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For the administration of fluids from a container into a patient's vascular system through a vascular access device.

The proposed device consists of an IV Extension Set (Light Resistant Extension Set). It is a single use disposable, non-pyrogenic, sterile device intended for the administration of fluids from a container into the patient's vascular system. This IV extension set can be directly attached to a syringe but also used as an extension set to a primary set that is connected to a syringe (primarily to add length). The Light Resistant Extension Set consists of non-DEHP (<0.1% DEHP) PVC tubing, a notch clamp, female Luer, non-vented cap for female Luer, and filter vented cap for male Luer. It is used to administer fluids from a syringe into the patient's vascular system through a vascular access device, specifically fluids/drugs sensitive to light to the patients of all ages ranges - neonatal, pediatric, and adult.

The provided text describes the regulatory clearance of the Baxter Healthcare Corporation's Intravascular Extension Set (Light Resistant Extension Set) (K210430). The focus is on demonstrating substantial equivalence to a predicate device (K192366) through non-clinical testing.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

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

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

The document explicitly states that the studies were non-clinical bench tests. Therefore, the concept of "sample size for the test set" as applied to human subjects or medical imagery doesn't directly apply here. Instead, samples refer to manufactured units of the device tested in a laboratory setting. Specific numbers of units tested are not provided in this summary.

• Data Provenance: The tests are internal to Baxter Healthcare Corporation ("Per Baxter Test Method") or adhere to international standards (ISO, BS EN ISO, USP, ANSI/AAMI/ISO). There is no mention of country of origin for the data (beyond the standard bodies) or whether it's retrospective or prospective, as these terms are generally applicable to clinical or observational studies involving patients.

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

Not applicable. This report details non-clinical bench testing for device performance and safety, guided by engineering standards and internal protocols. There is no concept of "ground truth" established by medical experts for these types of tests.

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

Not applicable. Adjudication methods are typically used in clinical studies or studies involving expert interpretation of medical data to resolve discrepancies. This document describes objective bench testing with predefined acceptance criteria.

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 not a study involving AI assistance for human readers or interpretation of medical cases. It is a submission for a physical medical device (intravascular extension set).

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

Not applicable. This is not an algorithm or software device.

7. The type of ground truth used:

The "ground truth" in this context is defined by the objective pass/fail criteria outlined in the referenced international standards (e.g., ISO 80369-7, BS EN ISO 8536-9, USP 788) and Baxter's internal validated test methods. Meeting these established criteria confirms the device's functional performance, material properties, and safety.

8. The sample size for the training set:

Not applicable. There is no training set in the context of this physical device's non-clinical testing. Training sets are relevant to machine learning or AI models.

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

Not applicable, as there is no training set.

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