(233 days)
The MiroCam® Capsule Endoscope System is intended for visualization of the small bowel mucosa.
- It may be used in the visualization and monitoring of lesions that may indicate Crohn's disease not detected by upper and lower endoscopy.
- It may be used in the visualization and monitoring of lesions that may be a source of obscure bleeding (either overt or occult) not detected by upper and lower endoscopy.
- It may be used in the visualization and monitoring of lesions that may be potential causes of iron deficiency anemia (IDA) not detected by upper and lower endoscopy.
It may be used as a tool in the detection of abnormalities of the small bowel and this device is indicated for adults and children from two years of age.
The Suspected GI Bleeding Indicator (SGIB) is intended to mark frames of the video suspected of containing blood or red areas.
The MiroCam® Capsule Endoscope System is comprised of the following core components:
- MiroCam® Capsule: MC1600-B
- MiroCam® Receiver: MR2000
- Data Cable / Data Belt (Optional): MR1000-D / MR1000-D(S) or MR1000-D(M) or MR1000-D(L)
- MiroView™ Software: MiroView™ U 4.0
The general usage workflow of the MiroCam® system is as follows, the MiroCam® capsule captures images of the GI tract, which are sent via Human Body Communication to sensor pads which are affixed to the patient body. The sensor pads are connected to the receiver by the data cables. The image data is stored on the receiver for the duration of the patient procedure. After removing the receiver set from the patient body, the receiver is connected via USB to the Commercial PC and the image data is uploaded. Following upload, the physician (Gastroenterologist) reviews the patient image data for suspected abnormalities of the small bowel.
The provided text describes the MiroCam® Capsule Endoscope System and its substantial equivalence to predicate devices, including performance testing results for the MiroView™ Express 3.0 software. While it refers to "acceptance criteria" through comparison with predicate devices and mentions performance testing, explicit, quantifiable acceptance criteria are not clearly laid out in a dedicated table format with corresponding performance metrics for the AI component (Suspected GI Bleeding Indicator - SGIB).
However, the closest information to acceptance criteria for the software component's performance (specifically the MiroView™ Express 3.0 with its "informatics algorithm" for detecting significant images) can be inferred from the clinical study summary.
Here's an attempt to extract and present the information based on the provided text:
Table of Acceptance Criteria (Inferred) and Reported Device Performance
The document does not provide a formal table of acceptance criteria with "pass/fail" thresholds. Instead, it describes a clinical study to evaluate the performance of the "express view reading mode" (which includes an "informatics algorithm") for the MiroCam® Capsule Endoscope System, particularly concerning the detection of "significant lesions" and "significant images." The implicit acceptance criterion is that the new system's performance, particularly in terms of sensitivity and reading time, is comparable or improved compared to standard reading, while also demonstrating clinical utility.
| Feature / Metric | Inferred Acceptance Criteria (Implicit) | Reported Device Performance (MiroView™ Express 3.0 informatics algorithm) |
|---|---|---|
| Sensitivity for Significant Lesions (Express View Reading) | High sensitivity, comparable to standard reading. (The study aimed to show high sensitivity, not necessarily specific thresholds, but implicit is that it should not be significantly worse than standard reading). | 82.2% sensitivity (Standard reading had 93.3% sensitivity, noted as "NS" - not statistically significant difference, suggesting comparability was deemed acceptable). |
| Reading Time (Express View Mode) | Significant shortening of reading time compared to standard reading. | 19.7 minutes (Mean reading time) compared to 39.7 minutes for standard mode (P |
§ 876.1300 Ingestible telemetric gastrointestinal capsule imaging system.
(a)
Identification. An ingestible telemetric gastrointestinal capsule imaging system is used for visualization of the small bowel mucosa as an adjunctive tool in the detection of abnormalities of the small bowel. The device captures images of the small bowel with a wireless camera contained in a capsule. This device includes an ingestible capsule (containing a light source, camera, transmitter, and battery), an antenna array, a receiving/recording unit, a data storage device, computer software to process the images, and accessories.(b)
Classification. Class II (special controls). The special control is FDA's guidance, “Class II Special Controls Guidance Document: Ingestible Telemetric Gastrointestinal Capsule Imaging Systems; Final Guidance for Industry and FDA.”