(29 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 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.
§ 876.1520 Gastrointestinal lesion software detection system.
(a)
Identification. A gastrointestinal lesion software detection system is a computer-assisted detection device used in conjunction with endoscopy for the detection of abnormal lesions in the gastrointestinal tract. This device with advanced software algorithms brings attention to images to aid in the detection of lesions. The device may contain hardware to support interfacing with an endoscope.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including detection of gastrointestinal lesions and evaluation of all adverse events.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must include:
(i) Standalone algorithm performance testing;
(ii) Pixel-level comparison of degradation of image quality due to the device;
(iii) Assessment of video delay due to marker annotation; and
(iv) Assessment of real-time endoscopic video delay due to the device.
(3) Usability assessment must demonstrate that the intended user(s) can safely and correctly use the device.
(4) Performance data must demonstrate electromagnetic compatibility and electrical safety, mechanical safety, and thermal safety testing for any hardware components of the device.
(5) Software verification, validation, and hazard analysis must be provided. Software description must include a detailed, technical description including the impact of any software and hardware on the device's functions, the associated capabilities and limitations of each part, the associated inputs and outputs, mapping of the software architecture, and a description of the video signal pipeline.
(6) Labeling must include:
(i) Instructions for use, including a detailed description of the device and compatibility information;
(ii) Warnings to avoid overreliance on the device, that the device is not intended to be used for diagnosis or characterization of lesions, and that the device does not replace clinical decision making;
(iii) A summary of the clinical performance testing conducted with the device, including detailed definitions of the study endpoints and statistical confidence intervals; and
(iv) A summary of the standalone performance testing and associated statistical analysis.