(84 days)
The MiroCam® Capsule Endoscope System is intended for visualization of the small bowel mucosa. It may be used as a tool in the detection of abnormalities of the small bowel in 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: MC1200-B
- MiroCam® Receiver: MR1100
- Data Cable / Data Belt (Optional): MR1000-D / MR1000-D(S) or MR1000-D(M) or MR1000-D(L)
- MiroView™ Software: MiroView™ U 3.0, MiroView™ RTV, MiroView™ RTV-i
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.
I am sorry, but the provided documentation does not contain the information requested in your prompt regarding acceptance criteria and the comprehensive study details (sample sizes, ground truth provenance, expert qualifications, adjudication, MRMC studies, standalone performance, training set details).
The document is an FDA 510(k) clearance letter for the MiroCam® Capsule Endoscope System. It primarily focuses on demonstrating substantial equivalence to a predicate device (K134005).
While it mentions "Performance Testing" for the device, it explicitly states: "The performance testing are exactly the same as the predicate device (K134005)." This means the details of the performance testing are not included in this document but rather in the prior submission for K134005.
Therefore, I cannot extract the specific information you requested from this text.
§ 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.”