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The Hospira Extension Sets are intended for use as gravity sets. Hospira Extension sets are comprised of various components including the following: male luer adapter with cap, tubing, female luer adapter, flow control device, in-line adapter, injection site assembly, and Dial-A-Flo. Extension sets are configured to ensure the intended use of the device is met. Hospira Extension sets are intended for the delivery of fluids from a container to a patient's vascular system. The sets are disposable devices for single patient use.

AI/ML Overview

The provided text describes a 510(k) premarket notification for Hospira Extension Sets, which are intravascular administration sets. The document focuses on demonstrating substantial equivalence to predicate devices, primarily due to changes in tubing material and a needleless valve component.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily derived from international standards for medical devices, specifically those relating to biocompatibility and mechanical/functional performance of IV administration sets. The reported device performance indicates that the new Hospira Extension Sets meet these standards.

Acceptance Criteria (Standard & Section)	Reported Device Performance
Biocompatibility:
ISO 10993-4 Hemocompatibility	Acceptable
ISO 10993-5 Cytotoxicity	Acceptable
ISO 10993-10 Sensitization	Acceptable
ISO 10993-11 Intracutaneous Reactivity	Acceptable
Systemic Toxicity	Acceptable
Acute Toxicity	Acceptable
Subchronic Toxicity	Acceptable
Pyrogenicity	Acceptable
Mechanical/Functional Performance:
ISO 594-1 (Conical fittings with a 6% (Luer) taper for syringes, needles, and certain other medical equipment):
4.1 Gauging	Acceptable
4.2 Liquid Leakage	Acceptable
4.3 Air Leakage	Acceptable
4.4 Separation Force	Acceptable
4.5 Stress Cracking	Acceptable
ISO 594-2 (Conical fittings with a 6% (Luer) taper - Part 2: Lock fittings):
4.1 Gauging	Acceptable
4.2 Liquid Leakage	Acceptable
4.3 Separation Force	Acceptable
4.4 Unscrewing Torque	Acceptable
4.5 Ease of Assembly	Acceptable
4.6 Resistance to Overriding	Acceptable
4.7 Stress Cracking	Acceptable
ISO 8536-4 (Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed):
6.1 Particulate Contamination	Acceptable
6.2 Leakage	Acceptable
6.3 Tensile Strength	Acceptable
6.6 Tubing	Acceptable
6.7 Fluid Filter	Acceptable
6.9 Flow Regulator	Acceptable
6.10 Flow Rate	Acceptable
6.11 Injection Site	Acceptable
6.12 Male Conical Fitting	Acceptable
6.13 Protective Caps	Acceptable
Sterilization:
Sterility Assurance Level (ANSI/AAMI/ISO 11137-1 and 11737-1)	10^-6

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

The document does not explicitly state the sample sizes used for each specific test mentioned (e.g., number of devices tested for liquid leakage, number of samples for cytotoxicity). It broadly states that "new data has been generated" and "all testing is acceptable."

The data provenance is not specified in terms of country of origin. The studies are non-clinical (laboratory testing) rather than studies on human subjects, so the retrospective or prospective nature isn't directly applicable in the same way it would be for clinical trials. The focus is on demonstrating compliance with recognized international standards for device performance and safety.

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

This information is not applicable and not provided in the document. The "ground truth" for non-clinical performance and biocompatibility testing is established by the specified standards (ISO 10993, ISO 594-1, ISO 594-2, ISO 8536-4), rather than expert consensus on interpretive data. The tests themselves are objective measurements against defined parameters.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving subjective assessment (e.g., image interpretation by multiple readers). For objective bench testing against defined standards, the outcome is determined by whether the device's performance falls within the specified acceptance limits for each test.

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

No MRMC comparative effectiveness study was done. This type of study is not relevant for the evaluation of an invasive medical device like an extension set, which does not involve human interpretation of diagnostic data or AI assistance in a clinical workflow.

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

No standalone algorithm performance study was done. This device is not an AI/ML-based diagnostic or therapeutic algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for the device's performance is defined by adherence to objective, quantitative and qualitative criteria set forth in recognized international standards (ISO 10993, ISO 594-1, ISO 594-2, ISO 8536-4, ANSI/AAMI/ISO 11137-1, ANSI/AAMI/ISO 11737-1). For example, for "liquid leakage," the ground truth is whether the device leaks or not under specified test conditions, as defined by the ISO standard. For "cytotoxicity," it's whether the materials cause a cytotoxic reaction above a defined threshold.

8. The Sample Size for the Training Set

This information is not applicable. The development of this medical device (Hospira Extension Sets) does not involve a "training set" in the context of machine learning or AI. The design and validation are based on engineering principles, materials science, and compliance with established performance standards.

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

This information is not applicable for the same reason as point 8.

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