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The Sterile Safety Hypodermic Needles for Single Use are 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 needlesticks.

The Sterile Safety Hypodermic Needles for Single Use are composed of a hypodermic needle with a needle safety shield attached to the needle hub, which can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks. The device is compatible for use with standard luer slip and luer lock syringes. The Sterile Safety Hypodermic Needles for Single Use is for single use only. It is provided sterile. The sterilization method is EO sterilization and the sterilization assurance level is 10-6.

The provided text describes the regulatory clearance of "Sterile Safety Hypodermic Needles for Single Use" (K213535) and does not contain detailed information about a study proving the device meets specific acceptance criteria in the format requested.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device (K191644, TK Safety Needle), rather than providing a detailed report of a single study designed to directly prove acceptance criteria.

The "Performance testing" section lists the standards to which the device conforms, implying that testing was conducted to meet the requirements of these standards. However, it does not provide:

• A table of specific acceptance criteria values with corresponding reported device performance values.
• Sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or details about training sets/ground truth for any specific performance study.

Instead, it broadly states that "Performance testing is performed according to the following standards," and that "The non-clinical testing demonstrates that the device is as safe, as effective and performs as well as the legally marketed device."

Therefore, based solely on the provided text, I cannot extract the detailed information requested regarding specific acceptance criteria and a study proving the device meets them. The document asserts compliance with established medical device standards but does not detail the individual test results against specific criteria.

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The Sterile Auto-Disable syringes with/without needle for single use is used for aspiration of fluids from vials and ampoules and a variety of fluid injections below the surface of the skin except phlebotomy.

The Sterile Auto-Disable syringes with/without needle for single use is a syringe with or without needle, sterile, single use hypodermic syringe with a 6% (Luer) male connector/lock fitting in various sizes. The syringe assembly consists of a lubricated polypropylene barrel with a graduated scale, a lubricated synthetic rubber stopper and a polypropylene plunger rod. The plunger rod is pulled back to aspirate fluids or depressed to inject or expel fluids. The main principle of the syringe is that after the injection is completed, the device automatically locks the plunger to prevent reuse.

The provided document is a 510(k) summary for a medical device (Sterile Auto-Disable Syringes with/without Needle for Single Use). It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence. However, the document does not contain the specific details about acceptance criteria and the comprehensive study results to prove that the device meets those criteria, as requested in your prompt regarding a typical device performance study.

The prompt asks for details like:

1. A table of acceptance criteria and the reported device performance: This is not provided in a summarized table format for specific performance metrics.
2. Sample sizes used for the test set and the data provenance: Not specified for each test.
3. Number of experts used to establish the ground truth... and their qualifications: Not applicable as this is a physical medical device, not an AI/diagnostic software.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone performance: The document describes performance testing for the device itself (standalone in a physical sense), but not algorithm standalone performance.
7. Type of ground truth used: For physical device testing, ground truth refers to established standard measurements and specifications (e.g., ISO standards).
8. Sample size for the training set: Not applicable (not an AI/ML device).
9. How the ground truth for the training set was established: Not applicable.

What the document does provide regarding performance and testing:

The Section "VII Performance Testing" lists the types of tests conducted:

• Biocompatibility testing:
  • Classification: Externally Communicating Device, Blood Path Indirect, Limited Contact (.
  • Acceptance Criteria/Reported Performance: It states "Conforms to ISO 10993" and "Non-pyrogenic" but does not provide specific numerical outcomes or detailed acceptance criteria for each sub-test.
• Sterilization, Shipping and shelf-life:
  • Tests conducted: EO sterilization validation per ISO11135:2014, Pyrogen testing per USP , EO residuals per ISO 10993-7, Simulated shipping per ASTM D4169, Sterile Barrier Package testing (Seal Strength ASTM F88/F88M-2015, Bubble leak testing ASTM D3078-02(2013), Dye Penetration ASTM F1929-2015).
  • Acceptance Criteria/Reported Performance: "Shelf life of 5 years validated using FDA recognized standards ASTM F1980-16." It implies compliance with these standards, but doesn't offer specific data points or "acceptance criteria met" statements for each.
• Performance testing:
  • Tests conducted according to: ISO 7864:2016, ISO 9626:2016, ISO 80369-7:2016, ISO 7886-4:2018, ISO 7886-1:2017.
  • Acceptance Criteria/Reported Performance: The comparison table (Table 5-1) under "Performance specifications" states: "Complies with ISO 7864, ISO 7886-1, ISO 7886-4." This indicates the device passed these standards, which inherently include acceptance criteria for parameters like syringe dimensions, fluid leakage, plunger force, auto-disable features, etc. However, the exact specific criteria and the numerical results are not detailed in this summary.

In summary, based only on the provided text, I cannot construct the detailed table and answer all points of your prompt because the 510(k) summary provides a high-level overview of the types of tests performed and the standards met, rather than detailed acceptance criteria and specific reported performance metrics for each test. The document confirms that testing was done to demonstrate compliance with relevant international standards, which is typical for a 510(k) submission showing substantial equivalence for a physical device.

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The Sterile Hypodermic Needles for Single Use are intended to be used with a luer slip syringe and injection devices for general purpose fluid injection/aspiration.

The Sterile Hypodermic Needles for Single Use is composed of a needle hub, protective cover, needle tube and jointing, connected with a syringe for general purpose fluid injection/aspiration.

The provided document K210232 "Sterile Hypodermic Needles for Single Use" is a 510(k) summary, which is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device. This document focuses on demonstrating substantial equivalence rather than proving performance against specific acceptance criteria for a new, non-comparative device.

Therefore, the information presented in the document is primarily related to comparison with a predicate device and adherence to recognized standards, rather than a standalone performance study with detailed acceptance criteria and results for the device itself.

Based on the provided text, I can infer some aspects related to acceptance criteria and the "study" (mostly non-clinical testing) that proves the device meets the criteria.

Acceptance Criteria and Device Performance for Sterile Hypodermic Needles for Single Use (K210232)

1. Table of Acceptance Criteria and Reported Device Performance:

The document defines "acceptance criteria" primarily through compliance with established international standards for hypodermic needles and related medical device characteristics. The "performance" is reported as demonstrating compliance with these standards.

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

• Sample Size: The document does not specify exact sample sizes for each test. For medical devices like hypodermic needles, sample sizes for performance testing (e.g., force to penetrate, cannula rigidity) are typically defined by the relevant ISO standards (e.g., ISO 7864) and would vary based on the specific test and lot size. Biocompatibility testing often involves a smaller number of samples for each specific assay.
• Data Provenance: The testing is non-clinical/bench testing. The manufacturer is Zhejiang Kangkang Medical-Devices CO., Ltd. in China. The data would originate from their internal testing labs or contract research organizations (CROs) in China or elsewhere, conducting tests according to the specified international standards. The data is retrospective to the submission date.

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

• This is not applicable as the "ground truth" for hypodermic needles is established by objective, quantitative measurements against published international consensus standards (e.g., ISO 7864, ISO 9626) and regulatory requirements (e.g., 21 CFR 801, ISO 10993 for biocompatibility). There is no "ground truth" established by human experts in the sense of image interpretation or diagnostic accuracy for this type of device. The "experts" involved would be technicians and engineers skilled in performing the standardized tests and interpreting their results according to the defined specifications.

4. Adjudication Method for the Test Set:

• Not applicable. Performance is objectively measured against a quantifiable pass/fail criterion defined by the relevant standards (e.g., "force shall not exceed X N," "no hemolysis greater than Y," "no pyrogenicity detected"). No human adjudication of results is described, nor is it typically necessary for these types of physical and chemical tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No, an MRMC comparative effectiveness study was not done. This type of study (comparative effectiveness, MRMC, human-in-the-loop with AI) is relevant for diagnostic devices, especially those incorporating AI, where human interpretation affects clinical outcomes. This document is for a physical medical device (hypodermic needle) where performance is determined by physical and biological properties.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• No, this is not applicable. The device is a physical hypodermic needle, not an algorithm or software-as-a-medical-device (SaMD). Its performance is inherently physical and does not involve an "algorithm" operating independently.

7. The Type of Ground Truth Used:

• The "ground truth" is established by international consensus standards and regulatory guidelines. For example, the ground truth for biocompatibility is whether the device materials pass specific biological tests (cytotoxicity, irritation, sensitization) as defined by ISO 10993. The ground truth for needle performance is whether it meets the physical and mechanical specifications (e.g., dimensions, penetration force, corrosion resistance) outlined in standards like ISO 7864 and ISO 9626.

8. The Sample Size for the Training Set:

• Not applicable. This device is a manufactured medical product that undergoes physical and biological performance testing, not a machine learning model that requires a "training set."

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

• Not applicable. See point 8.

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The Sterile syringes for single use with/without needle are intended to be used for medical purposes to inject fluid into or withdraw fluid from body.

The Sterile Syringes for Single Use with/without Needle are three-piece, sterile, single use hypodermic syringes with a 6% (Luer) male connector/lock fitting in various sizes. Each syringe assembly consists of a lubricated polypropylene barrel with a graduated scale, a lubricated synthetic rubber stopper and a polypropylene plunger rod. The plunger rod is pulled back to aspirate fluids or depressed to inject or expel fluids.

The provided document is an FDA 510(k) clearance letter and associated summary for a medical device (Sterile syringes for single use with/without needle). This document describes the device, its intended use, comparison to a predicate device, and the testing conducted to demonstrate substantial equivalence.

However, the document does not describe a study involving an AI/algorithm-driven device with human-in-the-loop performance, nor does it detail acceptance criteria and performance for such a device in the way requested by your prompt. The device cleared is a manual medical device (syringes), not an AI-powered diagnostic or therapeutic tool.

Therefore, many of the requested details regarding AI acceptance criteria, data provenance, expert ground truth, MRMC studies, or standalone algorithm performance are not applicable and not present in this document.

Below is a breakdown of the relevant information found in the document, framed as closely as possible to your prompt's structure, along with clear statements about what information is not available given the nature of the cleared device:

Analysis of Acceptance Criteria and Study for the Sterile Syringes for Single Use with/without Needle

The acceptance criteria and study detailed in the provided FDA 510(k) summary pertain to the physical, chemical, and biological performance of a manual medical device (sterile syringes), not an AI-powered system. As such, information regarding AI-specific criteria, human reader improvement with AI assistance, or expert consensus on AI outputs is not present.

The study proves the device meets the acceptance criteria through demonstrating substantial equivalence to a legally marketed predicate device, primarily by showing compliance with recognized international and national standards for syrings and needles.

1. Table of Acceptance Criteria and the Reported Device Performance

The acceptance criteria are generally established by compliance with a comprehensive set of recognized industry standards. The reported device performance is that it "meets the requirements" or "complies with" these standards.

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

The document does not specify exact sample sizes for each test mentioned (e.g., how many syringes were tested for each performance criterion). It generally states that "The Sterile Syringes for Single Use with/without Needle are intended to be used for medical purposes to inject fluid into or withdraw fluid from body."

• Data Provenance: The testing was conducted by or on behalf of the manufacturer, Zhejiang Kangkang Medical-Devices CO., Ltd., based in China. The data would therefore originate from China and pertain to laboratory testing of the manufactured device. The studies described are prospective laboratory tests performed specifically for this submission.

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

This information is not applicable as the evaluation is based on compliance with harmonized standards for physical and chemical properties of a device, not on clinical interpretation or ground truth established by medical experts for diagnostic accuracy. The "ground truth" here is the pass/fail result against established standard specifications.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are used for clinical trials involving human interpretation of medical images or data, not for laboratory compliance testing of a physical medical device. The "adjudication" is the assessment of compliance with the specified test methods and criteria in the standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices that assist human readers (e.g., radiologists, pathologists). The device under review is a manual syringe, which does not involve human readers in this context or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done. This concept is completely irrelevant to a manual medical device like a syringe.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is defined by the specified physical, chemical, and biological requirements and test methods outlined in the referenced international and national standards (e.g., ISO 7886-1, ISO 10993, USP , etc.). For instance, for sterility, the ground truth is achieving a Sterility Assurance Level (SAL) of $10^{-6}$. For dimensions, the ground truth is meeting the specified dimensional tolerances. This is entirely lab-based and objective measurement.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical medical device (syringe), not an AI algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as above. There is no AI training set.

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