The PreView PHP™ is intended for use in the detection and monitoring the progression of Agerelated Macular Degeneration (AMD) including, but not limited to, the detection of choroidal neovascularization (CNV).

The PreView Preferential Hyperacuity Perimeter (PreView PHP™) 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 progression of assouse ration (CNV). It is intended to be used in the office of a licensed eye care practitioner in patients with stable fixation.

Device Description

The PreView PHP™ system is an interactive software driven device that provides a series of horizontal and vertical linear images to the macular region of the eye to detect abnormalities of the central and paracentral visual field that will detect and monitor progression of age related macular degeneration including detection of choroidal neovascularization. The changes in macular and near macular function are identified by the device thus enabling the reader to detect intermediate and advancing changes in macular degeneration and associated diseases to provide the capability for earlier intervention.

The PreView PHP™ is a specialized perimeter, and applies the concept of the static and automated permeter in the detection of visual field defects. The device incorporates the theory of hyperacuity to address more highly specific central and paracentral visual fields. Because of hyperacuity, perception of more finite relative spatial localization. Hyperacuity is defined as the ability to perceive a difference in the relative spatial localization of points on the central field, more specific distortions or misalignments within the central and paracentral field can be mapped with greater accuracy. The device monitors and manages the progressive changes associated with advancing macular degeneration and differentiates the different stages of AMD including but not limited to choroidal neovascularization.

The PreView PHP™ system is designed for use with standard off-the-shelf PC units in the office of the practitioner. It is aimed to detect advancing changes of AMD-related lesions including but not limited to choroidal neovascularlization.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the PreView PHP™ device, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Sensitivity to detect recent onset of CNV ≥ 80%	82% (95% CI: 72% to 92%)
Specificity to differentiate recent onset of CNV from intermediate stage AMD ≥ 80%	88% (95% CI: 81% to 96%)

Study Details:

Sample Size used for the test set and data provenance:
- The document does not explicitly state the sample size of the test set patients. However, it does mention that the study was a "prospective, comparative, concurrent, non-randomized multicenter study."
- Data Provenance: The document states the manufacturer is Notal Vision, Inc. from Tel Aviv, Israel, and the clinical investigation was also conducted in Israel. Based on the mention of "multicenter study," it suggests data was collected from multiple sites.
Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- The document does not provide information on the specific number of experts or their qualifications that established the ground truth for the test set.
Adjudication method for the test set:
- The document does not specify an adjudication method.
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 provided text does not describe an MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The study focused on the standalone performance of the PreView PHP™ device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone study was done. The clinical investigation assessed the ability of the Preferential Hyperacuity Perimeter (PreView PHP™) itself to detect recent onset of choroidal neovascularization (CNV) and differentiate it from an intermediate stage of AMD. The reported sensitivity and specificity are for the device's performance directly.
The type of ground truth used:
- The ground truth for the test set was based on untreated CNV from AMD diagnosed within the last 60 days or an intermediate stage of AMD (at least 1 large druse or at least 20 medium-size drusen) with no evidence of geographic atrophy or other macular diseases. This implies a clinical diagnosis by ophthalmologists, likely supported by other diagnostic methods (which are not explicitly detailed in the provided text for ground truth establishment, though the referenced predicate devices include technologies like the Heidelberg Retina Angiograph FA/ICGA).
The sample size for the training set:
- The document does not specify a separate training set or its sample size. The clinical investigation appears to be a validation study.
How the ground truth for the training set was established:
- As no separate training set is explicitly mentioned, how its ground truth was established is not provided. The device likely predates or was developed concurrently with modern machine learning paradigms requiring distinct training and test sets in the same way.

Summary

{0}------------------------------------------------

K050350

		APR 29 2005
Notal Vision, Inc.		Original 510(k)

PreView PHP™		SUMMARY STATEMENT

510(k) Summary of Safety and Substantial Equivalance

Submitter:	Company Name:	Notal Vision, Inc.5 Droyanov StreetTel Aviv 93143Israel
	Phone:FAX:Contact Person:Registration Number:	(011) 972 3 6293763 Ext. 103(011) 972 3 6293764Ori Lubin3004103096

Manufacturer Information:

	Company Name:Address:	Notal Vision, Inc.5 Droyanov StreetTel Aviv 93143Israel
	Phone:Registration Number:	(011) 972 3 62937639058077

Official Correspondent:

	Address:	Richard E. Lippman, O.D., F.A.A.O.R.P. Chiacchierini & Associates, LLC15825 Shady Grove Road Suite 30Rockville, MD 20850
	Phone:FAX:	(240) 683-3738(240) 683-9236

DEVICE IDENTIFICATION:

	Trade Name:Common Name:Classification Name:	PreView Hyperacuity Perimeter(Preview PHP™)PerimeterAutomated Perimeter
--	-----------------------------------------------------	-------------------------------------------------------------------------------------

CLASSIFICATION NAME AND REFERENCE: 21 CFR Part 886.1605

	REGULATORY CLASS:	Class I
	DEVICE PANEL AND PRODUCT CODE:	Ophthalmic: 86 HPT
	STANDARDS:	US FDA has not issued performance standards for automated perimeters.

{1}------------------------------------------------

Notal Vision, Inc.	Original 510(k)
PreView PHP	SUMMARY STATEMENT

INDICATIONS FOR USE:

SUBSTANTIAL EQUIVALENCE:

The Notal Vision Ltd. PreView Preferential Hyperacuity Perimeter (PreView PHP™) is substantially equivalent to the following combination of predicate medical devices:

Humphrey Field Analyzer: Perimeter, Automatic, AC-Powered, a class I Exempt medical . device (21 CFR 886.1605); (K954167) Product Code HPT
Octopus 500/500e (21CFR 886.1605); (K841099) Product Code HPT. .

The Heidelberg Retina Angiograph FA/ICGA (HRA/C), (Heidelberg Engineering, . Germany) cleared under K971671; Product Code HLI
The Macular Computerized Psychophysical Test (MCPT), (Notal Vision, Inc.) cleared . under K014044: Product Code HOQ
Amsler Grid, a Class I Exempt Preamendments Medical Device (21 CFR 886.1330): . Product Code HOQ 10- 14-2

DEVICE DESCRIPTION:

clinical investigation

ﺑ

11:11 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . The purpose of the clinical investigation was to assess the ability of the Preferential Hyperacuity Perimeter (PreView PHP™) to detect the recent onset of choroidal neovascularization (CNV) due to age-related macular degeneration (AMD) and differentiate it from an intermediate stage of

. ....

ਿੰਗ ਦੇ ਦੇ ਕਾਰ ਸਿੰਘ ਸੀ। ਇਸ ਦੀ ਸੀ। ਇਸ ਦੀ ਸਾਰੇ ਦੇ ਸਾਰੇ ਦੇ ਸਾਰੇ ਦੇ ਸਾਰੇ ਦੇ ਸੰ
ਦੀ ਹੈ ਅਤੇ ਇਸ ਦੀ ਸੰਗਰ ਸੀ। ਇਸ ਦੇ ਸੰਸਕ ਸੀ। ਇਸ ਦੀ ਇੱਕ ਸਿੰਘ ਦੇ ਵੱ Section 2011 11 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 A FREE BREAD POST AND A

{2}------------------------------------------------

Notal Vision, Inc.	Original 510(k)
PreView PHP TM	SUMMARY STATEMENT

AMD. The study design was a prospective, comparative, concurrent, non-randomized multicenter study

Eligible subjects had in their study eye a corrected visual acuity of 20/160 or better as well as either untreated CNV from AMD diagnosed within the last 60 days or an intermediate stage of AMD (at least 1 large druse or at least 20 medium-size drusen) with no evidence of geographic atrophy of the retinal pigment epithelium or other macular diseases.

A successful outcome was defined a priori as a sensitivity of at least 80% and a specificity of at least 80%.

The results demonstrated that the sensitivity to detect recent onset of CNV was 82% (95% confidence interval [CI]: 72% to 92%). The specificity to differentiate recent onset of CNV from the intermediate stage of AMD was 88% (95% CI: 81% to 96%).

In conclusion, the PreView PHP™ testing can detect recent onset of CNV due to AMD and differentiate it from an intermediate stage of AMD with high sensitivity and specificity. These data suggest that monitoring with PHP should detect most CNV of recent onset with few false positives at a stage when treatment usually would be beneficial so that this monitoring should be considered in the management of the intermediate stage of AMD.

LABELING

The Notal Vision PreView PHP™ system is provided with a User Manual for the Practitioner. The information is available from the company: :: : : :

Notal Vision, Inc.
5 Droyanov Street
Tel Aviv 63143, Israel

{3}------------------------------------------------

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 or bird symbol, composed of three curved lines that suggest the head and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

APR 2 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Notal Vision, Inc. c/o Richard E. Lippman, O.D., F.A.A.O. Vice President, Ophthalmic Product Regulatory Affairs R.P. Chiacchierini & Associates, LLC 15835 Shady Grove Road, Suite 30 Rockville, MD 20850

K050350 Re:

Trade/Device Name: PreView Preferential Hyperacuity Perimeter (PreView PHP™) Regulation Number: 21 CFR 886.1605 Regulation Name: Perimeter Regulatory Class: Class I Product Code: HPT Dated: February 9, 2005 Received: February 11, 2005

Dear Dr. Lippman:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations) it togens and ment date of the Medical Device Amendments. or to commerce provision to May 20, 1978, and excordance with the provisions of the Federal Food. Drug. devices may have been reculire approval of a premarket approval application (PMA). allia Cosmette Act (1107 market the device, subject to the general controls provisions of the Act. The T ou may, therefore, mance of the Act include requirements for annual registration, listing of general controls provisions of the tice, 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 If your device is classinod 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 ov round in the over ents concerning your device in the Federal Register

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r rease oc acvisou that i Dr wation that your device complies with other requirements of the Act that I Drives made a and regulations administered by other Federal agencies. You must of any Federal batiates the requirements, including, but not limited to: registration and listing Comply whil an the Heeling (21 CFR Part 801); good manufacturing practice requirements as set (21 CFR Part 801), accemes (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in and quinn control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{4}------------------------------------------------

Page 2- Richard E. Lippman, O.D., F.A.A.O.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 827-8910. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

David M. Whipple

Acting Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Indications Statement

510(k) Number (if known): K020350

Device Name: The Notal Vision Preview Preferential Hyperacuity Perimeter (Preview PHPTM)

Indications for Use:

The PreView Preferential Hyperacuity Perimeter (PreView PHP™) 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 distorion) in patients from ago
progression of disease factors causing metamorphopsia including but not limited to progression of assouse ration (CNV). It is intended to be used in the office of a licensed eye care practitioner in patients with stable fixation.

Additional Claims:

Image /page/5/Figure/6 description: The image contains a collection of text snippets, seemingly extracted from a document. The phrases "comparent of the comments of the comments of" and "and the country of the comment" appear, suggesting a discussion or analysis of comments within a specific country. The repetition of "and the comments of the count" and "and the country of the count" further emphasizes the focus on comment analysis and geographical context. The overall impression is that the image represents a fragment of text related to comment analysis, possibly within a research or analytical context.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Presription Use __

M.L.B. Nicholas

(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises

i l

510(k) Number K050350

Over -The-Counter Use

(Oprtional Format 1-2-96)

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.