(265 days)
The fecal incontinence insert is indicated for the management of accidental bowel leakage (ABL) due to bowel incontinence. The rectal insert is designed for self insertion to seal and help prevent the involuntary leakage of stool from the rectum.
The device is a simple rectal insert which is used to control accidental bowel leakage in adult patients. The single use device is inserted via the anus into the anal canal and rectum. The device engages with and conforms to the anorectal junction and the anal canal to control the accidental leakage of fecal matter.
The device consists of two components: a soft, pre-lubricated, liquid-filled silicone Insert device, and a plastic applicator. The Insert device is soft and flexible which allows engagement with the anorectal junction and the anal canal. The applicator is preassembled inside the Insert device to facilitate insertion of the device and is removed and discarded after the device is in place. The device is available in two sizes, Standard and Large. The device is provided preassembled and non-sterile in individual single-use packages.
The provided text is a 510(k) clearance letter and summary for a medical device, the Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle). It does not describe an AI/ML-driven device or study. Therefore, several sections of your request regarding AI/ML-specific details (like multi-reader multi-case studies, effect size of AI assistance, standalone algorithm performance, training set details, and ground truth for the training set) are not applicable to this document.
However, I can extract information related to the acceptance criteria, the study details, and ground truth as it pertains to the clinical performance of this medical device.
1. A table of acceptance criteria and the reported device performance
The document defines "effectiveness" based on a primary endpoint. While it doesn't explicitly state a pre-defined "acceptance criterion" as a specific threshold that had to be met for clearance, it presents the study's primary effectiveness endpoint and the result. We can infer the "acceptance criterion" was that the device demonstrate a statistically significant reduction in ABL episodes.
| Acceptance Criterion (Primary Effectiveness Endpoint) | Reported Device Performance |
|---|---|
| Effectiveness: Relative percentage change in episodes of Accidental Bowel Leakage (ABL) determined by comparing treatment results to pre-treatment results from the baseline period as measured by daily diary recordings. | 44 of 58 subjects (75.9%, 95% CI: 62.8%, 86.1%) achieved a ≥ 50% reduction in ABL episodes. This demonstrated a highly significant device effect (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.