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The AbbVie NJ is intended to provide short-term enteral access for administration of medication to the small intestine. The AbbVie NJ is indicated for the administration of the medication DUOPA (carbidopa and levodopa enteral suspension).

The AbbVie NJ (List Number 62903) is a 10 FR, 152 cm, naso-jejunal (NJ) tube made of white radiopaque polyurethane. The distal coiled end region and bolus tip are coated with a water activated lubricant. The AbbVie NJ includes a silicone coated stainless steel Stylet. The kit is supplied sterile (ethylene oxide). The AbbVie NJ is inserted through the nose and advanced into the small intestine for administration of medication in a home and/or healthcare facility environment. The Stylet is used to aid insertion and is removed once the tube is in place.

The provided text describes a 510(k) submission for the AbbVie NJ device, a naso-jejunal tube. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria for a novel device. Therefore, much of the requested information about device performance, study design, and ground truth establishment is not available in the provided text.

Based on the information given:

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document states, "No animal or clinical evaluations were performed or relied upon for the determination of substantial equivalence." This implies that there was no specific test set or clinical data of human subjects to evaluate the device's performance in a clinical setting against acceptance criteria.
• The "test set" for performance evaluation consisted of the physical device undergoing various laboratory tests (biocompatibility, product-specific performance, material compatibility). The sample size for these laboratory tests is not specified in the provided text, nor is the data provenance in terms of country of origin or retrospective/prospective nature.

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

• Not applicable. As no clinical or animal studies were conducted, there were no human subjects or cases requiring expert consensus for ground truth. The "ground truth" for the laboratory tests would be the accepted standards and methods for those tests.

4. Adjudication method for the test set:

• Not applicable. No clinical data requiring adjudication was generated or relied upon.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:

• No. The document explicitly states, "No animal or clinical evaluations were performed or relied upon for the determination of substantial equivalence." Therefore, no MRMC study was conducted.

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 (naso-jejunal tube), not a software algorithm or AI model.

7. The type of ground truth used:

• The "ground truth" implicitly used for this submission is based on established international and FDA-recognized standards and test methods for biocompatibility (ISO 10993 series), product-specific performance (BS EN 1615:2000, ISO 80369-1:2010), and material compatibility. The successful completion of these tests serves as the "ground truth" for meeting the regulatory requirements for substantial equivalence.

8. The sample size for the training set:

• Not applicable. This device is a physical medical device, not an AI/ML model that requires a training set.

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

• Not applicable. (See point 8).

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

The AbbVie™ NJ is a 10 FR, 152 cm, naso-jejunal (NJ) tube made of white radiopaque polyurethane. The distal coiled end region and bolus tip are coated with a water activated lubricant. The AbbVie NJ includes a silicone coated Stylet.

This document describes the pre-market notification for the AbbVie™ NJ device, a naso-jejunal tube. It explicitly states that "No clinical evaluations were performed or relied upon for the determination of substantial equivalence." This means that the device's performance was assessed through non-clinical data and comparison to a predicate device, rather than through a clinical study that would generate the kind of data you're asking for regarding acceptance criteria, sample sizes, and expert review.

Therefore, I cannot provide the requested information, including a table of acceptance criteria and reported device performance based on a human study, sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or details about training sets.

The relevant information from the document is as follows:

1. Acceptance Criteria and Reported Device Performance (Non-Clinical):

2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No clinical test set.
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 a medical device (tube), not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done: Not applicable. This is a medical device (tube).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For non-clinical studies, conformance to established industry standards and substantial equivalence to a legally marketed predicate device.
8. The sample size for the training set: Not applicable. No clinical training set.
9. How the ground truth for the training set was established: Not applicable. No clinical training set.

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