The Pachycam is designed 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.

Device Description

The Pachycam is a non-invasive, diagnostic system created to take photos of the anterior segment of the eye, portable and AC powered. The system is based on the Scheimpflug Principle for Slit Image photography. The device consists of a measurement unit, power supply and a CPU. 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 the anterior segment of the eye from one fixed location (180°) and analyses one, selected by software.

AI/ML Overview

The Pachycam Scheimpflug Camera is a non-invasive diagnostic system designed to photograph the eye and take Scheimpflug images of the anterior segment of the eye to evaluate the thickness of the cornea. It also measures the central radii of the cornea using an implanted keratometer.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state quantitative acceptance criteria or specific performance metrics in a structured table. Instead, it focuses on demonstrating substantial equivalence to a predicate device (OCULUS Pentacam) and safety. The key aspects of "performance" are implicitly related to its ability to perform its intended functions accurately, consistently, and safely, as shown by internal company studies.

However, based on the device description and comparison to the predicate, we can infer some performance aspects:

Feature/Metric	Acceptance Criteria (Inferred from Predicate Equivalence & Intended Use)	Reported Device Performance (Pachycam)
Accuracy of corneal thickness evaluation	Sufficiently accurate for clinical evaluation, comparable to predicate.	"The Pachycam is designed to photograph the eye and take Scheimpflug images of the anterior segment of the eye to evaluate the thickness of the cornea." "The Pachycam is proven effective for its intended uses through internal company studies." (Implies meeting the accuracy requirement for its stated purpose).
Accuracy of central radii measurement (keratometry)	Sufficiently accurate for clinical measurement, comparable to predicate.	"The implanted keratometer measures the central radii of the cornea." "The Pachycam is proven effective for its intended uses through internal company studies." (Implies meeting the accuracy requirement for its stated purpose).
Image Resolution	Clear enough for diagnostic interpretation (e.g., to evaluate corneal thickness).	640 x 480 pixels (Compared to Pentacam's 800 x 600 pixels) - This difference is noted in the comparison table but is deemed acceptable for substantial equivalence, implying it still meets diagnostic utility.
Measurement Points per Image	Sufficient data points for accurate corneal analysis, comparable to predicate.	600 per image (Compared to Pentacam's 500 per image) - This indicates an improvement in data density.
Safety (Eye, Electrical)	Must be eye-safe and meet electrical safety standards for medical devices.	"The light output is of an eye safe intensity and wavelength. The electrical safety requirements for medical devices are met."
Non-invasiveness	Device contact limited to chin and forehead, no direct eye contact during measurement.	"The Pachycam is a non-invasive diagnostic system, which contacts the patient only on his/her chin and forehead."

Study Proving Acceptance Criteria:

The document explicitly states: "The Pachycam is proven effective for its intended uses through internal company studies."

This indicates that internal testing was conducted by OCULUS Optikgeräte GmbH to validate the device's performance against its intended uses, including the evaluation of corneal thickness and measurement of central corneal radii. While the specific details of these internal studies are not provided in the publicly available summary, the FDA's clearance (K041841) suggests they found sufficient evidence to support the claims of safety and effectiveness for substantial equivalence.

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

The document does not provide specific details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective) for the "internal company studies."

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

The document does not specify the number or qualifications of experts used to establish ground truth for the test set in the internal company studies.

4. Adjudication Method for the Test Set:

The document does not describe any adjudication method used for a test set. This detail is typically found in studies involving subjective interpretation of data, which may not be the primary evaluation method for a device like a Scheimpflug camera that provides quantitative measurements.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or described in the provided document. The submission focuses on substantial equivalence to a predicate device based on technical and functional similarity, and internal effectiveness studies, rather than a direct comparison of human reader performance with and without AI assistance. The Pachycam primarily provides objective measurements.

6. Standalone (Algorithm Only) Performance Study:

Yes, the "internal company studies" that proved the device effective for its intended uses can be considered a form of standalone performance study. The Pachycam is described as generating images and measurements, implying the algorithm's ability to perform these functions independently to evaluate corneal thickness and measure central radii. The device's "effectiveness" through these studies would refer to the performance of its built-in measurement algorithms in producing accurate data.

7. Type of Ground Truth Used:

The document does not explicitly state the specific "type" of ground truth used for the internal company studies. However, for a device measuring corneal thickness and radii, the ground truth would typically involve:

Reference Measurements: Comparison to established gold standard devices or methods (e.g., ultrasonic pachymetry, other validated keratometers, optical coherence tomography).
Clinical Correlation: Evaluation of the device's measurements against clinical findings and established norms.

8. Sample Size for the Training Set:

The document does not provide any information regarding a training set sample size. This is understandable as the Pachycam is described as an optical imaging and measurement device based on a physical principle (Scheimpflug principle) and its effectiveness is likely validated through its measurement accuracy against known standards, rather than through a machine learning model that requires explicit training data.

9. How the Ground Truth for the Training Set Was Established:

As no training set is mentioned or implied for a machine learning model, specific information on how ground truth for a training set was established is not applicable/not provided in this document. The device's functionality relies on optical physics and algorithms inherent to the Scheimpflug principle for image acquisition and measurement, not on a machine learning model that is "trained."

Summary

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Description of the Pachycam Scheimpflug Camera

JAN 2 8 2005

Image /page/0/Picture/2 description: The image shows a logo with a geometric design above the word "OCULUS". The geometric design features a stylized shape resembling a mountain or a stylized letter "M", with additional lines and shapes within it. The word "OCULUS" is written in a blocky, sans-serif font, with each letter clearly defined.

K041841 510(K) SUMMARY Substantially equivalent

General Information

Applicant's Name and Address:	OCULUS Optikgeräte GmbH
	Münchholzhäuser Straße 29
	D-35582 Wetzlar
Date of Summary:	17 June 2004
Owner/Operator Number:	8010318
Contact person:	Mr. Joerg Iwanczuk
	Product Manager

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

Predicate Devices

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

Pentacam, Scheimpflug Camera, OCULUS Optikgeraete GmbH, Germany; K 030179

Device Description:

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Product Comparison

Image /page/1/Picture/2 description: The image shows a logo with a geometric design. The upper part of the logo features a stylized star-like shape with an eye-like symbol in the center. Below the geometric shape, the word "OCULUS" is written in a blocky, sans-serif font, with each letter clearly defined.

	OCULUS Pentacam	New device, Pachycam
Manufacturer	OCULUS Optikgeräte GmbH	OCULUS Optikgeräte GmbH
Measuring Principle	Scheimpflug Principle for SlitImage photography	Scheimpflug Principle forSlit Image photography
Optical	Please refer to the detailed description
ObservationIllumination	Infrared LED 800nm for pupilillumination	Infrared LED 800nm forpupil illumination
Flash OutputIllumination	Blue LED Light (UV-free)475nm, max. 2.5W PowerInput	Blue LED Light (UV-free)455nm, max. 2.5W PowerInput
Camera	CCD-Camera	CCD-Camera
Display	Data digital, displayed on aCPU	Data digital, displayed ona CPU
Image resolution	800 x 600 pixel	640 x 480 pixel
Measuring points	500 per image	600 per image
Image size	5.6 x 4.5mm	4.8mm x 3.6mm
Photographic range	Eligible 0 to 360°automatically	Fixed slit position in 180°
Photographic Series	1 to 50 photos	5 images
Exposure Control	Fixed during calibration, max2.5Wsec. Power input	Fixed during calibration,max 2.5Wsec. Powerinput
Slit Length	14mm 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	Please refer to the detailed description
Materials	Housing is made of steel, theback is made of Polyurethane,specially treated, not	Housing is made ofPolyurethane, speciallytreated, not inflammable
	inflammable	OCULUS
Mechanical safety	Please refer to the detailed description
Power supply	External, 110/220 VAC, 50/60Hz	External, 110/220 VAC, 50/60Hz
Power Consumption	50VA	27 VA
Power requirement	25 VDC 2A / 5 VDC 2A	9 VDC, 3A
Weight	9 kg	1 kg

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Basics for Substantial Equivalence

Image /page/3/Picture/2 description: The image shows a logo with the word "OCULUS" in block letters at the bottom. Above the word is a stylized symbol that resembles a star or crown shape. Inside the star shape is a design that looks like an eye or lens. The logo is simple and geometric in style.

The systems utilize the same or similar Operating System. It contain

an optical system, .
a source of illumination for observation and photography, .
a CCD-Camera as photographic medium, .

Both systems have the same intended use, to measure the anterior eye segment

Both systems use the same device features like a

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

Both systems 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)

Indications for Use

Intended Use:

Safety

The Pachycam is a non-invasive diagnostic system, which contacts the patient only on his/her chin and forehead. The Pachycam 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 Pachycam is proven effective for its intended uses through internal company studies.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 8 2005

OCULUS Optikgeräte GmbH c/o Mr. Joerg Iwanczuk Dutenhofen Münchholzhäuser Strasse 29 D-35582 Wetzlar Germany

Re: K041841

Trade/Device Name: Pachycam Scheimpflug Camera Regulation Number: 21 CFR 886.1850 Regulation Name: AC-powered slitlamp biomicroscope Regulatory Class: Class II Product Code: MXK Dated: December 23, 2004 Received: January 4, 2005

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 (OS) 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 - Mr. Joerg Iwanczuk

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 helyi 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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Description of the Pachycam Scheimpflug Camera

10 Intended use

510(k) number: k_04/84/

Device name: Pachycam Scheimpflug Camera

Indications For Use:

Prescription Use(Part 21 CFR 801 Subpart D)	✓
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AND/OR

Over-The-Counter Use(21 CFR 801 Subpart C)
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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Ophthalmic Ear, Nose and Throat Devices

K041841 510 (k) Number_

(Optional Format 3-10-98)

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.