(225 days)
The Entuit Start Initial Placement Gastrostomy Set is intended to assist the physician with the initial placement of feeding tubes while performing a gastrostomy in adult patients only.
The Entuit™ Start Initial Placement Gastrostomy Set includes a heavy duty stainless steel polytetrafluoroethylene (PTFE) coated Amplatz extra stiff wire guide, dilators, and one or more Peel-Away® Introducers. Depending upon set specifications, two or three dilators may be included. The set also includes an entry access needle, scalpel, syringe, and gauze. The Entuit Start Initial Placement Gastrostomy Set is sterilized by ethylene oxide and intended for one-time use.
This document describes the Cook Incorporated Entuit Start Initial Placement Gastrostomy Set, but it does not contain information about software or AI devices, nor does it conduct a study on device performance against acceptance criteria in the manner you described.
The document is a 510(k) premarket notification for a medical device that assists with the initial placement of feeding tubes. It focuses on demonstrating substantial equivalence to a predicate device through a comparison of physical characteristics and the results of various engineering and biocompatibility tests.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving a device meets these criteria in the context of an AI/software device. The document details the following for a physical medical device:
1. Table of acceptance criteria and reported device performance:
The document lists various mechanical and biocompatibility tests performed. It states that "The results of these tests show that the Entuit™ Start Initial Placement Gastrostomy Set met the design input requirements based on the intended use and support the conclusion that this device does not raise new questions of safety or effectiveness and support a determination of substantial equivalence." However, it does not provide specific quantitative acceptance criteria or detailed reported performance values for each test. For example, it lists "Wire Guide Tensile" but does not state the minimum tensile strength required (acceptance criteria) or the measured tensile strength (reported performance).
2. Sample size used for the test set and the data provenance:
This information is not provided. The document generally refers to "applicable testing" but does not detail the methodology, sample sizes, or data provenance for these engineering tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable as this is not a study requiring expert-established ground truth. The tests are engineering and biocompatibility tests for a physical device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This is not applicable.
5. If a multi-reader multicase (MRMC) comparative effectiveness study was done:
No, this type of study was not performed or described. This is a 510(k) submission for a physical device, not an AI or imaging device requiring human reader assessment.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable as this is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. The "ground truth" for the engineering tests would be the established engineering and safety standards.
8. The sample size for the training set:
Not applicable as there is no training set for an AI/software device.
9. How the ground truth for the training set was established:
Not applicable.
Summary of available information from the document (relevant to a physical device):
The document details the device, its intended use, a comparison to a predicate device, and a list of various physical, mechanical, and biocompatibility tests that were performed. The conclusion states that the device "met the design input requirements."
Specific tests listed:
- Compatibility - (Peel away sheath and Gastrostomy Catheter, Dilator and Wire Guide, Needle and Wire Guide)
- Wire Guide Tensile
- Wire Guide Corrosion
- Wire Guide Flex
- Wire Guide Fracture
- Dilator Shaft Tensile
- Dilator Hub-to-Shaft Tensile
- Peel-Away Introducer Shaft Tensile
- Peel-Away Introducer Knob-to-Shaft Tensile
- Peel Force Testing
- Radiopacity Testing
- Biocompatibility Testing Per ISO 10993-1 and FDA guidance, testing for cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity, and acute systemic toxicity were performed to ensure the biocompatibility of the subject device 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.