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The LILY Volume Meteric Administration Set is designed to administer fluids from a container to a patient's vascular system through a catheter inserted into a vein.

The LILY Volume Meteric Administration Set, CIB-100ES, CHB-120ES, CIB-150ES, is a single-use, non-toxic, non-pyrogenic and sterile infusion set to administer fluids from a container to a patient's vascular system through a catheter inserted into a vein.

This is a 510(k) premarket notification for a medical device, not an AI/ML device, so many of the requested categories (like number of experts, adjudication methods, MRMC study, standalone performance, training set details) are not applicable. I will provide information relevant to a traditional medical device submission based on the provided text.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify exact sample sizes for bench, biocompatibility, or sterility testing. It states these tests were "employed upon submission." It is a regulatory submission, so the provenance of the testing itself would be the manufacturer (Lily Medical Supplies Co., Ltd.) performing the tests in their facilities or through contracted labs. The data would be prospective, as it was generated to support this particular submission. There is no mention of country of origin for the data; the manufacturer is based in Taiwan.

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

Not applicable for this type of device. "Ground truth" in this context refers to engineering and laboratory test results demonstrating compliance with established performance standards for infusion sets, not expert interpretation of medical images or clinical outcomes.

4. Adjudication method for the test set

Not applicable. This is a medical device performance test, not a diagnostic or interpretive task requiring adjudication of results from multiple reviewers. Performance is evaluated against objective engineering specifications and standards.

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 conventional medical device (infusion set), not an AI/ML diagnostic or assistive device.

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

Not applicable. This is a conventional medical device.

7. The type of ground truth used

The ground truth for this device's performance relies on several factors:

• Engineering Specifications and Standards: The device's physical properties (e.g., flow rate accuracy, drip chamber volume, material strength, connection integrity) are measured against predefined engineering standards for intravascular administration sets, often those specified in FDA guidance documents (e.g., ANSI/AAMI/ISO standards).
• Biocompatibility Testing Standards: Adherence to established ISO standards (e.g., ISO 10993 series) for evaluating the biological effects of medical devices.
• Sterility Testing Standards: Compliance with pharmacopeial and ISO standards for demonstrating sterility (e.g., absence of microorganisms) and non-pyrogenicity.
• Substantial Equivalence to a Predicate Device: The primary "ground truth" for regulatory approval in a 510(k) often comes from demonstrating that the new device is as safe and effective as a legally marketed predicate device, meaning it performs similarly and has the same intended use.

8. The sample size for the training set

Not applicable. This is a conventional medical device, not an AI/ML device that requires a training set.

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

Not applicable.

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