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IV Administration Sets are intended for delivery of fluids from a container into a patient's vascular system. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy.

Quest Medical's Q2 IV Administration Sets are single use, disposable intravenous administration sets used to deliver fluids from a container into a patient's vascular system. These sets may be comprised of various components including insertion spike, drip chamber, clamp, check valye, stopcock, tubing, luer connections and needleless connector,

The provided text is a 510(k) Premarket Notification for a medical device (Q2 IV Administration Sets), not a software or AI-based diagnostic device. Therefore, the information requested in points 2 through 9 regarding test sets, ground truth, experts, MRMC studies, and training sets is not applicable to this document. The document describes the substantial equivalence of a physical medical device to a predicate device, focusing on bench and nonclinical performance testing rather than the performance of an algorithm or diagnostic accuracy.

However, I can extract the acceptance criteria and reported device performance from the provided text as it relates to the physical characteristics and functional tests performed on the IV administration sets.

Here's the relevant information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list quantitative "acceptance criteria" alongside "reported device performance" in a direct comparison table as one might find for a diagnostic algorithm. Instead, it states that "All necessary bench, nonclinical, and human factors testing was conducted... The subject device met all performance specifications necessary to fulfil its intended use," and "all acceptance criteria were met" for specific tests.

The document lists various nonclinical tests performed to demonstrate safety and effectiveness. For each of these tests, the reported device performance is broadly stated as having met all performance specifications and acceptance criteria. The specific quantitative criteria for each test are not detailed in this summary document, but the conclusion is that the device performed acceptably for its intended use.

The following points are mostly Not Applicable (N/A) because the provided document concerns a physical device (IV administration set) submission, not an AI/software as a medical device (SaMD).

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

N/A. The document refers to "nonclinical testing" and "bench tests" rather than a clinical "test set" in the context of an AI/ML algorithm. The specific number of physical units tested for each nonclinical test is not provided in this summary. Data provenance (country of origin, retrospective/prospective) is not relevant for physical device bench testing as described here.

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

N/A. Ground truth in the context of diagnostic accuracy (e.g., for an AI algorithm) is not relevant for this physical device's performance testing. The "ground truth" for the device here is whether it meets engineering and safety specifications through defined physical and chemical tests.

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

N/A. Adjudication methods are typically used in clinical studies or for establishing ground truth from expert opinions, which does not apply to the bench testing of a physical device.

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

N/A. This is a physical device, not an AI software. No human reader studies were performed.

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

N/A. This is a physical device, not an algorithm.

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

The "ground truth" implicitly used for this device's acceptance is adherence to established engineering standards, material specifications, and performance criteria for IV administration sets, as defined by relevant ISO, USP, and other medical device standards. This is determined through physical, chemical, and biological testing rather than expert consensus on diagnostic images or outcomes data.

8. The sample size for the training set

N/A. This is a physical device, not an AI/ML algorithm that requires a training set.

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

N/A. As above, this is a physical device.

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