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510(k) Data Aggregation
(36 days)
Iterative Scopes, Inc.
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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(29 days)
Iterative Scopes, Inc.
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.
Ask a specific question about this device
(29 days)
Iterative Scopes Inc.
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 highdefinition 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.
Polyp Detection Notification: The SKOUT system has a main graphical user interface (GUI) feature of the polyp detection notification. The polyp detection notification is a two-dimensional blue rectanqular outline generated around any suspected polyps on the endoscopic video feed. If there is no polyp detected, the bounding box does not appear. SKOUT® system pauses polyp detection when an endoscopic tools are detected in the video feed to ensure that the bounding box does not hinder any surgical procedure, biopsy, or resection or this may also occur when lighting conditions are deemed to be inadequate.
Device Status Indicator: The SKOUT system has an additional GUI feature that notifies users of the current device status (active or error):
- a two-dimensional green box with letter (S) when the device is powered on and actively processing video.
- o a two-dimensional grav box with letter (S) when a surgical tool is present.
- a red (X) with an error message: when there is an error with the video processing function of the SKOUT system, the green box will be replaced with a red X and error message to indicate an error has occurred.
The provided document is a 510(k) summary for the SKOUT® system, detailing its substantial equivalence to a previously cleared device. It does not contain an explicit list of acceptance criteria or a dedicated study section proving the device meets these criteria in the format requested.
However, based on the non-clinical testing section and the overall claim of substantial equivalence, we can infer some aspects related to performance and how it aligns with the predicate device. The document explicitly states that "Performance data demonstrates that the SKOUT system is as safe and effective as the predicate device."
Here's an attempt to answer your request based on the provided text, while acknowledging limitations due to the document's content:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria for clinical performance that the device must meet in this 510(k) summary. Instead, it relies on the assertion of the algorithm remaining the same as the predicate and the overall safety and effectiveness being equivalent.
| Acceptance Criteria (Inferred/General) | Reported Device Performance (Implied from Substantial Equivalence to SKOUT K213686) |
|---|---|
| Clinical Performance (Polyp Detection) | The document states: "The algorithm between the two devices remains the same, therefore clinical performance remains unchanged." This implies that the current SKOUT® system (K230658) is expected to have the same clinical performance in polyp detection as the predicate SKOUT® system (K213686). The details of the predicate's performance (e.g., sensitivity, specificity, or improvement over unassisted colonoscopy) are not provided in this document. |
| Software Verification and Validation | "Software verification and validation was conducted on the SKOUT System software to validate it for its intended use per the design documentation in line with recommendations outlined in General Principles of Software Validation, Guidance for Industry and FDA Staff. The SKOUT software demonstrated passing results on all applicable testing." |
| Electrical Safety / EMC | "The SKOUT system was evaluated for compliance to the following FDA-Recognized Consensus Standards: IEC 60601-1:2005, AMD 1:2012; IEC 60601-1-2: 2014; IEC 60601-2-18: 2009." (Implies meeting these standards). |
| Human Factors Validation | "Human factors validation was performed following the FDA Guidance document... The human factors validation demonstrated that the device functioned as intended, use-related risk has been mitigated, and the SKOUT system is safe for its intended use." |
| Video Delay | Subject Device: "SDI 0.0ms (error 1.1ms)" for marker annotation and device delay. (This is an improvement from the predicate which had delays of 56.00ms and 62.33ms for annotation, and 56.67ms and 60.67ms for device delay, respectively). |
| Pixel Level Degradation | "No pixel level degradation is introduced by SKOUT to the Endoscopic System." (Predicate reported "No visually detectable differences"). |
| Obstruction of Field of View (Safety Feature) | "The polyp detection marker is disabled if a biopsy tool enters the field of view to prevent obstruction of the area of interest during intervention." (This is a shared safety feature with the predicate). |
| Device Status Indication | Subject device has "an additional GUI feature that notifies users of the current device status (active or error): a two-dimensional green box with letter (S) when the device is powered on and actively processing video; a two-dimensional gray box with letter (S) when a surgical tool is present; a red (X) with an error message..." (This is an improvement/enhancement over the predicate's single green square indicator). |
2. Sample size used for the test set and the data provenance
The document does not provide details on the sample size for a specific test set used to demonstrate clinical performance for the subject device (K230658). It relies on the assertion that "the algorithm between the two devices remains the same, therefore clinical performance remains unchanged" from the predicate device (K213686). This typically means that the clinical performance data was generated for the predicate.
For non-clinical testing:
- Software V&V, Electrical Safety, Human Factors: These tests were performed for the subject device (K230658), but the sample sizes (e.g., number of test cases, participants for human factors) are not specified in this summary.
- Data Provenance: Not specified for any clinical performance data for either the subject or predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the given 510(k) summary. Given that the clinical performance is deemed "unchanged" from the predicate device due to the same algorithm, any studies defining ground truth would have been associated with the predicate submission (K213686).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the given 510(k) summary.
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 report on an MRMC comparative effectiveness study for the subject device (K230658) or its predicate (K213686) in this summary. It only states that the device is "intended to assist qualified and trained gastroenterologists in identifying potential colorectal polyps." The effect size of human reader improvement with AI assistance is also not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document defines the SKOUT system as a "computer-aided detection tool providing colorectal polyps location information to assist qualified and trained gastroenterologists." It also explicitly states, "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." This strongly suggests the device is intended for human-in-the-loop use.
While the "polyp detection function" is performed by an "artificial intelligence-based algorithm," the summary does not provide standalone algorithmic performance metrics (e.g., sensitivity, specificity, PPV, NPV for the algorithm alone). The focus is on its assistive role.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not provided in the given 510(k) summary. For systems detecting polyps, pathology confirmation is the gold standard for ground truth, but this is not explicitly stated here.
8. The sample size for the training set
This information is not provided in the given 510(k) summary.
9. How the ground truth for the training set was established
This information is not provided in the given 510(k) summary.
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(263 days)
Iterative Scopes Inc.
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 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.
Acceptance Criteria and Device Performance for SKOUT™ System
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't explicitly state "acceptance criteria" in a separate section. However, it presents the results of "Non-clinical performance testing" and "Clinical Testing" with specific metrics and confidence intervals, which serve as the performance benchmarks the device has met.
Based on the information provided, here's a table summarizing the implicit acceptance criteria (as demonstrated by the positive study outcomes) and the reported device performance:
| Acceptance Criterion (Implicit) | Reported Device Performance | Study Type |
|---|---|---|
| Non-Clinical Performance: | ||
| Object Level True Positive Rate (TPR): High proportion of actual polyps detected by the device. | 97.87% (95% CI: 94.96%, 100.0%) | Standalone Algorithm Performance Testing |
| Object Level False Positives (FP): Low number of non-polyps flagged as polyps per procedure. | 22.55 objects per 15-minute interval (95% CI: 18.954, 26.148) | Standalone Algorithm Performance Testing |
| Frame Level True Positive Rate (TPR): High proportion of frames with confirmed polyps where the device bounds the polyp. | Mean: 55.66% (95% CI: 55.50%, 55.83%) | Standalone Algorithm Performance Testing |
| Frame Level False Positive Rate (FPR): Low proportion of frames where the device bounds an object not detected by the gastroenterologist. | Mean: 2.31% (95% CI: 2.16%–2.44%) | Standalone Algorithm Performance Testing |
| Marker Overlap (IOGT): High proportion of ground truth polyp area engulfed by the SKOUT bounding box to ensure appropriate visibility for the physician. (Implied acceptance of IOGT = 1.0 as a positive indicator given the purpose of bounding box enlargement). | Median IOGT of signal: 1.0 (meaning on a median basis, all polyps were engulfed by a SKOUT bounding box). Mean IOU: 0.299 (95% CI: 0.289, 0.309) which is expected to be low due to artificial bounding box enlargement. | Standalone Algorithm Performance Testing |
| Image Quality Degradation: No visually detectable degradation due to the device. | No visually detectable differences between images found with the introduction of the SKOUT™ system. | Special Control Testing |
| Video Delay due to Marker Annotation: Minimal delay introduced by the device. | SDI: 56.00ms (95% CI: 50.54, 61.46) and 3.25 frame delay (95% CI: 2.93, 3.56). DVI: 62.33ms (95% CI: 60.76, 63.90) and 3.74 frame delay (95% CI: 3.65, 3.83). | Special Control Testing |
| Real-time Endoscopic Video Delay: Minimal delay in real-time video feed. | SDI: 56.67ms (95% CI: 51.01, 62.33) and 3.28 frame delay (95% CI: 2.96, 3.62). DVI: 60.67ms (95% CI: 57.72, 63.61) and 3.64 frame delay (95% CI: 3.46, 3.81). | Special Control Testing |
| Clinical Performance: | ||
| Adenomas Per Colonoscopy (APC): Significant improvement in the number of adenomas detected per colonoscopy with AI assistance. | Treatment (AI-aided arm): 1.054 Control (Standard colonoscopy): 0.830 Difference (Treatment - Control): 0.224 (95% CI: 0.060, 0.382), p-value: 0.002 (Statistically significant increase) | Multi-center, prospective, randomized controlled trial (Clinical Study) |
| Positive Percent Agreement (PPA) / Positive Predictive Value (PPV): Non-inferiority or comparable safety profile to standard colonoscopy. (PPA/PPV used as a safety endpoint representing the fraction of resected lesions that were indeed polyps). | PPA (mITT cohort): Control: 75.7% Treatment: 70.9% Difference: -4.8% (95% CI: -9.5% to 0.3%) and p-value: ** |
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