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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 colorectal polyps and the gastroenterologist is responsible for reviewing SKOUT® 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 document, an FDA 510(k) summary for the SKOUT® system (K240781), primarily focuses on demonstrating substantial equivalence to a predicate device (K230658) and does not contain the detailed acceptance criteria or the specific study results from a primary clinical performance study.

The document indicates that "the inference algorithms have remained the same, therefore clinical performance remains unchanged from the clinical performance submitted in K213686." This suggests that the clinical performance evaluation was conducted for a previous version or submission (K213686), and the current submission relies on that prior assessment.

Therefore, I cannot provide all the requested information using only the text you provided. The document explicitly states: "Performance data demonstrates that the SKOUT system is as safe and effective as the predicate device." However, it does not explicitly show the full performance data, acceptance criteria, sample sizes, or ground truth establishment details for that primary performance study (K213686).

Based on the provided text, here is what can be extracted and what information is missing:

Information Extracted from the Provided Text:

• Device Performance Reported: The document states that "SKOUT system demonstrated passing results in all applicable testing." and "Performance data demonstrates that the SKOUT system is as safe and effective as the predicate device."
• Adjudication Method: "None" is inferred for the listed "Performance Testing" which are non-clinical tests (Software verification and validation, bench software testing). For the clinical performance from K213686, the adjudication method is not described in this document.
• Standalone Performance: The non-clinical testing described seems to be for algorithm-only performance ("bench software testing was performed to confirm the device meets the special controls in 21 CFR 876.1520 for true and false positives, pixel degradation and video delays."). However, the specific metrics (e.g., sensitivity, specificity for polyp detection) are not reported here.
• Ground Truth Type: For the non-clinical testing, the "ground truth" seems to be defined by the design requirements and special controls for software (e.g., "true and false positives"). For the clinical performance (K213686), the type of ground truth is not specified.

Missing Information (Not Present in the Provided Text):

• A table of acceptance criteria and the reported device performance: While it states "passing results," the specific numerical acceptance criteria and the corresponding numerical performance values are not provided.
• Sample sized used for the test set and the data provenance: Not described for the underlying clinical performance study (K213686).
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not described for the underlying clinical performance study (K213686).
• 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 described for the underlying clinical performance study (K213686). The device is a CADe system, which suggests human-in-the-loop, but specific MRMC study results are not here.
• The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not described for the underlying clinical performance study (K213686).
• The sample size for the training set: Not described.
• How the ground truth for the training set was established: Not described.

Based on the provided document, here's a structured response (with noted limitations):

The provided document (FDA 510(k) Summary for SKOUT® system, K240781) primarily asserts substantial equivalence to a predicate device (K230658) and refers to prior performance data from K213686. It does not contain the detailed acceptance criteria or the specific study results from the primary clinical performance evaluation.

The document states: "Performance data demonstrates that the SKOUT system is as safe and effective as the predicate device. Thus, the SKOUT system is substantially equivalent." and "the inference algorithms have remained the same, therefore clinical performance remains unchanged from the clinical performance submitted in K213686." This implies that the definitive study proving device performance against acceptance criteria was conducted for the K213686 submission, not detailed within this current document.

Here's what can be gathered:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions "Additional bench software testing was performed to confirm the device meets the special controls in 21 CFR 876.1520 for true and false positives, pixel degradation and video delays." and "SKOUT system demonstrated passing results in all applicable testing." However, the specific numerical acceptance criteria (e.g., minimum sensitivity, maximum false positives per minute) and the quantified reported device performance values against these criteria are not provided in this document.

2. Sample Size and Data Provenance (for the test set):

Not explicitly stated for the underlying clinical performance study (K213686). The "Performance Testing" section describes non-clinical software verification and validation, which usually involves test cases rather than patient sample sizes.

3. Number of Experts and Qualifications for Ground Truth:

Not explicitly stated for the underlying clinical performance study (K213686).

4. Adjudication Method for the Test Set:

Not explicitly stated for the underlying clinical performance study (K213686). For the "Performance Testing" described in this document (non-clinical bench software testing), an adjudication method is not applicable in the human-reader sense.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The document does not provide information about an MRMC comparative effectiveness study or the effect size of human readers improving with AI vs. without AI assistance. While the device is a Computer-Aided Detection (CADe) tool, which inherently assists human readers, the details of such a study are absent here.

6. Standalone (Algorithm Only) Performance:

The document states "Additional bench software testing was performed to confirm the device meets the special controls in 21 CFR 876.1520 for true and false positives, pixel degradation and video delays." This indicates that the algorithm's performance in detecting polyps and managing system lags was tested independently. However, the specific metrics (e.g., standalone sensitivity, specificity, or FPs/min rate) from this testing are not numerically reported in this document.

7. Type of Ground Truth Used:

For the clinical performance (referred to as K213686), the type of ground truth (e.g., expert consensus, pathology, follow-up outcomes) is not specified in this document. For the non-clinical performance testing, the ground truth is defined by the design requirements and regulatory standards for "true and false positives, pixel degradation and video delays."

8. Sample Size for the Training Set:

Not provided in this document.

9. How the Ground Truth for the Training Set Was Established:

Not provided in this document.

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