The Foresce Home is intended for use in the detection and characterization of central and paracentral metamorphopsia (visual distortion) in patients with age-related macular degeneration, as an aid in monitoring progression of disease factors causing metamorphopsia including but not limited to choroidal neovascularization (CNV). It is intended to be used at home for patients with stable fixation.

Device Description

The Foresee Home system is an interactive software driven device that provides a series of linear images to the macular and peri-macular region of the eye. The changes in macular and near macular function can be quantified by the device thus enabling the reader to detect early changes in macular degeneration and associated diseases to allow earlier intervention.

The Foresee Home applies the concept of the static and automated perimeter in the detection of visual field defects. The technology, based on hyperacuity, is used for highly specific quantification of central and paracentral visual fields defects. Hyperacuity (also termed "Vernier acuity") is defined as the ability to perceive a difference in the relative spatial localization of two or more visual stimuli. Hyperacuity threshold may be as low as 3-6 sec of arc and the hyperacuity stimuli are highly resistant to retinal image degradation and thus suitable for assessing retinal function in patients with opaque media as well. Retinal pigment epithelium (RPE) elevation, such as that which occurs in AMD, causes a shift in the regular position of photoreceptors. It is hypothesized that such a shift causes an object to be perceived at a different location from its true location in space.

The analysis engine of the device tries to define areas in the visual field that are suspected as being related to CNV. Such areas are called CNV related zones. Although these zones are called 'CNV-related,' they simply indicate areas of greater metamorphopsia and can often occur in non-CNV lesions."

Note that the response on this indicator is only indicative of the presence or absence of significant metamorphopsia that may exist in conditions NOT associated with CNV (such as geographic atrophy or drusen).

The Foresee Home is intended to be used in a home environment following training given by a qualified healthcare professional. The user interface and interaction with the device is similar to office Preview PHP. The results of each testing session, the test reports, similar to these generated by the Preview PHP system, will be transmitted electronically directly to the healthcare professional. Test reports will not be displayed on the monitor in the patient's home, but rather will be used by the healthcare professional in the same fashion as it is currently employed with the in-office Preview PHP. Thus, the only difference between the Preview PHP system and the Foresee Home is that the Foresee Home unit is placed in the patient's home environment to facilitate testing and the test report is then transmitted to the healthcare professional.

It should be noted that the Foresee Home is not intended to provide automated interpretation, evaluation, treatment decisions, or to be used as a substitute for professional healthcare judgment.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Foresee Home™ device, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Minimal percent positive agreement > 80% with gold standard	81.5%
Minimal percent negative agreement > 80% with gold standard	87.7%
Capability of users to perform the test by themselves after clinic training	98.5%
Correlation between unsupervised home simulated environment tests and supervised clinic tests	93.85%

Study Details

2. Sample Sizes and Data Provenance

The provided document refers to a clinical study submitted in K050350 for the Preview PHP (the predicate device) to validate the positive and negative agreement. However, the specific sample size for this test set is not explicitly stated in the provided text.

Regarding data provenance, the document does not specify the country of origin. The study for Preview PHP was likely retrospective or prospective, but this detail is not provided. The usability study for Foresee Home™ and the comparison between unsupervised and supervised tests were likely prospective, given their nature of evaluating user capability and test correlation, but this isn't explicitly stated.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

The document states that the Preview PHP results were compared to "gold standards, i.e., color fundus photographs and fluorescein angiographics." It does not specify the number of experts used to establish the ground truth from these images, nor their specific qualifications (e.g., "radiologist with 10 years of experience").

4. Adjudication Method (Test Set)

The adjudication method used to establish the ground truth for the test set is not described in the provided text.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being done. The document does not discuss the effect size of how much human readers improve with AI vs. without AI assistance, as the device is primarily for home monitoring and subsequent review by a healthcare professional, not for direct AI-assisted reading in real-time by a human.

6. Standalone Performance Study

A standalone performance study (algorithm only without human-in-the-loop performance) was effectively done as part of the predicate device's (Preview PHP) validation. The document states: "The clinical study submitted in K050350 for the Preview PHP was designed to validate that that the minimal percent positive agreement and minimal percent negative agreement are greater than 80%." This implies an evaluation of the device's ability to detect and characterize metamorphopsia (as reflected in positive and negative agreement) independent of human interpretation during the actual test, with human interpretation occurring after the test data is generated.

7. Type of Ground Truth Used (Test Set)

The type of ground truth used for the clinical study of the predicate device (Preview PHP) was expert consensus based on clinical imaging: "gold standards, i.e., color fundus photographs and fluorescein angiographics."

8. Sample Size for the Training Set

The document does not provide any information regarding the sample size for a training set. The descriptions focus on the validation of the device's performance against clinical gold standards, without detailing any machine learning training processes or associated datasets.

9. How Ground Truth for the Training Set Was Established

As no training set is discussed or implied within the context of machine learning, there is no information on how ground truth for a training set was established. The device is described as applying "the concept of the static and automated perimeter in the detection of visual field defects" and using "hyperacuity" for quantification, suggesting a more rule-based or signal processing approach rather than a deep learning model requiring a large labeled training set.

Summary

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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

APPLICANT:	Notal Vision Ltd.
TRADE NAME:	Foresee HomeTM
COMMON NAME:	Perimeter
CLASSIFICATIONNAME:	Automated perimeter
DEVICECLASSIFICATION:	Class I
PRODUCT CODE:	HPT
PREDICATEDEVICE:	Preview PHPTM

SUBSTANTIALLY EQUIVALENT TO:

510K	TRADE OR PROPRIETARY NAME	MANUFACTURER
K050350	Preview PHPTM	Notal Vision Ltd.
K063609	River 1	SHL TelemedicineInternational, Ltd.
NA	Amsler Grid Chart	NA
K053303	Commander III	Cardiocom
K071564	Motiva	Philips Medical Systems

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION

DEC 2 3 2009

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which occurs in AMD, causes a shift in the regular position of photoreceptors. It is hypothesized that such a shift causes an object to be perceived at a different location from its true location in space.

It should be noted that the Foresee Home is not intended to provide automated interpretation, evaluation, treatment decisions, or to be used as a substitute for professional healthcare judgment.

INDICATION FOR USE

The Foresee Home is intended for use in the detection and characterization of central and paracentral metamorphopsia (visual distortion) in patients with age-related macular degeneration, as an aid in monitoring progression of disease factors causing metamorphopsia including but not limited to choroidal neovascularization (CNV). It is intended to be used at home for patients with stable fixation.

TECHNICAL CHARACTERISTICS

The technical characteristics of the Foresee Home are similar to the Preview PHP (KOSO350).

PERFORMANCE DATA

Since the results of testing of the Foresee Home results are similar to those of the Preview PHP, the performance. i.e., percent positive agreement and percent negative agreement of the Foresee Home, are also similar to the performance of Preview PHP (K050350).

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The clinical study submitted in K050350 for the Preview PHP was designed to validate that that the minimal percent positive agreement and minimal percent negative agreement are greater than 80%. The study results demonstrated that the percent positive agreement was 81.5% and percent negative agreement was 87.7%. The Preview PHP results were compared to the gold standards, i.e., color fundus photographs and fluorescein angiographics.

This 510K addresses the ability of the system to be used in home environment. The Foresee Home usability study showed that after clinic training, 98.5% of the users were capable of performing the test by themselves.

Comparison between unsupervised test in a home simulated environment and supervised test in the clinic showed correlation of 93.85%, indicating that the test results are similar no matter if the examination was supervised at the clinic or performed without assistance by the users at their home environment.

BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE

The technological characteristics and testing results of the Foresee Home in home use are similar to these of the predicate device, the Preview PHP, cleared under K050350.

The Amsler Grid has similar intended use: to rapidly detect central and paracentral irregularities in the visual field.

Data transfer is accomplished by means of a telemedicine module that is substantially equivalent to the Motiva Monitor Device, cleared under K071564. Additional predicate devices are included and offer similar collection and transmission of health related information from the patient's home to health care professionals; these include the River I telemedicine system (K063609) and the Commander III (K053303).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter.

( :

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

Notal Vision Ltd c/o Judy F. Gordon, D.V.M. ClinReg Consulting Services, Inc. 733 Bolsana Drive Laguna Beach, CA 92651

Re: K091579

Trade Name: ForeSce Home Regulation Number: 21 CFR 886.1605 Regulation Name: Perimeter Regulatory Class: Class I Product Code: HPT Dated: November 2, 2009 Received: November 3, 2009

DEC 2 3 2009

Dear Ms. Gordon:

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.

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 (reporting of medical device-related 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.

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Page 2 - Ms. Judy F. Gordon

1 . ..........................................................................................................................................................................

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/Aboutl-DA/CentersOffices/CDRH/CDRHOffices/ucm115809.html for 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 Part 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

E. A. Roepke

Malvina B. Eydelman, I Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K091579

Device Name: Foresee Home™

Indications for Use:

ﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ

. .

Prescription Use X (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)

Signature

(Diviston Sign-Off) Division of Ophthalmic, Neurological and Ear. Nose and Throat Devices

Page

510(k) Number K091579

Regulation Number and Section

§ 886.1605 Perimeter.

(a)
Identification. A perimeter is an AC-powered or manual device intended to determine the extent of the peripheral visual field of a patient. The device projects light on various points of a curved surface, and the patient indicates whether he or she sees the light.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.