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ResQ Administration set is intended to administer fluids from a container to a patient's venous system through a needle or catheter inserted into the vein. The set is a sterile, disposable for a single use. The ResQ Administration Set should be used no more frequently than at 96-hour intervals. It can be used on patients of all age groups under the supervision of a qualified physicians or nurses in hospital or clinical settings.

ResO Administration set is a single use, gravity feed, sterile device sterilized with Ethylene Oxide Gas. ResQ Administration set is intended to administer fluids from a container to a patient's venous system through a needle or catheter inserted into the vein. The set is a sterile, disposable for a single use. The ResQ Administration Set should be used no more frequently than at 96-hour intervals. It can be used on patients of all age groups under the supervision of a qualified physicians or nurses in hospital or clinical settings.

ResQ Administration set is compatible with various cannula or catheters models and can be used for most low viscosity fluids or medications.

The proposed device consists of protective cap, air filtration membrane, closure-piercing device, drip chamber, medicine fluid filter, roller clamp, tubing, flow regulator, injection sites (needle access - needleless access), in-line filter &two-part luer lock connector.

The protective cap is intended to maintain sterility and to protect the closure piercing device that 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 roller clamp is used to control the flow of the medicine solution, the tubing is used to connect various components, 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, the in-line filter used for retention of particles, bacteria and fungi, also it used for elimination of the air, two-part luer lock connector is used to connect the infusion needle or catheter with the tubing.

• It is single use device, sterilized by EO sterilization. ●
• . Environment of Use: healthcare facility/hospital

The provided text describes a 510(k) premarket notification for a medical device called the "ResQ Administration Set". This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving novel clinical effectiveness through comparative studies with human readers. Therefore, several of the requested sections related to AI performance, multi-reader multi-case studies, and human reader improvement are not applicable to this type of submission.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

The document provides a list of standards and guidelines used for performance testing (bench testing) and biocompatibility testing. It states that "the subject device testing results were all accepted as per acceptance criteria for the tests" and "all the results was accepted for the subject device and their testing results was accepted as per testing ISO standard requirements." However, specific quantitative acceptance criteria and detailed reported performance values (e.g., exact leakage rates, precise flow rates achieved vs. target range) are not explicitly listed in the summaries provided. Instead, the document generally affirms compliance with the standards.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document primarily refers to bench testing and biocompatibility testing against established international standards. For these types of tests, specific "samples" are devices or materials, not patient data. The sample sizes for each specific test are not enumerated in this summary. The tests were performed to verify the performance of the device against the referenced standards. The provenance of the data in terms of "country of origin for testing" or "retrospective/prospective" is not detailed in the provided excerpt, though the submitter's address is listed as Egypt.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable to the type of device and submission. The "ground truth" for this device's performance is established by adherence to recognized international standards and bench testing protocols, not by expert consensus on clinical imagery or diagnostic interpretations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This device is an intravenous administration set, and its evaluation involves
bench testing and biocompatibility against established standards, not expert adjudication of clinical outcomes or images.

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 device is not an AI-assisted diagnostic tool. No MRMC comparative effectiveness study was conducted or is relevant for this type of medical device submission.

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

Not applicable. This device is a physical medical device (an intravenous administration set), not an algorithm or software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the performance of the ResQ Administration Set is defined by the acceptance criteria within the international standards and guidelines referenced in Table 2 (Bench Testing) and Table 3 (Biocompatibility Evaluation). This includes:

• Engineering specifications and performance limits defined by standards like ISO 8536-4, ISO 80369-7, ASTM F1980-16, etc., for aspects like leakage, flow rate, tensile strength, and packaging integrity.
• Biological safety endpoints determined by biocompatibility standards like ISO 10993-5, ISO 10993-10, etc., assessed for cytotoxicity, sensitization, irritation, and systemic toxicity.
• Sterility assurance levels confirmed by standards like ISO 11135 for EO sterilization and USP 41 chapter 71 for sterility testing.

8. The sample size for the training set

Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI models.

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

Not applicable, as no training set is relevant for this device.

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