(91 days)
The Given® Diagnostic 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.
The Suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas.
The Given® Diagnostic System is comprised of three subsystems-M2ATM Capsule, Data Recorder Set, and RAPID® Workstation.
The M2A® Capsule is a wireless, disposable capsule designed to glide smoothly through the digestive system by the peristaltic activity of the intestinal muscles and is excreted naturally. During its passage, the capsule transmits digital data that is captured by receiving antennas attached to the patient's body. The images are stored in the DataRecorder that is connected to the receiving antennas and is worn on a belt around the waist of the patient. When the test is over, the antennas and recorder are removed from the patient's body. The images from the recorder are downloaded to the RAPID® Workstation for processing and viewing by the physician.
The RAPID 2.0 software, contains an optional feature called Suspected Blood Indicator (SBI), which automatically marks images that correlate with the existence of suspected blood or red areas. The analysis is based on detection of colorimetric abnormalities, or deviations from an expected spectrum, corresponding to normal tissue.
The provided text is a 510(k) summary for the Given® Diagnostic System with the Suspected Blood Indicator (SBI) feature. It describes the device, its intended use, and states that it meets performance standards and special controls. However, this document does not contain the specific details of a study that proves the device meets acceptance criteria, nor does it define explicit acceptance criteria in a quantifiable manner.
The document only states that the system "complies with the requirements presented in Ingestible Telemetric Gastrointestinal Capsule Imaging System: Final Guidance for Industry and FDA issued on November 28, 2001." It also asserts substantial equivalence to predicate devices "without raising any new safety and/or efficacy issue."
Therefore, I cannot fulfill your request for the following sections based on the provided text:
- A table of acceptance criteria and the reported device performance
- Sample size 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 the effect size
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The sample size for the training set
- How the ground truth for the training set was established
The document is a regulatory submission summary stating compliance and substantial equivalence, not a detailed clinical study report. Such details would typically be found in the actual studies conducted to support the 510(k) submission, which are not part of this summary 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.”