The EYE-deas EyesOPen tonometer is used to measure the intraocular pressure (IOP) during routine eye examinations or when an increased IOP is suspected.

Device Description

The Eye-deas EyesOPen tonometer is a precision electronic tonometer, which measures intraocular pressure (IOP). The body of the instrument is specially designed to fit comfortably in the user's hand, facilitating fast and accurate measurements.

The EyesOPen tonometer contains a solid-state force transducer and a CMOS image transducer that together produces electrical signals from which intraocular pressure is derived. When sufficient valid readings are obtained an IOP reading is displayed on a liquid crystal display.

Under each of the four digits are bars. The bars correspond to the goodness of fit to a linear regression of pressure against applanated diameter. The regression coefficient is 95% or better if the first bar is illuminated, 90%-95% if the second bar is illuminated, 80%-90% if the third bar is illuminated, or less than 80% if the fourth bar is illuminated.

AI/ML Overview

The provided text does not contain a performance study with detailed acceptance criteria, sample sizes, or ground truth establishment for the EyesOPen Manual Tonometer that typically accompanies a medical device submission.

Instead, it states:

"Although not required to establish substantial equivalence, the EyesOPen tonometer was tested to establish baseline performance. The EyesOPen tonometer was tested on a simulated human eye. The EyesOPen tonometer performance was consistent with the performance of the predicate tonometer devices on this simulator."

This suggests that a formal clinical study with human subjects, defined acceptance criteria, and detailed statistical analysis, was not conducted or provided in this submission for proving the device meets specific performance criteria against a clinical ground truth. The submission focuses on demonstrating substantial equivalence to predicate devices (Perkins Tonometer and Tono-Pen 3) based on design features, intended use, and general performance consistency with a simulator.

Therefore, I cannot populate the requested tables and information based on the provided text, as the specific details of performance testing are largely absent.

What is present is a statement regarding performance testing against a simulator, indicating consistency with predicate devices, but no quantifiable acceptance criteria or detailed study results are provided.

Given this limitation, I can only provide the information that is mentioned or can be inferred:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Not explicitly stated in document for clinical performance)	Reported Device Performance (as stated in document)
(Not explicitly defined beyond "consistency with predicate performance on simulator")	"The EyesOPen tonometer performance was consistent with the performance of the predicate tonometer devices on this simulator."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not specified. The testing was conducted "on a simulated human eye," implying a single or a limited number of simulated eyes were used.
Data Provenance: Not applicable, as the testing was performed on a "simulated human eye" rather than human data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: Not applicable. The ground truth for the "simulated human eye" would be inherent to the simulated eye's design, not established by human experts.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. There is no mention of human expert adjudication as the testing was done on a simulator.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

Was an MRMC study done? No. The document only mentions testing on a simulated eye and does not describe any human reader study, with or without AI assistance.
Effect size of human readers improvement with AI vs. without AI assistance: Not applicable, as no MRMC study was performed and this device is a standalone tonometer, not an AI assistance tool for human readers.

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

Was a standalone study done? Yes, the performance testing described is standalone, as it involves the device (EyesOPen tonometer) being tested on a "simulated human eye" without human intervention for interpretation or decision-making. The device itself performs the measurement and displays the result.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth was based on the "simulated human eye" and its known or calibrated properties for intraocular pressure. The document states its performance was consistent with predicate devices on this simulator, suggesting the simulator itself provided the reference.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device is described as having a "solid-state force transducer and a CMOS image transducer" to derive IOP using a "Goldmann" algorithm basis. There is no indication that the device utilizes machine learning requiring a training set.

9. How the Ground Truth for the Training Set was Established

How Ground Truth for Training Set was Established: Not applicable, as no training set is mentioned or implied for this device.

Summary

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Eye-deas, LLC

510(k) Submission

EyesOPen Manual Tonometer

510(k) Summary

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

The assigned 510(k) number is: K032769

Submitted by: Steven E. Feldon, M.D. President Eye-deas, LLC 39 Sandringham Road Rochester, New York 14610

Date Prepared: July 21, 2003

Device Name

Proprietary Name:	EyesOPen Tonometer
Common Name:	Ocular Tonometer
Classification Name:	Tonometer, Manual

Substantial Equivalence

The Eye-deas EyesOPen tonometer is similar in indications, optical design and IOP calculation methodology to the Perkins tonometer.

The Eye-deas EyesOPen tonometer is similar in indications, size, user interface, microprocessor operation and solid-state force transducer design to the Tono-Pen 3 tonometer.

Device Description

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Eye-deas, LLC

EyesOPen Manual Tonometer

510(k) Submission

illuminated, 90%-95% if the second bar is illuminated, 80%-90% if the third bar is illuminated, or less than 80% if the fourth bar is illuminated.

Intended Use

The Eye-deas EyesOPen tonometer is used to measure the intraocular pressure (IOP) during routine eye examinations or when an increased IOP is suspected.

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EyesOPen Manual Tonometer

Substantial Equivalence Comparison - Perkins Tonometer

	EyesOPen tonometer	Perkins tonometer		EyesOPen tonometer	Tono-Pen 3
Indication	Intraocular pressure (IOP)measurement	Same	Indication	Intraocular pressure (IOP)measurement	Same
Design	Hand-held microprocessorbased	Hand-held manual dial	Design	Hand-held microprocessorbased	Same
Force transducer	Solid state element	Spring and weight	Force Transducer	Solid-state	Same
Imaging transducer	Electronic imager	Operator's eye	Imaging Transducer	Electronic CMOS imager	No imaging elements
IOP algorithm basis	Goldmann	Same	IOP calculation basis	Goldmann	Mackay-Marg
Calibration	None required	External weights	Calibration	None required	None required
Contact tip	6mm glass coaxial	6 mm glass transverse	Contact tip	6mm glass coaxial	3 mm stainless steelcoaxial
User interface	Briefly touched against eye	Held on patient's eye whiledial is adjusted	Measurement technique	Briefly touched against eye	Same
Display	4 digit LCD	Scribed dial	User control	Single push button	Same
Range of measurement	5 - 90 mmHg	5-50 mmHg	Single use sanitary tipcover	Required	Not required
Statistical reliability of thereading	The bars correspond to thegoodness of fit to a linearregression ofpressure againstapplanated diameter. Theregression coefficient is95% or better if the first baris illuminated, 90%-95% ifthe second bar isilluminated, 80%-90% if thethird bar is illuminated, orless than 80% if the fourthbar is illuminated.	No indication of readingreliability	Display	4 digit LCD	Same
Versatility	Patient can be in anyposition.	Same.	Range of Measurement	5 - 90 mmHg	Same
Weight (with batteries)	3 ounces	12.4 ounces	Statistical Reliability	The bars correspond to thegoodness of fit to a linearregression ofpressure againstapplanated diameter. Theregression coefficient is95% or better if the first baris illuminated, 90%-95% ifthe second bar isilluminated, 80%-90% if thethird bar is illuminated, orless than 80% if the fourthbar is illuminated.	The bars correspond tostandard deviationexpressed as a percentageof the mean pressure. Thefirst bar is illuminated at<5%, the second bar isilluminated at 5% to 10%,the third bar is illuminatedat 10% to 20%, the fourthbar is illuminated at >20%.
Dimensions	1" H x 1¼" W x 7" L	1 ½" H x 1 ½" W x 11" L	Versatility	Patient can be in anyposition.	Same.
Power source	2 ea 3.0 volt lithiumbatteries	4 ea. 1.5 volt AA batteries	Weight (with batteries)	3 ounces	2.3 ounces
Dimensions	1" H x 1 ¼" W x 7 " L	1" H x 1" W x 7 3/4" L
Power Source	2 ea 3 volt lithium batteries	2 ea. 1/3N 3 volt lithiumbatteries

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EyesOPen Manual Tonometer

Substantial Equivalence Comparison - Tono-Pen 3 Tonometer

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Eye-deas, LLC

EyesOPen Manual Tonometer

Performance Testing

Although not required to establish substantial equivalence, the EyesOPen tonometer was tested to establish baseline performance. The EyesOPen tonometer was tested on a simulated human eye. The EyesOPen tonometer performance was consistent with the performance of the predicate tonometer devices on this simulator.

Stivin Foldm

Submitter's Signature

7-28-03

Date

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Image /page/5/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The eagle is facing to the left and has three lines that make up its body. The text is in all caps and is evenly spaced around the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 3 2003

Eye-deas, LLC c/o Erin Sparnon CITECH 5200 Butler Pike Plymouth Meeting, PA 19462

Re: K032769

Trade/Device Name: EyesOPen Tonometer Regulation Number: 21 CFR 886.1930 Regulation Name: Tonometer and accesories Regulatory Class: Class II Product Code: HKY Dated: September 5, 2003 Received: September 8, 2003

Dear Ms. Sparnon:

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 such 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); 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 - Erin Sparnon

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. Károlyi Károly

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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Attachment I b

Page 1 of 1

510(k) Number (if known): K032769
Device Name: EyesOpen tonometer (manual tonometer)

Indications for Use:

The EYE-deas EyesOPen tonometer is used to measure the intraocular pressure (IOP) during routine eye examinations or when an increased IOP is suspected. This device is intended for use by Ophthalmologists. Optometrists, and other trained medical professionals.

(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	K032769
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Prescription Use		OR	Over-the-Counter Use
(Per 21CFR801.109)

Regulation Number and Section

§ 886.1930 Tonometer and accessories.

(a)
Identification. A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. The device is intended for use in the diagnosis of glaucoma.(b)
Classification. Class II.