(78 days)
The Given PillCam® Platform with the PillCam® SB Capsules 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 PillCam® Platform is comprised of three main subsystems; (1) the ingestible PillCam capsule, (2) the RAPID® software, and (3) the Given® Workstation and Hardware.
l. Ingestible PillCam Capsule
The disposable, ingestible PillCam Capsule is designed to acquire video images during the natural propulsion through the GI tract. The capsule transmits the acquired images via a RF communication channel to the DataRecorder located outside the body.
2 RAPID Software
The RAPID Software is a software application that is utilized to process, analyze, store, and view the acquired images collected from the DataRecorder to create a RAPID video of the images. The software also includes a reporting function to create detailed clinical reports, in-service training videos, and patient instruction forms.
3 Given Workstation and Hardware
The Workstation is a modified standard personal computer that is the operational platform for the RAPID software. The DataRecorder is an external receiving/recording unit that receives acquired images from the capsule. The PillCam® SensorBelt receives data from the PillCam capsule and transfers the data to the DataRecorder. The RAPID Real Time is a handheld device that allows for real-time viewing of acquired images through the GI tract. Other accessories include a flat panel LCD monitor, a high-capacity mass storage device, and a high-capacity USB portable storage device.
The provided text focuses on the 510(k) summary for the Given PillCam® Platform and does not contain detailed information about specific acceptance criteria or a dedicated study proving the device meets them. The document states that the "devices meet the guidance entitled 'Class II Special Controls Guidance Document: Ingestible Telemetric Gastrointestinal Capsule Imaging System; Final Guidance for Industry and FDA dated November 28, 2001." However, it does not provide the specific metrics or outcomes from any study demonstrating this compliance.
Therefore, most of the requested information cannot be extracted from the given text.
Here's an attempt to answer the questions based only on the provided snippet, acknowledging the lack of detailed performance data:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from guidance document) | Reported Device Performance (from guidance document compliance) |
|---|---|
| (Not specified in this document, but referred to as "Class II Special Controls Guidance Document: Ingestible Telemetric Gastrointestinal Capsule Imaging System; Final Guidance for Industry and FDA dated November 28, 2001") | "The devices meet the guidance entitled 'Class II Special Controls Guidance Document: Ingestible Telemetric Gastrointestinal Capsule Imaging System; Final Guidance for Industry and FDA dated November 28, 2001." |
2. Sample size used for the test set and the data provenance
Not provided in the document. The document only mentions "design control (verification and validation) activities" without detailing specific studies, sample sizes, or data provenance for any test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not provided in the document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not provided in the document.
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 mentioned or indicated in the document. The "Suspected Blood Indicator (SBI) feature" is described as intended to "mark frames of the video suspected of containing blood or red areas," but no study on reader improvement with this feature is presented.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not specifically stated in the document. The SBI feature is an algorithm, but its standalone performance metrics are not given.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not provided in the document.
8. The sample size for the training set
Not provided in the document.
9. How the ground truth for the training set was established
Not provided in the document.
Summary of what is known:
The filing states that the device's technological characteristics are "exactly the same as the predicate device" and that the "devices meet the guidance entitled 'Class II Special Controls Guidance Document: Ingestible Telemetric Gastrointestinal Capsule Imaging System; Final Guidance for Industry and FDA dated November 28, 2001." The submission concludes that the device is "substantially equivalent" to predicate devices, implying that its performance is considered comparable and acceptable under the existing regulatory framework for such devices. However, the specific data, metrics, and study details that demonstrate this compliance are not included in the provided 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.”