(238 days)
With PillCam SB Capsule: The PillCam SB capsule is intended for visualization of the small bowel 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 Suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas. The PillCam SB capsule may be used as a tool in the detection of abnormalities of the small bowel and is intended for use in adults and children from two years of age.
With PillCam ESO Capsule: The PillCam capsule endoscopy system with PillCam ESO capsules is intended for the visualization of esophageal mucosa.
The Given PillCam Endoscopy system is comprised of four main subsystems: (1) the ingestible PillCam capsule, (2) the DR 3 PillCam Recorder, (3) the RAPID software, and (4) the Given Workstation and Accessories.
This document is a 510(k) summary for the Given PillCam endoscopy system with RAPID 8.0 and Given PillCam SB 3 capsule endoscopy system. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, the provided text does not contain details about acceptance criteria, a specific study proving device performance against these criteria, or most of the other requested information.
The document states: "The Given PillCam endoscopy system with RAPID 8.0 was validated with clinical data. The Advanced A-Mode software feature was also validated with clinical data. The proposed changes in this submission do not raise new performance or safety issues." This is a general statement and not a detailed study description.
Therefore, most of the requested information cannot be extracted from the provided text.
Here is what can be inferred or explicitly stated from the provided document, recognizing the significant limitations:
Acceptance Criteria and Device Performance (Based on provided text, this information is not explicitly detailed)
The document primarily focuses on establishing substantial equivalence to predicate devices rather than demonstrating performance against specific quantitative acceptance criteria for a new clinical study. It mentions improved features, but not specific performance metrics.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| (Not explicitly stated in the document) | (Not explicitly stated in the document) |
Study Information (Inferred/Not Available)
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Available. The document states "The Given PillCam endoscopy system with RAPID 8.0 was validated with clinical data," but does not provide details on the sample size, data origin, or study design (retrospective/prospective).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Available. The document mentions "clinical data" for validation but does not detail how ground truth was established or by whom.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Available.
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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 Available. The document does not describe an MRMC study or AI assistance. The "RAPID software" processes and views images, and the "Suspected Blood Indicator (SBI) feature" marks suspected frames, which might be considered an assistive feature, but no comparative effectiveness study with human readers is detailed.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Available. The document describes the system as a tool for visualization, implying human review. While the SBI feature marks frames, there's no standalone performance data for the algorithm itself beyond this marking function.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Available. While "clinical data" is mentioned, the method of establishing ground truth (e.g., pathology correlation for lesions) is not specified.
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The sample size for the training set:
- Not Available. The document does not refer to a "training set" as it would for a machine learning model. The study described is for validation of performance, likely with a clinical dataset.
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How the ground truth for the training set was established:
- Not Applicable/Not Available. As no "training set" or specific machine learning model training is described for this submission (which focuses on substantial equivalence for hardware and software updates), this information is not present. The validation focuses on the overall system performance.
Summary of what the document does describe regarding validation:
- Bench Testing:
- The document states that since the PillCam SB 3 capsule and predicate device are identical in external components and technology, existing biting and pH resistance tests for the predicate apply.
- Additional bench testing included: Field of View (FOV), battery life, wireless communication, color reproduction, image quality, frame rate verification, and optical resolution.
- Conclusion from Bench Testing: The devices meet the guidance entitled "Class II Special Performance Data: Guidance Document: Ingestible Telemetric Controls Gastrointestinal Capsule Imaging System; Final Guidance for Industry and FDA dated November 28, 2001."
- Clinical Data Validation:
- "The Given PillCam endoscopy system with RAPID 8.0 was validated with clinical data."
- "The Advanced A-Mode software feature was also validated with clinical data."
- The overall conclusion is that the new features (improved optical spatial resolution, higher effective and adaptive frame rate, real-time SB detection, bi-directional communication, and AFR activation) "do not raise new safety issues" and the devices are "substantially equivalent" to predicate devices.
Key Missing Information: The document is a 510(k) summary, which generally focuses on demonstrating substantial equivalence to pre-existing legally marketed devices rather than providing detailed, quantitative performance studies against specific acceptance criteria for a novel AI device. The general statement about "validated with clinical data" lacks the specifics requested in your prompt.
§ 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.”