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The Sterile Syringe for Single Use (with Needle) is intended to be used for medical purposes to inject fluid into or withdraw fluid from body.

The Sterile Hypodermic Needle for Single Use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.

The Sterile Hypodermic Syringe is a sterile, single-use, polypropylene syringe that consists of the barrel, plunger, and stopper and is assembled with a hypodermic needle.

The Sterile Hypodermic Needle is a single lumen needle made of austenitic steel, consisting of a protective cap, a needle seat and a needle tube connection.

This document describes the FDA 510(k) premarket notification for a Sterile Syringe for Single Use (with Needle) and a Sterile Hypodermic Needle for Single Use by Jiangsu Zhiyu Medical Instrument Co., Ltd. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device (K201284).

However, the provided text does not contain details about a study conducted to prove the device meets acceptance criteria in the context of an AI/human reader performance study. The document is a regulatory submission for a physical medical device (syringes and needles) and focuses on demonstrating substantial equivalence through bench testing (per ISO standards) and biocompatibility testing.

Therefore, I cannot provide the information requested in your prompt regarding:

• A table of acceptance criteria and reported device performance related to AI/human reader studies. The acceptance criteria discussed pertain to physical properties and safety of the syringe/needle, not diagnostic performance.
• Sample size and data provenance for an AI test set.
• Number of experts and qualifications for ground truth establishment for an AI study.
• Adjudication method for an AI test set.
• MRMC comparative effectiveness study results (AI vs. without AI assistance).
• Standalone (algorithm only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data) for an AI study.
• Sample size for the training set (for an AI model).
• How ground truth for the training set was established (for an AI model).

The document explicitly states: "No clinical study is included in this submission." This further confirms that no studies involving human reader performance comparisons or algorithm-only performance for diagnostic purposes (the typical context for MRMC or standalone AI studies) were conducted or submitted.

What the document DOES provide regarding acceptance criteria and performance:

The acceptance criteria for these devices are based on adherence to recognized international and US standards for medical devices, primarily ISO standards and USP. The "study" proving the device meets these criteria refers to bench testing, biocompatibility testing, and sterilization validation.

Here's a summary of the actual acceptance criteria and performance demonstrated (not a diagnostic AI study):

1. Table of Acceptance Criteria and Reported Device Performance (as per the document):

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

• For physical and performance testing, the sample sizes would be based on the specific ISO standards and industry best practices for device testing, typically involving a statistically significant number of units to ensure consistency and reliability. The exact numbers are not provided in this summary document.
• Data provenance: This is a submission from Jiangsu Zhiyu Medical Instrument Co., Ltd. in China. The tests are internal company tests conducted to demonstrate compliance with standards.

3. Number of experts used to establish the ground truth and their qualifications:

• Not applicable in the context of this document. Ground truth for this type of device is established by adherence to engineering specifications and performance standards through laboratory testing, not expert clinical interpretation of images or patient data.

4. Adjudication method for the test set:

• Not applicable. Adjudication is relevant for subjective assessments, typically in clinical readings or AI ground truth labeling. Bench testing results are objective measurements against defined criteria.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done:

• No. The document explicitly states: "No clinical study is included in this submission."

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

• No. This is not an AI device.

7. The type of ground truth used:

• The "ground truth" for this device's performance is defined by the specifications and acceptable limits set forth in the referenced ISO and USP standards. This includes, for example, specific force required to move a plunger, volume accuracy, needle sharpness, and biocompatibility limits. It is established through physical measurements and laboratory assays.

8. The sample size for the training set:

• Not applicable. This device does not use a training set as it is not an AI/ML device.

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

• Not applicable.

In summary, the provided document is for a conventional medical device (syringes and needles) seeking 510(k) clearance based on substantial equivalence to a predicate device, demonstrated through rigorous bench testing and adherence to recognized performance and safety standards, not through AI performance studies.

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The Sterile Syringe for Single Use is intended for use by health care professionals for general purpose aspiration and injection of fluids.

The Syringe with needle is intended for manual and single use only. It consists of six components 1) Barrel (luer lock or luer slip) 2) Plunger 3) Piston 4) Needle Tube 5) Protective Cap and 6) Needle Hub. The proposed device is available in various combination of syringe volume, connector type (luer lock or luer slip), connector location (central type or eccentric type) and needle size. The Syringe without needle is intended for manual and single use only. It consists of three components 1) Barrel (luer lock or luer slip) 2) Plunger and 3) Piston. The proposed syringe is available in various combination of syringe volume, connector type (luer lock or luer slip), and connector location (central type or eccentric type). The proposed device is sterilized by Ethylene Oxide to achieve a SAL of 106 and supplied in sterility maintenance package which could maintain the sterility of the device during the shelf life of 5 years.

The provided document is a 510(k) Summary for a Sterile Syringe for Single Use. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing an AI/ML powered device. Therefore, many of the requested categories related to AI/ML device studies (such as MRMC studies, training set details, or ground truth establishment for AI models) are not applicable.

However, based on the information provided, here's a breakdown of the acceptance criteria and the study that proves the device meets those criteria, interpreted within the context of a medical device clearance:

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

The document defines "acceptance criteria" through compliance with recognized standards and the demonstration of substantial equivalence to a predicate device. The performance is reported as meeting these standards.

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

The document does not specify exact sample sizes for each non-clinical test conducted. It states "Non-clinical tests were conducted to verify that the proposed device met all design specifications." The data provenance is implied to be from internal testing conducted by Jiangsu Suyun Medical Material Co., Ltd. or its contracted labs, with the country of origin being China (where the manufacturer is located). The testing is prospective for the purpose of this submission, meaning the tests were performed on the proposed device to gather data for regulatory submission.

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

This question is not applicable. The "ground truth" for a medical device like a sterile syringe is based on established engineering and biological standards (e.g., ISO, ASTM, USP) and laboratory measurements, not subjective expert assessment in the way it would be for an AI diagnostic tool. The "experts" involved are the certified laboratory technicians and quality control personnel who perform and interpret these standardized tests. Their qualifications are inherent in their ability to conduct these specific tests according to recognized protocols.

4. Adjudication method for the test set

This is not applicable in the context of this device and type of testing. The tests are typically objective measurements against defined pass/fail criteria in the standards. There is no mention of a human adjudication process for resolving conflicting results, as would be common in image interpretation studies.

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. The device is a physical sterile syringe, not an AI/ML-powered diagnostic or assistive tool.

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

This is not applicable. The device is a physical sterile syringe, not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance relies on objective measurements from standardized non-clinical tests. These include:

• Biological/Chemical endpoint measurements: e.g., cell viability (cytotoxicity), skin reactions (irritation/sensitization), blood cell lysis (hemolysis), particulate counts, endotoxin levels.
• Physical performance measurements: e.g., seal strength, leak detection, plunger force, barrel integrity, needle sharpness and elasticity.
• Sterility verification: Growth/no-growth tests for sterility assurance.

The "ground truth" is defined by the Pass/Fail criteria specified within the referenced ISO, ASTM, and USP standards.

8. The sample size for the training set

This is not applicable. There is no AI/ML component or "training set" for this sterile syringe device. The document describes non-clinical performance testing.

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

This is not applicable. As there is no AI/ML component, there is no training set and no ground truth established for one.

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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 <788>, 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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