(140 days)
The EnteraLoc Flow spouted pouch with ENFit® Connector is indicated for use as a dispenser of enteral nutrition by way of direct connection to a feeding tube or extension set. It is intended to deliver nutrition into the gastrointestinal system of a patient. The pouch, once filled, is intended to be used in clinical or home care settings by users ranging from laypersons to clinicians, in all age groups.
The Vonco Products EnteraLoc Flow spouted pouch with ENFit Connector consists of a foil pouch with an integrated female ENFit connector at one end. The EnteraLoc Flow pouch is provided with a tamper evident cap. The pouch is designed to be pre-filled with liquid nutrition formula for tube feeding.
The EnteraLoc Flow spouted pouch with ENFit Connector will be available in sizes ranging from 30mL - 1500mL dependent upon market and customer need.
The provided text is a 510(k) summary for the Vonco Products EnteraLoc Flow device, which is an enteral nutrition dispensing pouch. This document details the device's technical specifications and the testing performed to demonstrate its substantial equivalence to predicate devices, but it does not describe an AI/ML medical device or a study involving human readers and AI assistance.
Therefore, I cannot provide the detailed information requested in the prompt regarding:
- A table of acceptance criteria and reported device performance related to diagnostic accuracy or clinical outcomes of an AI/ML model.
- Sample sizes for test sets, data provenance, ground truth establishment for AI/ML models.
- Number of experts, qualifications, and adjudication methods for AI/ML ground truth.
- Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance for AI/ML.
The performance data listed in Section 5.8 of the document are for the physical device (a pouch with a connector), not an AI/ML algorithm. These tests include:
- Flow Rate Analysis
- Biocompatibility Testing (Cytotoxicity, Irritation/Intracutaneous Reactivity, Sensitization)
- Performance Testing per ISO 80369-3:2016 (Dimensioning, Falling Drop Positive Pressure Liquid Leakage, Stress Cracking, Resistance to Separation from Axial Load, Resistance to Separation from Unscrewing, Resistance to Overriding, Disconnection by Unscrewing)
- ISO 80369-1:2018 Misconnection Analysis
- Spouted Pouch Functional Testing
- Retort Suitability
The document states, "The results of the performance testing listed above show that the subject device meets its specifications." However, it does not provide the specific acceptance criteria or the numerical performance results for these tests. It only generally states that the device met its specifications.
In summary, this document describes the regulatory approval of a physical medical device (an enteral nutrition pouch), not an AI/ML medical device. Therefore, the information needed to answer your prompt about AI/ML device acceptance criteria and study design is not present in this text.
§ 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.