(14 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 in adults and children from 10 years of age and up.
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 M2A® 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. A Pediatric Accessory Kit for use of the system on pediatric (age 10 and up) population has been added.
The provided text focuses on the 510(k) summary for the Given® Diagnostic System, specifically regarding the addition of a Pediatric Accessory Kit. It establishes substantial equivalence to previous versions of the device and outlines its intended use and general description.
However, the document does not contain any information about specific acceptance criteria, study methodologies, performance metrics (like sensitivity, specificity, or F1 score), sample sizes for test or training sets, ground truth establishment, or details about expert involvement for performance evaluation. The information provided is primarily regulatory in nature, confirming the device's classification and substantial equivalence to a predicate device.
Therefore, I cannot populate the requested table or provide answers to most of the specific questions.
Here's a summary of what can be extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
- Cannot be created. The document does not specify acceptance criteria or report specific device performance metrics in numerical terms. It states the device "complies with the requirements presented in 'Class II Special Controls Guidance Document; Ingestible Telemetric Gastrointestinal Capsule Imaging System'," but does not detail what those requirements are or how performance against them was measured for this specific submission.
2. Sample size used for the test set and the data provenance:
- Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not provided.
4. Adjudication method for the test set:
- Not provided.
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:
- Not provided. The document describes the "Suspected Blood Indicator (SBI) feature" which marks frames "suspected of containing blood or red areas," implying an algorithmic assist, but no MRMC study or effect size is detailed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not provided.
7. The type of ground truth used:
- Not provided.
8. The sample size for the training set:
- Not provided.
9. How the ground truth for the training set was established:
- Not provided.
In conclusion, the provided text serves as a regulatory submission for substantial equivalence and does not include the detailed performance study information typically found in a scientific publication or a more comprehensive technical report.
§ 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.”