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The AUTO DISABLE SYRINGE is intended for use in the suction of vaccine for medical purposes. Additionally , after injection to the body, the plunger can be automatically locked by the triggered mechanism to prevent the re-use of this syringe.

The AUTO DISABLE SYRINGE is designed for the hypodermic injection of the intended micro scale solution. It has the automatic function in the structure of the syringe which after injection of an intended fixed dose locks the syringe to prevent re-use of the syringe. It can be widely used for injection of vaccine for the immunization.
The syringe consists of a calibrated hollow barrel, a movable plunger, a rubber stopper (piston) assembled at end of the plunger, and a steel clip installed between the barrel and the plunger that functions to prevent re-use of the syringe.
At the end of the barrel, a fixed an unmovable needle is installed, and a needle cap covers the needle. The zero line and nominal capacity line are printed outside of barrel. The main materials are PP, latex free (polyisoprene rubber) and stainless steel.

This document describes the regulatory approval for an "Auto Disable Syringe" (K210464). The acceptance criteria are essentially the compliance with various international standards, and the "study" that proves the device meets these criteria is a series of non-clinical, functional performance, sterility, shelf-life, and biocompatibility tests.

Here's the breakdown of the requested information:

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

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 explicitly state the specific sample sizes for each test mentioned (e.g., how many syringes were tested for flow rate, or how many were used in biocompatibility studies). It broadly states that the "AUTO DISABLE SYRINGE described in this summary were tested".

Regarding data provenance:

• Country of Origin: The manufacturer is Anhui Tiankang Medical Technology Co., Ltd. from Tianchang, Anhui, China. It is highly probable that the non-clinical testing was performed in China or by labs commissioned by the Chinese manufacturer.
• Retrospective or Prospective: The testing described (functional performance, sterility, shelf-life, biocompatibility) is typically prospective and conducted specifically for regulatory submission to demonstrate compliance with standards and safety/effectiveness 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)

This is a medical device (syringe), not an AI/diagnostic imaging device. Therefore, the concept of "experts establishing ground truth for a test set" in the context of medical image interpretation (e.g., radiologists) does not apply. The "ground truth" for this device's performance is established by objective measurements against recognized international standards through laboratory testing.

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

Not applicable. As noted above, this device's performance is determined by objective physical, chemical, and biological tests against established standards, not by human interpretation that would require 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 a physical medical device (syringe), not a diagnostic imaging device utilizing AI.

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

Not applicable. This is a physical medical device (syringe), not an algorithm or AI.

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

The "ground truth" for this device is established by objective measurements and pass/fail criteria defined by recognized international standards (e.g., ISO, ASTM, USP). For example:

• Functional performance: Measurements of flow rate, penetration force, bonding strength, tolerance on nominal capacity, etc., against predefined limits in standards like ISO 7864, ISO 7886, ISO 9626.
• Sterility: Demonstrated sterile assurance level (SAL) of 10-6 per ISO 11135.
• Biocompatibility: Absence of cytotoxic, sensitizing, irritating, systemic toxic, pyrogenic, or hemocompatible effects as determined by tests outlined in ISO 10993 series.
• Shelf-life: Maintenance of package integrity and device functionality over a specified period (5 years) as per ASTM F1980.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI model, so there is no "training set."

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

Not applicable. As there is no training set for a physical medical device.

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The TK Insulin Syringe with Safety Retractable Device is a sterile, single-use, disposable and non-reusable, manual retractable safety insulin syringe intended for injection of U-100 insulin into the body, while reducing the risk of sharps injuries and the potential for insulin syringe reuse.

The TK Insulin Syringe is a sterile, single-use, disposable, insulin syringe intended for injection of U-100 insulin into the body.

The TK Insulin Syringe with/without Safety Retractable Device are similar devices except one has a safety feature and the other is a standard insulin syringe.

The TK Insulin Syringe with/without Safety Retractable Device is an integrated needle and piston syringe with an anti-needle-stick mechanism. The mechanism allows clear visualization of the injection site at all times. The mechanism shows the needle is contained within the syringe barrel. After standard techniques for injection, the plunger is withdrawn and snapped off which renders the needle unusable and prevents accidental needle sticks. The used syringe is then discarded into a sharp's container.

The subject devices are sterile, single-use, disposable and non-reusable, insulin syringe intended for injection of U-100 insulin into the body.

The provided text describes a 510(k) premarket notification for the "TK Insulin Syringe with/without Safety Retractable Device." The submission aims to demonstrate substantial equivalence to a predicate device, the "U&U Insulin Syringe with/without Safety Retractable Device."

Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided document:

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

The document does not explicitly present a table of acceptance criteria with corresponding reported device performance values. Instead, it relies on demonstrating conformance to established international and national standards. The implicit acceptance criteria are defined by these standards, and the reported performance is that the device "conforms" to them.

Here's a summary of the standards the device was tested against, which serve as the implicit acceptance criteria:

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

The document does not specify the sample sizes used for any of the non-clinical tests performed on the subject device (e.g., number of syringes tested for performance standards, number of samples for biocompatibility).

The data provenance for these tests is that they were "performed on the subject device" by the manufacturer, Anhui Tiankang Medical Technology Co.,Ltd. The origin of the data would be associated with the manufacturing and testing facility in Tianchang City, Anhui, China. The studies are by nature prospective, as they involve testing the newly manufactured device against established criteria.

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

This information is not applicable to this type of device submission. The "ground truth" for insulin syringes and needles is established by internationally recognized performance and safety standards (e.g., ISO, USP), not by expert consensus on individual test instances in the way one might evaluate an AI diagnostic tool. The compliance with these standards is objectively measurable through predefined test methods.

4. Adjudication method for the test set

This information is not applicable. Since the evaluation is based on conformance to objective standards with predefined test methods, there is no need for expert adjudication of results in the traditional sense of a clinical or image interpretation study. The interpretation of test results against the specified criteria of the standards would be straightforward.

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. The device is an insulin syringe, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance would not be relevant or performed.

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

This information is not applicable. The device is a physical medical device (an insulin syringe), not a standalone algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance and safety is derived from established international and national standards for medical devices, specifically:

• Performance Standards: ISO 8537, ISO 7864, ISO 9626, ISO 23908.
• Biocompatibility Standards: ISO 10993 (various parts).
• Other Quality Standards: USP (Particulate Matter), 21 CFR Part 801 (Labeling).

8. The sample size for the training set

This information is not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI. The design and manufacturing processes are informed by established engineering principles and prior knowledge from similar devices, but not by a data training set.

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

This information is not applicable for the same reasons as #8.

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The TK Intravascular Administration Set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.

The TK Intravascular Administration Set is a gravity single use device sterilized with Ethylene Oxide gas. It is utilized to administer fluids from a container to a patient's vascular system through a catheter or needle inserted into a vein. The device includes the following components: Protective cap of spike, Spike, Micron filter, Air inlet, Drip chamber, Fluid filter, Tubing, Slide clamp, Pinch clamp, Flow regulator, Roller, Male luer lock, Stopcock (without needleless luer access valve), 4.0mm Connector, Y-site (access by needle), Rotating luer lock, Back check valve, Luer lock cap.

The provided document is a 510(k) summary for the "TK Intravascular Administration Set". This document primarily focuses on establishing substantial equivalence to a predicate device (U&U Intravascular Administration Set, K151151) rather than detailing a specific clinical study with acceptance criteria and reported device performance directly.

The document lists "Non Clinical Performance Testing" and references various ISO standards and FDA guidance documents. These standards likely define the acceptance criteria for physical, chemical, and biological properties of the device. However, the document does not explicitly list a table of acceptance criteria alongside reported device performance for these non-clinical tests. It states that evaluations were performed using industry consensus standards and evaluated per the performance requirements of the device, and that the results for pyrogenicity and sterility were in line with requirements.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies are not present in this 510(k) summary, as it is a premarket notification for a Class II medical device focused on substantial equivalence to a predicate, not a detailed clinical study report.

However, I can extract the information that is present and indicate where information is missing.

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not provide a table with explicit acceptance criteria and corresponding reported performance results for a device study. Instead, it outlines the non-clinical tests performed to demonstrate substantial equivalence to the predicate device, relying on compliance with recognized standards.

Implicit Acceptance Criteria (based on referenced standards) and Partial Reported Performance:

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

• Test Set Sample Size: Not specified for any of the non-clinical tests.
• Data Provenance: The tests are non-clinical (laboratory/bench testing) of the device components and entire product in China, performed by the manufacturer, Anhui Tiankang Medical Technology Co., Ltd.

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

• Not applicable as this is a 510(k) summary for a Class II medical device, focusing on non-clinical performance and substantial equivalence. There is no mention of a "test set" requiring expert-established ground truth in a clinical context. The "ground truth" for the non-clinical tests would be the established scientific/engineering principles and performance requirements outlined in the referenced ISO standards.

4. Adjudication Method for the Test Set

• Not applicable. As described above, there is no clinical "test set" requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging devices or AI systems where human readers interpret patient cases. The "TK Intravascular Administration Set" is a physical medical device (infusion set), and a clinical study with human readers would not be relevant in this context.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

• No, a standalone (algorithm only) performance study was not done. This device is a physical medical administration set, not an algorithm or AI-powered system that would have a "standalone" or "human-in-the-loop" performance.

7. Type of Ground Truth Used

• The "ground truth" for the non-clinical performance evaluations described (biocompatibility, sterility, pyrogenicity, etc.) is based on recognized international standards (e.g., ISO, ASTM, USP) and FDA guidance documents. These standards define the acceptable limits and methodologies for testing.

8. Sample Size for the Training Set

• Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI models. The product design and manufacturing processes are likely informed by engineering principles, material science, and regulatory requirements, not by training data in the AI sense.

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

• Not applicable, as there is no "training set" for this type of device.

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TK Sterile Piston Syringes is intended for use by health care professionals for general purpose fluid aspirations injection.

The piston syringe is a device intended for medical purposes, consisting of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male Luer Slip / lock connector (nozzle) for attaching the female Luer connector (hub) of a hypodermic single lumen needle, or for attaching other devices with a female Luer. The syringe is sterilized by EtO gas and is labeled Non-Pyrogenic. The device is intended for single use only.

The provided text is a 510(k) summary for a medical device called "TK Sterile Piston Syringe without Needle." It outlines the device's characteristics and compares them to a legally marketed predicate device (U&U Sterile Piston Syringe without Needle) to establish substantial equivalence.

However, the provided document DOES NOT contain information about a study that uses an AI/ML algorithm or requires ground truth established by experts. It describes a conventional medical device (syringe) and its testing against established international standards for physical, chemical, and biological properties. Therefore, I cannot generate the requested table and study details related to acceptance criteria for an AI/ML device, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or specific ground truth methodologies in the context of an AI/ML study.

The document focuses on demonstrating that the new syringe complies with performance standards through non-clinical performance testing (e.g., liquid leakage, air leakage, conical fitting integrity), sterility testing, and biocompatibility testing.

Here's what I can extract and present based on the provided text, reinterpreting "acceptance criteria" in the context of a non-AI/ML medical device's performance testing:

Acceptance Criteria and Device Performance (for a non-AI/ML device)

The device, "TK Sterile Piston Syringe without Needle," is a conventional medical device. Its acceptance criteria are based on compliance with established international standards for syringes, rather than AI/ML performance metrics. The study described focuses on demonstrating equivalence to these standards and to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the AI/ML specific questions:

2. Sample sizes used for the test set and the data provenance: Not applicable. This document is for a physical medical device, not an AI/ML algorithm. Testing involves physical samples of syringes.
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 syringe's performance is established by objective physical, chemical, and biological measurements against established standards, not expert consensus on an AI's output.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods like those listed are used for human reader studies with AI, not for physical device testing.
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.
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.): For this device, the "ground truth" for performance is defined by the objective pass/fail criteria of the various ISO and USP standards referenced (e.g., specific thresholds for fluid leakage, absence of microbial growth, acceptable levels for extractable metals, absence of adverse biological reactions).
8. The sample size for the training set: Not applicable. This applies to AI/ML devices.
9. How the ground truth for the training set was established: Not applicable. This applies to AI/ML devices.

Conclusion stated by the submitter:

"The TK Sterile Piston Syringe without Needle is substantially equivalent to the U&U Sterile Piston Syringe without Needle. The materials, performance, and operational features of both the subject device and the predicate device are substantially equivalent."

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

The TK Sterile Hypodermic Needle is a hypodermic single lumen needle, designed for use with syringe and injection devices for general purpose fluid injection / aspiration. The TK Sterile Hypodermic Needle are offered in various gauge sizes and needle lengths. The TK Sterile Hypodermic Needle is sterilized by EtO gas. The TK Sterile Hypodermic Needle is Non-Pyrogenic, disposable and intended for single use. Hypodermic needle for single use can be used Hypodermic injection. It suits users of different age and is the basic methods of infusion. And the device does not have the safety mechanism.

The provided document is a 510(k) summary for a medical device called the "TK Sterile Hypodermic Needle." This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the performance of an AI/ML algorithm. Therefore, many of the requested items related to AI/ML studies are not applicable to this document.

However, I can extract information regarding the safety and performance testing conducted to support the substantial equivalence claim.

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

The document primarily states that the device's performance "conforms to" or "meets the requirements" of various ISO and ASTM standards. The specific quantitative acceptance criteria (e.g., maximum force, minimum flow rate) are not listed in this summary, nor are the precise numerical results of the tests. The summary indicates compliance rather than detailed performance metrics.

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

The document does not specify the sample sizes used for the non-clinical tests. It also does not explicitly state the country of origin of the data or whether the tests were retrospective or prospective, though they are inherently prospective tests designed to prove compliance with standards for the device being submitted.

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

This information is not applicable as the document describes non-clinical laboratory testing against established international standards, not studies involving expert evaluation for ground truth like in AI/ML performance testing.

4. Adjudication method for the test set:

This is not applicable. Laboratory tests against standards do not typically involve adjudication in the way AI/ML studies do (e.g., 2+1 reader consensus). The tests yielded objective physical, chemical, or biological results.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs. without AI assistance:

This is not applicable. There is no AI/ML component described for the TK Sterile Hypodermic Needle, and thus no MRMC study was performed.

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

This is not applicable. There is no algorithm or AI component in this device.

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

For the non-clinical tests, the "ground truth" is defined by the objective pass/fail criteria established within the referenced international standards (e.g., ISO, ASTM, USP). For example, for sterility, the ground truth is the absence of microbial growth as detected by USP. For biocompatibility, it's the satisfactory outcome of specific biological tests as per ISO 10993.

8. The sample size for the training set:

This is not applicable. There is no AI/ML component, and therefore no training set.

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

This is not applicable. There is no AI/ML component, and therefore no training set or ground truth for it.

Summary of Study:

The studies described are non-clinical bench and lab tests performed to demonstrate that the TK Sterile Hypodermic Needle meets the safety and performance requirements of established international and national standards relevant to hypodermic needles. These tests include:

• Chemical properties inspection according to ISO7864.
• Sterility inspection according to USP.
• Biocompatibility evaluation according to ISO 10993 series and FDA Blue Book Memorandum #G95-1, covering tests like Cytotoxicity, endotoxin, Skin sensitization, Hemolysis, Intracutaneous reactivity, Acute systemic toxicity, and Pyrogenicity.
• Conformity to other design and performance standards such as ISO7864 (general requirements), ISO80369-7 (small-bore connectors), ISO 6009 (color coding), ISO9626 (stainless steel needle tubing), and packaging standards (ISO11607-1, ISO11607-2, ASTM F1980, ASTM F1929, ASTM F88).
• Compliance with sterilization process standards (ISO11135) and labeling regulations (21 CFR Part 801).

The conclusion of the submission is that the TK Sterile Hypodermic Needle is substantially equivalent to the predicate device (U&U Sterile Hypodermic Needle K132552) based on the comparison of technological characteristics and the non-clinical testing demonstrating compliance with relevant standards.

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