The PARK 1 is designed to photograph the eye and take Scheimpflug images of the anterior segment to evaluate the thickness of the cornea. The implanted keratometer measures the central radii of the cornea. The implanted Ophthalmic Refractometer measures the refractive power of the eye.

Device Description

The PARK 1 is a non-invasive, diagnostic system created to:

take photos of the anterior segment of the eye
measure the refractive power of the eye
measure the central corneal K-values.
The device is stationary and AC powered. The PARK 1:
is based on the Scheimpflug Principle for Slit Image photography. The measuring system uses blue light (UV-free) given to a slit to illuminate the eye, and a CCD-Camera for photography. The device takes a series of images of the anterior segment of the eye from one fixed location (180°) and analyses one, selected by software
has a real keratometer to measure directly the central keratometer values as per definition in the 3.1mm ring.
includes an Ophthalmic Refractometer to measure the refractive power of the eye (21CFR886.1760)
The device consists of a measurement unit, built in CPU, head and chin rest and an external power supply.

AI/ML Overview

This application for the PARK 1 device does not explicitly define "acceptance criteria" as a separate section with specific thresholds. Instead, the "Brief summary of nonclinical tests and results" section presents repeatability data, which implies that the device's performance is deemed acceptable if it demonstrates a certain level of precision for pachymetry and keratometry measurements. The substantial equivalence claim is based on similarity to predicate devices rather than meeting a predefined performance standard.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Reported Device Performance

Given the lack of explicit acceptance criteria, the table below presents the reported repeatability measurements, which are the primary performance metrics provided for the device. The "Acceptance Criteria" column is inferred as the reported repeatability values themselves, implying that these values were considered appropriate for demonstrating substantial equivalence.

Measurement Category	Measurement	Acceptance Criteria (Implied)	Reported Device Performance (Repeatability)
Pachymetry	Apical Thickness	≤ 4.79 µm	4.79 µm
	Min. Thickness	≤ 5.51 µm	5.51 µm
Keratometry	K1	≤ 0.11 dpt	0.11 dpt
	K2	≤ 0.12 dpt	0.12 dpt

Detailed Study Information

Sample size used for the test set and the data provenance:
- Sample Size: 46 subjects (92 eyes).
- Data Provenance: The study was "internally performed" by OCULUS Optikgeräte GmbH. It is retrospective, as the measurements were taken and then analyzed. The country of origin is not explicitly stated for the subjects, but the applicant is based in Germany.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. The study measured the device's repeatability rather than comparing its measurements to a "ground truth" established by experts. The measurements were taken by "the same operator" to determine how consistently the device performs.
- Qualifications of Experts: Not applicable, as there were no experts establishing ground truth in this study design.
Adjudication method for the test set:
- Adjudication Method: Not applicable. There was no ground truth that required adjudication. The study focused on the variability of the device's own measurements.
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:
- MRMC Study: No. This study was a device repeatability study, not a comparative effectiveness study involving human readers or AI assistance. The PARK 1 is a diagnostic measurement device, not an AI-assisted diagnostic tool.
- Effect Size: Not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Yes, in a sense. The study evaluated the device's intrinsic repeatability when operated by a single individual, focusing on the consistency of the device's measurements. The "algorithm" here refers to the device's measurement system. However, it's not a standalone AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: Not applicable. The study aimed to determine the repeatability of the device's measurements, not its accuracy against an external gold standard or ground truth. Each measurement performed by the device on an eye served as its own data point for assessing consistency.
The sample size for the training set:
- Training Set Sample Size: Not applicable. This device is not an AI/ML algorithm that requires a "training set" in the conventional sense. It's an optical measurement device. Its internal algorithms are part of its fixed design, not learned from data.
How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable. As it's not an AI/ML device with a training set, the concept of establishing ground truth for a training set does not apply.

Summary

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

Description of the PARK 1

510(K) SUMMARY Substantially equivalent

SEP 1 1 2008

General Information

Applicant's Name and Address:	OCULUS Optikgeräte GmbH
	Münchholzhäuser Straße 29
	D-35582 Wetzlar
Date of Summary:	18 August 2008
Owner/Operator Number:	8010318
Contact person:	Mr. Joerg Iwanczuk
	Product Manager

Device Name
Trade Name:	PARK 1
Class:	Class II
Classification Name:	Scheimpflug Camera
Product Code:	MXK Anterior Eye-Segment Analysis System
Regulation Number:	886.1850

Predicate Devices

The PARK 1 is claimed to be substantially equivalent to the following currently market device:

Pachycam, Scheimpflug Camera, OCULUS Optikgeraete GmbH, Germany; K 041841

Auto-Ref-Keratometer, CANON Inc.; exempted (21CFR886.1760)

Device Description:

The PARK 1 is a non-invasive, diagnostic system created to:

ං take photos of the anterior segment of the eye
measure the refractive power of the eye o
measure the central corneal K-values. o

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

The device is stationary and AC powered. The PARK 1:

o is based on the Scheimpflug Principle for Slit Image photography. The measuring system uses blue light (UV-free) given to a slit to illuminate the eye, and a CCD-Camera for photography. The device takes a series of images of the anterior segment of the eye from one fixed location (180°) and analyses one, selected by software
o has a real keratometer to measure directly the central keratometer values as per definition in the 3.1mm ring.
includes an Ophthalmic Refractometer to measure the refractive power of the eye o (21CFR886.1760)

The device consists of a measurement unit, built in CPU, head and chin rest and an external power supply.

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

Product Comparison between PARK 1 and Pachycam

	OCULUS Pachycam	New device, PARK 1
Manufacturer	OCULUS Optikgeräte GmbH	OCULUS OptikgeräteGmbH
Measuring Principle	Scheimpflug Principle for SlitImage photography	Scheimpflug Principle forSlit Image photography
ObservationIllumination	Infrared LED 800nm for pupilillumination	Infrared LED 950nm forpupil illumination
Flash OutputIllumination	Blue LED Light (UV-free)455nm, max. 2.5W PowerInput	Blue LED Light (UV-free)460nm, max. 2.5W PowerInput
Camera	CCD-Camera	CCD-Camera
Display	Data digital, displayed on aCPU	Data digital, displayed ona CPU
Image resolution	640 x 480 pixel	640 x 480 pixel
Measuring points	600 per image	600 per image
Image size	4.8mm x 3.6mm	4.8mm x 3.6mm
Photographic range	Fixed slit position in 180°	Fixed slit position in 180°
Photographic Series	5 images	5 images
Exposure Control	Fixed during calibration, max2.5Wsec. Power input	Fixed during calibration,max 2.5Wsec. Powerinput
Slit Length	5mm fixed	5mm fixed
Illumination time duringalignment	Limited to 300 seconds	Limited to 300 seconds
Where used	Hospital, ambulance	Hospital, ambulance
Intended use	Please refer to the detailed description
Sterilisation	Not necessary	Not necessary
Materials	Housing is made ofPolyurethane, speciallytreated, not inflammable	Housing is made ofPolyurethane, speciallytreated, not inflammable
Mechanical safety	Please refer to the detailed description
Power supply	External, 110/220 VAC	External, 110/230 VAC
	50/60Hz	50/60Hz
Power Consumption	27 VA	49,5 VA
Power requirement	9 VDC, 3A	15VDC, 3,3A see testcertificate
Weight	1 kg	12 kg

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

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

Basics for Substantial Equivalence

The PARK 1 utilizes same or similar operating systems.

In comparison to the device Pachycam, Oculus Optikgeräte GmbH, it contains:

. same Scheimpflug optical system,
. same source of illumination for observation and photography.
. same CCD-Camera as photographic medium,
. same Keratometer for the central corneal keratometer readings
. same alignment system

In comparison to the Ophthalmic Refractometer, Canon Inc, exempted (21CFR886.1760), it contains

. same measurement principle
The PARK 1 has same intended use:

In comparison to PACHYCAM:

to photograph the eye and take Scheimpflug images of the anterior segment of the eye to evaluate the thickness of the cornea. The implanted keratometer measures the central radii of the cornea.

In comparison to the Ophthalmic Refractometer: to measure the refractive power of the eye (21CFR886.1760).

The PARK 1 and the Pachycam uses same device features like a

head stabilizing device .
. external fixation target
. joy stick for control mechanism.

The PARK 1 and the Pachycam are considered "Non Invasive" as defined in 21 CFR §812.3(k) and considered not to be a "Significant Risk Device" as defined in 21 CFR §812.3(m).

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

Indications for Use

Intended Use:

The PARK 1 is designed to photograph the eye and take Scheimpflug images of the anterior segment to evaluate the thickness of the implanted keratometer measures the central radii of the cornea. The implanted Ophthalmic Refractometer measures the refractive power of the eye (21CFR886.1760)

Safety

The PARK 1 is a non-invasive diagnostic system, which contacts the patient only on his/her chin and forehead. The PARK 1 does not present or pose any new or additional effects for risk on the safety prescribed intended uses. The light output is of an eye safe intensity and wavelength. The electrical safety requirements for medical devices are met. The PARK 1 is proven effective for its intended uses through internal company studies.

{6}------------------------------------------------

Brief summary of nonclinical tests and results

In an internally performed study 46 subjects (92 eyes) were examined with an OCULUS PARK 1 by the same operator to determine the repeatability of the measurement results of the Pachymetry and Keratometry. Both eyes of a patient were measured and every eye was measured three times with the same device. The measurement ranges of the examined eyes were: Apical Thickness [460 .. 636um]; Min. Thickness [453 .. 635μm] ; K1 [38.66 .. 46.04dpt] ; K2 [39.02 .. 47.14dpt]. For this study design repeatability is a pooled standard deviation across subjects and eyes calculated in the following manner: For each set of triplicate results per eye per subject, the variance (standard deviation squared) had been calculated. Then these variances were averaged and the square root of the average had been taken.

Measurement	Value	Repeatability	SD1
			Min.	Max.
Pachymetry	ApicalThickness	4.79 µm	0.00 µm	14.74 µm
	Min.Thickness	5.51 µm	0.58 µm	14.93 µm
Keratometry	K1	0.11 dpt	0.00 dpt	0.35 dpt
	K2	0.12 dpt	0.00 dpt	0.31 dpt

1 : SD : Standard Deviation (across triplicate results)

{7}------------------------------------------------

Image /page/7/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Public Health Service

SEP 1 1 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Oculus Optikgeräte GmbH c/o Joerg Iwanczuk Product Manager OCULUS Optikgeräte GmbH Muenchholzhaeuser Strasse 29 Wetzlar D-35582 Germany

Re: K073508

Trade Name: PARKONE Regulation Number: 21 CFR 886.1850 Regulation Name: AC-powered slitlamp biomicroscope Regulatory Class: Class II Product Code: MXK, HLQ, HKO Dated: May 13, 2008 Received: June 30, 2008

Dear Mr. Iwanczuk:

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.

{8}------------------------------------------------

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Malvina B. Edwards, and

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

Enclosure

{9}------------------------------------------------

Indications for Use

510(k) Number: K073508 Device Name: PARK 1

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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)

Tean.

Division Sign-Off) on of Onhthalmic Ear. lose and Throat Devises

510(k) Number K073508

Regulation Number and Section

§ 886.1850 AC-powered slitlamp biomicroscope.

(a)
Identification. An AC-powered slitlamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light.(b)
Classification. Class II (special controls). The device, when it is intended only for the visual examination of the anterior segment of the eye, is classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, does not provide any quantitative output, and is not intended for screening or automated diagnostic indications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.