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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 under the action of gravity.

The device is a Disposable infusion set with needle. Its configuration includes a Protective Cap of Closure-piercing Device, Closure-piercing Device, Clamp, Fluid channel (tubing), Drip chamber upper cover (including the dropper), Drip chamber, Drip chamber base (including Fluid Filter membrane), Flow regulator, Regulator wheel, Luer Lock Connector, Infusion needle hub, Needle tube, Plastic needle handle, Infusion needle protector, Integral air-inlet with air filter and closure, Tubing, Lubricant, and Adhesives. It has a Tubing Diameter of 4 mm and Filter Characteristics of 15µm. It is available in various Needle Gauges and Lengths.

The provided document is a 510(k) summary for a "Disposable infusion set with needle," which is a Class II medical device. This type of device is a physical medical device, not an AI/software device. Therefore, the request for "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of AI/software performance metrics (like sensitivity, specificity, MRMC studies, ground truth establishment by experts, training/test set sample sizes for AI, etc.) is not applicable to this document.

The document discusses physical, mechanical, chemical, and biocompatibility testing according to various ISO and ASTM standards to demonstrate substantial equivalence to a predicate device.

However, to address the spirit of the request regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" for a physical medical device as described in this document, I can extract the relevant performance criteria and testing methods from the provided text.

Here's an interpretation based on the provided content for a physical medical device:

Acceptance Criteria and Device Performance for a Disposable Infusion Set with Needle

This document describes the regulatory submission for a Disposable Infusion Set with Needle (K232475) to demonstrate substantial equivalence to a predicate device (K163160). The "acceptance criteria" here refer to the performance requirements established by recognized standards, and the "study" refers to non-clinical performance testing conducted to prove the device meets these criteria.

1. Table of Acceptance Criteria and the Reported Device Performance

The document presents a comparison between the predicate device and the subject device, outlining various performance parameters. The "acceptance criteria" for the subject device are generally implied to be meeting the same performance standards as the predicate, or demonstrating that any differences do not adversely affect safety or performance, as evaluated against relevant ISO and ASRM standards.

"Reported Device Performance" is indicated by the statement that the subject device "met all design specifications as Substantially Equivalent (SE) to the predicate device" and that "The requirements of the standards are met." Specific quantitative results are generally not provided in this summary, but rather a confirmation of compliance.

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

The document does not explicitly state the sample sizes used for each specific test (e.g., number of infusion sets tested for leakage, tensile strength, etc.). It generally refers to compliance with recognized standards (e.g., ISO 8536-4, ISO 7864), which themselves specify required sample sizes for testing.

• Data Provenance: The tests are non-clinical (laboratory/bench testing) performed by the manufacturer, Shandong Zhushi Pharmaceutical Group Co., Ltd. in China. The data would be derived from these internal tests. The term "retrospective or prospective" is not applicable to this type of device performance testing.

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

This question is not applicable. For a physical medical device like an infusion set, "ground truth" is established by direct physical, chemical, and biological testing against engineering and safety standards, not by expert consensus or interpretation of images. The tests evaluate measurable properties (e.g., tensile strength, flow rate, particulate count, presence of toxins) directly.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (e.g., 2+1, 3+1) are common in studies involving human interpretation (e.g., radiologists reviewing images) where there might be inter-reader variability. For physical device performance testing, results are typically objective measurements or observations against predefined pass/fail criteria from a standard.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

This question is not applicable. MRMC studies are used to assess the performance of diagnostic devices or AI systems, particularly how human readers perform with and without AI assistance on cases. This device is an infusion set, not a diagnostic or AI-enabled device.

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

This question is not applicable. This device is a physical medical device, not an algorithm or AI.

7. The type of ground truth used

For this physical medical device, the "ground truth" is defined by:

• Established Industry Standards: Such as ISO 8536-4, ISO 7864, ISO 9626, USP NF , USP NF , ISO 10993 series, ASTM F1929, ASTM F88, etc. These standards specify acceptable ranges, limits, or characteristics for device performance and material safety.
• Direct Measurement and Observation: Performance is determined by physical tests (e.g., measuring tensile strength, observing leakage), chemical analyses (e.g., residual EO, particulate count), and biological assays (e.g., cytotoxicity, pyrogen testing).

8. The sample size for the training set

This question is not applicable. There is no "training set" in the context of a physical medical device. This term refers to data used to train an AI algorithm.

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

This question is not applicable for the same reason as #8.

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The devices are indicated for the delivery of fluids from a container to a patient's vascular system.

The proposed devices are indicated for the delivery of fluids from a container to a patient's vascular system through the infusion needle under the action of gravity. The proposed devices are comprised of air filter, protective cap of closure-piercing device, closure-piercing device, drip chamber, flexible tubing, flow regulator, filter and an infusion needle attached to a luer adaptor. For the Burette-type Infusion Sets for Single Use, an additional component of burette can used for quantitative infusion. For Disposable Infusion Sets with Precision Filters, a precision membrane is provided for filtration operation.

I am sorry, but the provided text does not contain the information required to answer your request. This document is a 510(k) premarket notification summary for medical devices (infusion sets). It outlines the device description, indications for use, comparison to predicate devices, and non-clinical test conclusions to establish substantial equivalence.

It does not include:

• A table of acceptance criteria and reported device performance beyond general compliance with ISO standards.
• Details about a specific study proving the device meets acceptance criteria, such as sample sizes, data provenance, ground truth establishment, or expert qualifications.
• Information on multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.

Therefore, I cannot provide the requested information based on this text.

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JT series Disposable infusion set is used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein.

The applicant device-JT series disposable infusion set is plastic, single-use, sterile disposable infusion device, which is intended to be used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein. The protective cap is intended to protect the needle; The puncturing needle is made of Polyethylene and used to pierce the container; the catheter is made of Polyvinyl chloride and used to connect various components; the drip is transparent so that the user can observe the dropping condition of the medical solution, and it has a filtration mesh which can prevent the micro particle with diameter larger than 200 um to from entering human vessel; Flow regulator is used to adjust the flow rate from zero to maximum; Male conical fitting is used for connecting with vein needle for medical solution transfusion. The proposed device is provided sterilized.

Here's a breakdown of the acceptance criteria and study information for the Disposable Infusion Set, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly list specific acceptance criteria with numerical targets for the device's performance. Instead, it states that the device "comply[s] with voluntary standards as detailed in Section 9, 11 and 17 of this premarket submission" (which are not included in the provided text).

The reported device performance is indirect and qualitative:

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

• Sample Size: Not specified. The document states "Testing on unit level (Module verification)", "Integration testing (System verification)", "Final acceptance testing (Validation)", "Performance testing (Verification)", and "Safety testing (Verification)" were performed, but no sample sizes are given for these tests.
• Data Provenance: Not specified. However, the manufacturer is Shanghai Jinta Medical Co., Ltd. in China, so it's likely the testing occurred in China. The study type is non-clinical testing, which implies lab-based testing rather than patient data.

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

• Number of Experts: Not applicable. This was a non-clinical study, so there was no "ground truth" established by medical experts for a test set of patient data. The ground truth would be based on engineering specifications and compliance with standards.
• Qualifications of Experts: Not applicable.

4. Adjudication Method:

• Adjudication Method: Not applicable, as this was a non-clinical study without human interpretation of clinical cases.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The document explicitly states: "The subject of this premarket submission, Disposable infusion set, did not require clinical studies to support substantial equivalence."

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

• Standalone Study: Yes, this essentially describes the non-clinical performance and safety testing conducted. The device (Disposable Infusion Set) itself is a physical medical device, not an algorithm. The testing described ("Risk Analysis," "Requirements Reviews," "Design Reviews," "Testing on unit level," "Integration testing," "Final acceptance testing," "Performance testing," "Safety testing") demonstrates its standalone performance against design specifications and voluntary standards. There is no "human-in-the-loop" aspect to the function of this specific device to be evaluated.

7. Type of Ground Truth Used (for the test set):

• Ground Truth Type: For this non-clinical submission, the "ground truth" for the test set would be derived from engineering specifications, design requirements, and voluntary standards. Performance was measured against these predefined technical benchmarks and safety requirements for medical devices of this type.

8. Sample Size for the Training Set:

• Sample Size: Not applicable. This document describes the submission for a physical medical device (infusion set), not an AI/ML algorithm. Therefore, there is no "training set" in the machine learning sense. The device is designed and manufactured based on established engineering principles and materials.

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

• Ground Truth Establishment: Not applicable, as there is no training set for this type of device. The device's design and manufacturing are based on established engineering and material science principles, guided by regulatory standards for medical devices.

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KDL Disposable Infusion Set 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, KDL Disposable Infusion Set, 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 consists of protective cap, air filtration membrane, air-inlet set, closure-piercing device, drip chamber, medicine fluid filter, locked clamp, tubing, check valve, flow regulator, clamp, injection sites, two-part luer lock connector, infusion needle.

The protective cap is intended to protect the needle; the closure-piercing device is used to pierce the container; the drip chamber is transparent so that the user can observe the dropping condition of the medical solution, it has an air filtration membrane which can filter the air into the container and an air-inlet set which can control the air into the container and a medicine fluid filter which can filter the medical solution; the locked clamp is used to control the flow of the medicine solution; the tubing is used to connect various components; the check valve is used to make the medicine solution flow in one direction; the flow regulator is used to adjust the flow rate from zero to maximum; there are two injection sites, one is needleless and the other is needle access, which are used to inject solution into the tubing; two-part luer lock connector is used to connect the infusion needle with the tubing; infusion needle is inserted into human vessel for medical solution transfusion and it is made of stainless steel.

It is provided EO sterilized.

Here's an analysis of the provided text regarding the acceptance criteria and study for the KDL Disposable Infusion Set:

Based on the provided 510(k) Summary (K112204), the device is a KDL Disposable Infusion Set, which is a typically low-risk medical device. For such devices, "acceptance criteria" are usually met by demonstrating compliance with recognized international standards and proving substantial equivalence to a predicate device through non-clinical (bench) testing. There isn't typically a "study" involving human subjects or complex statistical analysis for performance metrics in the same way one would find for diagnostic AI.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: The document does not specify a numerical sample size for the "bench tests." For medical devices like infusion sets, bench testing typically involves a sufficient number of units to ensure statistical confidence in the results for each specific test (e.g., fluid flow rate, leakage, strength of connections).
• Data Provenance: The tests were non-clinical (bench tests) conducted to assess compliance with international standards. The country of origin for the data generation would likely be China, where the manufacturer (Shanghai Kindly Enterprise Development Group Co., Ltd) is located, although this is not explicitly stated for the testing itself. The data is prospective for the device being tested but not in the context of human subject data.

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

• This question is not applicable in the context of this 510(k) submission. "Ground truth" established by experts, especially clinical experts like radiologists, is relevant for diagnostic devices or AI algorithms where clinical interpretations are being evaluated. For an infusion set, the "ground truth" for its performance is determined by meeting the objective criteria set forth in the international standards through physical and mechanical testing.

4. Adjudication Method for the Test Set

• This question is not applicable. Adjudication methods involving multiple experts (e.g., 2+1, 3+1) are used to resolve discrepancies in expert interpretations, particularly in clinical studies for diagnostic tools. For bench testing of a physical device, the results are typically quantitative measurements and either pass or fail predetermined criteria, not subject to expert adjudication of interpretation in the same manner.

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 question is not applicable. MRMC studies are specifically designed for evaluating the performance of diagnostic imaging devices or AI algorithms used in conjunction with human readers. The KDL Disposable Infusion Set is a mechanical device for fluid administration, not a diagnostic tool or an AI-powered system that assists human readers.

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

• This question is not applicable. The KDL Disposable Infusion Set is a physical medical device; it does not contain an algorithm or AI component to be evaluated in a standalone performance study.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• The "ground truth" for this device's performance is objective compliance with established international engineering and medical device standards (ISO standards). This is confirmed through physical and mechanical bench testing, where quantifiable parameters (e.g., material strength, dimensions, flow rates, luer lock integrity) are measured against predefined specifications within the standards. There is no "expert consensus," "pathology," or "outcomes data" ground truth in the context of evaluating the device's basic functional performance for 510(k) submission.

8. The Sample Size for the Training Set

• This question is not applicable. There is no "training set" for the KDL Disposable Infusion Set as it is not an AI/machine learning device. The design, development, and testing process does not involve training an algorithm on a dataset.

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

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

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Disposable Infusion Set is used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein.

The applicant device is plastic, single-use, sterile disposable infusion device, which is intended to be used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein. The protective cap is intended to protect the needle; The puncturing needle is made of Polyethylene and used to pierce the container; the catheter is made of Polyvinyl chloride and used to connect various components, there is no DEHP used in the proposed device; the drip is transparent so that the user can observe the dropping condition of the medical solution, and it has a filtration mesh which can prevent the micro particle with diameter larger than 200 um to from entering human vessel; Flow regulator is used to adjust the flow rate from zero to maximum; Infusion needle is inserted into human vessel for medical solution transfusion, it is made of stainless steel. The proposed device is provided sterilized.

The provided text describes a 510(k) summary for a Disposable Infusion Set and does not contain information about acceptance criteria, device performance, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The document discusses:

• Device Name: Disposable Infusion Set
• Intended Use: To administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein.
• Device Description: Plastic, single-use, sterile infusion device with components like a protective cap, puncturing needle, catheter (no DEHP), drip with filtration mesh, flow regulator, and infusion needle.
• Test Conclusion: "Laboratory testing was conducted to validate and verify that disposable infusion set met all design specifications and was substantially equivalent to the predicate device."
• Predicate Device: Tianjin Medis Disposable Infusion Set (K060082)
• Substantial Equivalence Conclusion: The subject device is substantially equivalent to the predicate device.

Therefore, I cannot provide the requested information as it is not present in the given text. The information provided focuses on the regulatory submission process and the declaration of substantial equivalence based on unspecified "laboratory testing" and "design specifications."

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Tianjin Medis Disposable Infusion set is a device intended to administer fluids from a container to a patient's vascular system through a catheter inserted into a vein.

Not Found

The provided text is an FDA 510(k) clearance letter for a medical device (Tianjin Medis Disposable Infusion Set). It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria, device performance studies, or ground truth establishment.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria based on the provided text. The document is primarily a regulatory approval notice, not a performance study report.

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