UltraSightHD™ with ImageSense™ is a digital colposcope designed to image the cervix and lower genital tract under illumination and magnification. Colposcopy is indicated for women with an abnormal Pap smear in order to affirm normality or detect abnormal appearances consistent with neoplasia, often with directed biopsy.

OpacityViewer™ is an ImageSense™ digital filter for displaying areas of acetowhitening. It is a tool that should NOT be used as a substitute for a thorough colposcopic evaluation.

Device Description

The UltraSight HD™ Digital Colposcopy System with ImageSense™ Technology is a digital colposcope designed to image the cervix and lower genital tract under illumination and magnification.

ImageSense™ is an image processing suite available for the UltraSightHD™ digital colposcope. The ImageSense™ suite consists of two different modules: UltraGreen™ filter and Acetownite OpacityViewer™.

The UltraGreen™ filter provides the user with greater contrast than an unprocessed image. UltraGreen™ is displayed as a reqular full color image, and is available to be used on any stillframe image displayed in the Review Hi-Res Imagery, View ImageSense Results, and Annotate lmage modes.

The Acetowhite OpacityViewer™ compares two images, one taken prior to the application of Acetic Acid and an additional image taken 60 seconds after the application of Acetic Acid, otherwise known as the pre- and post- Acetic Acid images. The Acetowhite OpacityViewer™ then generates a difference map that shows the extent of white difference between the two images, which is indicated by a gradient color scale ranging from blue (no measurable difference between the images), through white (some difference) and vellow (moderate difference), to red (large difference). Red, on the difference map, indicates only the greatest color difference between the images.

The illumination and optical design of the device allow the user to capture high resolution digital images. The optical subsystem is augmented by integrated image quality assessment algorithms. ensuring that focused and balanced-contrast images are acquired. Two liquid crystal displays (LCDs) provide video display and user interface information. The software includes functionality for annotating, filtering and storing the images on external PACS servers via the DICOM protocol.

AI/ML Overview

The provided text describes the UltraSightHD™ Digital Colposcopy System with ImageSense™ Technology. However, it does not include specific acceptance criteria with numerical targets or detailed results of a study designed to prove the device meets such criteria.

The document states: "Test results indicate that the device meets the performance specifications." and "Appropriate risk analysis-driven product testing was conducted to evaluate conformance to product specification and substantial equivalence to the predicate device." However, the specific performance specifications and the quantitative results proving conformance are not detailed within the provided text.

Here's an analysis based on the information that is available, and what is explicitly stated as not performed:

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

No explicit table of acceptance criteria with numerical targets is provided in the document. The document lists areas of testing but does not offer specific criteria or quantitative results against them.

Acceptance Criteria	Reported Device Performance
Not Explicitly Stated (e.g., x% resolution, y distortion)	"Test results indicate that the device meets the performance specifications." (General statement, no specific data provided)
Electrical Safety	Conformed
Electromagnetic Compatibility	Conformed
Optical Radiation	Conformed
Resolution	Conformed (Specifications not detailed)
Distortion	Conformed (Specifications not detailed)
Illumination Variance	Conformed (Specifications not detailed)
Image Registration	Validated by clinical studies
Color Difference Map Range	Conformed (Specifications not detailed)
Mechanical Subsystem (Ease of movement, Orientation motion, Settling time, Affect of internal vibration, Height adjustment)	Conformed

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

Clinical Studies: The document explicitly states: "The only clinical studies conducted were run to validate image registration."
Sample Size for Image Registration Validation: The sample size for this validation is not specified in the provided text.
Data Provenance: The provenance of data for the image registration validation is not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable, as no detailed clinical study is described where experts established ground truth for a test set to evaluate the ImageSense™ features (e.g., OpacityViewer™). The clinical studies were limited to "image registration," and details are missing.

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

Not applicable, as no detailed clinical study is described that involved multiple readers or adjudication for establishing ground truth for the test set.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical studies were conducted to demonstrate improved clinical performance using the new OpacityViewer digital filter."

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

This is difficult to ascertain directly from the provided text for the ImageSense™ features. The "ImageSense™ Technology" (UltraGreen™ filter and Acetowhite OpacityViewer™) are described as image processing tools available to the user, suggesting they are meant to be used with a human in the loop. The document states "OpacityViewer™ is a tool that should NOT be used as a substitute for a thorough colposcopic evaluation," further emphasizing the human's role.

The clinical studies were only to validate "image registration," which is a technical aspect of the device's image processing rather than a standalone clinical performance study of the ImageSense™ diagnostic features.

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

For the image registration validation, the type of ground truth is not specified.
For the ImageSense™ features (UltraGreen™ and OpacityViewer™), no clinical studies were performed to establish ground truth for their "improved clinical performance." The OpacityViewer creates a "difference map that shows the extent of white difference between the two images," which is an algorithmic output, not a ground truth derived from expert consensus, pathology, or outcomes data in the context of clinical effectiveness.

8. The sample size for the training set

Not applicable. The document describes a medical device with image processing features, not a machine learning model that would require a distinct "training set" in the conventional sense for a clinical algorithm.

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

Not applicable, as there is no mention of a training set for a machine learning model in the context of the ImageSense™ features.

Summary

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7. 510(k) SUMMARY

DEC 2 0 2010

General Information

{

Classification	Class II
Trade Name	UltraSightHD™ Digital Colposcopy System with ImageSense™Technology
Common Name:	Colposcope (21 CFR 884.1630),
Manufacturer	STI Medical Systems, LLC99-193 Aiea Heights Drive, Suite 139Aiea, HI USA 96701
Contact	Rolf WoltersSenior Vice PresidentTelephone Number: (808) 540-4728

Date Summary Prepared: December 12, 2010

Intended Use / Indications for use:

OpacityViewer™ is an ImageSense™ digital filter for displaying areas of acetowhitening. It is a tool that should NOT be used as a substitute for a thorough colposcopic evaluation.

Predicate Device

The predicate device is the Cervical MD Model C10. STI Medical Systems, K072691, January 31, 2008. The proposed device differs from the predicate with respect to the addition of new imaging features referred to as ImageSense™.

Device Description

The UltraSight HD™ Digital Colposcopy System with ImageSense™ Technology is a digital colposcope designed to image the cervix and lower genital tract under illumination and magnification.

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difference map that shows the extent of white difference between the two images, which is indicated by a gradient color scale ranging from blue (no measurable difference between the images), through white (some difference) and vellow (moderate difference), to red (large difference). Red, on the difference map, indicates only the greatest color difference between the images.

(Note: The UltraSightHD™ with ImageSense™ has not been shown to identify areas of cervical neoplasia. Therefore, this system should not be used to omit a biopsy selected on the basis of colposcopic examination.)

Materials

The materials in the UltraSightHD™ Digital Colposcope are suitable for their intended use and have been used in previously cleared products. The device is not patient contacting and therefore no biocompatibility testing was required.

Testing

Appropriate risk analysis-driven product testing was conducted to evaluate conformance to product specification and substantial equivalence to the predicate device.

Testing included assessments of the following:

Electrical Safetv .
. Electromagnetic Compatibility
. Optical Radiation
. Resolution
. Distortion
. Illumination Variance
. Image Registration
Color Difference Map Range .
. Mechanical Subsystem
- Ease of movement o
- Orientation motion of the optic system (pitch/yaw) o
- . 0 Settling time of motion caused by release of aiming handle
- o Affect of internal vibration on image
- Imaging system height adjustment 0

Clinical Studies

The only clinical studies conducted were run to validate image registration.

No clinical studies were conducted to demonstrate improved clinical performance using the new OpacityViewer digital filter.

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Test results indicate that the device meets the performance specifications.

Summary of Substantial Equivalence

く

The UltraSightHD™ Digital Colposcopy System with ImageSense™ Technology is equivalent to the Cervical MD Model C10 predicate device. The indications for use, basic overall design and function, product performance, and materials used are equivalent.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Rolf Walters, Ph.D. Senior Vice President STI Medical Systems, LLC 733 Bishop Street, Suite 3100 HONOLULU HAWAII 96813

DEC 20 2010

Re: K090324

Trade/Device Name: UltraSightHD"" Digital Colposcopy System with ImageSense" Technology

Regulation Number: 21 CFR §884.1630 Regulation Name: Colposcope Regulatory Class: Il

Product Code: HEX Dated: October 23, 2009 Received: October 29, 2009

Dear Dr. Walters:

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. 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.

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

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adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHO/Tices/ucm 1178007/jpm fast the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Paul 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Hubert Humphrey

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

DEC 20 2010

510(k) Number (if known): K090324

UltraSightHD™ Digital Colposcopy System with ImageSense™ Device Name: Technology

Indications For Use:

OpacityViewer™ is an ImageSense™ digital filter for displaying areas of acetowhitening. It is a tool that should NOT be used as a substitute for a thorough colposcopic evaluation.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nalv Ressr

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K090324

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 884.1630 Colposcope.

(a)
Identification. A colposcope is a device designed to permit direct viewing of the tissues of the vagina and cervix by a telescopic system located outside the vagina. It is used to diagnose abnormalities and select areas for biopsy. This generic type of device may include a light source, cables, and component parts.(b)
Classification. Class II (special controls). The device, when it is a standard colposcope (or colpomicroscope) that uses only a white light source, does not use filters other than a green filter, does not include image analysis software, and is not smartphone-based, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.