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The AbbVie J is intended to provide long-term enteral access for administration of medication to the small intestine.

The AbbVie™ J is a 9 FR intestinal (J) tube, 120 cm in length. The kit includes: AbbVie J tube with Teflon™-coated Guide Wire and Blue Guide Wire Lock, Y-Connector, Fixation Screw (blue or violet) with Outer Ring, Click Adaptor consisting of: Click Adaptor Cap and Click Adaptor Connector.

Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size for Test Set and Data Provenance:

The document explicitly states: "No clinical evaluations were performed or relied upon for the determination of substantial equivalence." This means there was no test set in the traditional sense of patient data or clinical trials for evaluating device performance in humans. The testing was entirely non-clinical (bench testing and material assessments). Therefore, there is no information about sample size for a test set or data provenance related to human subjects.

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

Since no clinical evaluations were performed, there was no "ground truth" derived from patient outcomes or expert consensus on clinical data. The acceptance criteria were based on adherence to international standards and non-clinical performance characteristics. The "experts" involved would likely be the engineers, toxicologists, and regulatory specialists within AbbVie who conducted and reviewed the non-clinical testing. Their specific qualifications are not detailed.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set requiring adjudication by experts was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. The device's approval was based on non-clinical performance and substantial equivalence to a predicate device, not on human-in-the-loop performance or comparison of human readers with and without AI assistance.

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

Not applicable. This device is a physical medical device (an intestinal tube), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used:

The "ground truth" for the device's acceptance relied on:

• Compliance with recognized international standards: ISO 10993-1:2009, EN 1615:2000, and ISO 80369-1:2010.
• Bench test results: Demonstrating mechanical and material properties meet specified requirements.
• Biocompatibility testing: As per ISO 10993, which provides a "ground truth" for material interaction with biological systems.
• Comparison to a predicate device: Establishing substantial equivalence based on technical characteristics and intended use.

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. The design and manufacturing process would involve various prototypes and batch testing, but these are not considered a "training set" for an algorithm.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no "training set" for this type of device. The design specifications and performance requirements for the device would have been established through engineering principles, prior knowledge of similar devices, and regulatory standards.

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