(196 days)
The VPS is a non-invasive ultrasonic device intended to measure the pattern of eye and head movement when viewing lateral visual stimulus, to use as a guide for prescribing progressive power eyeglass lenses.
The VPS is a non-invasive ultrasonic device intended to measure the pattern of eye and head movement when viewing lateral LED fixation lamps. It consists of a headset and a main body with an ultrasonic transmitter. Two ultrasonic receivers are imbedded in the center nosepiece of the headset. The patient wears the headset and looks at three orange LED fixation lamps in the main body as they light up in succession. As the patient follows the lights from side to side, the device measures the degree of head movement from the center light against a target angle of 40° and a standard deviation. Eye movement is extrapolated to fill the remaining vision angle. The calculated ratio of head/eye movement is used to determine the shape of the peripheral and central fields of the progressive spectacle lenses.
Here's a breakdown of the acceptance criteria and study information for the Varilux® VisionPrint™ System (VPS) based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state pre-defined "acceptance criteria" against which the device performance was measured. Instead, it describes characteristics of the device's performance in a clinical study. The performance described focuses on the reproducibility and correlation of the VPS measurements.
| Performance Metric | Reported Device Performance and Interpretation |
|---|---|
| Reproducibility of Measurements (Day-to-day) | For 90% of subjects, the differences between measurements taken on two separate days were lower than 0.20 (units not specified, but likely relates to head/eye movement pattern). This indicates a high level of consistency in the individual subject's measurements over time. |
| Reproducibility of Measurements (Within-session Standard Deviation) | For 98% of subjects, the differences in the standard deviation (dispersion among 20 measurements taken in one session) were lower than 0.11 (units not specified). This suggests that the device provides consistent measurements within a single testing session, with low variability in how a subject's eye/head movements are reported. |
| Correlation with Predicate Device | The measurements taken by the ultrasound device (VPS) showed a close correlation with those taken by the electromagnetic Polhemus Fastrak. This indicates that the VPS produces results that are comparable and consistent with a recognized, established method for measuring eye and head movement. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 175 presbyopic patients.
- Data Provenance: The document does not explicitly state the country of origin. It is a "clinical study," implying prospective data collection for the purpose of the submission. The date of the 510(k) summary (December 19, 2003) and the FDA approval date (July 2, 2004) suggest recent data for that period.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The provided summary does not mention the use of experts to establish ground truth for the test set. Instead, it uses a comparator device (Polhemus Fastrak) as a reference for comparison.
4. Adjudication Method for the Test Set
Not applicable. There's no mention of an adjudication process as external experts were not used to establish ground truth.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. The study focused on the device's internal consistency and its correlation with another measurement device, not on how human readers' performance with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Yes, the performance data presented is for the standalone device. The VPS is an "Eye Movement Monitor" that measures eye and head movement; the study describes its measurements directly, not its impact on human performance. It is a measurement device, not an interpretative AI.
7. The Type of Ground Truth Used
The "ground truth" for the comparative analysis was the measurements obtained from an "electromagnetic sensor -- the Polhemus Fastrak." This serves as a reference standard to demonstrate the accuracy or agreement of the VPS's measurements.
8. The Sample Size for the Training Set
The document does not mention a "training set" or "training data." The VPS is described as an ultrasonic measurement device, not an AI/machine learning algorithm requiring a distinct training phase. The clinical study described appears to be a validation or performance evaluation study of the device itself.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set or AI algorithm requiring ground truth for training is explicitly described.
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TAB D
510(k) SUMMARY Varilux® VisionPrint™ System Essilor International, Inc.
This 510(k) summary of safety and effectiveness for the Varilux® VisionPrint™ System is submitted in accordance with the requirements of SMDA and follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.
| Applicant: | Essilor International, Inc. |
|---|---|
| Address: | c/o Essilor of America, Inc.2400 118" Avenue NorthSt Petersburg, FL 33176(727) 572-0844(727) 592-0358 (FAX)gwalsh@essilorusa.com |
| Contact Person: | Marc J. Scheineson, Esq.Regulatory Counsel |
| Telephone: | (202) 414-9243 (telephone)(202) 414-9299 (fax) |
| Preparation Date: | December 19, 2003 |
| Device Trade Name: | Varilux® VisionPrint™ System or VPS |
| Common Name: | Eye Movement Monitor |
| Classification Name: | Eye Movement Monitor (see 21 C.F.R. § 886.1510) |
| Product Code: | HLL |
| Predicate Device: | OBER2 Eye Movement Monitor, 510(k) # K902954 |
| Device Description: | The VPS is a non-invasive ultrasonic device intended tomeasure the pattern of eye and head movement whenviewing lateral LED fixation lamps. It consists of a headsetand a main body with an ultrasonic transmitter. Twoultrasonic receivers are imbedded in the center nosepiece ofthe headset. The patient wears the headset and looks atthree orange LED fixation lamps in the main body as theylight up in succession. As the patient follows the lights from |
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| side to side, the device measures the degree of headmovement from the center light against a target angle of 40°and a standard deviation. Eye movement is extrapolated tofill the remaining vision angle. The calculated ratio ofhead/eye movement is used to determine the shape of theperipheral and central fields of the progressive spectaclelenses. | |
|---|---|
| Specifications: | The VPS emits ultrasound at sound pressure levels of 115dB at 40 kHz, to which the patient is exposed forapproximately 2 minutes during testing. |
| Intended Use: | The VPS is a non-invasive ultrasonic device intended tomeasure the pattern of eye and head movement whenviewing lateral visual stimulus, to use as a guide forprescribing progressive power eyeglass lenses. |
| Performance Data: | In a clinical study, 175 presbyopic patients were measuredfor head and eye movement by two devices: anelectromagnetic sensor -- the Polhemus Fastrak -- and anultrasound transmitter and receivers. The measurement bythe ultrasound device was reproducible. Subjects weremeasured on two separate days. For 90% of those subjectsthe differences between the measurements were lower than0.20. Moreover, the standard deviation - i.e. , the dispersionamong the 20 measurements for each subject taken in onesession - was similarly reliable, with 98% of themeasurement differences lower than 0.11. Themeasurements taken by the ultrasound device showed aclose correlation with those taken by the electromagneticPolhemus Fastrak. |
| CONCLUSIONS: | Based on the foregoing and other information contained inthis application, Essilor believes that the Varilux® VPS issubstantially equivalent to its claimed predicates underconditions of intended use. |
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Image /page/2/Picture/1 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top and bottom of the circle. Inside the circle is a stylized image of an eagle or bird with three curved lines representing its wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 2 2004
Essilor International, Inc. c/o Marc J. Scheineson, Esq. Alston & Bird, L.L.P. 601 Pennsylvania Avenue, N.W. Washington, DC 20004-2601
Re: K033949
K059947
Trade/Device Name: Varilux® VisionPrint™ System Regulation Number: 21 CFR 886.1510 Regulation Name: Eye Movement Monitor Regulatory Class: Class II Product Code: HLL Dated: June 25, 2004 Received: June 25, 2004
Dear Mr. Scheineson:
We have reviewed your Section 510(k) premarket notification of intent to market the device in we nave reviewed your becaon 910(x) premained 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 commerce prof to May 20, 1976, the encordance with the provisions of the Federal Food, Drug, devices that have been reculise in assess approval of a premarket approval application (PMA). and Costience Act (Act) that do not require to the general controls provisions of the Act. The 1 ou may, merceive, market 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 classified (600 abor of ols. Existing major regulations affecting your device can may be subject to succeral Regulations, Title 21, Parts 800 to 898. In addition, FDA may ou found in the Overning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loast be advised that I Dri- brosan that your device complies with other requirements of the Act that I DA has made a acterimations administered by other Federal agencies. You must or any I cacial statutes and equirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI K Far 607); adoling (21 CFR Part 820); and if applicable, the electronic 101111 m the quality of bections (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2- Marc J. Scheineson
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) 594-4613. 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/dsma/dsmamain.html
Sincerely yours,
A Kalpi Rosenthal
A. Ralph Rosenthal, M.D Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): KO33949_
Device Name: Varilux® VisionPrint™ System (VPS)
Indications For Use:
The VPS is a non-invasive ultrasonic device intended to measure the pattern of eye and head movement when viewing lateral visual stimulus, to use as a guide for prescribing progressive power eyeglass lenses.
Prescription Use_ X (Part 21 CFR 801 Subpart D)
AND/OR
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Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Ophthalmic Ear, | |
| Nose and Throat Devises | |
| 510(k) Number | K033949 |
§ 886.1510 Eye movement monitor.
(a)
Identification. An eye movement monitor is an AC-powered device with an electrode intended to measure and record ocular movements.(b)
Classification. Class II.