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The Sterile Hypodermic Syringe with needle, for Single Use is intended to be used for medical purposes to inject fluid into body.

The Sterile Hypodermic Syringe for Single Use is intended for manual and single use only to aspirate and inject of fluids for medical purpose, which consists of a hypodermic needle and a luer lock syringe. The proposed device is available in a variety combination of syringe volume and needle gauge (refer to Table 1).

The provided document is a 510(k) Summary for a Sterile Hypodermic Syringe with needle for Single Use. This type of device is a physical medical instrument, not a software or AI/ML-based device.

Therefore, the document does not contain any information related to:

• Acceptance criteria for an AI/ML device
• Study data proving an AI/ML device meets acceptance criteria
• Sample sizes for test sets (in the context of AI/ML)
• Number of experts for ground truth establishment
• Adjudication methods
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies
• Standalone algorithm performance
• Training set details (sample size, ground truth establishment)

The document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical tests (e.g., biological evaluation, sterility, mechanical performance) and comparison of technical characteristics, as summarized in the "Non-Clinical Test Conclusion" and "Substantially Equivalent (SE) Comparison" sections.

In summary, the provided text does not describe an AI/ML device or its associated acceptance criteria and performance study as requested. It pertains to a physical medical device.

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The Sterile Safety Syringe with Needle for Single Use 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 needlesticks.

The Sterile Safety Hypodermic Needle for Single Use 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 from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks.

The Sterile Auto-Disable Syringe with Needle for Single Use is intended for aspiration and injection of fluids.

The Sterile Safety Syringe with Needle for Single Use is intended for manual and single use only, which consists of a hypodermic needle with a safety shield attached to the needle hub and a luer slip or luer lock syringe. The proposed device is available in a variety combination of syringe volume and needle size. The safety shield will be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.

The Sterile Safety Hypodermic Needle for Single Use is intended for manual and single use only, which consists of a hypodermic needle with a safety shield attached to the connector hub. The proposed device is available in variety combination of needle gauge and needle length. The proposed device is compatible for use with a luer slip or luer lock syringe. The safety sheath will be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.

The Sterile Auto-Disable Syringe with Needle for Single Use is intended for aspiration and injection of fluids. The Sterile Auto-Disable Syringe with Needle for Single Use is available in various capacities of syringes.

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

The provided text describes a 510(k) summary for Sterile Safety Syringes and Needles. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study or a multi-reader multi-case (MRMC) study.

Therefore, many of the requested details related to acceptance criteria, specific performance metrics, sample sizes for test sets, expert involvement, and ground truth establishment for AI/ML device validation are not present in this document, as this is a traditional medical device submission.

However, I can extract information related to the non-clinical performance tests that serve as acceptance criteria for this type of device and how the device proved it met them.

Here's a breakdown of the available information:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for this non-AI/ML device are primarily based on compliance with established international standards and demonstration of substantial equivalence to predicate devices through various non-clinical tests. The reported device performance is presented as meeting these standards and showing similar performance to predicates.

Additional Details (Based on available information and the nature of this submission):

2. Sample sizes used for the test set and the data provenance:

   • The document does not specify exact sample sizes for each non-clinical test performed (e.g., how many syringes were tested for each performance characteristic, or how many samples for biocompatibility).
   • The data provenance is implied to be from non-clinical testing conducted by the manufacturer, Shandong Weigao Group Medical Polymer Co., Ltd. (China). These are laboratory tests, not human data. The document does not specify if the tests were performed retrospectively or prospectively relative to the submission date, but typical device testing for 510(k) is performed as part of the development and validation process.

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

   • N/A. This is a submission for a traditional medical device (syringes and needles), not an AI/ML device that requires human expert review to establish "ground truth" for interpretive tasks (like image classification). The "ground truth" for this device's performance is established by objective measurements and compliance with international standards in laboratory settings.

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

   • N/A. This concept applies to human reader studies often conducted for AI/ML devices where there might be disagreement among readers. For physical device testing, adjudication methods generally involve standardized measurement protocols and calibration, not expert consensus.

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:

   • No. This is not an AI/ML device, so an MRMC study is not applicable or mentioned.

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

   • N/A. This is not an AI/ML device. The "standalone" performance here refers to the device itself meeting the defined physical and performance criteria.

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

   • The "ground truth" for this device's performance is based on objective, measurable criteria as defined by international standards (e.g., ISO, ASTM). For example:
     • Needle sharpness and bend resistance are measured via mechanical tests.
     • Syringe flow rates and accuracy are measured via fluid dynamics tests.
     • Biocompatibility is assessed through standardized biological assays.
     • Sterility is validated through microbiological testing (SAL).
     • Safety mechanism effectiveness is assessed via simulated use tests following FDA guidance and ISO standards.

8. The sample size for the training set:

   • N/A. This is a manufactured physical device, not an AI/ML algorithm that requires a "training set."

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

   • N/A. Not applicable.

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