(129 days)
The Given® AGILE Patency System is an accessory to the PillCam video capsule and is intended to verify adequate patency of the gastrointestinal tract prior to administration of the PillCam video capsule in patients with known or suspected strictures.
The Given® AGILE Patency System is a simple and easy to use device for verifying the patency of the GI tract. It consists of the following components:
- · Given AGILE Patency capsule
- · Given AGILE Patency Scanner
- · TesTag (interference tester)
Once the patient ingests the Given AGILE Patency capsule it is propelled through the GI tract by normal peristalsis. If the AGILE Patency capsule is excreted structurally whole, then this indicates patency of the GI tract of the patient and a PillCam capsule can be administered. The capsule is designed to dissolve starting 30 hours following ingestion, during a period of approximately 12 hours. If anytime before 30 hours after capsule ingestion the AGILE Patency capsule cannot be detected in the patient's body by the Given AGILE Patency Scanner, it indicates that the GI tract is patent and that the capsule was excreted naturally.
The Given AGILE Patency Scanner is used to detect the presence of the Given AGILE Patency capsule in the patient's body. If a scanner is not available, or if localization of a retained capsule is desired, fluoroscopy can be used.
If the Given AGILE Patency Scanner detects the Given AGILE Patency capsule in the GI tract 30 hours post-ingestion, then patency of the GI tract is not indicated. Eventually, the capsule dissolves into small fragments and is naturally excreted.
Here's a breakdown of the acceptance criteria and the study information for the Given AGILE Patency System, based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state numerical acceptance criteria in a table format. However, the core function and intended outcome of the device serve as the de facto "acceptance criteria." The device's performance is reported in relation to its ability to confirm or deny GI tract patency.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Criterion 1: Accurate indication of GI tract patency if the capsule is excreted structurally whole. | "If the AGILE Patency capsule is excreted structurally whole, then this indicates patency of the GI tract of the patient and a PillCam capsule can be administered." |
| Criterion 2: Accurate indication of GI tract patency if the capsule cannot be detected by the scanner before 30 hours post-ingestion. | "If anytime before 30 hours after capsule ingestion the AGILE Patency capsule cannot be detected in the patient's body by the Given AGILE Patency Scanner, it indicates that the GI tract is patent and that the capsule was excreted naturally." |
| Criterion 3: Accurate indication of non-patency if the capsule is detected in the GI tract 30 hours post-ingestion or later. | "If the Given AGILE Patency Scanner detects the Given AGILE Patency capsule in the GI tract 30 hours post-ingestion, then patency of the GI tract is not indicated." The capsule "eventually... dissolves into small fragments and is naturally excreted." |
Study Information:
The provided 510(k) summary does not contain details of a clinical study that provides specific data on the device's performance, such as sensitivity, specificity, accuracy, or a breakdown of results from a test set. The document focuses on describing the device, its intended use, and its substantial equivalence to predicate devices. It states that "Given Imaging Ltd. believes that, based on the information provided in the submission, the Given® AGILE Patency System is substantially equivalent to its predicate devices without raising any new safety and/or efficacy issue." This implies that the justification for clearance is primarily based on equivalence to existing cleared devices rather than a de novo clinical performance study demonstrating specific metrics against a test set.
Therefore, for the following points, the answer is "Not provided in the document" as the requested details would typically be found in a clinical study report, which is not part of this 510(k) summary.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not provided in the document.
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)
- 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 applicable / Not provided in the document. This device is a patency system, not an imaging analysis system that would involve human readers interpreting images with or without AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- While the device operates somewhat "stand-alone" in determining retention (scanner detects presence), the overall system relies on human interpretation of the scanner results (and potentially fluoroscopy) to make a clinical decision. However, no specific "standalone performance study" data is presented.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not provided in the document. Given the nature of the device, the ground truth for patency would likely be established by direct observation of capsule passage, subsequent passage of a PillCam, or alternative diagnostic procedures (e.g., endoscopy, imaging).
8. The sample size for the training set
- Not applicable / Not provided in the document. This device does not appear to be an AI/machine learning system that requires a "training set" in the conventional sense. Its function is based on physical dissolution and a scanner detection mechanism.
9. How the ground truth for the training set was established
- Not applicable / Not provided in the document. (See point 8).
§ 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.”