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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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