(57 days)
The Amertius Entral™ Feeding Tube is intended for nasogastric delivery of various types of liquid nutritional media through the gastro intestinal tract of neonatal and small pediatric patients, and is not intended for use beyond 30 days.
The Ameritus Entral™ Feeding Tubes are composed of two families of Feeding Tubes each made with different materials: polyurethane and silicone. The two families of Feeding Tubes are all made with a single lumen catheter that is used to deliver fluids as prescribed by the physician including liquid nutritional media and/or medication.
The Ameritus Entral " Feeding Tubes are sterile, individually packaged, Latex Free and DEHP Free. The orange color coding provides easy visual recognition of the enteral connection. The Ameritus Entral "" Feeding Tubes are designed with a Radiopaque stripe for X-ray visualization to confirm proper feeding tube placement. French size and length clearly printed on the feeding tube as well as centimeter markings (approx.) to assist tube placement or check for migration. A Tethered plug for connector closure is incorporated to prevent air and fluid ingress when not in use.
The device consists of the following main components: A feeding tube single lumen catheter and a connector with molded closure plug.
This document is a 510(k) premarket notification for a medical device, the Ameritus Entral™ Feeding Tube. It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and conducting a study to prove device performance against those criteria in a typical AI/software context.
Therefore, many of the requested points regarding acceptance criteria, study design, expert involvement, and ground truth establishment are not applicable or cannot be extracted from this document, as it describes a physical medical device (feeding tube) and its bench testing for functional equivalence.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with specific numerical thresholds for performance. Instead, it states:
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Functional equivalence to predicate devices | "Bench testing demonstrated that Ameritus Entral™ Feeding Tubes made of either Polyurethane or Silicone are functionally equivalent to the predicate devices and that any minor differences do not affect safety or effectiveness." |
| Performance as per intended use | "Both design verification and performance test results demonstrated that Ameritus Entral™ Feeding Tube two families made of either Polyurethane or Silicone performed as per their intended use and are equivalent to their respective predicate devices." |
| Delivery of fluids | Adheres to the "same method of operation, delivery of fluids including liquid nutrition media and medication through single lumen catheter" as predicate devices. |
| Radiopaque for X-ray visualization to confirm proper placement | "The Ameritus Entral "" Feeding Tubes are designed with a Radiopaque stripe for X-ray visualization to confirm proper feeding tube placement." (This is a feature, not a performance metric itself from the tests, but suggests it performs as designed). |
| Marking for placement/migration | "French size and length clearly printed on the feeding tube as well as centimeter markings (approx.) to assist tube placement or check for migration." (Feature, not a measured performance metric from tests). |
| Prevention of air/fluid ingress when not in use | "A Tethered plug for connector closure is incorporated to prevent air and fluid ingress when not in use." (Feature, not a measured performance metric from tests). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "bench testing," "design verification," and "performance test results." However, it does not specify the sample size for these tests. There's no information on data provenance (country of origin, retrospective/prospective) because this isn't a data-driven AI study; it's a physical device validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable to this type of device and study. "Ground truth" in the context of feeding tube performance and equivalence involves engineering and functional testing, not expert interpretation of outputs like in AI. The "truth" is whether the tube physically performs its functions (e.g., fluid delivery, radiopacity) as expected and comparably to predicates.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods like 2+1 are typically used in clinical or image-based studies where expert consensus is needed. Bench testing of a physical device does not involve such methods.
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
This is not applicable. An MRMC study is relevant for diagnostic imaging AI systems and involves evaluating human reader performance with and without AI assistance. This document is for a physical feeding tube.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This document describes a physical medical device. There is no algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance would be established through engineering specifications, physical measurements, and functional tests comparing the device's characteristics (e.g., flow rates, material integrity, radiopacity, resistance to kinking) directly against the predicate device and established industry standards. This is inherent to bench testing. The document doesn't explicitly state the methodology for establishing this "ground truth" but implies it through the mention of "bench testing," "design verification," and "performance test results."
8. The sample size for the training set
This is not applicable. There is no training set as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
This is not applicable. There is no training set.
§ 876.5980 Gastrointestinal tube and accessories.
(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.