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510(k) Data Aggregation
(32 days)
The SKOUT system is a software device designed to detect potential colorectal polyps in real time during colonoscopy examinations. It is indicated as a computer-aided detection tool providing colorectal polyps location information to assist qualified and trained gastroenterologists in identifying potential colorectal polyps during colonoscopy examinations in adult patients undergoing colorectal cancer screening or surveillance.
The SKOUT system is only intended to assist the gastroenterologist in identifying suspected polyp areas and confirming the presence or absence of a polyp based on their own medical judgment. SKOUT is not intended to replace a full patient evaluation, nor is it intended to be relied upon to make a primary interpretation of endoscopic procedures, medical diagnosis, or recommendations of treatment/course of action for patients. SKOUT is indicated for white light colonoscopy only.
The SKOUT® system is a software-based computer aided detection (CADe) system for the analysis of high-definition endoscopic video during colonoscopy procedures. The SKOUT® system is intended to aid gastroenterologists with the detection of potential colorectal polyps during colonoscopy by providing an informational visual aid on the endoscopic monitor using trained software that processes the endoscopic video in real time.
Users will primarily interact with the SKOUT® system by observing the software display, including the polyp detection box and device status indicator signal.
The provided FDA 510(k) clearance letter describes the SKOUT system, a software device designed to detect potential colorectal polyps in real-time during colonoscopy examinations. The document outlines acceptance criteria and summarizes performance testing.
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly list "acceptance criteria" in a table format with numerical targets. Instead, it refers to performance objectives implicitly through comparisons to the predicate device and mentions passing results in applicable testing. Based on the "Performance Testing" section, the following can be inferred as the general performance areas that were assessed:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Software Verification and Validation | SKOUT® system software meets design requirements for its intended use, in line with recommendations outlined in "General Principles of Software Validation, Guidance for Industry and FDA Staff." |
| Algorithm Performance (True Positives, False Positives, Polyp Detection Time) | Standalone and on-device algorithm performance testing was conducted, with passing results. Optimized performance with Endocuff, multiple polyps, and/or sessile serrated lesions, and reduced false positive rate. |
| Pixel Degradation | No pixel level degradation is introduced by SKOUT® to the Endoscopic System. |
| Video Delay (due to marker annotation) | Video delay due to marker annotation = 0ms (no standard error; all results were 0, minimum resolution 1.1ms). |
| Video Delay (due to device) | Video delay due to device = 0ms (no standard error; all results were 0, minimum resolution 1.1ms). |
| Endocuff Compatibility | Optimized performance in videos with Endocuff. |
| Multiple Polyps and Sessile Serrated Lesions | Optimized performance for multiple polyps and/or sessile serrated lesions. |
| Reduced False Positive Rate | Reduced false positive rate. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document mentions "an expanded dataset for the added Endocuff compatibility" for standalone and on-device algorithm performance testing. However, it does not specify the exact numerical sample size (e.g., number of videos, number of polyps, or number of patients) of this expanded dataset.
- Data Provenance: The document does not specify the country of origin of the data used for testing, nor whether the data was retrospective or prospective.
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 information on the number of experts used to establish ground truth or their specific qualifications.
4. Adjudication method for the test set:
The document does not specify the adjudication method used for the test set (e.g., 2+1, 3+1, none).
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 explicitly states that the "clinical performance remains unchanged from the clinical performance submitted in K213686." This implies that a new MRMC comparative effectiveness study was not conducted for this submission (K253664). The existing clinical performance from K213686 was relied upon. Therefore, no new effect size for human reader improvement with AI vs. without AI assistance is reported here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Yes, a standalone algorithm performance study was done. The "Performance Testing" section states: "Standalone and on-device algorithm performance testing was conducted for evaluation of true positives, false positives, and polyp detection time, with an expanded dataset for the added Endocuff compatibility."
7. The type of ground truth used:
The type of ground truth used is not explicitly specified in this document. Given it's a device for detecting polyps, it would typically be based on expert consensus (e.g., gastroenterologists reviewing videos and annotating polyps) or pathology (histopathological confirmation of removed lesions). However, the document does not confirm this.
8. The sample size for the training set:
The document does not specify the sample size used for the training set. It mentions "Retraining and refinement of inference algorithms... optimized performance," which indicates that a training process occurred, but details on the training set size are absent.
9. How the ground truth for the training set was established:
The document does not provide information on how the ground truth for the training set was established.
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