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.

Device Description

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.

AI/ML Overview

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.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 7, 2023

Iterative Scopes Inc. Dennis Francoeur Director of Regulatory Affairs 675 Massachusetts Ave 2nd Floor Cambridge, MA 02139

Re: K230658

Trade/Device Name: SKOUT® system Regulation Number: 21 CFR 876.1520 Regulation Name: Gastrointestinal Lesion Software Detection System Regulatory Class: Class II Product Code: QNP Dated: March 9, 2023 Received: March 9, 2023

Dear Dennis Francoeur:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Shanil P. Haugen -S

Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known)

K230658

Device Name

SKOUT® System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	□ Over-The-Counter Use (21 CFR 801 Subpart C)

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VII. 510(K) SUMMARY

510(k) SUMMARY

SKOUT® system

Submitter:

Iterative Health, Inc. (Iterative Scopes)

675 Massachusetts Ave

Cambridge MA 02139

Phone: (603) 819-8387

Contact Person: Dennis Francoeur, Director of Regulatory Affairs

Date Prepared: March 9, 2023

Name of Device: SKOUT® System

Classification Name: Gastrointestinal Lesion Software Detection System

Classification Panel: Gastroenterology and Urology

Regulation Number: 876.1520

Product Code: QNP

Predicate Device: SKOUT System, Iterative Scopes, K213686

Device Description

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.

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The polyp detection notification enables users to:

Detect potential colorectal polyps during colonoscopy examinations in adult patients undergoing a . colorectal cancer screeninq or surveillance procedure.
Utilize a tool that provides additional information for endoscopic observation. ●

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.

Intended Use / Indications for Use

The SKOUT system is only intended to assist the aastroenterologist 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.

Design Changes

Hardware architecture changes: The multi piece tethered system of the predicate to a single box containing all of the components. Some of the components included in the subject device have been updated to improve component longevity and image quality performance.

Software architecture changes: To support the updated hardware design the software was updated in addition to improvements to image handling for image quality performance and error handling for improved usability performance.

Non-Clinical Testing

Software verification and validation was conducted on the SKQUT 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 Electromagnetic Compatibility the SKOUT system was evaluated for compliance to the following FDA-Recognized Consensus Standards:
- IEC 60601-1:2005, AMD 1:2012 Medical electrical equipment Part 1: General о requirements for basic requirements for basic safety and essential performance

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IEC 60601-1-2: 2014 Medical electrical equipment Part 1-2: General requirements for o basic requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility – Requirements and tests
IEC 60601-2-18: 2009 Medical electrical equipment Part 2-24: Particular requirements o for the basic safety and essential performance of endoscopic equipment
Human factors validation was performed following the FDA Guidance document Applying Human Factors and Usability Engineering to Medical Devices, Guidance for Industry and FDA Staff recommendations. 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.

Summary of Technological Characteristics

The predicate device represents a previous revision of the subject device, SKOUT System FDA cleared via K213686 on August 12, 2022.

	Subject Device SKOUT System	Predicate Device SKOUT System(K213686)
Intended Use	A gastrointestinal lesion softwaredetection system is a computer-assisted detection device used inconjunction with endoscopy for thedetection of abnormal lesions in thegastrointestinal tract. This device withadvanced software algorithms bringsattention to images to aid in thedetection of lesions. The device hashardware components to supportinterfacing with an endoscope.	Same - A gastrointestinal lesionsoftware detection system is acomputer-assisted detection deviceused in conjunction with endoscopy forthe detection of abnormal lesions in thegastrointestinal tract. This device withadvanced software algorithms bringsattention to images to aid in thedetection of lesions. The device hashardware components to supportinterfacing with an endoscope.
Indications forUse	The SKOUT system is a softwaredevice designed to detect potentialcolorectal polyps in real time duringcolonoscopy examinations. It isindicated as a computer-aideddetection tool providing colorectalpolyps location information to assistqualified and trainedgastroenterologists in identifyingpotential colorectal polyps duringcolonoscopy examinations in adultpatients undergoing colorectal cancerscreening or surveillance.The SKOUT system is only intended toassist the gastroenterologist inidentifying suspected colorectal polypsand the gastroenterologist isresponsible for reviewing SKOUTsuspected polyp areas and confirmingthe presence or absence of a polypbased on their own medical judgment.SKOUT is not intended to replace a fullpatient evaluation, nor is it intended tobe relied upon to make a primary	Same - The SKOUT system is asoftware device designed to detectpotential colorectal polyps in real timeduring colonoscopy examinations. It isindicated as a computer-aideddetection tool providing colorectalpolyps location information to assistqualified and trainedgastroenterologists in identifyingpotential colorectal polyps duringcolonoscopy examinations in adultpatients undergoing colorectal cancerscreening or surveillance.The SKOUT system is only intended toassist the gastroenterologist inidentifying suspected colorectal polypsand the gastroenterologist isresponsible for reviewing SKOUTsuspected polyp areas and confirmingthe presence or absence of a polypbased on their own medical judgment.SKOUT is not intended to replace a fullpatient evaluation, nor is it intended tobe relied upon to make a primary
	Subject Device SKOUT System	Predicate Device SKOUT System(K213686)
	interpretation of endoscopicprocedures, medical diagnosis, orrecommendations of treatment/courseof action for patients. SKOUT isindicated for white light colonoscopyonly.	interpretation of endoscopicprocedures, medical diagnosis, orrecommendations of treatment/courseof action for patients. SKOUT isindicated for white light colonoscopyonly.
User Population	Adult patients undergoing colorectalcancer screening or surveillancecolonoscopy.	Same - Adult patients undergoingcolorectal cancer screening orsurveillance colonoscopy.
TechnologicalCharacteristics	The SKOUT system is composed of asingle piece hardware design andsoftware designed to highlight portionsof the colon where the device detectspotential colorectal polyps.	Similar - The SKOUT system iscomposed of a multi piece hardwaredesign and software designed tohighlight portions of the colon wherethe device detects potential colorectalpolyps.
SoftwareAlgorithm	The SKOUT system utilizes an artificialintelligence-based algorithm to performthe polyp detection function.	Same - The SKOUT system utilizes anartificial intelligence-based algorithm toperform the polyp detection function.
Power Source	Hospital mains power	Same - Hospital mains power
Safety Features	The Mode Selection Button allows forinstantaneous toggling between theSKOUT video feed and the bypassvideo feed in the event of softwareerror that affects video quality.	Similar - The Video Display Switchallows for instantaneous togglingbetween the SKOUT video feed andthe standard video feed in the event ofsoftware error that affects video quality.
	The polyp detection marker is disabledif a biopsy tool enters the field of viewto prevent obstruction of the area ofinterest during intervention.	The polyp detection marker is disabledif a biopsy tool enters the field of viewto prevent obstruction of the area ofinterest during intervention.
	SKOUT system GUI also has a devicestatus indicator, the subject device hasan additional GUI feature that notifiesusers of the current device status(active or error):a two-dimensional green boxwith letter (S) when the deviceis powered on and activelyprocessing video. a two-dimensional gray boxwith letter (S) when a surgicaltool is present. a red (X) with an errormessage; when there is anerror with the video processingfunction of the SKOUT®system, the green box will bereplaced with a red X and errormessage to indicate an error	SKOUT system GUI also has a devicestatus indicator, a green square,located in the top left corner of theSKOUT video feed. This GUI feature isan additional check to the user that theSKOUT system is on and in use, evenwhen polyp detection notifications arenot on the screen to prevent undesireduse of the AI.
	Subject Device SKOUT System	Predicate Device SKOUT System(K213686)
Device Output	SKOUT system generates markers inthe form of blue rectanglessuperimposed on the endoscopic videowhen potential colorectal polyps areidentified. SKOUT markers are notaccompanied by a sound.	Same - SKOUT system generatesmarkers in the form of blue rectanglessuperimposed on the endoscopic videowhen potential colorectal polyps areidentified. SKOUT markers are notaccompanied by a sound.
	The polyp detection marker is disabledif a biopsy tool enters the field of viewto prevent obstruction of the area ofinterest during intervention.	The polyp detection marker is disabledif a biopsy tool enters the field of viewto prevent obstruction of the area ofinterest during intervention.
CompatibleEndoscopes	Olympus EVIS EXERA III and FUJIEC760 series	Same - Olympus EVIS EXERA III andFUJI EC760 series
Video Delay	Assessment of video delay due tomarker annotation; SDI 0.0ms (error1.1ms )Assessment of video delay due todevice; SDI 0.0ms (error 1.1ms)Subject device does not have DVIinput.	Similar - Assessment of video delay due to marker annotation; 56.00ms(95% CI: 50.54,61.46) and 3.25 (95% CI: 2.93, 3.56)frame delay for Serial Digital Interface(SDI) and 62.33ms (95% CI: 60.76,63.90) and 3.74 (95% CI: 3.65, 3.83)frame delay for Digital Visual Interface(DVI).Assessment of real-time endoscopicvideo delay due to the device; 56.67ms(95% CI: 51.01, 62.33) and 3.28 (95%CI: 2.96, 3.62) frame delay for SDI and60.67ms (95% CI: 57.72, 63.61) and3.64 (95% CI: 3.46, 3.81) frame delayfor DVI.
Pixel LevelDegradation	No pixel level degradation is introducedby SKOUT to the Endoscopic System.	Similar - No visually detectabledifferences between images werefound with the introduction of theSKOUT system @

Table 1: Technological Characteristics Comparison

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The hardware and software differences to the subject device that result in improved performance, these differences do not introduce new questions of safety or effectiveness.

Conclusions

The SKOUT system has the same intended use, indications for use, technological characteristics, and principles of operation as its predicate device. The minor differences in hardware design and software do not affect its safety and effectiveness when used as labeled. The algorithm between the two devices remains the same, therefore clinical performance remains unchanged. Performance data demonstrates that the SKOUT system is as safe and effective as the predicate device. Thus, the SKOUT system can be considered substantially equivalent.

Regulation Number and Section

§ 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.