(224 days)
The AMT Bridle - Nasal Tube Retention System is indicated to prevent inadvertent displacement or removal of Nasogastric/Nasointestinal (NG/NI) tubes.
The AMT Bridle™ – Nasal Tube Retention System is placed around the vomer bone of the nasal septum and attached to a nasogastric/nasointestinal (NG/NI) tube to prevent inadvertent displacement or removal of the tube. The AMT Bridle™ – Nasal Tube Retention System consists of a retrieval probe, catheter with stylet guide, a nasal tube clip, and removal pick. The AMT Bridle™ retrieval probe and catheter are the device components inserted through the patient's nares with the probe magnetically retrieving the catheter and creating a loop around the vomer bone. The nasal tube clip is the component directly attached to both the nasal tube and bridle catheter loop to hold the tube in place.
Here's an analysis of the provided text regarding the AMT Bridle - Nasal Tube Retention System, focusing on acceptance criteria and supporting studies:
This document is a 510(k) Summary for a medical device seeking substantial equivalence to a predicate device, rather than a report on an AI algorithm's performance. As such, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set sample size) are not applicable or directly addressed in this type of submission.
The "acceptance criteria" discussed are related to the safety and performance specifications of the physical medical device and its components, not an AI's accuracy or predictive power.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Tests/Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993-1, -5, -6, -10, -11, -12 for prolonged contact (≤ 30 days) | Met acceptance criteria for prolonged contact. |
| Performance Testing | Clip hinge and teeth integrity | Passed all performance testing. |
| Retention force | Met or exceeded design specifications. | |
| Bond strength of material joints | Met or exceeded design specifications. | |
| Tape pullout force | Met or exceeded design specifications. | |
| Usability testing | (No specific outcome provided, but implied as satisfactory to meet equivalence) | |
| Shelf life testing | (No specific outcome provided, but implied as satisfactory to meet equivalence) | |
| New clip sizes (hinge integrity, clamp integrity, grip strength) | Passed all performance testing for hinge integrity, clamp integrity, and grip strength. | |
| Substantial Equivalence | Equivalence to predicate device (K030784) in intended use, patient population, design, biocompatibility and testing criteria, and method of operation. | Concluded to be substantially equivalent. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: This document does not describe a "test set" in the context of an AI algorithm's performance evaluation. The performance testing was conducted on components of the physical device. The exact number of units or samples tested for each performance criterion (e.g., number of clips for hinge integrity) is not specified in this summary.
- Data Provenance: Not applicable in the context of AI algorithm evaluation. The testing was physical device performance testing conducted by the manufacturer, Applied Medical Technology, Inc. (AMT).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not an AI algorithm study requiring expert-established ground truth. The "ground truth" for the device's performance is derived from standardized physical and biological tests against established specifications.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This is not an AI algorithm study.
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 document pertains to a physical medical device, 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 not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's acceptance is based on:
- Biocompatibility Standards: Adherence to international ISO 10993 standards (e.g., in vitro cytotoxicity, local effects, irritation, systemic toxicity).
- Engineering Specifications: The device's components meeting established design specifications for physical properties such as retention force, bond strength, and integrity (hinge, clamp, grip strength). These specifications were likely derived from device design requirements and clinical needs for tube retention.
8. The sample size for the training set
Not applicable. This is not an AI algorithm and therefore does not involve a "training set."
9. How the ground truth for the training set was established
Not applicable. This is not an AI algorithm.
§ 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.