(213 days)
With PillCam® SB Capsule: The PillCam Platform with a PillCam SB capsules is intended for visualization of the small bowel mucosa. The PillCam Platform with PillCam SB capsules may be used in the visualization and monitoring of lesions that may indicate Crohn's disease not detected by upper and lower endoscopy. The PillCam Platform with PillCam SB capsules may be used in the visualization of lesions that may be a source of obscure bleeding (either overt or occult) not detected by upper and lower endoscopy. The PillCam Platform with PillCam SB capsules may be used in the visualization of lesions that may be potential causes of iron deficiency anemia (IDA) not detected by upper and lower endoscopy. The Suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas. The PillCam Platform with PillCam SB capsules may be used as a tool in the detection of abnormalities of the small bowel and is intended for use in adults and children from two years of age.
With PillCam® ESO Capsule: The PillCam® Platform with a PillCam® ESO capsule is intended for the visualization of esophageal mucosa in adults and children from 18 years of age.
Given PillCam® Platform with PillCam® ESO 3 Capsule: The PillCam® Platform with a PillCam® ESO 3 capsule is intended for the visualization of esophageal mucosa in adults and children from 18 years of age.
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. 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. 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. RAPID 6.5 supports PillCam capsule endoscopy of the GI tract with all PillCam video capsules. 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 SensorArray or 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.
Here's an analysis of the acceptance criteria and study information provided in the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety of PillCam ESO 3 Capsules (due to size change): Ingesting difficulties rate with the new capsule should be comparable to or not significantly increased from the predicate device (PillCam ESO 2). | Out of 55 volunteers, 53 successfully ingested the PillCam ESO 3 capsule with no reported adverse events or difficulties. Two volunteers (3.6%) faced difficulties in a flat position but successfully ingested it when sitting up. This rate (3.6%) is comparable to the 7% ingestion difficulty rate observed in a clinical study with 100 subjects using PillCam ESO 2 capsules. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 55 volunteers participated in the test to evaluate the safety of the PillCam® ESO 3 capsules.
- Data Provenance: Not explicitly stated, but given the submitter's address (Yokneam, Israel) and the general tone of the document being for FDA submission, it's likely a prospective clinical study conducted perhaps in Israel or a similar location convenient for the manufacturer. The study is described as having "volunteers" and "underwent" the procedure, indicating a prospective nature.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document describes a safety study focused on ingestion difficulties due to capsule size, not a study requiring expert interpretation of medical images or establishment of a diagnostic ground truth. Therefore, information about experts for establishing ground truth is not applicable in this context. The "ground truth" here is the observable event of ingestion difficulty or successful ingestion, as reported by the volunteers and observed by study personnel.
4. Adjudication Method for the Test Set
Not applicable. The study assesses a direct observable event (ingestion difficulty) based on volunteer experience and direct observation, not an interpretation requiring adjudication like imaging diagnoses.
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
No. This document does not describe an MRMC comparative effectiveness study, nor does it mention AI assistance. The focus is on the safety of the physical device (capsule dimensions).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This document describes a usability/safety study of a physical capsule, not an algorithm, and therefore standalone algorithm performance is not applicable.
7. The Type of Ground Truth Used
The ground truth used was observational data and self-reported patient experience regarding the ease or difficulty of capsule ingestion. This is a direct assessment of a physical interaction rather than a diagnostic 'ground truth'.
8. The Sample Size for the Training Set
Not applicable. The document does not describe a training set as this study is not related to algorithm development or performance in image analysis.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no training set mentioned.
§ 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.”