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This product is intended for use in neonatal and pediatric patients to provide nutrition via nasal or orogastric placement. The Polyurethane Feeding Tube is not intended for use beyond 30 days. The PVC Feeding Tube is not intended for use beyond 24 hours.

The Feeding Tube consists of the following main components: a feeding tube single lumen catheter and an enteral only connector hub with integral tethered connection closure plug. The catheter tubing is made of Polyurethane or PVC. The catheter tubing has an orange or purple radiopaque stripe of barium sulfate embedded in the tubing wall which can be visualized on x-ray, for exact placement of the tip. The single lumen catheter tubing has side holes for better flow and to provide multiple openings for aspiration. The proposed Feeding Tube is sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of three years.

This document is a 510(k) premarket notification decision letter from the FDA to Anhui Tiankang Medical Technology Co., Ltd. regarding their "Feeding Tube" device. It primarily focuses on the device's substantial equivalence to a predicate device and outlines the non-clinical performance data provided to support this claim.

Based on the provided text, the device is a medical feeding tube, and the "acceptance criteria" and "proof" relate to demonstrating its safety and effectiveness through non-clinical performance testing and biocompatibility testing, rather than a study involving human subjects or an AI algorithm. Thus, many of the typical elements of AI/ML device acceptance criteria (e.g., sample size for test set, expert adjudication, MRMC studies, standalone algorithm performance, training set details) are not applicable here as this is a traditional medical device submission.

Here's an analysis of the acceptance criteria and the study (non-clinical testing) that proves the device meets them, based only on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily defined by adherence to recognized international standards and successful completion of specific physical and biological tests. The "reported device performance" indicates that the subject device met these standards and test requirements.

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

The document does not specify the exact sample sizes (number of units tested) for each non-clinical performance and biocompatibility test. It simply states that the tests were "performed" according to the relevant standards.
Data provenance is not directly addressed in terms of "country of origin for data" or "retrospective/prospective" as these are non-clinical, in-vitro/bench tests, not clinical studies. The testing would have been conducted by the manufacturer or a contracted lab to demonstrate compliance.

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

Not applicable. Ground truth, in the context of device performance, is established by adherence to codified international standards and test methods (e.g., ISO, ASTM). These tests are objective measurements, not subjective evaluations requiring expert consensus from human readers or assessors.

4. Adjudication method for the test set

Not applicable. As described above, these are objective physical and biological tests, not human assessments requiring adjudication.

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 device is a physical medical device (feeding tube), not an AI/ML diagnostic or assistive device for human readers. No MRMC study was performed or is relevant to this submission.

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

Not applicable. This device does not involve an algorithm.

7. The type of ground truth used

The "ground truth" for this device's acceptance is established by international standards and validated test methodologies. For example, a successful biocompatibility test result (per ISO 10993) is the "ground truth" that the material is biocompatible. Similarly, meeting specified force or leakage requirements (per ISO 80369-3, ISO 20695) constitutes the "ground truth" for mechanical performance.

8. The sample size for the training set

Not applicable. This device is a physical medical device and does not involve AI/ML requiring a training set.

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

Not applicable. As above, no training set is relevant for this type of device.

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