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The Sterile Hypodermic Syringes for Single Use with Needles is intended for use in the aspiration of fluids for medical purpose.

The Sterile Hypodermic Syringes for Single Use with Needles is intended for manual and single use only to aspirate and inject of fluids for medical purpose, which consists of piston, barrel, plunger and a hypodermic needle. The proposed device is available in a variety combination of syringe volume and needle size.

The provided text describes a 510(k) premarket notification for "Sterile Hypodermic Syringes for Single Use with Needles." This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study or a standalone algorithm evaluation.

Therefore, many of the requested sections about acceptance criteria, clinical studies, reader studies, and ground truth establishment are not applicable to this type of regulatory submission and the provided document.

Here's an analysis based on the available information:

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

The document does not present a table of acceptance criteria and reported device performance in the way a clinical study or standalone algorithm study would. Instead, it demonstrates compliance with recognized international standards for medical devices. 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 (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document describes non-clinical laboratory testing (e.g., physical performance, biocompatibility, sterilization validation) but does not detail the sample sizes for these tests or the data provenance. The tests are general in nature for medical device components and manufacturing processes, not related to patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable to this submission. Ground truth established by medical experts (like radiologists) is relevant for diagnostic devices or AI algorithms that interpret medical data. This submission is for a physical medical device (syringes and needles). The "ground truth" here is compliance with engineering and material standards, which is assessed through laboratory testing by qualified personnel, not by medical experts establishing diagnostic ground truth.

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

This is not applicable to this submission. Adjudication methods are typically used in clinical trials or reader studies where multiple human readers or algorithms provide interpretations that need to be resolved to establish a definitive ground truth. The testing described here is based on 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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices or decision support systems. The device in question is a sterile hypodermic syringe with needles, which is a physical device used for aspiration and injection, not an AI or diagnostic tool.

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

A standalone performance study for an algorithm was not done. This device is not an algorithm.

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

The "ground truth" for the device's performance is established by international standards and regulations for the physical, chemical, and biological properties of sterile hypodermic syringes and needles. This includes:

• Physical performance requirements (e.g., according to ISO 7886-1, ISO 7864, ISO 9626)
• Biocompatibility (e.g., according to ISO 10993-1)
• Sterility Assurance Level (SAL) (e.g., according to ISO 11135)
• Particulate matter levels (e.g., according to USP )
• Endotoxin levels (e.g., according to USP )

These are objective, measurable criteria, not subjective interpretations requiring expert consensus or pathology reports.

8. The sample size for the training set

This is not applicable. This device is a physical medical product, not an AI algorithm that requires a training set.

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

This is not applicable. As stated above, this device is not an AI algorithm and therefore does not have a "training set" or "ground truth for a training set."

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The Sterile Hypodermic Syringes for Single Use with Safety Needles 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 Hypodermic Syringes for Single Use with Safety Needles is intended for manual and single use only to aspirate and inject of fluids for medical purpose, which consists of piston, barrel, plunger and a hypodermic needle with a safety mechanism. The proposed device is available in a variety combination of syringe volume and needle size.

The provided text describes the regulatory clearance (510(k)) for the "Sterile Hypodermic Syringes for Single Use with Safety Needles" by Sichuan Prius Biotechnology Co., Ltd. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study report for AI-powered medical devices. Therefore, much of the requested information regarding AI-specific studies (e.g., sample sizes for test/training sets, number of experts for ground truth, MRMC study, standalone performance) is not applicable or present in this given text.

However, I can extract the acceptance criteria and performance data for the non-clinical functional and safety aspects of the device, as well as general information about testing methodologies.

1. Table of acceptance criteria and the reported device performance:

The following questions are not applicable as the document describes a traditional medical device (syringes with safety needles) and not an AI/ML-powered device:

2. Sample size used for the test set and the data provenance: Not applicable. The testing described is for physical characteristics and biological safety, not a "test set" in the AI/ML context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. This refers to expert review for AI/ML model training/validation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for an AI context. For physical device testing, "ground truth" is established by the specified ISO/ASTM standards and their associated test methods for measuring properties (e.g., strength, sterility, dimensions).
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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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 Disposable Syringe is intended for manual and single use only, which consists of barrel, plunger and piston. The syringe is available in luer slip and luer lock two connector types which are intended to be connected with a hypodermic needle. The proposed device is available in a variety syringe volume. Syringe volume: 1ml, 2ml, 3ml, 5ml, 20ml, 30ml, 50ml, 60ml, 100ml

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 5 years.

This document is a 510(k) Summary for a medical device called "Sterile Hypodermic Syringes for Single Use" (K221079). It focuses on demonstrating substantial equivalence to a predicate device (K180417) rather than providing detailed acceptance criteria and a study proving device performance in the context of an AI/algorithm-based device.

Therefore, many of the requested categories for acceptance criteria and study details for an AI/algorithm device (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set size, ground truth for training set) are not applicable to this submission.

However, I can extract the relevant information regarding the performance criteria and the non-clinical studies conducted to demonstrate its safety and effectiveness against recognized standards.

Here's the breakdown of the available information:

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

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable. This document pertains to a physical medical device (syringes), not an AI/algorithm. Performance is demonstrated through non-clinical laboratory testing of the manufactured product, not data analysis of a test set in the context of AI. The country of origin for the device manufacturer is China (Sichuan Prius Biotechnology Co., Ltd.). The studies are non-clinical, involving physical testing of the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. Ground truth, in the context of AI/algorithm performance, is not relevant here. Performance is measured against recognized industry standards and validated laboratory methods for physical device characteristics (e.g., sterility, biocompatibility, mechanical performance).

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

• Not Applicable. Adjudication is a method for resolving discrepancies in expert labeling or diagnoses used in AI/algorithm studies. It is not relevant for the non-clinical testing of a physical device.

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 a physical medical device, not an AI-assisted diagnostic tool. Therefore, MRMC studies and the concept of human reader improvement with AI assistance are not relevant.

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

• Not Applicable. This refers to the performance of an AI algorithm. This submission is for a physical syringe.

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

• For the performance of this physical device, the "ground truth" is defined by compliance with established international and national standards (e.g., ISO for syringe performance, biocompatibility, sterility; USP for particulate matter and endotoxins) and validated test methodologies.

8. The sample size for the training set

• Not Applicable. Training sets are used for machine learning. This submission is for a sterile syringe.

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

• Not Applicable. This question relates to AI/machine learning model development, which is not relevant to this medical device submission.

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The Sterile Hypodermic Syringes for Single Use are intended to be used for medical purposes on adult and pediatric population to inject fluids into or withdraw fluids from the body.

The Sterile Hypodermic Syringe for Single Use is intended for single use only, which consists of barrel, plunger and piston. The proposed device is available in a variety syringe volume. The syringe is available in luer slip and luer lock two connector types which are intended to be connected with a hypodermic needle.

The provided text is a 510(k) summary for a medical device (Sterile Hypodermic Syringe for Single Use) and does not contain information about acceptance criteria and study details as typically found for AI/ML-based medical devices. The document focuses on demonstrating substantial equivalence to a predicate device based on non-clinical performance, material comparisons, and adherence to recognized standards.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set specifics, as these are not discussed in the provided text.

The document primarily outlines:

1. Device Description: Sterile Hypodermic Syringe for Single Use, consisting of a barrel, plunger, and piston, available in various volumes and luer slip/luer lock connector types.
2. Indication for Use: Intended for medical purposes on adult and pediatric populations to inject fluids into or withdraw fluids from the body.
3. Predicate Device: K210227, Sterile syringe for single use with/without needle.
4. Comparison to Predicate: Differences noted include volume specifications, piston material (Polyisoprene Rubber vs. Silicone Rubber), patient population explicit mention, and shelf-life (5 years vs. 3 years). These differences are argued not to affect safety and effectiveness.
5. Non-Clinical Test Performance Testing: The device was tested for conformance with:
   • ISO 7886-1:2017 (Sterile hypodermic syringes for single use)
   • ISO 80369-7: 2016 (Small-bore connectors for liquids and gases in healthcare applications)
   • Biocompatibility Testing (ISO 10993-1): Cytotoxicity, Sensitization, Intracutaneous Reactivity Test, Acute Systemic Toxicity, Hemocompatibility, Pyrogenicity.
   • Particulate Matter Testing: USP .
   • Sterile Barrier Packaging Test: Visual inspection (ASTM F1886/F1886M-16), seal strength (ASTM F88/F88-15), and dye penetration test (ASTM F1929-15).
   • Sterilization and Shelf Life Test: Validated per ISO 11135, including EO residue, ECH residue (ISO 10993-7:2008), Bacteria Endotoxin Limit (USP ), and Shelf Life Evaluation (physical, mechanical, chemical, package tests on aging samples).

The document declares that the device is substantially equivalent to the predicate based on these non-clinical tests and comparisons. It does not involve AI/ML components or the types of studies typically associated with such technologies.

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The Sterile hypodermic syringes for single use are intended to inject fluids into or withdraw fluids from the body.

The Sterile hypodermic syringes for single use are intended for manual and single use only to aspirate and inject of fluids for medical purpose, and consist of syringe (barrel, plunger, piston) and hypodermic needle (needle tube, hub, needle cap). The proposed device is available in a variety of syringe and needle sizes.

The provided text describes the 510(k) summary for "Sterile hypodermic syringes for single use" and does not contain information about an AI/ML powered medical device. Therefore, it's not possible to extract information related to acceptance criteria or studies performed for such a device.

The document focuses on demonstrating the substantial equivalence of the subject device (syringes) to a predicate device based on material, design, performance, and compliance with established standards (ISO, ASTM, USP).

Specifically, the provided information does not include:

• A table of acceptance criteria and reported device performance for an AI/ML device.
• Sample size for a test set or data provenance for an AI/ML device.
• Number of experts or their qualifications for establishing ground truth for an AI/ML device.
• Adjudication methods for an AI/ML device.
• Multi-reader multi-case (MRMC) comparative effectiveness study or effect size for AI assistance.
• Standalone performance for an AI/ML algorithm.
• Type of ground truth used for an AI/ML device study.
• Sample size for a training set for an AI/ML device.
• How ground truth for the training set was established for an AI/ML device.

The 'Performance data' section lists various tests performed on the syringes, such as biocompatibility, sterilization, shelf-life, and physical performance tests according to ISO and ASTM standards. These are standard tests for physical medical devices to ensure their safety and effectiveness.

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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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