(78 days)
The OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM is intended for visualization of the small intestine mucosa.
• It may be used in the visualization and monitoring of lesions that may indicate Crohn's disease not detected by upper and lower endoscopy.
• It may be used in the visualization and monitoring of lesions that may be a source of obscure bleeding (either overt or occult) not detected by upper and lower endoscopy.
• It may be used in the visualization and monitoring of lesions that may be potential causes of iron deficiency anemia (IDA) not detected by upper and lower endoscopy.
The Red Color Detection Function is intended to mark frames of the video suspected of containing blood or red areas.
The OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM may be used as a tool in the detection of abnormalities of the small intestine.
OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM is a capsule imaging system used for visualization of the small intestine mucosa.
This system consists of capsule endoscopes which capture images and transmit the data, an antenna unit and a recorder which are secured around the patient and receive data from the capsule, and workstation software which downloads the image data from the recorder and processes images for visualization. The devices comprising this system, device design, and specifications are identical with the legally marketed predicate device. K142680. with the exception of minor modications that did not trigger the need for a new 510(k) and were documented internally at Olympus.
- The ENDOCAPSULE SMALL INTESTINAL CAPSULE ENDOSCOPE (OLYMPUS EC-10) is operated by mercury-free silver oxide batteries while the batteries for the predicate device contain mercury.
- The ENDOCAPSULE SOFTWARE 10 UPGRADE PACKAGE (MAJ-2190) is an upgraded software version to the previous models listed below:
- ENDOCAPSULE SOFTWARE 10 SERVER-CLIENT (Ver.1.00 and Ver.1.01)
- ENDOCAPSULE SOFTWARE 10 CLIENT (Ver.1.00 and Ver.1.01)
Expanding the indications for use to include the detection of Crohn's disease, obscure bleeding, and iron deficiency anemia (IDA) for this system is the scope of this submission.
The provided text is a 510(k) summary for the OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM. It focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing (battery changes, software upgrades) and a literature review to support expanded indications for use.
Crucially, the document does NOT describe an AI or algorithm-based device that requires acceptance criteria based on performance metrics (e.g., sensitivity, specificity, AUC) from a test set of data. Instead, the "Red Color Detection Function" is mentioned as an intended function to mark frames suspected of containing blood or red areas, but there's no performance study data provided for this function.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions related to sample size, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, as these elements are not present in the provided document.
The "study that proves the device meets the acceptance criteria" in this context refers to the summary of non-clinical testing and the summary of clinical literature review aiming to support the expanded indications for use by demonstrating safety and efficacy comparable to the predicate device and the broader class of capsule endoscopy devices.
Here's an analysis based on the information available:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria for Device Functionality (Non-Clinical): The document implies acceptance criteria related to the testing for battery life, temperature and humidity tolerance (medical environment, transportation, storage), and software validation (functional, performance, security, usability engineering, database, operation/maintenance requirements).
- Reported Device Performance (Non-Clinical):
- Battery Change Validation: "the following tests were conducted. - Battery Life - Test on Temperature and Humidity in Medical Environment - Test on Temperature and Humidity During Transportation and Storage" (Implies successful completion, but no specific performance metrics like 'battery life > X hours' are given).
- Software Upgrade Validation: "The software validation activities were performed in accordance with the FDA Guidance... The validation tests were performed against each function in regards to the following points [listed]." (Implies successful completion according to requirements, but no specific software performance metrics are provided).
- Acceptance Criteria for Expanded Indications (Clinical Literature Review): The implicit acceptance criteria for the expanded indications (Crohn's disease, obscure bleeding, IDA) are that the device, being technologically identical to the predicate (except for minor changes not affecting safety/efficacy) and similar to other clinically accepted CE devices, should demonstrate comparable safety and diagnostic utility as evidenced by existing clinical literature.
- Reported Device Performance (Clinical Literature Review):
- Iron Deficiency Anemia (IDA): Meta-analysis of four studies (264 IDA patients) revealed a higher diagnostic yield of 66.6% (95% CI, 61.0%-72.3%) for detecting sources of IDA using CE (specifically the reference device PillCam™ SB1). Complication rates were low (0-5%, pooled 1.4% retention).
- Obscure Gastrointestinal Bleeding (OGIB): Diagnostic yield generally ranges from 70%, with an overall positive diagnostic yield of ~50% for CE.
- Crohn's Disease (CD):
- Chong et al. (established CD): CE diagnostic yield 77.3% (17/22 patients), leading to change in clinical management in 76%.
- Dubcenco et al.: CE sensitivity 89.6%, specificity 100% (compared to histopathology in 39 patients with established/suspected CD), diagnostic yield 66.6%.
- CE for post-ileocolonic surgery CD: Diagnostic findings in 68% of patients, therapeutic modification recommended in 72.7%.
- Voderholzer et al.: CE diagnostic findings in 60.9% of patients. Therapy changed in 24% of patients.
- Safety: Low complication rates reported across studies (e.g., 1.4% retention for all indications, 1 in 800-1,000 procedures for aspiration).
2. Sample sized used for the test set and the data provenance:
- Test Set (for expanded indications): Not a single, unified test set. The clinical performance is supported by a review of existing clinical literature.
- For IDA: Four studies summarized, involving 264 IDA patients.
- For CD: Multiple studies cited (e.g., Chong et al. 22 patients; Dubcenco et al. 39 patients).
- Data Provenance: The document implies the data is retrospective, drawn from published clinical studies. Countries of origin are not specified but are likely international given the nature of academic publications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as the "test set" is composed of data from numerous existing clinical studies, where ground truth would have been established by the methods, diagnoses, and follow-up defined within each individual study (e.g., endoscopic findings, surgical findings, histopathology, clinical outcomes). The document does not describe a new study where a panel of experts retrospectively reviewed cases for ground truth.
4. Adjudication method for the test set:
- Not applicable for the same reasons as #3. Ground truth was established within the original studies cited, not through a unified adjudication process for this 510(k) submission.
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 MRMC study was done. This device is a capsule endoscope system, not an AI-assisted reading tool beyond the "Red Color Detection Function" which is not subjected to performance testing in this document. The submission focuses on the performance of the capsule endoscopy system itself for visualization and detection, not on improving human reader performance with AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No standalone algorithm performance study was done for the "Red Color Detection Function." The document mentions its intended purpose but provides no performance data for it. The overall device performance is described in terms of its ability to visualize and identify lesions, which generally requires human interpretation of the captured images.
7. The type of ground truth used:
- For the clinical literature review, the ground truth types would vary depending on the original study but generally include:
- Histopathology (e.g., from biopsies or surgical resections)
- Other endoscopic findings (upper and lower endoscopy, push enteroscopy)
- Radiological findings (e.g., enteroclysis, small bowel radiology)
- Clinical follow-up and outcomes data
- Consensus diagnoses from the original study's clinical team.
8. The sample size for the training set:
- Not applicable. The "Red Color Detection Function" is mentioned, but there is no description of an AI model or machine learning component that would require a distinct training set. The software validation detailed in the document is for the general functionality of the software, not for training a specific image analysis algorithm.
9. How the ground truth for the training set was established:
- Not applicable. As per #8, there's no mention of an AI model with a training set.
§ 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.”