Search Results

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.

Ask a specific question about this device

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.

This is an FDA 510(k) clearance letter for a medical device, specifically Sterile Safety Hypodermic Needles for Single Use. The primary purpose of this document is to establish substantial equivalence to a predicate device, not to present a detailed study on the device's original performance against a specific set of acceptance criteria with explicit human reader performance metrics, as would be typical for an AI/ML medical device.

Therefore, many of the requested items (e.g., sample size for test set with ground truth, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, training set details) are not applicable to this type of device clearance and the information provided in this document.

However, I can extract the acceptance criteria and performance data that are relevant to this type of conventional medical device.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:
This document describes a premarket notification for a conventional medical device (hypodermic needles), not an AI/ML device. Therefore, there isn't a "test set" in the context of diagnostic performance evaluation with specific data provenance (country of origin, retrospective/prospective clinical data) as requested. The performance is assessed through engineering and biological testing against established international and national standards. The sample sizes for these tests would be determined by the specific standards and protocols followed (e.g., number of units tested for particulate matter, tensile strength, sterility, etc.), but are not detailed in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth, in the context of AI/ML, refers to a definitive diagnosis or finding. For this device, ground truth is established by objective measurements and standardized testing against predefined physical, chemical, and biological properties as specified in the referenced ISO, ASTM, and USP standards. The "experts" involved would be the qualified personnel performing the laboratory and engineering tests, whose qualifications are implicit in their ability to conduct these standardized tests accurately.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This device does not involve human interpretation of outputs that would require adjudication for establishing ground truth in a diagnostic context.

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/ML device, and no human reader studies are mentioned or relevant for its clearance.

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this device's performance is established by objective measurements and results from standardized laboratory and engineering tests (e.g., sterility testing, material strength, biocompatibility assays, particulate counts, sharps injury prevention mechanism functionality) against predefined acceptance criteria established in international and national standards.

8. The sample size for the training set:
Not applicable. This is not an AI/ML device. There is no concept of a "training set" for this type of medical device clearance.

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

Ask a specific question about this device

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 Safety 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 1) Needle, 2) Safety shield, 3) Protective Cap, 4) Needle Hub. The proposed device is available in a variety needle length and needle gauge. The proposed device is compatible for use with a luer slip or 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.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) summary:

This device, Sterile Safety Hypodermic Needles for Single Use (K221080), is a medical device and therefore its acceptance criteria and validation studies are primarily focused on demonstrating its safety and effectiveness, often by showing substantial equivalence to a legally marketed predicate device.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are largely based on compliance with recognized international standards and demonstration of comparable performance to the predicate device.

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

The document specifies "test sets" for various non-clinical tests. However, it does not provide specific numerical sample sizes for each test. For example, it states:

• Simulated Clinical Study: "A simulated clinical study was performed on proposed device according to FDA Guidance... and ISO 23908:2011 to evaluate the safety mechanism of the proposed device."
• Safety Feature Test: "The safety feature test was performed on both proposed device and predicate device..."
• Biocompatibility Testing: "The following testing was conducted: Cytotoxicity, Irritation, Skin Sensitization, Acute Systemic Toxicity, Pyrogenicity, Hemolysis, Material Mediated Toxicity."

The data provenance is retrospective in the sense that these are non-clinical (laboratory/bench) tests conducted by the manufacturer as part of the premarket submission. The country of origin of the data is not explicitly stated for each test, but the manufacturing company (Sichuan Prius Biotechnology Co., Ltd.) is based in China. The adherence to international ISO and ASTM standards implies a global applicability of the testing methodologies.

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

This type of device (hypodermic needle) does not involve subjective interpretation or a "ground truth" derived from human experts in the same way an AI diagnostic device would. The "ground truth" for these tests are the objective acceptance criteria defined by the recognized standards (e.g., a specific force required for needle penetration, a certain level of extractable chemicals, or a maximum particle count). Therefore, no human experts were used to establish ground truth in the context of diagnostic interpretation. The experts involved would be those performing and interpreting the bench and lab tests according to the standards, but not interpreting "cases" for a diagnostic task.

4. Adjudication method for the test set

Not applicable. This is not a diagnostic device requiring adjudication of expert interpretations for a test set. The tests are objective measurements against established international 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 device is a sterile safety hypodermic needle, not an AI diagnostic tool. Therefore, MRMC studies and AI assistance comparisons are not relevant.

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

Not applicable. This device is a physical medical instrument, not an algorithm.

7. The type of ground truth used

The ground truth used for this device's evaluation is primarily objective metrics derived from recognized international standards (e.g., ISO, ASTM, USP) and the FDA's guidance documents. These standards define measurable acceptance criteria for device performance, safety features, biocompatibility, sterility, and shelf-life.

8. The sample size for the training set

Not applicable. This device is a physical medical instrument evaluated through non-clinical testing against standards, not a machine learning algorithm that requires a training set.

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

Not applicable, as there is no training set for a physical device.

Ask a specific question about this device

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.

Ask a specific question about this device