(47 days)
The Given® Diagnostic System with the PillCam™ ESO2 Capsule is intended for visualization of the esophageal mucosa
The Given® Diagnostic System is comprised of three subsystems: PillCam™ Capsule (SB, ESO), Data Recorder Set, and RAPID® Workstation or RAPID® Software.
The modifications to the Given® Diagnostic System, which are subject of this Special 510(k) is the addition of a new model of esophageal capsule, the PillCam™ ESO2 Capsule, and the addition of an alternative ingestion procedure, the simplified ingestion procedure (SIP) for the esophageal capsules.
The provided text describes a 510(k) submission for the Given® Diagnostic System with PillCam™ ESO2 Capsule, focusing on its substantial equivalence to a predicate device. However, the document does not contain explicit acceptance criteria or a study that directly proves the device meets specific performance criteria beyond the general statement of substantial equivalence.
The 510(k) summary explains that the submission is for a modification to an existing device, specifically the addition of a new esophageal capsule model (PillCam™ ESO2) and an alternative ingestion procedure. The core of the submission is to demonstrate that these modifications do not introduce new safety or efficacy issues and that the modified device is "substantially equivalent" to already cleared devices.
Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, and adjudication methods are not present in the provided document. The 510(k) process primarily relies on demonstrating equivalence rather than on de novo performance studies against pre-defined acceptance criteria (unless a special controls guidance document specifies them, which is mentioned as being complied with in a general sense, but no specific performance endpoints are given).
Here's an analysis of the information that can be extracted or inferred based on the provided text, and where information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| NOT PROVIDED | NOT PROVIDED |
| (Specific quantitative criteria like sensitivity, specificity, accuracy, or image metrics are not detailed in this document. The primary "performance" demonstrated is substantial equivalence to a predicate device for visualization of esophageal mucosa.) | (No specific performance metrics are reported in this document beyond the device being cleared based on substantial equivalence for its stated intended use.) |
2. Sample size used for the test set and the data provenance
- Sample size for test set: NOT PROVIDED. The document doesn't detail a specific clinical study for performance testing of the PillCam™ ESO2 capsule against a ground truth. The submission likely relies on previous studies for the predicate device and potentially bridging studies that confirm the new capsule's similar performance.
- Data provenance: NOT PROVIDED. No information on country of origin of data or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: NOT PROVIDED. Since no specific performance study with a test set is detailed, information on experts used to establish ground truth is absent.
- Qualifications of experts: NOT PROVIDED.
4. Adjudication method for the test set
- Adjudication method: NOT PROVIDED. No test set or corresponding adjudication method is mentioned in this 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
- MRMC study: NOT APPLICABLE / NOT PROVIDED. The device is an "Ingestible Telemetric Esophageal Capsule Imaging System" which typically functions as a diagnostic tool for visualization, not an AI-assisted diagnostic. There is no mention of AI integrated into the system described in this document, nor any MRMC study comparing human readers with and without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone algorithm performance: NOT APPLICABLE / NOT PROVIDED. The device is a capsule imaging system, not an algorithm, and the document does not describe any standalone algorithmic performance evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of ground truth: NOT PROVIDED. The document does not describe a specific study with a defined ground truth for the PillCam™ ESO2 capsule's performance. The basis for equivalence is likely derived from the predicate device's demonstrated ability to visualize the esophageal mucosa, which would have implicitly relied on a comparison to standard clinical evaluations (e.g., endoscopy findings by expert clinicians, or possibly biopsy results for pathology).
8. The sample size for the training set
- Sample size for training set: NOT APPLICABLE / NOT PROVIDED. As this is an imaging device and not an AI/ML algorithm that requires a training set in the typical sense, this information is not relevant or provided in the document.
9. How the ground truth for the training set was established
- Ground truth for training set: NOT APPLICABLE / NOT PROVIDED. Same as above, not relevant for this type of device and submission.
Summary of what IS provided:
- Device Name: Given® Diagnostic System with PillCam™ ESO2 Capsule
- Intended Use: Visualization of the esophageal mucosa.
- Predicate Device: Given® Diagnostic System with PillCam™ ESO Capsule (cleared under K041149 and K042960).
- Basis for Clearance: Substantial equivalence to the predicate device.
- Modifications: Addition of the PillCam™ ESO2 Capsule and an alternative ingestion procedure (simplified ingestion procedure - SIP).
- Regulatory Compliance: Complies with "Class II Special Controls Guidance in Document; Ingestible Telemetric Gastrointestinal Capsule Imaging System; Final Guidance for Industry and FDA" issued on November 28, 2001. (However, the specific performance requirements from this guidance are not detailed in this 510(k) summary).
In essence, this document is a summary of the 510(k) submission, not a detailed clinical study report. It focuses on the regulatory argument for substantial equivalence rather than reporting explicit performance metrics from a specific new clinical study with the ESO2 capsule.
§ 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.”