(55 days)
The ENConnect 40 mm Screw Cap to ENPlus Adapter is intended to connect enteral giving sets, equipped with an ENPlus connector, to enteral nutrition crown cap bottles or wide neck reservoirs in order to deliver nutritional fluids.
The ENConnect 40 mm Screw Cap to ENPlus Adapter (the proposed device) is a non-sterile, single use device consisting of screw cap with a 40 mm thread, an ENPlus port, vent, and gasket. The proposed device is intended to connect enteral giving sets, equipped with an ENPlus connector, via the ENPlus port to wide neck reservoirs and/or crown cap bottles containing enteral nutrition.
This document, K190327, is a 510(k) Premarket Notification for a medical device called the "ENConnect 40 mm Screw Cap to ENPlus Adapter." It describes the device and its testing to demonstrate substantial equivalence to a predicate device.
However, the request asks for information about acceptance criteria and studies proving an AI/Software as a Medical Device (SaMD) meets those criteria. Specifically, it asks about:
- A table of acceptance criteria and reported device performance (typical for AI/SaMD metrics like sensitivity, specificity, F1-score, AUC).
- Sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set sample size, and how training ground truth was established.
The provided document (K190327) is for a physical medical device (an adapter for enteral feeding), not an AI/SaMD. Therefore, it does not contain any of the information requested regarding AI/SaMD performance, ground truth establishment, or clinical study design specific to AI models.
The document focuses on demonstrating substantial equivalence for a physical device through:
- Non-clinical performance testing: This includes biocompatibility, flow rate, fluid leakage, ISO 18250-3 evaluations (dimensions, pressure leakage, stress cracking, resistance to separation), tensile testing, distribution simulation, and packaging tests. These are standard engineering and material science tests for physical devices to ensure safety and function, not AI performance metrics.
- Comparison to a predicate device: The document explicitly states that the designs are different but do not impact safety and effectiveness, and then lists various physical characteristics and operational aspects for comparison.
Therefore, it is impossible to extract the requested information from this document because it is not relevant to an AI/SaMD.
To illustrate, if this were an AI/SaMD document, the acceptance criteria table might look like this (hypothetical, as the document doesn't provide it):
1. Table of Acceptance Criteria and Reported Device Performance (Hypothetical for an AI/SaMD)
| Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Standalone Performance: | ||
| Sensitivity | ≥ 90% | 92.5% |
| Specificity | ≥ 80% | 85.1% |
| AUC | ≥ 0.90 | 0.93 |
| Human-in-the-Loop Performance (with AI assistance): | ||
| Reader AUC Improvement | Statistically significant improvement over unassisted reading | p |
§ 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.