(401 days)
For evaluation of colonic transit in adult patients with chronic constipation and used to aid in differentiating slow and normal constipation.
Transit-Pellets is intended to be used for evaluation of colonic transit time in patients with chronic constipation and used to aid in differentiating slow and normal transit constipation. Ten (10) radiopaque markers per day are swallowed for six consecutive days. On day seven an abdominal radiograph is taken. Based on the number of retained markers and the position in colon a colonic transit time is calculated and compared to reference values. Both total transit and segmental transit dysfunction in the colon can be evaluated with the device. By dividing the particle dose on day six by taking five (5) markers in the morning and five (5) markers in the evening, the whole range of transit times (slow, normal, rapid) transit can be measured from the radiograph.
Transit-Pellets is a convenience package of radiopaque markers (22% Barium Sulphate, 78% Elastosil® R 401/60 Silicone rubber) placed in veqetarian capsules from cellulose (HPMC, Hydroxypropyl-methylcellulose), intended for single patient use. The dimension of the markers is 2x4.5mm (ring-formed markers) and 6x2mm (tube-formed markers). The capsules are packed in a blister pack and the blister pack is placed inside a folding box.
The provided text describes a 510(k) premarket notification for the "Transit-Pellets" device, which is a gastrointestinal motility monitoring system. This document is a clearance letter from the FDA, asserting substantial equivalence to a predicate device, rather than a detailed study report for a novel AI device requiring extensive performance metrics against acceptance criteria.
Therefore, much of the requested information (acceptance criteria for AI, sample size for test sets/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone AI performance, etc.) is not applicable to this specific device and submission type, as it is a physical medical device (radiopaque markers) and not an AI/ML software. The crucial point is that no AI component is described or evaluated in this document.
However, I can extract and present the information relevant to a traditional medical device's performance and equivalence.
Device Name: Transit-Pellets
Regulation Name: Gastrointestinal Motility Monitoring System
Regulatory Class: Class II
Product Code: FFX
Indications for Use: For evaluation of colonic transit in adult patients with chronic constipation and used to aid in differentiating slow and normal constipation.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative, measurable table as one would for an AI model's performance (e.g., AUC > X, sensitivity > Y%). Instead, the device's performance is demonstrated through comparisons to a predicate device and safety/material testing, confirming it performs "as intended" and is "safe and effective."
| Characteristic/Criterion | Predicate Device (Sitzmarks) | Applicant Device (Transit-Pellets) | Substantial Equivalence (SE) Declared | Explanation of Performance / Meeting Criterion |
|---|---|---|---|---|
| Intended Use | For evaluation of colonic transit in patients with chronic constipation and used to aid in differentiating slow and normal constipation. | For evaluation of colonic transit in patients with chronic constipation and used to aid in differentiating slow and normal constipation. | X | Identical wording for intended use. |
| Application | Measuring and using colonic transit time to evaluate patients with chronic (severe) constipation. | Measuring and using colonic transit time to evaluate patients with chronic (severe) constipation. | X | Identical application described. |
| Target Population | Adult patients with chronic (severe) constipation. | Adult patients with chronic (severe) constipation. | X | Identical target population. |
| Anatomical Site | Gastrointestinal tract/colon | Gastrointestinal tract/colon | X | Identical anatomical site. |
| Where Used | Hospitals, clinics | Hospitals, clinics | X | Identical use environments. |
| Design | Three different shapes: O Rings, Double D, Tri-Chamber. | Ring-formed and tube-formed markers. | X | Different shapes but considered substantially equivalent as studies showed transit through colon was identical for ring-formed, tube-formed and cube-formed markers. |
| Dimensions | 1mm x 4.5mm | 2 x 4.5mm, 6 x 2mm | X | Different dimensions but considered equivalent; device claims sizes |
§ 876.1725 Gastrointestinal motility monitoring system.
(a)
Identification. A gastrointestinal motility monitoring system is a device used to measure peristalic activity or pressure in the stomach or esophagus by means of a probe with transducers that is introduced through the mouth into the gastrointestinal tract. The device may include signal conditioning, amplifying, and recording equipment. This generic type of device includes the esophageal motility monitor and tube, the gastrointestinal motility (electrical) system, and certain accessories, such as a pressure transducer, amplifier, and external recorder.(b)
Classification. Class II (performance standards).