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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.

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.

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