The Pentacam is designed to take photos of the anterior segment of the eye which includes the cornea, pupil, anterior chamber and lens of the eye. To evaluate:

• corneal shape,
analyse condition of the lens (opaque crystalline lens), ●
analyse the anterior chamber angle, ●
analyse anterior chamber depth, .
analyse the volume of the anterior chamber, .
. analyse anterior or posterior cortical opacity,
analyse the location of cataracts (nuclear, subcapsular and or cortical), using cross . slit imaging with densitometry,
corneal thickness. ●

Device Description

The Pentacam Scheimpflug Camera is a non-invasive, diagnostic system created to take photographs of the anterior segment of the eye, table mounted 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 measuring system offers the possibility of automatically rotation to get photographs of every part of the eye. The system calculates from the photos a 3D-modell of the eye.

AI/ML Overview

The provided text describes the Pentacam Scheimpflug Camera and its substantial equivalence to a predicate device, but it does not contain a detailed study report with specific acceptance criteria and performance data in the format requested.

Therefore, I cannot populate the table or answer most of the questions directly from the given input. The document is primarily a 510(k) summary for regulatory clearance, which focuses on demonstrating substantial equivalence rather than presenting a full clinical study with quantitative performance metrics against predefined acceptance criteria.

Here's what I can extract and infer based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not Explicitly Stated for the Device Under Review (Pentacam)	Not Explicitly Stated in a Quantitative Manner
(Likely implicit: Performance comparable to predicate device NIDEK EAS-1000 in terms of image capture and analysis capabilities for anterior eye segment.)	The document states: "The Pentacam is proven effective for its intended uses through internal company and independent clinical studies." However, specific numerical performance results or how they compare to acceptance criteria are not provided.
(Examples of potential criteria, not found in text: Accuracy of pachymetry within X microns, repeatability of anterior chamber depth measurements within Y mm, etc.)	(No specific values provided.)

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified.
Data Provenance: "internal company and independent clinical studies" are mentioned, but no details on country of origin or whether they were retrospective or prospective are provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not specified. The document does not describe how ground truth was established for any test sets.

4. Adjudication method for the test set:

Not specified.

5. 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:

No, an MRMC comparative effectiveness study is not mentioned. The device is described as a diagnostic system based on the Scheimpflug principle, not an AI-assisted diagnostic tool that would typically involve human readers interpreting results with and without AI.

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

The device itself IS a standalone imaging and analysis system. The "algorithm" is integral to its function of calculating a 3D model and various ocular parameters from the acquired photos. The effectiveness mentioned in the text likely refers to the overall system's ability to produce these measurements, but no specific "standalone" performance study in the context of an AI algorithm only is detailed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not specified.

8. The sample size for the training set:

Not applicable as the document does not describe a machine learning algorithm that requires a separate training set. The device's operation is based on established optical and mathematical principles (Scheimpflug principle, 3D model calculation).

9. How the ground truth for the training set was established:

Not applicable (see point 8).

Summary of what is present in the document relevant to performance and validation:

The document states that "The Pentacam is proven effective for its intended uses through internal company and independent clinical studies."
The primary method for demonstrating "effectiveness" (and substantial equivalence) described in the document is through comparison to a predicate device (NIDEK EAS-1000) based on shared technology (Scheimpflug principle, CCD camera, similar operating system) and intended uses (anterior segment photography and evaluation of corneal shape, lens condition, anterior chamber, pachymetry, etc.).
It highlights safety aspects, such as being non-invasive, using eye-safe light intensity, and meeting electrical safety requirements.

To provide the detailed information requested in your prompt, a dedicated clinical study report or validation protocol for the Pentacam would be needed, which is not part of this 510(k) summary.

Summary

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SEP 1 6 2003

K030719

510(K) SUMMARY

substantially equivalent

General Information

Applicant's Name and Address:	OCULUS Optikgeräte GmbHMünchholzhäuser Straße 29D-35582 Wetzlar
Date of Summary:	04 March 2003
Owner/Operator Number:	8010318
	Mr. Joerg IwanczukProduct Manager
Device Name
Trade Name:	Pentacam Scheimpflug Camera

Class: Classification Name: Product Code: Regulation Number:

Class II Scheimpflug Camera MXK Anterior Eye-Segment Analysis System 886.1850

Predicate Devices

The Pentacam Scheimpflug Camera is claimed to be substantially equivalent to the following currently market device:

NIDEK, EAS-1000 Anterior Eye-Segment Analysis System- K991284

Device Description:

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Product Comparison

,。

	New Device	Anterior Eye-Segment AnalysisSystem
Manufacturer	OCULUS OptikgeräteGmbH	Nidek Inc.
Measuring Principle	Scheimpflug Principle forSlit Image photography	Scheimpflug Principle for SlitImage photography
Optical	Single Aperture	Single Aperture
Viewing Optics	15" Coloured Screen	5.5" Black and White CRT
Observation Illumination	Infrared LED 800nm	Infrared LED for Retro-Illumination 800nm
Flash Output Illumination	Blue LED Light (UV-free)475nm, max. 2.5Wsec	Xenon Lamp 200Wsec
Photography Camera	CCD-Camera	CCD-Camera
Display	Data digital, displayed on aCPU	Data digital and can be displayedon a CPU
Image resolution	800 x 600 pixels	640 x 400 pixels
Image size	5.6 x 4.5mm	8mm x 6.6mm
Photographic range	Eligible 0 to 180°	Offers Photographic angles from0 to 180°
Photographic Series	1 to 50 photos	N/A
Slit Length	14mm	2 – 14mm adjustable
Power Consumption	50VA	150 VA
Power requirement	110/220 VAC, 50/60Hz	100VAC, 50/60Hz
Weight	9 kg	25 kg

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Basics for Substantial Equivalence

The systems utilize the same or similar Operating System. They 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 eye and the anterior eve segment A
Both systems use the same device features like a 公
- 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: The Pentacam is designed to take photos of the anterior segment of the eye, which includes cornea, lens and anterior chamber. To evaluate:

Corneal shape

Analyse condition of the lens

Densitometry, cataract degree and location using the Scheimpflug Image State of the lens (pre and post intraocular lens implant)

Analyse anterior chamber (size, volume and angle)

Pachymetry (thickness of the cornea)

Scheimpflug Image

Analysing center position of the cornea to iris and lens

Safety

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

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of three human profiles facing to the right, with lines connecting them to form a single, abstract shape.

SEP 1 6 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCULUS Optikgeräte GmbH c/o Tom Weatherby 18902 NE 150th St. Woodinville, WA 98072

Re: K030719

Trade/Device Name: Pentacam Scheimpflug Camera Regulation Number: 21 CFR 886.1850 Regulation Name: AC-powered slitlamp biomicroscope Regulatory Class: Class II Product Code: MXK Dated: July 18, 2003 Received: July 21, 2003

Dear Mr. Weatherby:

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 - Tom Weatherby

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 halepi 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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Image /page/5/Picture/0 description: The image shows a logo with the word "OCULUS" underneath a star-shaped design. The left side of the star is filled in with black, while the right side is outlined. There is a triangle shape in the middle of the star. The word "Page" is on the bottom left.

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Pentacam Scheimpflug Camera Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The Pentacam is designed to take photos of the anterior segment of the eye which includes the cornea, pupil, anterior chamber and lens of the eye. To evaluate:

• corneal shape,
analyse condition of the lens (opaque crystalline lens), ●
analyse the anterior chamber angle, ●
analyse anterior chamber depth, .
analyse the volume of the anterior chamber, .
. analyse anterior or posterior cortical opacity,
analyse the location of cataracts (nuclear, subcapsular and or cortical), using cross . slit imaging with densitometry,
corneal thickness. ●

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dea/ Kriclmen

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.