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The Sterile Safety Hypodermic Needles for Single Use are 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 needlestick.

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

The Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles are intended to be used with a luer slip or luer lock syringes and injection devices for general purpose fluid injection/aspiration.

The proposed devices are provided in two types of configurations; one type is a Sterile Safety Hypodermic Needles for Single Use, the other is Sterile Hypodermic Needles for Single Use. The Sterile Hypodermic Needles also divided into two types, one type is an ordinary disposable needle contained in a sterility maintenance package, the other is self-sealing hypodermic needle with an end cap, the protective cap and end cap form a sterility maintenance package.

The Sterile Safety Hypodermic Needles for Single Use are intended for single use only, which consists of a hypodermic needle with a safety sheath attached to the needle hub. The proposed device is available in 28-34 gauge and 4-32 mm lengths. The safety sheath will be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.

The Sterile Hypodermic Needles for Single Use are intended for single use only. The proposed device is available in 18-34 gauge and 2-40 mm lengths.

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

The provided text describes the 510(k) summary for hypodermic needles and does not contain information about an AI/ML-enabled medical device. Therefore, I cannot address the specific points regarding acceptance criteria and study details for such a device. The document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing for physical, mechanical, chemical, biocompatibility, and sterilization properties of the needles.

• No AI/ML device: The document pertains to "Sterile Safety Hypodermic Needles for Single Use" and "Sterile Hypodermic Needles for Single Use-Disposable Needles," and "Sterile Hypodermic Needles for Single Use-Self-sealing Hypodermic Needles." These are physical medical devices, not AI/ML-enabled software.
• No AI/ML performance data: Consequently, there are no acceptance criteria or study details related to the performance of an AI/ML algorithm (e.g., sensitivity, specificity, AUC) or its impact on human reader performance.
• Non-clinical tests: The document lists numerous non-clinical tests conducted to prove the device meets standards like ISO 7864, ISO 9626, and ISO 80369-7, as well as biocompatibility tests (cytotoxicity, irritation, sensitization, systemic toxicity, hemolysis, pyrogen). It also mentions a "Simulated Clinical Study" and "Safety Feature Test" for the sharps injury prevention feature, though details on the study design or sample size are not provided beyond stating that pre-established criteria were met.

Therefore, I cannot generate the table or information requested as it is not present in the provided text.

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

The proposed device, Sterile Hypodermic Needles For Single Use consists of needle tube, needle hub and hard pack(Butt-end lower protective cap and Upper needle protective cap) or protective cap for needle tube is made from stainless steel (SUS 304), the needle hub made of Polypropylene material (abb. PP) and the colour complies with ISO 6009. Sterile Hypodermic Needles for Single Use have two kinds of sterile barrier type, paper-film package type and hard-pack package. Besides the sterile barrier, the materials of middle package and outer package are same. Middle package is made of 350g ivory board and the outer package is made from double-corrugated paper. The conical fitting of Sterile Hypodermic Needles for Single Use is luer can be used with syringes or other medical device which have 6% conical fitting. It is provided as sterile with EO sterilization, and the sterilization assurance level (SAL) is 10-6. Additionally, each component is made from properly tested raw materials.

This is a 510(k) premarket notification for a medical device (Sterile Hypodermic Needles for Single Use), which focuses on demonstrating substantial equivalence to predicate devices rather than providing a study proving performance against predefined acceptance criteria for a new AI or diagnostic device. As such, most of the requested information regarding acceptance criteria and study details for an AI/diagnostic device is not applicable or cannot be extracted from this document.

However, I can provide information based on the reported performance specifications (which serve as acceptance criteria for basic device characteristics) and the non-clinical performance testing conducted to demonstrate compliance with relevant standards.

Here's a breakdown of the applicable information:

1. Table of Acceptance Criteria and Reported Device Performance

For a medical device like a hypodermic needle, acceptance criteria are typically defined by compliance with recognized international standards for manufacturing, materials, and specific performance attributes. The document states that the proposed device complies with these standards, thus the reported performance meets the acceptance criteria.

2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes for each test conducted to demonstrate compliance with the standards (e.g., number of needles tested for bend strength, fluid leakage, etc.). It only states that "Non-clinical tests were conducted to verify that the proposed device met all design specifications" and "all test results meet the acceptance criteria per the standards." The provenance of the testing data (e.g., country of origin, retrospective/prospective) is not detailed, though the manufacturer is based in China.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a submission for a mechanical medical device (hypodermic needle), not an AI or diagnostic device that relies on expert interpretation for ground truth. Compliance is determined by physical and chemical testing against established international standards.

4. Adjudication method for the test set
Not applicable. Testing is against objective criteria defined by international standards rather than subjective human assessment requiring adjudication.

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 not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/algorithm-based device.

7. The type of ground truth used
The ground truth is established by international standards and their specified test methods, such as ISO 7864 (Sterile hypodermic needles), ISO 9626 (Stainless steel needle tubing), ISO 80369 series (Small-bore connectors), ISO 10993 series (Biocompatibility), ASTM standards for packaging, and USP for particulate matter. These standards define the acceptable performance limits and methodologies for testing.

8. The sample size for the training set
Not applicable. There is no "training set" in the context of this traditional medical device submission.

9. How the ground truth for the training set was established
Not applicable.

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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 luer lock or luer slip syringe and injection devices for general purpose fluid injection. The Sterile Hypodermic Needles for Single Use is for single use only. After opening the inner packaging and taking out the product, tighten the needle to the syringe and remove the protective cover, extract the drug liquid, exhaust the air and then inject. It is provided sterile. The sterilization method is EO sterilization and the sterilization assurance level is 10-6.

This document outlines the acceptance criteria and supporting study details for a Sterile Hypodermic Needle for Single Use (K231720) according to its 510(k) summary. This is not an AI/ML-based device, so many of the requested fields (especially those related to AI algorithm performance, human reader studies, and ground truth establishment for AI training/test sets) are not applicable.

The "device" in question is a physical medical device (hypodermic needles), not a software or AI-driven system. Therefore, the acceptance criteria and study descriptions are focused on physical and biological performance, rather than algorithm performance.

Acceptance Criteria and Device Performance for Sterile Hypodermic Needles for Single Use (K231720)

The substantial equivalence determination for this device is based on its compliance with established international and national standards for medical devices, rather than a comparative effectiveness study involving human readers or AI.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify exact sample sizes for each test. Testing of physical medical devices typically involves testing a statistically significant sample size from a production lot to demonstrate compliance with standards. The data provenance is implied to be from laboratory testing performed on the manufacturer's device, likely in China (where the manufacturer is located). The testing is prospective for the purpose of demonstrating compliance for this specific device model.

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

This information is not applicable as the device is a physical medical device (hypodermic needle), not an AI/ML diagnostic or image analysis system. Ground truth is established through validated laboratory test methods and established international/national standards, not through expert consensus in the medical imaging context.

4. Adjudication Method for the Test Set

This is not applicable as the ground truth is established through objective laboratory testing against defined standards (e.g., ISO, ASTM, USP), not through the adjudication of medical opinion.

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/ML-driven diagnostic aids that assist human readers in interpreting medical images. This device is a sterile hypodermic needle, a physical disposable medical tool.

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

No, a standalone performance evaluation in the context of an AI algorithm was not done. This is not an algorithmic device.

7. The Type of Ground Truth Used

The "ground truth" for this physical device is defined by the acceptance criteria specified in the referenced international standards (e.g., ISO 10993, ISO 7864, ISO 9626, ISO 80369, ASTM, USP). These standards define the physical, chemical, and biological properties a device must meet to be considered safe and effective for its intended use. Testing protocols outlined within these standards serve as the objective 'ground truth' against which the device's performance is measured. Compliance is determined by the device meeting all the specified numerical and qualitative requirements of these standards.

8. The Sample Size for the Training Set

This information is not applicable as there is no "training set" in the context of a physical medical device. The manufacturing process is controlled by Good Manufacturing Practices (GMP) and validated testing, not machine learning training.

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

This information is not applicable as there is no "training set" involved in the development or evaluation of this physical medical device.

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

The proposed device, Sterile Hypodermic Needles For Single Use, consists of a needle tube, needle hub and protective cap. The needle tube is made from stainless steel (SUS 304), the needle hub made of Polypropylene material (abb. PP) and the color complies with ISO 6009.The protective cap is made of PP and does not contact the patient. The conical fitting of Sterile Hypodermic Needles For Single Use is a luer that can be used with other medical devices which have 6% conical fitting. It is provided sterile with EO sterilization, and the sterilization assurance level (SAL) is 10-6. Additionally, each component is made from properly tested raw materials. And the Hypodermic Needles For Single Use are individually packaged in a sterile Sterile barrier.

This document is a 510(k) summary for a medical device (Sterile Hypodermic Needles for Single Use). It details the substantial equivalence of the proposed device to a predicate device, focusing on non-clinical performance and biocompatibility.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on compliance with a set of international and national standards, which dictate the performance and safety requirements for sterile hypodermic needles. The "reported device performance" is essentially the statement that the device complies with these standards.

Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria

The study conducted to prove the device meets the acceptance criteria is a non-clinical performance testing study. This type of study demonstrates equivalence by showing that the proposed device performs comparably to a legally marketed predicate device against established performance and safety standards.

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

• Test Set Sample Size: The document does not specify the exact sample sizes (number of units) used for each individual test (e.g., how many needles were tested for seal strength, how many samples for biocompatibility). It generally states that "Non-clinical tests were conducted to verify that the proposed device met all design specifications." However, for each listed standard (ISO, ASTM, USP), there are usually defined sample size requirements for the tests prescribed within that standard.
• Data Provenance: The document implies that the testing was performed by or for Zhejiang Kindly Medical Device Co., Ltd., based in Zhejiang Province, China. The testing appears to be retrospective, as it was completed before the 510(k) submission. No specific country of origin is mentioned for the data itself beyond the company's location.

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

• Not Applicable: For this type of medical device (sterile hypodermic needles) and the nature of the non-clinical performance testing, "ground truth" is not established by human experts in the way it would be for AI/imaging diagnostics. Instead, the ground truth is defined by the objective, quantified pass/fail criteria outlined in the referenced international standards (e.g., flow rate requirements, needle stiffness, biocompatibility limits). The "experts" involved are presumed to be the qualified laboratory personnel conducting the tests and interpreting the results against the standard's specifications. Their qualifications are not explicitly stated.

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

• None (Not Applicable): Adjudication methods like "2+1" or "3+1" are typically used in clinical studies, especially for evaluating diagnostic performance (e.g., radiology reads where multiple experts might disagree). This non-clinical study relies on objective, measurable parameters against established standard criteria, so human adjudication in this sense is not relevant.

4. 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 (Not Applicable): An MRMC study is relevant for evaluating the performance of AI-assisted diagnostic tools where human readers interpret medical images or data. This submission is for a physical medical device (hypodermic needles), not an AI diagnostic tool. Therefore, no MRMC study was performed.

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

• No (Not Applicable): This question also pertains to AI algorithm performance. A hypodermic needle does not involve an algorithm, nor does it have "human-in-the-loop performance" in the sense of a software-assisted task.

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

• Standard-defined Objective Criteria: The ground truth for this device is based on the objective, measurable pass/fail criteria specified within the referenced international standards (ISO, ASTM, USP). For example, a needle must meet specific force requirements for penetration, sterility levels, or biocompatibility limits as defined by these standards. This is fundamentally different from a diagnostic ground truth (e.g., confirmed pathology diagnosis for an image).

7. The sample size for the training set:

• Not Applicable: This device is a physical product, not a machine learning model. Therefore, there is no "training set." The performance is validated through direct physical and chemical testing.

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

• Not Applicable: As there is no training set, this question is not relevant.

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

The Sterile Hypodermic Needles for Single Use is intended for manual and single use only to aspirate and inject of fluids for medical purpose, which consists of needle and a needle hub. The proposed device is available in variety of needle length and needle gauge. The proposed device is compatible for use with a luer slip or luer lock syringe.

This information is pertaining to a 510(k) premarket notification for a medical device called "Sterile Hypodermic Needles for Single Use." This is a regulatory submission for a device, not a study of an AI algorithm. Therefore, many of the requested categories are not applicable.

Here's the relevant information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document indicates that the device was tested against recognized international standards for hypodermic needles. The "reported device performance" is essentially that the device "complied with" these standards.

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

• The document does not specify the exact sample sizes for each non-clinical test. It states that tests were "conducted" and "met" or "complied" with standards.
• Data Provenance: The document does not explicitly state the country of origin for the data (beyond the manufacturer being in China), nor whether it was retrospective or prospective. Given it's a 510(k) submission, the testing would generally be prospective to demonstrate compliance with standards.

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

• This is not applicable as this is not a study involving ground truth established by human experts for interpretive tasks. The evaluation is based on objective measurements against engineering and biological standards.

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

• Not applicable for non-clinical engineering and biological tests.

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 not an AI device or an MRMC study.

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

• Not applicable. This is not an AI algorithm.

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

• The "ground truth" for this device's evaluation consists of the acceptance limits and methodologies defined by recognized international and national standards (e.g., ISO, USP, ASTM). The device's performance is measured against these objective criteria.

8. The sample size for the training set:

• Not applicable. This is not a machine learning model; therefore, there is no "training set."

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

• Not applicable, as there is no training set.

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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. The Sterile 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 document, K211214, is an FDA 510(k) summary for a medical device: Sterile Hypodermic Needles for Single Use. This document outlines the manufacturer's claims that their device is substantially equivalent to an existing legally marketed predicate device (K180417 from Berpu Medical Technology Co., Ltd).

However, it's crucial to understand that this document describes a conventional medical device (a hypodermic needle), NOT an AI/ML-based device. Therefore, the questions related to AI/ML device testing (e.g., sample size for test/training sets, experts for ground truth, MRMC studies, standalone algorithm performance, effect size of human improvement with AI, ground truth establishment for training set) are not applicable to this submission.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" for a physical medical device like a hypodermic needle are based on performance testing against recognized industry standards (ISO standards, USP standards), and biocompatibility, sterilization, and shelf-life testing. These are fundamentally different from the validation methods for AI/ML algorithms.

Here's a breakdown of the requested information based on the provided document, addressing what is relevant and explicitly stating what is not applicable:

Acceptance Criteria and Device Performance (for a Hypodermic Needle)

1. Table of Acceptance Criteria and Reported Device Performance

For this conventional medical device, the "acceptance criteria" are compliance with various ISO and USP standards for physical and biological properties. The "reported device performance" is a statement that the device "meets the requirements" or "acceptance criteria" of these standards.

Information Relevant to AI/ML Device Testing (Not Applicable to this Device)

The following points are typically relevant for AI/ML-based medical devices but are not applicable to this 510(k) submission concerning a sterile hypodermic needle.

2. Sample size used for the test set and the data provenance: Not applicable. Testing involves physical samples of needles, not data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a needle is based on objective physical and chemical measurements against standards, not expert interpretation of AI outputs.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No human adjudication is involved in assessing a needle's compliance with ISO standards.
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 for AI-assisted diagnostic or interpretative devices.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For a hypodermic needle, "ground truth" is established by the specifications and performance requirements defined in the international standards (e.g., ISO 7864, ISO 9626, ISO 80369-7, ISO 10993 for biocompatibility) and direct physical/chemical measurements. It's not expert consensus on an image or pathology.
8. The sample size for the training set: Not applicable. There is no AI model to train.
9. How the ground truth for the training set was established: Not applicable. There is no AI model to train.

In summary: K211214 describes the regulatory clearance for a traditional medical device (hypodermic needle). The "acceptance criteria" and supporting "study" are engineering and biological validations demonstrating the device meets established international safety and performance standards for its physical form and intended use. The questions posed in your prompt are tailored for Artificial Intelligence/Machine Learning (AI/ML) medical devices, which operate under a entirely different set of validation and regulatory expectations than conventional devices.

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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 Self-destruction Safety Syringes for Single Use are intended to be used for medical purposes to inject fluid into or withdraw fluid from body. Its secondary intended use is to retract inside the safety barrel, contain the contaminated needle and aid in the prevention of accidental needle stick injuries.

The Sterile Hypodermic Syringes for Single Use are intended to be used for medical purpose to inject fluid into or withdraw fluid from body.

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 Safety Hypodermic Needles for Single Use are intended to be used with a luer slip or luer slip 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 Self-destruction Safety Syringes for Single Use are intended for single use only. The proposed device is available in 1mL, 3mL, 5mL, 10mL volumes with a 25 gauge, 25mm needle. The safety feature will be manually activated to retract the needle immediately after use to minimize risk of accidental needle sticks.

The Sterile Hypodermic Syringes for Single Use are intended for single use only, which consists of barrel, plunger and piston. The proposed device is available in 1mL, 2mL, 5mL, 10mL, 20mL, 30mL and 50mL volumes. The syringe is available in luer lock connector types which are intended to be connected with a hypodermic needle.

The Sterile Safety Hypodermic Needles for Single Use are intended for single use only, which consists of a hypodermic needle with a safety sheath attached to the needle hub. The proposed device is available in 18-27 gauge and 6-50 mm lengths. The safety sheath will be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.

The Sterile Hypodermic Needles for Single Use are intended for single use only. The proposed device is available in 14-30 gauge and 6-60 mm lengths.

The provided text is an FDA 510(k) summary for various medical devices, including "Self-destruction Safety Syringes for Single Use" and "Sterile Safety Hypodermic Needles for Single Use," which incorporate safety features to prevent accidental needle stick injuries. The summary describes the non-clinical tests performed to demonstrate substantial equivalence to predicate devices, focusing on physical, mechanical, chemical properties, sterility, shelf-life, and biocompatibility.

However, the provided document does not describe a study involving an AI-powered device or a multi-reader multi-case (MRMC) comparative effectiveness study. Instead, it focuses on the performance and safety of physical medical devices (syringes and needles). Therefore, I cannot extract the requested information related to acceptance criteria and study proving AI device performance, sample sizes for test and training sets, expert ground truth establishment, adjudication methods, or effects of AI assistance on human readers.

The section "Simulated Clinical Use" on page 8 of 13 does mention "pre-established criteria" and a study on 500 device samples for the safety features of the syringes and needles, but these are related to the physical device's function, not an AI or imaging diagnostic performance.

In summary, the provided document does not contain the information required to answer the prompt's specific questions about an AI device's acceptance criteria and performance study.

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