The CM3910 is a device intended to take images of the anterior segment of the eye which includes the cornea, iris, pupil, anterior chamber and lens, to evaluate and analyse

· Corneal shape
· Lens shape
· Pachymetry (thickness of the cornea)
· Pupil size
· Lens thickness
· Condition of the lens
- o Location of cataracts (nuclear, subcapsular and or cortical), using Scheimpflug slit imaging with densitometry
- State of the lens (opaque crystalline lens) o
· Condition and position of implants (e.g. iOLs, phakik IOLs, intracorneal rings)
· Anterior chamber (size, volume and angle)
· Scheimpflug Image
· Position of the cornea relative to iris and lens

Device Description

The CM 3910 Double-Scheimpflug Camera is a non-invasive, diagnostic system designed for the analysis of the anterior eye segment by means of Scheimpflug and Placido images. The Scheimpflug images are based on the Scheimpflug Principle for Slit Image photography. The system is table mounted and AC powered. The device consists of a measurement unit and a control unit with a CPU. The measuring system uses blue light (UV-free) given to a slit to illuminate the eye, and a CCD-Camera for taking images. The measuring unit takes pictures by a rotating scan of the anterior eye segment. It also includes a top view for eye tracking means and Placido imaging in the near infrared. From the acquired pictures, the control unit calculates a 3D-model and the topography of the eye.

AI/ML Overview

The provided text is a 510(k) summary for the CM 3910 Rotating Double Scheimpflug Camera. This type of document is submitted to the FDA to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device. While it describes the intended use, device description, and comparison to predicate devices, it does not provide specific acceptance criteria or an analytical study proving the device meets those criteria in the way you've requested for performance metrics like sensitivity, specificity, etc.

The summary states: "The CM 3910 is proven effective for its intended uses through internal performance tests." However, it does not elaborate on these internal performance tests, their methodologies, acceptance criteria, or the results.

Therefore, many of your requested points cannot be answered from the provided text. I will address the points that can be inferred or explicitly stated.

Acceptance Criteria and Study for CM 3910 Rotating Double Scheimpflug Camera:

Based on the provided 510(k) summary, the primary "acceptance criterion" for this device, as presented to the FDA, is its substantial equivalence to existing legally marketed predicate devices (Pentacam Scheimpflug Camera and Orbscan II™ Keratometer). The study that "proves the device meets the acceptance criteria" is essentially the product comparison demonstrating this substantial equivalence on various characteristics.

The summary highlights the following as rationale for substantial equivalence, implying these are the key "acceptance criteria" for demonstrating equivalence:

Same intended use: Taking photos of the anterior segment of the eye for evaluation and analysis.
Same measuring principles: Slit Scan and Placido Disc.
Same photographic medium: CCD Camera.
Comparable light sources: Wavelength and intensity.
Same features: Head stabilizing device, fixation target, joystick.
Classification: Non-invasive as defined in 21 CFR §812.3(k).

Here's a breakdown of your requested information, with disclaimers for what is not present in the document:

Table of acceptance criteria and the reported device performance:

Note: The document does not provide quantitative acceptance criteria (e.g., target accuracy, precision, sensitivity, specificity) for specific clinical measurements (e.g., corneal shape, pachymetry) of the CM 3910, nor does it provide detailed quantitative performance results from a clinical study for these parameters. The "performance" assessment here is implied through comparison to predicate devices.

Acceptance Criterion (Implied for Substantial Equivalence to Predicate)	Reported Device "Performance" (Comparison to Predicate)
Intended Use	CM 3910: Taking photos of the anterior segment of the eye which includes the cornea, pupil, anterior chamber and lens of the eye, to evaluate and analyze various parameters (Corneal shape, Lens shape, Pachymetry, Pupil size, Lens thickness, Condition of the lens (cataracts, opaque lens), Condition and position of implants, Anterior chamber (size, volume, angle), Scheimpflug Image, Position of the cornea relative to iris and lens).Predicate (Pentacam): Same.Predicate (Orbscan II™): Scan, map and display the geometry of the anterior segment of the eye (broader, but overlaps). Conclusion: Same intended use.
Measuring Principle	CM 3910: Rotational scan of Double-Scheimpflug slit images merged with Placido Disc images.Predicate (Pentacam): Rotational scan of Scheimpflug slit images.Predicate (Orbscan II™): Parallel scanned slit images and Placido Disc images. Conclusion: Uses same core principles (Slit Scan and Placido Disc).
Photographic Medium	CM 3910: CCD Camera.Predicate (Pentacam): CCD Camera.Predicate (Orbscan II™): CCD Camera. Conclusion: Same photographic medium.
Light Sources	CM 3910: Blue LED Light (UV-free) 470 nm, max. 15 mWsec.Predicate (Pentacam): Blue LED Light (UV-free) 475nm, max. 2.5 Wsec.Predicate (Orbscan II™): Not specified for flash. Infrared LED 810nm for observation (CM 3910) vs 800nm (Pentacam). Conclusion: Comparable wavelength and intensity (CM 3910 and Pentacam).
Core Features	CM 3910: Head stabilizing device, fixation target, joystick for measurement head adjustment.Predicates: Implied to have similar features or the absence of new/different features in CM 3910 does not raise safety/effectiveness concerns. Conclusion: Uses the same features.
Classification	CM 3910: Class II, MXK.This classification is not directly stated for the predicates in this document, but implied to be equivalent. Conclusion: Non-invasive diagnostic system.

Sample size used for the test set and the data provenance:
- Not provided. The document states "The CM 3910 is proven effective for its intended uses through internal performance tests," but it does not describe any specific clinical test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). The primary "test" presented for FDA submission is the comparison to predicate devices, which relies on the established performance of those devices rather than new clinical data for the CM 3910.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. Since no specific clinical test set and ground truth establishment methodology are described for the CM 3910's "internal performance tests" in this summary, information about experts and their qualifications is not available.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. No adjudication method is mentioned as a specific clinical test set is not described.
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:
- Not applicable. This device is an imaging system, not an AI-assisted diagnostic tool for human readers in the traditional MRMC sense. It provides images and calculated parameters. The document does not describe any studies comparing human reader performance with or without the device, or with differing versions of the device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, to an extent. The "internal performance tests" mentioned are likely standalone tests evaluating the device's ability to acquire and process images and calculate parameters. The device itself is an "algorithm only" type in that it performs calculations based on acquired images to provide data like corneal shape, pachymetry, etc. The document does not provide details of these tests or their results. The "Product Comparison" table implicitly serves as a standalone comparison against predicate device specifications.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not provided. For the device's "internal performance tests," the type of ground truth used is not specified. For the substantial equivalence argument, the "ground truth" is essentially the established safety and effectiveness of the legally marketed predicate devices.
The sample size for the training set:
- Not applicable / Not provided. As this is not an AI/ML device relying on a "training set" in the common sense, no such information is provided. Its calculations are based on established optical and geometric principles.
How the ground truth for the training set was established:
- Not applicable / Not provided. See point 8.

Summary

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Image /page/0/Picture/1 description: The image shows a handwritten string of characters. The characters appear to be a combination of letters and numbers. The string starts with the letter 'K', followed by the number '0', then '51940'. The characters are written in black ink on a white background.

510(k) Summary for the CM 3910 Rotating Double Scheimpflug Camera

Name and Address of Sponsor

SIS Surgical Instrument Systems Ltd. Registration Number: 9614468 Allmendstrasse 11 2502 Port Switzerland Phone: 0041 32 332 70 70 Fax: 0041 32 332 70 71 Email: frank.ziemer@sisItd.ch

Name and Address of Manufacturer

SIS Surgical Instrument Systems Ltd. Registration Number: 9614468 Allmendstrasse 11 2502 Port Switzerland Phone: 0041 32 332 70 70 Fax: 0041 32 332 70 71 Email: frank.ziemer@sisItd.ch

Name and Address of Official Correspondent

Kevin Walls, RAC Principal Consultant Regulatory Insight, Inc. 13 Red Fox Lane Littleton, Colorado 80127 Phone: 720-962-5412 Fax: 720-962-5413 Email: kevin@reginsight.com

Device Name

Device trade name: CM 3910 Rotating Double Scheimpflug Camera Classification name: Anterior segment analysis device Common name: AC-powered slitlamp biomicroscope

Classification, Panel and Product Code

Device Classification:	Class II, MXK
Reviewing Panel:	Ophthalmic Devices

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Indications for Use

The CM3910 is a device intended to take images of the anterior segment of the eye which includes the cornea, iris, pupil, anterior chamber and lens, to evaluate and analyse

· Corneal shape
· Lens shape
· Pachymetry (thickness of the cornea)
· Pupil size
· Lens thickness
· Condition of the lens
- o Location of cataracts (nuclear, subcapsular and or cortical), using Scheimpflug slit imaging with densitometry
- State of the lens (opaque crystalline lens) o
· Condition and position of implants (e.g. iOLs, phakik IOLs, intracorneal rings)
· Anterior chamber (size, volume and angle)
· Scheimpflug Image
· Position of the cornea relative to iris and lens

Predicate Devices

The Pentacam Scheimpflug Camera is claimed to be substantially equivalent to the following legally marketed devices:

. Pentacam Scheimpflug Camera of OCULUS Optikgeräte GmbH
Orbscan IITM Keratometer manufactured by Orbtek, Inc. .

Device Description

All light sources used (Slit lamp, Placido Disc illumination, Top view illumination) are Light Emitting Diodes (LED) which produce little heat. Excess heat is conducted by appropriate metallic heat sinks. The encapsulation of the light sources consists of non-inflammable materials (metals, glass). The device does not contain any incandescent lamp.

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Product Comparison

Characteristics	CM 3910	Pentacam Scheimpflug Camera (Predicate)	Orbscan II™ Keratometer (Predicate)
ReferencesIntended use	Taking photos of the anterior segment of the eye which includes the cornea, pupil, anterior chamber and lens of the eye.	510(k): K013941Taking photos of the anterior segment of the eye which includes the cornea, pupil, anterior chamber and lens of the eye.	510(k): K984443Scan, map and display the geometry of the anterior segment of the eye.
Measuring Principle	Rotational scan of Double-Scheimpflug slit images merged with Placido Disc images.	Rotational scan of Scheimpflug slit images.	Parallel scanned slit images and Placido Disc images
OpticalViewing Means	Three AperturesLCD on Measurement Unit, 17" monitor on table	Single Aperture15" Coloured Screen	Single Aperture15" Coloured Screen
ObservationIllumination	Infrared LED 810nm	Infrared LED 800nm	White flash light
Flash OutputIllumination	Blue LED Light (UV-free) 470 nm, max. 15 mWsec	Blue LED Light (UV-free) 475nm, max. 2.5 Wsec
PhotographyCamera	CCD Camera	CCD Camera	CCD Camera
DisplayImage Resolution	Data digital, displayed on a CPU1004 x 1004 pixels	Data digital, displayed on a CPU800 x 600 pixels	Data digital, displayed on a CPU0.25 diopters
Image Size	7.4 x 7.4 mm	5.6 x 4.5 mm	Parallel scan
Photographic Range	Eligible 0 to 180°	Eligible 0 to 180°	2x 20 images from two sides
Photographic Series	1 to 60 images	1 to 50 photos
Slit Length	15 mm	14 mm
Power Requirement	110/220 VAC, 50/60 Hz	110/220 VAC, 50/60 Hz	110/220 VAC, 50/60 Hz220/240 VAC, 50/60 Hz
Weight	10 kg (Measurement Unit)	9 kg	15kg

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K051990

Rationale for Substantial Equivalence

. The devices have the same intended use
The devices utilize the same measuring principles (Slit Scan and Placido Disc) .
The devices utilize the same photographic medium (CCD Camera) .
The CM 3910 and one predicate device use light sources of comparable wavelength and intensity . .
- The devices use the same features like a
  - o Head stabilizing device
  - Fixation target o
  - Joy stick for measurement head adjustment o
All devices are considered "non invasive" as defined in 21 CFR §812.3(k) .

Safety

The CM 3910 is a non-invasive diagnostic system, which contacts the patient only on his/her chin and forehead. The CM 3910 does not present or pose any new or additional risks for the prescribed intended uses. The light output is of an eye safe intensity and wavelength. The electrical safety requirements for medical devices are met. The CM 3910 is proven effective for its intended uses through internal performance tests.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol resembling a caduceus, with three angled lines representing the staff and a wavy line at the bottom representing the serpent.

SEP 2 8 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Surgical Instrument Systems c/o Kevin Walls, RAC Principal Consultant Regulatory Insight, Inc. 13 Red Fox Lane Littleton, CO 80127

Re: K051940

Trade/Device Name: CM 3910 Rotating Double Scheimpflug Camcra Regulation Number: 21 CFR 886.1850 Regulation Name: Anterior Eye-Segment Analysis Device Regulatory Class: Class II Product Code: MXK Dated: July 15, 2005 Received: July 20, 2005

Dear Mr. Walls:

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 10 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- Kevin Walls, RAC

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 2 legal) v 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) 827-8910. 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/industry/support/index.html

Sincerely yours,

David M. Whizzle

David M. Whipple Acting 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): ______________________

Device Name: CM 3910 Rotating Double Scheimpflug Camera

Indications for Usc: The CM3910 is a device intended to take images of the anterior segment of the eye which includes the cornea, iris, pupil, anterior chamber and lens, to evaluate and analyse

· Corneal shape
Lens shape
· Pachymetry (thickness of the cornea)
· Pupil size
· Lens thickness
· Condition of the lens
- Location of cataracts (nuclear, subcapsular and or cortical), using Scheimpflug slit imaging with densitometry
- State of the lens (opaque crystalline lens)
· Condition and position of implants (e.g. IOLs, phakik IOLs, intracorneal rings)
· Anterior chamber (size, volume and angle)
· Scheimpflug Image
· Position of the cornea relative to iris and lens

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Senio L. M'Carthy

(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises

510(k) Number

Page 1 of 1

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.