringe with Needle do not have a type of the syringe with fixed needle.

The proposed devices are sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of 5 years.

The provided document describes the 510(k) premarket notification for "Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle, Sterile Disposable Needle" (K221247) by Jiangsu Kangbao Medical Equipment Co., Ltd. The submission aims to demonstrate substantial equivalence to a predicate device (K170651) based on non-clinical testing.

Here's a breakdown of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists various international and ASTM standards that the device was tested against. The acceptance criterion for each standard is implicit within the standard itself (e.g., "complies with the requirements of related standards," "no cytotoxicity," "no hemolysis"). The reported performance consistently states that the proposed device met these criteria.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify the exact sample sizes for each non-clinical test performed on the test set. It mentions "non clinical tests were conducted to verify that the proposed device met all design specifications" and that "Physical, Mechanical, Chemical testing listed in following table were performed on the proposed device." Similarly, for biocompatibility and packaging tests, it states "The proposed device was evaluated for the following tests" and "Sterile barrier packaging testing were performed on the proposed device."

The data provenance is not explicitly stated in terms of country of origin, but the submitting company is Jiangsu Kangbao Medical Equipment Co., Ltd. from China. The studies are non-clinical, meaning they are lab-based and not involving human subjects. They are inherently prospective in nature as they test the new device against established standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This information is not applicable to this submission. The "ground truth" for non-clinical performance and biocompatibility is established by adherence to recognized international and national standards (e.g., ISO, ASTM, USP). These standards define the test methods and acceptance criteria, and the device's performance is measured against these objective criteria rather than expert consensus on a clinical outcome.

4. Adjudication Method for the Test Set:

This information is not applicable. Since the tests are against objective engineering and biological standards, there is no need for an adjudication method typically used in clinical studies involving human interpretation or subjective assessments.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical study is included in this submission." The submission focuses on non-clinical performance, biocompatibility, and substantial equivalence to a predicate device based on these non-clinical tests. Therefore, there is no effect size reported for human readers with or without AI assistance.

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

This question is not applicable as the device is a physical medical instrument (syringe and needle), not an algorithm or AI-powered system. No standalone "algorithm only" performance was evaluated.

7. The type of ground truth used:

The type of "ground truth" used for this submission is based on established international and national standards and their defined acceptance criteria. For example:

• Biocompatibility: Absence of cytotoxicity, sensitization, irritation, systemic toxicity, hemolysis, pyrogenicity, complement activation, and thrombogenicity as defined by the respective ISO and USP standards.
• Physical/Mechanical/Chemical Performance: Compliance with the specifications and performance requirements outlined in ISO 7886-1, ISO 7864, ISO 9626, ISO 80369-7, and USP <788>.
• Packaging Integrity: Maintenance of sterility barrier as per ASTM F1886/F1886M-16, ASTM F88/F88M-15, and ASTM F1929-15.
• Sterilization: EO/ECH residue within limits (ISO 10993-7), endotoxin limit (USP <85>), and sterile assurance level (SAL) of 10-6.
• Safety Feature: Meeting pre-established criteria as per FDA Guidance and ISO 23908:2011.

8. The Sample Size for the Training Set:

This information is not applicable. The device is a physical medical instrument, not a machine learning or AI model. Therefore, there is no "training set" to establish.

9. How the Ground Truth for the Training Set was Established:

This information is not applicable as there is no training set for this type of device.

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Vein set is intended for vein puncture to collect blood specimens for patients. It is also indicated for intravenous administration of fluids after removing the attached luer adapter from the blood collection set connector and attaching a syringe, or other compatible/appropriate device may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy

Safety vein set is intended for vein puncture to collect blood specimens. It is also indicated for intravenous administration of fluids after removing the attached luer adapter from the blood collection set connector and attaching a syringe, or other compatible/appropriate device may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy. Additionally, after withdraw of the needle from the patient's vein, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle stick.

Blood collection needle (vein set type) is intended for use in the blood collection or short-term infusion (up to 2 hours) of intravenous fluids.

Blood collection needle (needle holder type) is intended for use in the blood collection or short-term infusion (up to 2 hours) of intravenous fluids.

Safety blood collection needle (vein set type) is intended for use in the blood collection or short-term influsion (up to 2 hours) of intravenous fluids. The device is designed with a safety mechanism to help reduce the risk injury.

Safety blood collection needle (needle holder type) is intended for use in the blood collection or short-term infusion (up to 2 hours) of intravenous fluids. The device is designed with a safety mechanism to help reduce stick injury

The proposed device is a blood collection device that forms a passage between the patient's vein and a vacuum blood collection tube for collecting blood. The proposed device can also be used for short-term infusion. The proposed devices are divided into several types, some have safety devices and some do not have safety devices, and the safety mechanism helps to reduce the risk of needle stick injuries. The proposed devices are provided sterile, single use. The propose device can be used for vein collect blood/infusion as well as peripheral vein collect blood/infusion, but not central vein collect blood/infusion.

The provided text details the 510(k) submission for several blood collection and intravenous administration devices. It focuses on demonstrating substantial equivalence to a predicate device, rather than defining and proving acceptance criteria for a new, innovative device with a complex algorithm. Therefore, many of the questions about acceptance criteria, specific performance metrics, expert qualifications, and study designs for algorithmic performance (like MRMC studies) are not directly applicable or available in this document.

However, I can extract information related to the device's performance as demonstrated by the non-clinical tests conducted to support its substantial equivalence. The "acceptance criteria" here are largely defined by the requirements of the referenced ISO standards and general safety/effectiveness considerations for medical devices of this type.

Here's an attempt to answer your questions based on the provided text, while acknowledging its limitations for certain aspects:

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

The document doesn't explicitly state "acceptance criteria" as singular numerical targets for a new algorithm. Instead, it refers to conformity with established international standards for medical devices and safety features. The "reported device performance" is essentially the outcome of these tests, demonstrating compliance.

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 generally refers to "non clinical tests" and "simulated clinical study" without specifying the exact sample sizes (e.g., number of devices tested) for each specific test mentioned (e.g., cytotoxicity, seal strength). The provenance of the data (country of origin, retrospective/prospective) is not explicitly stated, but the submission is from Jiangsu Kangbao Medical Equipment Co., Ltd. in China, implying testing was likely conducted in China or by labs contracted by them. The studies described are non-clinical and simulated clinical, not human clinical trials.

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 question is not applicable to the provided document. The device is a physical medical instrument (vein set, blood collection needle), not an AI/algorithmic device that requires expert review to establish "ground truth" for interpretations of data like images or clinical signals. The "truth" here is determined by objective physical and biological measurements against established standards.

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or performance evaluations where human experts are making subjective assessments and a consensus is needed. For physical medical devices tested against standards, the "ground truth" is determined by the test methodology itself (e.g., a tensile strength test yields a numerical result, a cytotoxicity test yields a "yes/no" result based on cellular response).

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 question is not applicable. MRMC studies are used to evaluate the performance of diagnostic imaging aids or similar AI-powered tools that assist human readers. The submitted device is a physical sterile device for blood collection and IV administration, not an AI diagnostic tool.

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

This question is not applicable. The device described does not involve an algorithm.

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

For this type of device, the "ground truth" is based on:

• Compliance with international standards: ISO standards (e.g., ISO 10993 for biocompatibility, ISO 594 for Luer fittings, ISO 7864 for needles) and US Pharmacopeia (USP <788>) for particulate matter.
• Physical and chemical tests: Measuring attributes like seal strength, leak detection, mechanical properties, and material composition.
• Biological tests: Assays for cytotoxicity, sensitization, systemic toxicity, pyrogenicity, hemolysis, etc.
• Safety mechanism evaluation: Verification that the safety feature (for applicable models) functions as intended to prevent needle stick injuries, as evaluated in a "simulated clinical study" and "safety feature test".

8. The sample size for the training set

This question is not applicable, as there is no mention of an algorithm or training set for this physical medical device.

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

This question is not applicable, as there is no mention of an algorithm or training set for this physical medical device.

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