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IMM™ Infusion Syringe Set is intended for delivering controlled volume of fluids from reservoirs consistent with the labeled route of administration of fluids by manual operation.

IMM 110 Infusion Syringe Set is single use product which contains disposable parts of one spike infusion set for connecting to fluid reservoir and fluid delivery, and a control syringe for delivery fluid supply from a solution bag to access device for purpose of delivering controlled volume of fluids from reservoirs consistent with the labeled route of administration of fluids by manual operation. The distal end of the set is a dual valve with 6% taper design for connecting to other access device such as needles before use. The IMM Infusion Syringe Set is provided sterile in fluid path, and to be disposed after single patient use.

The provided text describes a 510(k) submission for the IMM™ Infusion Syringe Set. This type of regulatory submission is for medical devices and focuses on demonstrating "substantial equivalence" to a predicate device already legally marketed, rather than proving novel clinical effectiveness through a complex study design like those typically seen for new drugs or high-risk devices.

Therefore, the study presented here is primarily a bench-top performance evaluation to show that the device meets established engineering and safety standards, and functions equivalently to existing devices. It is not a clinical study involving human patients or complex AI algorithms.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the device meets the specific requirements established in voluntary standards ISO8536-4 and ISO7886-1. Unfortunately, the specific acceptance criteria (e.g., minimum tensile strength, flow rate tolerances) within these standards, and the exact measured performance of the device against each criterion, are not detailed within this summary. The summary only provides a general statement of compliance.

However, based on the "Element of Comparison" table, some performance characteristics are implicitly mentioned.

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

The document does not specify the sample size used for the functional and performance tests.
The data provenance is not explicitly stated as "country of origin," but the manufacturing company is located in Miaoli, Taiwan. The studies appear to be retrospective bench-top tests conducted internally to support the 510(k) submission.

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

This information is not applicable in the context of this device and study. The "ground truth" here is compliance with engineering standards and material properties, not clinical diagnoses that would require expert human interpretation. The tests are physical and chemical evaluations.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for resolving discrepancies in clinical image interpretation or diagnostic outcomes. For bench-top engineering tests, the outcome is usually a quantitative measurement or a pass/fail against a standard, not subject to subjective adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially those involving image interpretation by human readers, potentially with AI assistance) to assess improvements in reader performance. The IMM™ Infusion Syringe Set is a manual fluid delivery device, not a diagnostic tool where human reader performance is a primary outcome.

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

No, a standalone (algorithm only) performance study was not done. This concept is only relevant for AI/ML-based algorithms. The IMM™ Infusion Syringe Set is a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance evaluation primarily relies on:

• Engineering Standards: Compliance with international standards such as ISO8536-4 (Infusion equipment for medical use -- Part 4: Infusion sets for single use, gravity-fed) and ISO7886-1 (Sterile hypodermic syringes for single use -- Part 1: Syringes for manual use). These standards define mechanical properties, dimensional tolerances, flow rates, sterility, etc.
• Material Compatibility/Safety Standards: Compliance with ISO10993 (Biological evaluation of medical devices).
• Predicate Device Equivalence: The performance is also benchmarked for equivalence against the predicate devices (K063851 and K792227) in key areas like construction, transparency, bonding strength, flow regulation, syringe size, interface, material, and sterility.

8. The Sample Size for the Training Set

This information is not applicable. "Training set" refers to data used to train AI/ML algorithms. The IMM™ Infusion Syringe Set is a physical medical device, not an AI model.

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

This information is not applicable as there is no AI/ML algorithm or training set involved.

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