(194 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: MC1000-B
- MiroCam® Receiver: MR1100
- Data Cable / Data Belt (Optional): MR1000-D / MR1000-D(M) or MR1000-D(L)
- MiroView™ Software: MiroView™ U, 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.
The provided text describes a 510(k) submission for the MiroCam® Capsule Endoscope System, focusing on its substantial equivalence to a predicate device rather than presenting a standalone clinical study with specific acceptance criteria and performance data. Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert adjudication, and MRMC studies are not explicitly stated in this document.
However, based on the information provided, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or specific performance metrics as would be found in a standalone clinical study. Instead, it relies on substantial equivalence to a legally marketed predicate device (MiroCam® Capsule Endoscope System K111450). The performance testing mentioned is primarily for safety and functional characteristics, not clinical efficacy metrics like sensitivity or specificity.
| Aspect of Performance/Criteria | Reported Device Performance (Summary from text) |
|---|---|
| Biocompatibility | Concluded that material and technological characteristics have not diminished safety and effectiveness compared to predicate. |
| Electrical Safety | Concluded that material and technological characteristics have not diminished safety and effectiveness compared to predicate. |
| Software Life Cycle Validation | Concluded that material and technological characteristics have not diminished safety and effectiveness compared to predicate. |
| Mechanical Structural Integrity | Concluded that material and technological characteristics have not diminished safety and effectiveness compared to predicate. |
| Field of View | Concluded that material and technological characteristics have not diminished safety and effectiveness compared to predicate. |
| Depth of Field | Concluded that material and technological characteristics have not diminished safety and effectiveness compared to predicate. |
| Battery Life | Concluded that material and technological characteristics have not diminished safety and effectiveness compared to predicate. |
| Battery Short-Circuit Temp. | Concluded that material and technological characteristics have not diminished safety and effectiveness compared to predicate. |
| Shelf Life | Concluded that material and technological characteristics have not diminished safety and effectiveness compared to predicate. |
| pH Resistance | Concluded that material and technological characteristics have not diminished safety and effectiveness compared to predicate. |
| Biting Resistance | Concluded that material and technological characteristics have not diminished safety and effectiveness compared to predicate. |
| Sensor Bench Testing | Concluded that material and technological characteristics have not diminished safety and effectiveness compared to predicate. |
| Optical Performance | Concluded that material and technological characteristics have not diminished safety and effectiveness compared to predicate. |
| Wireless Coexistence | Concluded that material and technological characteristics have not diminished safety and effectiveness compared to predicate. |
| Overall Safety & Effectiveness | Demonstrated substantial equivalence to listed predicate devices; differences do not affect product's safety or effectiveness. |
| Suspected GI Bleeding Indicator (SGIB) Functionality | Intended to mark frames of the video suspected of containing blood or red areas (functionality described, no performance metrics stated). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a clinical test set with a specific sample size. The performance testing mentioned are "bench testing" and "non-clinical performance testing," which typically refers to laboratory or engineering tests rather than patient studies. Therefore, details regarding country of origin or retrospective/prospective nature of a clinical test set are absent.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided as the submission relies on substantial equivalence and does not detail a clinical study with expert ground truth establishment for a test set.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set with expert adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
A MRMC comparative effectiveness study is not mentioned. The submission is for a medical device that assists physicians (Gastroenterologists) in reviewing images, but it does not detail a study comparing human performance with and without the device's assistance. The document mentions the "Suspected GI Bleeding Indicator (SGIB)" as a feature to "mark frames of the video suspected of containing blood or red areas," which implies an assistive function, but no study measuring its impact on reader performance is presented.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
A standalone performance study for an algorithm like the SGIB is not explicitly detailed. The SGIB is described as an "indicator" intended to "mark frames," implying it's a feature within the system. The submission mainly focuses on the physical and functional aspects of the capsule endoscopy system itself, establishing substantial equivalence to a previous version.
7. The Type of Ground Truth Used
For the bench testing described, the "ground truth" would be established through engineering specifications, known physical properties, and controlled experimental conditions (e.g., specific field of view measurements, battery discharge curves, pH levels). For the SGIB, the nature of its "ground truth" for marking frames is not specified but would likely be based on visual characteristics of blood or redness. There is no mention of pathology, expert consensus on clinical cases, or outcomes data being used as ground truth in this submission.
8. The Sample Size for the Training Set
No training set is mentioned. This submission is for a device, not a machine learning algorithm requiring a distinct training phase documented here for its efficacy claims. While the SGIB feature might be algorithm-based, no details of its development or training are provided.
9. How the Ground Truth for the Training Set was Established
Not applicable, as no training set is mentioned in the document.
§ 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.”