(175 days)
The Given® Diagnostic System with the PillCam™ ESO Capsule is intended for the visualization of esophageal mucosa.
The Given® Diagnostic System with the PillCam™ ESO Capsule is intended for the visualization of the esophagus.
The Given® Diagnostic System with the PillCam™ ESO Capsule is comprised of three subsystems: PillCam™ ESO Capsule, Data Recorder Set, and RAPID® Workstation.
The PillCam™ ESO Capsule is a wireless, disposable capsule designed to glide smoothly through the esophagus. 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 provided text primarily focuses on regulatory information for the "Given® Diagnostic System with PillCam™ ESO Capsule" and does not contain details about specific acceptance criteria, study methodologies, or performance results in the way typically expected for a detailed scientific study review. The document is a 510(k) summary and FDA clearance letter, which establishes substantial equivalence rather than presenting comprehensive clinical trial data.
Therefore, many of the requested items cannot be definitively answered from the provided text. However, I can extract what is implied or stated generally.
Here's an analysis based on the provided text, highlighting what's missing:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the given text. A 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance table with specific acceptance criteria and results.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the given text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the given text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the given text.
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
This information is not provided in the given text. The description is of a capsule imaging system for visualization, not explicitly an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided in the given text. The "Given® Diagnostic System" described includes a "RAPID® Workstation" for processing and viewing by the physician, implying human-in-the-loop performance is key.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not provided in the given text.
8. The sample size for the training set
This information is not provided in the given text.
9. How the ground truth for the training set was established
This information is not provided in the given text.
Summary of what can be inferred or explicitly stated from the provided text:
- Device Name: Given® Diagnostic System with PillCam™ ESO Capsule
- Intended Use: Visualization of esophageal mucosa (and visualization of the esophagus).
- Classification: Class II device, product code 78NZE (later referred to as 78 NSI in the FDA letter).
- Predicate Device: Given® Diagnostic System (K010312, K020341, K022362, K022980, K031033, K032405, and K040248.)
- Compliance: Complies with "Class II Special Controls Guidance Document; Ingestible Telemetric Gastrointestinal Capsule Imaging System; Final Guidance for Industry and FDA" issued on November 28, 2001. This implies that the device meets the general performance and safety requirements outlined in this guidance. The guidance document would contain the "acceptance criteria" at a regulatory level, but not the specific quantitative performance metrics from a study report.
- Substantial Equivalence: The applicant believes the device is substantially equivalent to the cleared Given® Diagnostic System (with the M2A® SB Capsule) without raising new safety and/or efficacy issues. The FDA concurred with this assessment for market clearance.
To answer your questions thoroughly, you would need access to the actual clinical trial or validation study report that led to this 510(k) submission, which is not part of the provided text.
§ 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.”