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The Sterile Syringe with Safety Needle is 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 needle sticks.

The Sterile Disposable Syringe with Safety Needle is intended for manual and single use only. It consists of a hypodermic needle with a safety sheath attached to the needle hub and a luer slip or luer lock syringe. The subject device is available in a variety of syringe volumes and needle sizes. The safety sheath is manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.

The provided FDA 510(k) summary (K211753) is for a Sterile Syringe with Safety Needle. This document outlines the premarket notification for a Class II medical device, comparing it to a predicate device (K193526) to demonstrate substantial equivalence.

It's important to note that this document does not describe AI/ML device performance or studies proving such performance. This is a traditional medical device submission, focusing on compliance with established engineering and safety standards for the physical product.

Therefore, many of the requested elements pertaining to AI/ML device performance, such as sample size for test/training sets, data provenance, expert adjudication, MRMC studies, standalone algorithm performance, and ground truth establishment for AI models, are not applicable to this document.

The document primarily focuses on:

• Indications for Use: The device is for aspiration and injection of fluids, with a safety shield to prevent needle sticks.
• Technological Characteristics: Comparison of physical attributes like syringe volume, needle gauge, length, and material.
• Performance Standards: Compliance with international standards for syringes, needles, luer connectors, and sterilization.
• Biocompatibility: Leveraged from a previously cleared device (K163161) due to identical patient contact materials.

However, I can extract information related to the physical device's "acceptance criteria" and the "study that proves the device meets the acceptance criteria" in the context of this traditional medical device submission.

Here's the breakdown based on the provided text, focusing on the physical device performance and safety, not AI/ML:

Acceptance Criteria and Study for Sterile Syringe with Safety Needle (K211753)

The acceptance criteria for this device are primarily defined by compliance with recognized international and national standards for medical devices, particularly those related to syringes, needles, luer connectors, biocompatibility, and sterility. The studies proving the device meets these criteria are non-clinical bench tests.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify the exact sample sizes used for each individual non-clinical bench test. These are typically defined by the testing standards (e.g., ISO, ASTM).
• Data Provenance: The tests were conducted to demonstrate compliance with international standards (ISO, ASTM, USP). The manufacturing entity is Jiangxi Hongda Medical Equipment Group Ltd. in China. The testing would have been conducted by the manufacturer or a certified testing laboratory. The data is retrospective in the sense that the testing was completed prior to submission for clearance.

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 traditional medical device (syringe with safety needle), not an AI/ML device relying on expert consensus for ground truth. Compliance is determined by objective physical and chemical testing against established engineering and biological standards.

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

• Not Applicable. As above, this is a traditional medical device; "adjudication" in the context of clinical reads or expert consensus for AI models is not relevant here. Test results are compared directly against the quantitative and qualitative requirements of the referenced 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 document refers to a physical medical device (syringe), not an AI/ML diagnostic or assistive tool. MRMC studies are irrelevant for this type of submission.

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

• Not Applicable. There is no algorithm or software component described in this submission that would require standalone performance testing.

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

• Bench Testing Standards and Specifications: The "ground truth" for this device is its adherence to the performance requirements stipulated in the referenced international and national standards (e.g., ISO 7886-1 for syringe performance, ISO 9626 for needle tubing, ISO 80369-7 for luer connectors, ISO 10993 for biocompatibility, etc.). These standards define the acceptable mechanical, physical, chemical, and biological properties of the device.

8. The sample size for the training set

• Not Applicable. This is a hardware medical device, not an AI/ML model that requires a training set.

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

• Not Applicable. As above, there is no AI/ML training set.

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The Medical Nitrile Examination Gloves (Powder free, Blue) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The proposed device is Powder Free Nitrile Examination Gloves and has different size specification and color. The proposed device is provided in non-sterile. The proposed device is made of Nitrile. The proposed device has different size specification to the predicate device, but all proposed devices are meet the specifications of ASTM D6319.

This document is a 510(k) Summary for Medical Nitrile Examination Gloves. The acceptance criteria and the study proving the device meets these criteria are detailed as follows:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily defined by relevant ASTM and ISO standards, and the device performance is reported as complying with these standards.

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

The document does not explicitly state the sample sizes for each specific test (e.g., number of gloves tested for physical properties, number of animals for biocompatibility tests). However, it implies that the tests were conducted according to the methodologies prescribed by the referenced standards (ASTM D6319, ASTM D5151, ASTM D6124, ISO 10993-10, ISO 10993-11), which would include sample size requirements.

The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective nature of the data. However, the manufacturer is Jiangxi Hongda Medical Equipment Group Ltd. from China, and the testing results seem to be specific to their manufactured gloves. These appear to be prospective studies conducted specifically for this 510(k) submission to demonstrate compliance.

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

This information is not applicable to this type of device submission. The "ground truth" for medical gloves is established through objective physical, chemical, and biological testing against recognized international standards (ASTM and ISO), not through expert consensus or interpretation of images.

4. Adjudication Method for the Test Set

This information is not applicable as the evaluations are based on objective laboratory testing against predefined criteria in standards, not subjective assessments requiring expert 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

This information is not applicable. This is a submission for medical gloves, a physical device, and does not involve AI software or human readers for diagnostic interpretation.

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

This information is not applicable. This is a submission for medical gloves, a physical device, and does not involve an algorithm.

7. The Type of Ground Truth Used

The ground truth used for this device is based on objective measurements and laboratory testing results compared against the specifications defined in recognized international standards:

• ASTM D6319-19 (Standard Specification for Nitrile Examination Gloves for Medical Application)
• ASTM D5151-19 (Standard Test Method for Detection of Holes in Medical Gloves)
• ASTM D6124-17 (Standard Test Method for Residual Powder on Medical Gloves)
• ISO 10993-10:2010 (Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization)
• ISO 10993-11:2017 (Biological evaluation of medical devices - Part 11: Tests for systemic toxicity)

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical product (medical gloves), not an AI algorithm, and therefore does not have a training set.

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

This information is not applicable as there is no training set for this device.

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The Medical PVC Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The proposed device, Medical PVC Examination Gloves are disposable devices intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The proposed device is Powder Free Vinyl Patient Examination Gloves. The proposed device is clear, non-colored. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250.

The proposed device is not provided as sterilized

The proposed device is made of vinyl chloride.

The provided text describes the 510(k) submission for "Medical PVC Examination Gloves" and does not contain information about a study proving the device meets acceptance criteria in the context of an AI/ML medical device. The document explicitly states the device is a physical product (gloves) and outlines its physical and performance specifications, as well as biocompatibility tests.

Therefore, I cannot provide the requested information for acceptance criteria and a study from an AI/ML perspective because the provided document is not about an AI/ML device.

However, I can extract the acceptance criteria and reported device performance for the Medical PVC Examination Gloves based on the provided document.

Acceptance Criteria and Reported Device Performance (for Medical PVC Examination Gloves):

Regarding the other requested points for an AI/ML study, the document does not provide the information:

2. Sample sizes used for the test set and the data provenance: Not applicable, as this is a physical medical device (gloves).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable.
6. If a standalone performance (i.e. algorithm only, without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable. The "ground truth" for these gloves is established by laboratory testing against physical and chemical standards.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The study described in this 510(k) summary is a series of bench tests conducted to verify that the proposed device (Medical PVC Examination Gloves) met design specifications and was substantially equivalent to the predicate device. These tests align with the listed ASTM and ISO standards for physical properties, performance, and biocompatibility of examination gloves. The document states: "The test results demonstrated that the proposed device complies with the following standards: ASTM D5250-19, ASTM D5151-19, ASTM D6124-17, ISO 10993-10:2010, ISO 10993-11:2017."

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The device is intended to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein.

The proposed device is intended to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the action of gravity. The proposed device is provided with/without injection needle. It is comprised of protective cap of spike, air vent, air filter, drip chamber, fluid filter, flexible tube, injection site, roller clamp, luer lock connector, protector cap of luer lock connector. The devices are provided sterile and single use.

The provided text is a 510(k) summary for a Sterile Single-use Infusion Set. It describes the non-clinical tests performed to demonstrate substantial equivalence to a predicate device, rather than a clinical study of AI performance. Therefore, many of the requested categories regarding AI-specific studies (e.g., sample size for test set, number of experts, MRMC study, standalone performance, training set details) are not applicable to this document.

However, I can extract the acceptance criteria and reported device performance from the non-clinical test conclusions.

Acceptance Criteria and Device Performance for Sterile Single-use Infusion Set

Here's an analysis of the study based on your requested items:

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

   • See table above. The performance is reported as meeting the specified standards (e.g., ISO, ASTM, USP) or specific numerical/qualitative criteria.

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

   • The document does not specify sample sizes for individual non-clinical tests.
   • The tests were conducted by a Chinese manufacturer (Jiangxi Hongda Medical Equipment Group, Ltd. in Nanchang City, Jiangxi Province, China). The data provenance is China.
   • These are prospective tests conducted on the manufactured device 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 (e.g. radiologist with 10 years of experience)

   • This document describes non-clinical engineering and biological tests, not an AI or diagnostic study involving human expert interpretation for ground truth. Therefore, this question is not applicable. The "ground truth" for these tests is defined by the technical specifications of international and national standards.

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

   • Not applicable, as this is not a study involving human adjudication of results for a diagnostic or AI algorithm.

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

   • No MRMC or AI-related study was done. This is a 510(k) submission for a physical medical device (infusion set), not an AI algorithm. Therefore, this question is not applicable.

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

   • No standalone AI algorithm performance study was done. This is not an AI device. Therefore, this question is not applicable.

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

   • The "ground truth" for the non-clinical tests is based on established international and national standards (e.g., ISO 8536-4, ISO 9626, ISO 7864, ISO 594-1, ISO 594-2, ASTM F88, ASTM F1140, ASTM F1929, ISO 10993-7, USP 36-NF 31). These standards define the acceptable performance limits and methodologies for testing.

8. The sample size for the training set

   • Not applicable. This is not an AI device or a machine learning study.

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

   • Not applicable. This is not an AI device or a machine learning study.

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Sterile Single-use Syringe with Needle is intent fluids into or withdraw fluids from the body.

The proposed devices are for single use only, which are comprised of syringes and needles with various specifications. The syringe consists of barrel, plunger, piston, and the needle consists of needle tube, needle hub, needle cap. The proposed devices shall be operated manually, are not intended for use with syringe pumps. All specifications of proposed devices subject to the same design and the difference between each specification is syringe volume and needle size. The proposed devices are available in a variety combination of needle size and syringe volume.

The provided text describes a 510(k) premarket notification for a "Sterile Single-use Syringe with Needle." This document outlines the device's technical specifications and the testing conducted to demonstrate its substantial equivalence to a predicate device.

Crucially, this document is for a medical device (syringe with needle), not an AI/ML software device. Therefore, the concepts of acceptance criteria for AI model performance, test/training sets for algorithms, ground truth established by experts, MRMC studies, or standalone algorithm performance are not applicable to this submission.

The "acceptance criteria" discussed in this document refer to adherence to established international and national standards for physical, mechanical, chemical, and biological properties of syringes, needles, and packaging. The "study that proves the device meets the acceptance criteria" refers to the non-clinical bench testing and biocompatibility assessments conducted according to these standards.

Here's an interpretation of the information provided within the context of a medical device submission, recognizing it does not fit the AI/ML framework:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are defined by various clauses within a range of ISO and ASTM standards. The reported device performance is that the "non-clinical tests were conducted to verify that the proposed devices met all design specifications and are Substantially Equivalent (SE) to the predicate device." The document implies that the device passed these tests, thereby meeting the acceptance criteria set by these standards.

Since this document is not about an AI/ML device, the remaining points are addressed as "Not Applicable" for AI/ML concepts, or reinterpreted in the context of a traditional medical device submission if relevant.

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

• Test Set: The document does not specify exact sample sizes for each physical, mechanical, chemical, sterility, or biocompatibility test. It indicates "tests were performed on real time aging samples" for shelf life, implying prospective testing for that aspect. Other tests are generally conducted on representative samples of the manufactured device.
• Data Provenance: The manufacturing company is JiangXi HongDa Medical Equipment Group Ltd. in China. The testing was likely performed in China, but the document does not explicitly state the country of origin for the testing data. The testing is performed on the proposed device itself, not on human data.
• Retrospective/Prospective: Shelf-life testing is prospective (real-time aging). Other tests are typically performed on newly manufactured devices, which could be considered prospective testing for that specific batch.

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 (for AI/ML ground truth): Ground truth in this context refers to the verifiable performance of the physical device against established engineering and biological standards. There are no "experts" establishing ground truth in the AI/ML sense (e.g., clinicians labeling images). The standards themselves define the ground truth, and the testing methodology is designed to objectively measure compliance. The "experts" would be the engineers and technicians performing the tests, qualified in areas of materials science, mechanical testing, chemistry, microbiology, and biocompatibility.

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

• Not Applicable (for AI/ML adjudication): This concept does not apply to the physical testing of a syringe and needle. Test results are objectively measured against defined limits in the 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 a physical medical device, not an AI-assisted diagnostic tool. No MRMC study was performed.

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

• Not Applicable: This is a physical medical device, not an algorithm.

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

• Ground Truth (for physical device): The "ground truth" for this device is its adherence to the predefined physical, mechanical, chemical, sterility, and biocompatibility specifications as outlined in the referenced ISO and ASTM standards. This is determined by quantitative measurements and qualitative assessments described in these standards, rather than expert consensus on a diagnostic outcome or pathology.

8. The sample size for the training set

• Not Applicable: This is a physical medical device, not an AI/ML algorithm. There is no "training set."

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

• Not Applicable: This is a physical medical device. There is no "training set" or ground truth established for training.

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The Sterile Hypodermic Safety Syringes for Single Use is intended to be used for medical purpose to inject fluids into or withdraw fluids from the body. After injection, the anti-needlestick feature is manually activated to aid in the prevention of accidental needle stick injuries.

The proposed devices are for single use only, which are comprised of syringes and needles with various specifications. The proposed devices are available in a variety combination of needle sizes and syringe volumes. All specifications of proposed devices subject to the same design. The proposed devices are intended for manual use only.

The provided text describes the 510(k) summary for the "Sterile Hypodermic Safety Syringes for Single Use". This document focuses on demonstrating substantial equivalence to a predicate device, rather than defining and proving acceptance criteria for a novel AI device or a device requiring extensive clinical trials to establish effectiveness.

Therefore, many of the requested elements for an AI or complex medical device study (such as MRMC studies, training set details, expert ground truth adjudication) are not applicable or described in this document. The study described is primarily non-clinical verification and a simulated clinical study for the safety mechanism.

Here's a breakdown of the information that is available in the document, framed as closely as possible to your request, and identifying where information is not present:

Acceptance Criteria and Device Performance for Sterile Hypodermic Safety Syringes

The device in question is a "Sterile Hypodermic Safety Syringes for Single Use". The study presented is a 510(k) submission to demonstrate substantial equivalence to a legally marketed predicate device (K072739), not to establish novel acceptance criteria for a new type of functionality (like AI performance).

The "acceptance criteria" are derived from recognized international standards and FDA guidance for this class of medical device (syringes). The "reported device performance" refers to the results of testing performed against these standards.

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various tests conducted with reference to specific ISO and ASTM standards. The reported device performance is generally stated as "met all design specifications" or "demonstrated substantial equivalence" with the predicate device.

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

The document specifies that "Non clinical tests were conducted to verify that the proposed device met all design specifications". Specific sample sizes for each test are not provided in this summary. The data provenance is from JiangXi HongDa Medical Equipment Group Ltd. in Nanchang City, Jiangxi Province, China, indicating the testing was performed by the manufacturer, likely in China. The studies are non-clinical, meaning they involve laboratory or bench testing of the device itself, rather than human subjects.

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

This point is not applicable. For a device like a safety syringe, "ground truth" as requested (e.g., related to disease diagnosis or outcome based on expert consensus) is not established by medical experts for the performance tests listed. The "ground truth" for the non-clinical tests is the performance against the specified engineering and material standards.

4. Adjudication method for the test set

This point is not applicable. No adjudication by experts is described for these non-clinical performance and safety tests. The results are quantitative measurements against predefined 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

This point is not applicable. The device is a sterile hypodermic safety syringe, not an AI-assisted diagnostic or therapeutic device. Therefore, no MRMC study, human reader improvement, or AI component is involved.

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

This point is not applicable as the device is not an algorithm or AI system. Its performance relates to its physical and mechanical properties and its safety mechanism.

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

The ground truth used for the non-clinical tests is based on the objective measurements and results obtained when testing the device against the specified physical, mechanical, chemical, and biological criteria defined in the referenced ISO and ASTM international standards, as well as FDA guidance. For the simulated clinical study and safety feature test, the "ground truth" refers to meeting the pre-established criteria specified in the FDA guidance and demonstrating functional equivalence to the predicate device, respectively.

8. The sample size for the training set

This point is not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

This point is not applicable as there is no "training set" for this device.

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