(45 days)
The PillCam 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 PillCam Patency capsule should only be used within the specified patient age range based on the patient age of the indicated video capsule system.
Therefore, the PillCam Patency System is intended to be used:
- prior to PillCam SB capsule in adults and children from 2 years of age, or
- prior to PillCam UGI, COLON, and Crohn's capsules in adults
The PillCam Patency System is an accessory to the PillCam capsule endoscopy (CE) System and it is used for verifying the patency of the Gastrointestinal (GI) tract. The PillCam Patency System consists of the following components; The PillCam Patency capsule, the Patency scanner and TesTag (interference tester).
The Patency capsule is an ingestible and dissolvable capsule, similar in size to the PillCam CE. It is comprised of a body that surrounds a small Radio Frequency Identification (RFID) tag. The body is coated with an impermeable membrane, except for two small windows that are plugged by the Timer Plugs. The Timer plugs seal the capsule's body. If the Patency capsule is excreted structurally whole, then this confirms patency of the GI tract of the patient for objects similar in size to the capsule. However, if the capsule is retained in the GI tract, the Timer Plugs erode, allowing the penetration of body fluids into the capsule and the dissolution of the capsule's body. The remaining fragments of the capsule can pass even small orifices.
The Patency scanner may be utilized to detect RF signals from the RFID tag, to verify the PillCam Patency capsule presence in the body.
The only difference between the PillCam Patency System and the predicate device is the proposed labeling modification, to allow the use of the existing Patency capsule with the PillCam capsules that are slightly longer (PillCam COLON, Crohn's and UGI capsules). The intention of the proposed change is to offer physicians a clinical tool to evaluate the suitability of patients for CE, as an alternative to magnetic resonance enterography (MRE) or Computed Tomography (CT) which are already used in practice for this purpose.
The provided text is a 510(k) summary for the PillCam Patency System. It references a previous submission (K053639) for clinical testing data, but the details of that study, including specific acceptance criteria and detailed device performance, are not explicitly laid out in the current document. However, based on the information provided, I can construct a response with the available data and highlight where information is missing.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The current document (K180171) itself does not explicitly state quantitative acceptance criteria or detailed device performance metrics in a readily digestible table. Instead, it refers to prior clinical testing (K053639) and general statements about the system's performance.
| Criterion Type | Acceptance Criteria (Not explicitly stated in K180171) | Reported Device Performance (Leveraging K053639) |
|---|---|---|
| Patency Verification | (Implicit: Successful detection of intact capsule or dissolution if retained) | "In this testing, patients with known strictures ingested the Patency capsule and underwent periodic scanning until the capsule was excreted. If patency was established, capsule endoscopy procedure was performed. The results of this testing showed there were no cases of capsule retention." |
| Safety | (Implicit: No new safety concerns raised) | "The proposed change in this submission does not raise new performance or safety issues." |
| "In addition, three clinical investigations demonstrate the use of Patency System prior to ingestion of longer PillCam capsules with no safety concern raised." | ||
| Diagnostic Accuracy (Sensitivity & Specificity) | (Not explicitly stated) | "Many studies in the literature have shown that the PillCam Patency System has high diagnostic sensitivity and specificity and that the use of a PillCam Patency System reduces risk of PillCam CE retention." |
| Dissolution Time | (Implicit: Starts dissolving after 30 hours) | "The PillCam Patency capsule is designed to start dissolving after 30 hours." |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not explicitly stated in K180171. It refers to "patients with known strictures" in the leveraged K053639 study.
- Data Provenance: Not specified in K180171 (e.g., country of origin). The previous study (K053639) from which the data was leveraged would contain this information. The current submission is a regulatory document concerning a device from Israel (Given Imaging Ltd.).
- Retrospective or Prospective: Not explicitly stated for the leveraged K053639 study. However, the description "patients with known strictures ingested the Patency capsule and underwent periodic scanning until the capsule was excreted" suggests a prospective clinical study design.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the K180171 document. The document primarily focuses on the device's physical and functional characteristics and references prior clinical safety and efficacy without detailing the methodology of ground truth establishment in the studies themselves.
4. Adjudication method for the test set
This information is not provided in the K180171 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
This is not applicable to the PillCam Patency System as described. The Patency System's function is to verify GI tract patency, primarily through the detection of an RFID tag or the capsule's dissolution, not through interpretation of images by human readers or AI. It's an accessory to a video capsule, but its own function doesn't involve image interpretation where "human readers improve with AI" would be a relevant metric.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the core function of the PillCam Patency System, as described, is a standalone process. The Patency scanner detects RF signals from the RFID tag, and the capsule's dissolution is a physical process, both occurring without direct human interpretive intervention during the patency verification itself. The "human-in-the-loop" aspect would be the physician's decision based on the outcome (intact capsule excreted or not), but the patency test itself does not involve AI or human image interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the efficacy aspect (successful patency verification) would likely be based on:
- Direct observation of capsule excretion: If the capsule is excreted whole, patency is confirmed.
- Follow-up outcomes: The success of the subsequent capsule endoscopy (e.g., no retention) after a positive patency test would serve as an outcome-based ground truth.
- Clinical assessment: The resolution or passage of the capsule (or its fragments) and the patient's clinical status.
The K180171 document states: "If the Patency capsule is excreted structurally whole, then this confirms patency of the GI tract of the patient for objects similar in size to the capsule." This indicates direct observation as a primary ground truth.
8. The sample size for the training set
The K180171 document does not mention a training set. This is because the device is a physical capsule system, not an AI/ML algorithm that requires a training set. The "design" and "performance" of the capsule are based on engineering principles and clinical testing, not model training.
9. How the ground truth for the training set was established
As there is no training set for this type of device, this information is not applicable.
§ 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.”