(359 days)
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.
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
- Data Cables
- MiroCam® Receiver
- MiroView™ Software and Workstation
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 MiroView™ workstation and the image data is uploaded. Following upload, the physician (Gastroenterologist) reviews the patient image data for suspected abnormalities of the small bowel.
Here's a breakdown of the acceptance criteria and study details for the MiroCam® Capsule Endoscope System, based on the provided 510(k) summary:
Acceptance Criteria and Device Performance Study
The primary effectiveness endpoint for the MiroCam® Capsule Endoscope System was to compare its agreement with a predicate device (Given Diagnostic Imaging System, K070475) regarding the detection and identification of sources of small bowel bleeding.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Metric | Reported Device Performance |
|---|---|
| Agreement with predicate device on identification (cause) of small bowel bleeding | 74.16% concordance (66 of 79 evaluable subjects) |
| 95% Confidence Interval for concordance rate | Not explicitly stated, but implied by statistical analysis |
| Safety | Device concluded to be safe (based on clinical testing) |
| Performance as intended | Device concluded to perform as intended (based on clinical testing) |
| Meeting user needs | Device concluded to meet user needs (based on clinical testing) |
2. Sample Size and Data Provenance for the Test Set
- Sample Size: 105 subjects were enrolled. 89 subjects were evaluable for the effectiveness analysis (having at least 2 hours of small bowel imaging time successfully). The concordance rate was estimated based on 79 evaluable subjects where small bowel bleeding was identified.
- Data Provenance: The study was a "multi-center, prospective, randomized, open-label clinical trial." The country of origin is not explicitly stated, but the company is based in South Korea, suggesting it could involve centers there.
3. Number of Experts and Qualifications for Ground Truth
The document does not explicitly state the number of experts used to establish the ground truth for the test set or their specific qualifications (e.g., "Radiologist with 10 years of experience"). However, it mentions that the "physician (Gastroenterologist) reviews the patient image data for suspected abnormalities of the small bowel," implying gastroenterologists are the primary reviewers. The comparison was made against a predicate device, suggesting that the 'ground truth' for the study's primary endpoint was the finding of the predicate device.
4. Adjudication Method for the Test Set
The document does not explicitly describe an adjudication method (like 2+1, 3+1). The study compared the MiroCam® with the predicate device, implying a direct comparison of findings rather than a separate expert-adjudicated ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an explicit MRMC comparative effectiveness study where human readers improve with AI vs. without AI assistance was not described. The study compared the device itself to a predicate device, focusing on agreement in detecting and identifying small bowel bleeding. While the MiroView™ software includes features like a "Suspected GI Bleeding Indicator (SGIB)" to "optimize the efficiency of the diagnostic review," the clinical study primarily assessed the overall diagnostic performance of the MiroCam® system in comparison to the predicate, rather than the impact of these specific AI features on human reader performance.
6. Standalone (Algorithm Only) Performance
The study design described is a comparison of the entire MiroCam® Capsule Endoscope System against a predicate device. It does not isolate the performance of an algorithm only (i.e., standalone AI performance without human-in-the-loop). The "Suspected GI Bleeding Indicator (SGIB)" is part of the MiroView™ software, which aids the physician, but its standalone performance or its specific contribution to the main effectiveness endpoint is not detailed as a separate study.
7. Type of Ground Truth Used for the Test Set
The ground truth for the effectiveness endpoint was established by comparing the findings of the MiroCam® device to the findings of the predicate device (Given Diagnostic Imaging System) regarding the detection and identification of sources of small bowel bleeding. It's a comparative effectiveness study rather than using an independent, definitive "gold standard" like pathology report in all cases.
8. Sample Size for the Training Set
The document does not provide information regarding a training set sample size. This summary primarily details the clinical validation (test set) for regulatory approval.
9. How the Ground Truth for the Training Set Was Established
As no training set is described, this information is not available in the provided 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.”