(142 days)
The OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM is intended for visualization of the small intestine mucosa. The Red Color Detection Function is intended to mark frames of the video suspected of containing blood or red areas.
OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM is a capsule imaging system used for visualization of the small intestine mucosa. This system consists of a capsule endoscope which captures images and transmits the data, an antenna unit and a recorder which are secured around the patient and receive data from the capsule, workstation software which downloads the image data from the recorder and processes images for visualization.
The new workstation software, MAJ-2188 ENDOCAPSULE SOFTWARE 10 and MAJ-2189 ENDOCAPSULE SOFTWARE 10 LIGHT, are the subjects of this submission.
The provided text is a 510(k) summary for the OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM. It does not contain a study that proves the device meets specific acceptance criteria for a "Red Color Detection Function." The document mentions that the Red Color Detection Function is "intended to mark frames of the video suspected of containing blood or red areas," but it does not provide any performance metrics, acceptance criteria, or details of a study assessing this function.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (OLYMPUS CAPSULE ENDOSCOPE SYSTEM, K123421) based on "reconstructed...operability" and similar technological characteristics. It lists general non-clinical testing, risk analysis (ISO 14971:2007), and software validation activities, but these are related to the overall system's safety and effectiveness, not the specific performance of the "Red Color Detection Function."
Therefore, based solely on the provided text, I cannot answer the following parts of your request as the information is not present:
- A table of acceptance criteria and the reported device performance.
- Sample sized used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
- Adjudication method for the test set.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size.
- If a standalone performance (algorithm only) was done.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
The 510(k) summary does state that:
- The "Red Color Detection Function is intended to mark frames of the video suspected of containing blood or red areas." (This is the stated intention, not reported performance).
- Non-clinical testing, risk analysis (ISO 14971), and software validation (Moderate Level of Concern) were performed for the overall device.
Without additional documentation, the specific performance of the Red Color Detection Function and the studies supporting it are not detailed in this 510(k) summary.
§ 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.”