(142 days)
The CapsoCam ® Plus video capsule system is intended for visualization of the small bowel mucosa in adults. It may be used as a tool in the detection of abnormalities of the small bowel.
CapsoCam® Plus (SV-3) capsule is a single-use. ingestible video capsule that acquires and stores video images in on-board memory while moving through the gastrointestinal tract, propelled by natural peristalsis. The patient retrieves the provided retrieval kit and returns it to the physician who downloads and reviews the images on a computer. The capsule is typically excreted within 3 to 30 hours after swallowing.
CapsoCam® Plus (SV-3) capsule endoscope is a single-use ingestible capsule system for diagnostic visualization of the adult small bowel. The system consists of the following accessories:
- CapsoCam® Plus (SV-3) capsules, which are intended for visualization of the small bowel mucosa in adults and used as a tool in the detection of abnormalities of the small bowel.
- CapsoView (CVV) software program, which is used to download and view CapsoCam® Plus ● (SV-3) capsule images and to generate capsule endoscopy reports.
- CapsoAccess (CDAS) Capsule Data Access System, which accesses data from the ● CapsoCam® Plus (SV-3) capsules.
- CapsoRetrieve (CVR1) Capsule Retrieval Kit, which is used for the collection, storage, and ● transportation of the excreted CapsoCam® Plus (SV-3) capsules.
- CapsoCloud (CLD), which is a cloud-based software application used to manage procedures ● and to review and analyze images from the CapsoCam® Plus (SV-3) capsule.
Here's a breakdown of the acceptance criteria and study information for the CapsoCam® Plus (SV-3) Capsule Endoscopy System, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" with numerical targets for clinical performance. Instead, it focuses on demonstrating substantial equivalence to a predicate device (CapsoCam® Plus (SV-3) System, K183192).
The key performance aspect tested for the new CapsoCloud software application was image comparison and Image Substantial Equivalence Analysis between the proposed and predicate software.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Image Substantial Equivalence | Demonstrated substantial equivalence through testing of the CapsoCloud software application and in-vivo image comparison. |
| Safety and Effectiveness | The material and technological characteristics do not raise different questions of safety or effectiveness compared to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document states "in-vivo testing for the image comparison from the proposed and the predicate software."
- Sample Size: Not explicitly stated.
- Data Provenance: "in-vivo testing" suggests data from live subjects, but details like country of origin or whether it was retrospective or prospective are not provided.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the document.
4. Adjudication Method
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not conducted or reported in this document. The focus was on demonstrating substantial equivalence to a predicate device, specifically regarding the addition of a new cloud-based software. There is no mention of human reader performance improvement with or without AI assistance.
6. Standalone (Algorithm Only) Performance
A standalone performance study focused purely on the algorithm's diagnostic capabilities without human interaction was not explicitly described for this submission. The validation focused on the CapsoCloud software and image equivalence to the predicate system, which implies the system as a whole maintains its performance characteristics when the cloud software is introduced.
7. Type of Ground Truth Used
The ground truth for the "image comparison from the proposed and the predicate software" would be rooted in the images generated by the predicate device's software. The goal was to show that the new software (CapsoCloud) processes and presents images that are substantially equivalent to those processed by the predicate's CapsoView software. The document doesn't detail how the ground truth for actual abnormalities or diagnoses in these images was established, as the primary comparison was between software versions, not necessarily clinical diagnostic accuracy.
8. Sample Size for the Training Set
This information is not provided in the document.
9. How the Ground Truth for the Training Set Was Established
This information is not provided 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.”