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I.V. Catheter for Single Use, including Type I, Type Y and Type Straight, is intended to be inserted into a patient's vascular system for short term use to sample blood, administer fluid intravenously or through which to place monitoring equipment such as blood pressure monitors.

The proposed device, I.V. Catheter for Single Use including Type I, Type Y and Type Straight, is intended to be inserted into a patient's vascular system for short term use to sample blood, administer fluid intravenously or through which to place monitoring equipment such as blood pressure monitors. It is provided EO sterilized, latex free, prygon-free and DEHP-free. All types are available in four sized, which are 18G, 20G, 22G and 24G.

Type Straight Catheter for Single Use consists of a sheath, slender catheter tubing, stainless steel needle, catheter hub, needle wing, catheter body, clamp and straight connector. Type Y I.V. Catheter for Single Use consists of a sheath, slender catheter tubing, stainless steel needle, catheter hub, needle wing, catheter body, clamp and Y connector. And Type I I.V. Catheter for single Use consists of a sheath, slender catheter tubing, stainless steel needle, catheter hub, needle handle and vent fitting, Type Straight and Type Y are closed system while Type I is open system.

The provided text describes a 510(k) summary for an I.V. Catheter for Single Use. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data with detailed acceptance criteria and performance metrics typically found in efficacy studies for AI/software devices.

Therefore, much of the requested information, specifically related to acceptance criteria for device performance with specific metrics, study design for proving performance (e.g., sample sizes, ground truth establishment, expert involvement, MRMC studies, standalone performance), and training set details, is not present in the provided document. The device is a physical medical device (I.V. catheter), not a software or AI device, which explains the absence of these types of details.

However, I can extract the information that is available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of explicit, quantitative acceptance criteria for device performance in the manner of diagnostic accuracy (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" are implied by the statement that the device "met all design specifications" and was "substantially equivalent to the predicate device." The performance reported is that these design specifications were met during laboratory testing.

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

• Sample Size for Test Set: Not specified. The document only mentions "Laboratory testing was conducted." No specific number of units tested is provided.
• Data Provenance: Not specified. The testing was described as "Laboratory testing," implying internal testing by the manufacturer. The manufacturer is Weihai Jierui Medical Products Co., Ltd. in China.

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

Not applicable/Not specified. This information is typically relevant for studies validating diagnostic accuracy, often in AI or imaging devices, where human expert consensus forms the ground truth. Since this is a physical medical device (I.V. catheter), the "ground truth" would be objective measurements against design specifications, not expert interpretation of outputs.

4. Adjudication Method for the Test Set

Not applicable/Not specified. Adjudication methods (e.g., 2+1, 3+1) are used for resolving disagreements among multiple experts when establishing ground truth, which is not relevant for the type of testing described for this physical device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is a physical medical device, not a diagnostic or AI-powered system that would involve human readers interpreting cases. Therefore, an MRMC study is not relevant and was not performed.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No. This is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance assessment would be the objective measurements against its physical and material design specifications (e.g., strength, flow rate, biocompatibility, sterilization efficacy) as confirmed through laboratory tests. It is not expert consensus, pathology, or outcomes data in the traditional sense for diagnostic devices.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning or AI algorithm that requires a training set.

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

Not applicable. As described above, there is no training set for this type of device.

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