(92 days)
The CapsoCam Plus SV-3 capsule endoscopy system is intended for visualization of the small bowel mucosa in adults and children older than two years of age. It may be used as a tool in the detection of abnormalities of the small bowel.
The primary component of the CapsoCam Plus (SV-3) capsule endoscopy system is the eponymous single-use, ingestible capsule that acquires and stores video images in on-board memory while moving through the gastrointestinal tract, propelled by natural peristalsis. It is administered under medical supervision either in-person or remotely under video guidance (available for adult patients only). The capsule is typically excreted within 3 to 30 hours after swallowing. Upon excretion, the patient/authorized caregiver retrieves the capsule using the provided retrieval kit and returns it to the capsules to the download center in a pre-paid envelope) where the capsule is processed and data is downloaded.
The system consists of the following hardware components and accessories:
- CapsoCam Plus (SV-3) capsules, which are intended for visualization of the small bowel mucosa.
- CapsoRetrieve (CVR1) Capsule Retrieval Kit, a kit of non-powered tools used for the collection, storage, and transportation of the excreted CapsoCam Plus (SV-3) capsules.
- CapsoAccess (CDAS) Capsule Data Access System, a dock which facilitates download/access of data from the SV-3 capsules.
The system also includes software that is unchanged from K192662.
The provided text does not contain information about acceptance criteria for device performance, nor details about a study that proves the device meets specific performance criteria through metrics like sensitivity, specificity, or accuracy.
The document is an FDA 510(k) clearance letter for the CapsoCam Plus (SV-3) Capsule Endoscopy System. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed performance metrics from a specific clinical or technical validation study with acceptance criteria.
The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section states that:
- "performance testing was conducted per the appropriate FDA Recognized Consensus Standards and required bench testing specifically included 1) verification and validation of hardware changes to confirm that, upon the design changes these continue to meet the applicable product specifications, and 2) transportation and shelf-life testing..."
- "A human factors evaluation was conducted and supported by real world evidence to demonstrate that there the safely and effectively administered to adult patients in a remote setting."
- "The clinical evidence provided in the submission include (1) a subgroup analysis of the pivotal study for CapsoCam (K151635), which enrolled both transitional adolescents (n=3, age: 19-21) and adult subjects, (2) an analysis of real world data on the pediatric use of CapsoCam in a pediatric gastroenterology clinic in Australia (n=26, age: 3-18), and (3) a review of the clinical literature on the pediatic use of the reference device and other capsule endoscopes cleared by the FDA indicated for use for in patients 2 years and above."
However, it does not provide the specific acceptance criteria (e.g., minimum sensitivity or specificity values) or the reported device performance against such criteria. It also lacks details on:
- The *sample size used for the test set beyond the general mention of "subgroup analysis of the pivotal study for CapsoCam (K151635)" and "analysis of real world data on the pediatric use of CapsoCam in a pediatric gastroenterology clinic in Australia (n=26)". The data provenance is described as "real world data on the pediatric use of CapsoCam in a pediatric gastroenterology clinic in Australia" and a "subgroup analysis of the pivotal study for CapsoCam (K151635)". It implies retrospective analysis of existing data.
- The number of experts used to establish ground truth or their qualifications.
- The adjudication method used.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done or any effect size of human reader improvement with AI assistance. (Note: This is a capsule endoscopy system, not an AI-assisted reading device, so MRMC with AI assistance would likely not be relevant here).
- Whether a standalone (algorithm only) performance study was done.
- The type of ground truth used beyond "facilitate diagnostic evaluation."
- The sample size for the training set (as it refers to minor design changes and clinical evidence from existing data, it doesn't describe a new AI model training process).
- How ground truth for the training set was established.
In summary, the provided document is a 510(k) clearance letter confirming substantial equivalence, and it does not contain the detailed performance study information with specific acceptance criteria, reported metrics, and study design elements regarding ground truth establishment, expert adjudication, or AI model training/testing that your request asks for. This type of information is typically found in the full 510(k) submission, specifically the performance data section, which is not fully included in this clearance letter.
§ 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.”