(97 days)
The MiroCam® Capsule Endoscope System is intended for visualization of the small bowel mucosa. It may be used as a tool in the detection of abnormalities of the small bowel in adults and children from two years of age.
The Suspected GI Bleeding Indicator (SGIB) is intended to mark frames of the video suspected of containing blood or red areas.
The MiroCam® Capsule Endoscope System is comprised of the following core components:
- MiroCam® Capsule: MC1000-B
- MiroCam® Receiver: MR1100
- Data Cable / Data Belt (Optional): MR1000-D / MR1000-D(M) or MR1000-D(L)
- MiroView™ Software: MiroView™ U, MiroView™ RTV, MiroView™ RTV-i
The general usage workflow of the MiroCam® system is as follows, the MiroCam® capsule captures images of the Gl tract, which are sent via Human Body Communication to sensor pads which are affixed to the patient body. The sensor pads are connected to the receiver by the data cables. The image data is stored on the receiver for the duration of the patient procedure. After removing the receiver set from the patient body, the receiver is connected via USB to the Commercial PC and the image data is uploaded. Following upload, the physician (Gastroenterologist) reviews the patient image data for suspected abnormalities of the small bowel.
The provided text does not contain detailed information about specific acceptance criteria or an exhaustive study proving the device meets those criteria. The 510(k) summary states that "The performance testing are exactly the same as the predicate device (K123428)," implying that the current submission relies on the testing of its predicate device. This usually means that the device is shown to be substantially equivalent to the predicate through similar technological characteristics and equivalent intended use, rather than a new de novo performance study with specific acceptance criteria.
However, based on the structure of a typical 510(k) submission, and the limited information provided, I can infer some aspects and highlight what is missing.
Here's a breakdown of the requested information, indicating where the document provides details and where it is silent:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria or provide a table of reported device performance for this specific submission (K140751). It states that its performance testing is "exactly the same as the predicate device (K123428)." This implies that the current device is considered to have met the performance established for its predicate. Without access to K123428's full submission, specific quantitative acceptance criteria cannot be extracted from this text.
The closest to a performance claim is the intended function of the "Suspected GI Bleeding Indicator (SGIB) is intended to mark frames of the video suspected of containing blood or red areas." However, no metrics (e.g., sensitivity, specificity, accuracy) or acceptance criteria (e.g., >90% sensitivity for SGIB detection) are provided for this feature.
2. Sample size used for the test set and the data provenance
The document does not provide details about the sample size for a test set or data provenance for K140751, as it refers back to the predicate device (K123428) for performance testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide this information for K140751.
4. Adjudication method for the test set
The document does not provide this information for K140751.
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
The document does not indicate that an MRMC comparative effectiveness study was done for K140751. The device description mentions "MiroView™ U provides some kinds of Modes and Views to help the user review patient video data quickly and conveniently; however, IntroMedic Co., Ltd. recommends that the doctor review the patient video in the Normal Mode / Single View to prevent from a wrong diagnosis." This statement suggests a recommendation against relying solely on AI-assisted views for diagnosis and doesn't claim an improvement in human reader performance with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The document does not explicitly present data on standalone algorithm performance for K140751. The "Suspected GI Bleeding Indicator (SGIB)" feature could imply an algorithm-only function, but no performance metrics are given.
7. The type of ground truth used
The document does not provide information on the type of ground truth used for K140751.
8. The sample size for the training set
The document does not provide information on the sample size for any training set for K140751.
9. How the ground truth for the training set was established
The document does not provide information on how ground truth was established for any training set for K140751.
Summary of what is known from the provided text for K140751:
The submission for the MiroCam® Capsule Endoscope System (K140751) states that its "Technological Characteristics" and "Performance Testing" are "exactly the same as the predicate device (K123428)." This means that the current device is deemed substantially equivalent based on its similarity to a previously cleared device, rather than requiring new, detailed performance studies to be included in this specific 510(k) summary.
The only specific "performance" mentioned is the Suspected GI Bleeding Indicator (SGIB), which is "intended to mark frames of the video suspected of containing blood or red areas." However, no quantitative performance metrics (e.g., sensitivity, specificity, accuracy) or acceptance criteria for this feature are provided in the document.
To get the detailed information requested, one would need to access the full 510(k) submission for K123428, which is the predicate device for performance testing.
§ 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.”