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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 text describes an FDA 510(k) clearance for the SKOUT® system, a software device designed to detect potential colorectal polyps during colonoscopy. However, it focuses on demonstrating substantial equivalence to a predicate device (K240781), which itself was a predicate to an earlier device (K213686). The current submission (K241508) mainly highlights minor software refinements and states that the "clinical performance remains unchanged from the clinical performance submitted in K213686." Therefore, the details requested about acceptance criteria and the study proving the device meets them would primarily refer to the data supporting K213686, which is not fully detailed in this document.

Based on the provided K241508 document, here's the information that can be extracted, and where the information is missing:

1. A table of acceptance criteria and the reported device performance

The document states, "The inference algorithms the same architecture and meet the same performance requirements as the predicate device, therefore clinical performance remains unchanged from the clinical performance submitted in K213686." This implies that the acceptance criteria and reported performance for K241508 are identical to those established for K213686. However, the specific acceptance criteria and numerical performance metrics are not provided in this document.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Sample Size: Not explicitly stated for K241508. The document mentions "new data representing 61% of the cumulative data" from 27 new clinical sites compared to the predicate, used for retraining and refinement. However, the size of the test set that explicitly demonstrated performance against acceptance criteria for this specific submission is not detailed. The phrase "clinical performance remains unchanged from the clinical performance submitted in K213686" suggests that the original clinical performance evaluation from K213686 is referenced, but its test set details are not here.
• Data Provenance: The document states "Utilization of data from 30+ unique clinical sites, of which 27 were new compared to the predicate device." It does not specify the countries of origin or if 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 (e.g. radiologist with 10 years of experience)

Not explicitly stated in this document. This information would likely be found in the original K213686 submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not explicitly stated in this document. This information would likely be found in the original K213686 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

The document mentions "The inference algorithms the same architecture and meet the same performance requirements as the predicate device, therefore clinical performance remains unchanged from the clinical performance submitted in K213686." This suggests that if such a study was performed, it was for K213686. However, the details of whether an MRMC study was done, its effect size, or human reader improvement are not provided in this document.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document states that the system "is only intended to assist the gastroenterologist" and "is not intended to replace a full patient evaluation." This indicates its role as a human-in-the-loop tool. While standalone performance data might have been collected as part of the technical evaluation, the document does not explicitly describe a standalone performance study as the primary means of demonstrating effectiveness. It alludes to "algorithm performance" being assessed as part of "additional bench software testing" to meet special controls.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not explicitly stated in this document. This information would likely be found in the original K213686 submission. For polyp detection, pathology is a common ground truth, but expert consensus is also frequently used for live video analysis without immediate pathology.

8. The sample size for the training set

The document mentions "Utilization of data from 30+ unique clinical sites, of which 27 were new compared to the predicate device, with new data representing 61% of the cumulative data." This composite data was used for "Refinement/retraining of polyp detection algorithm." However, the total numerical sample size (e.g., number of colonoscopies, video frames, or polyps) for the training set is not explicitly stated.

9. How the ground truth for the training set was established

Not explicitly stated in this document. This information would likely be found in the original K213686 submission.

Summary of Missing Information and Recommendation:

The provided document (K241508) is a 510(k) summary for a modified device. It heavily relies on the performance demonstrated by an earlier predicate device (K213686) by asserting "clinical performance remains unchanged from the clinical performance submitted in K213686." To answer most of your detailed questions regarding acceptance criteria, study design, ground truth establishment, expert qualifications, and specific performance metrics, you would need to access the information contained in the K213686 FDA submission. The current document primarily confirms the substantial equivalence of the modified SKOUT® system (K241508) to its immediate predicate (K240781), which itself points back to K213686 for clinical performance.

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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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