SurgiCase Guides are intended to be used as surgical tools to transfer a pre-operative plan to the surgery. The devices are intended to guide the marking of bone and/or guide surgical instruments during craniofacial osteotomies.

SurgiCase Guides are intended for single use only.

Device Description

The SurgiCase Guides are patient specific devices or templates that are based on a pre-operative software planning and are designed to fit a specific patient. These templates are used to assist a surgeon in transferring this pre-operative plan to the surgery by guiding the marking of bone and/or guiding surgical instruments. Guides are individually designed and manufactured for each patient using a design and manufacturing process with strict procedures and work instructions to guarantee templates that consistently perform in a safe and effective way.

The SurgiCase Guides are based on a software planning generated using the previously cleared SurgiCase software (K073449).

AI/ML Overview

The provided text describes non-clinical tests but does not include a table of acceptance criteria or specific performance metrics with numerical values. Therefore, I cannot generate 'A table of acceptance criteria and the reported device performance'.

Here's the information extracted from the document regarding the study and acceptance criteria:

1. A table of acceptance criteria and the reported device performance
No quantitative acceptance criteria or reported performance metrics are provided in the document. The text broadly states: "The guides meet the predefined acceptance criteria." and "Testing verified that the accuracy and performance of the system is adequate to perform as intended."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified. The document mentions "bone models and cadaveric specimens" but does not give the number used.
Data Provenance: Not specified. The study involved "bone models and cadaveric specimens," implying a laboratory or simulated environment rather than human patient data, making it prospective in nature for device validation. Country of origin is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The ground truth for the "quantitative validation" would be based on measurements against the pre-operative plan, not expert consensus as it's a device accuracy study. Therefore, no experts were explicitly used to establish ground truth in this context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This study focused on the accuracy of the device in transferring a pre-operative plan, not on diagnostic interpretations requiring adjudication.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The study focused on the device's accuracy in guiding surgical procedures, not on human reader performance with or without AI assistance. The device in question is a surgical guide, not an AI-driven diagnostic tool for interpretation by human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, a standalone performance assessment was conducted for the device. The "Quantitative validation using bone models and cadaveric specimens to validate the accuracy the guides obtain in transferring a surgical planning to the actual surgery during craniofacial osteotomies" evaluated the device's inherent accuracy. This is a standalone assessment of the physical guide's performance.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The ground truth implicitly used for the "quantitative validation" would be the precise measurements and positions defined in the pre-operative software plan against which the actual surgical outcome (guided by the device) was compared. This is a form of direct measurement against a defined target. For "qualitative validation," the ground truth was the expected "fit and stability" as assessed by observers, but the specific criteria for this are not detailed.

8. The sample size for the training set
Not applicable. This device is a physical surgical guide developed through a design and manufacturing process, not a machine learning algorithm that requires a training set. The "SurgiCase software" which generates the planning data for the guides was "previously reviewed under K073449" and is not part of this 510(k) submission. Therefore, no training set for the SurgiCase Guides themselves is relevant here.

9. How the ground truth for the training set was established
Not applicable, as there is no training set for the SurgiCase Guides.

Summary

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510(k) Summary

Submitter information

Company name	Materialise N.V.
Establishment registration number	3003998208
Street Address	Technologielaan 15
City	Leuven
Postal code	3001
Country	Belgium
Phone number	+32 16 39 62 80
Fax number	+32 16 39 66 06
Contact name	Alexandra Razzhivina
Contact title	Regulatory Officer
Contact e-mail address	alexandra.razzhivina@materialise.be

Submission date

The date of the Traditional 510(k) submission is March 27th, 2012.

Submission information

Trade Name	SurgiCase Guide
Common Name	Craniofacial Osteotomy Guide
Classification Name	Stereotaxic Instrument
Product code	HAW (21 CFR 882.4560)

Predicate devices

Trade or proprietary or model name	SurgiCase Guides
510(k) number	K103136
Decision date	2011/03/18
Product code	JEY, MQN
Manufacturer	Materialise N.V.

Device Information

Description and functioning of the device

The SurgiCase Guides are based on a software planning generated using the previously cleared SurgiCase software (K073449).

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SurgiCase is software for pre-operative simulation of implant placement and surgical treatment options, based on imaging information from a medical scanner such as a CT scanner or a Magnetic Resonance Imaging (MRI) scanner. The SurgiCase software was previously reviewed under K073449 and is not submitted for review in this 510k submission. References to the software are included to give a complete overview on the guide design process.

Intended use

The principal difference between the subject and predicate device is with respect to the anatomical region where the guides will be applied -- craniofacial for the subject guides versus mandibular and maxillary for the predicate guides.

SurgiCase Guides are intended for single use only.

Summary of technological characteristics

Device comparison showed that the proposed device is substantially equivalent in intended use, material and performance characteristics to the predicate device.

The proposed device has the same principles of operation as the predicate device: Each guide, made from polyamide, consists of a basic shape that fits the patient's anatomy and serves as an anatomical reference to position the guide on the surgical site. For each planned drill location, a functional element for drilling is added to the base shape and for each planned bone cut, a functional element for cutting is added.

Performance data

Non-clinical tests

Non-clinical tests included to assess the safety and effectiveness of the device:

. Quantitative validation using bone models and cadaveric specimens to validate the accuracy the guides obtain in transferring a surgical planning to the actual surgery during craniofacial osteotomies. Qualitative validation to evaluate the fit and stability of the guides.
The guides meet the predefined acceptance criteria.
Biocompatibility testing: According to the results of biocompatibility testing on the finished device, the biocompatibility requirements have been met. Cytotoxicity testing was also performed on the finished device after sterilization. The finished product was determined to be non-cytotoxic.
Sterility testing: A sterilization dimensional stability test was performed to verify the device does not deform more than the predefined production tolerance after two sterilization cycles. A sterility test demonstrates that the device can be successfully sterilized with the recommended sterilization parameters.
. A packaging and shipment test was performed to demonstrate the device can be safely shipped without

Conclusion: Testing verified that the accuracy and performance of the system is adequate to perform as intended.

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No clinical testing was performed to support this submission.

Substantial equivalence to predicate devices

In conclusion, the SurgiCase Guides have similar intended use, principles of operation and performance characteristics compared to the predicate device. The only difference in intended use is the surgical region where the guides will be applied: cranial for the subject guides versus mandibular and maxillary for the predicate device.

Non-clinical testing data demonstrates that the accuracy and performance of the system is adequate to perform as intended during craniofacial osteotomies. The information presented supports substantial equivalence of these SurgiCase Guides to the predicate device for this new indication.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Materialise NV c/o Mr. Oliver Clemens, Quality and Regulatory Officer Technologielaan 15 3001 Leuven Belgium

MAR 2 7 2012

Re: K111558

Trade/Device Name: Surgicase Guides Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: March 7, 2012 Received: March 9, 2012

Dear Mr. Clemens:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Malvina B Eydelman. M.D. Director Division of Ophthalmic, Neurological, 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): K111558

Device Name: SurgiCase Guides (for cranial application)

Indications for Use:

SurgiCase Guides are intended for single use only.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear,
Nose and Throat Devices
510(k) Number	K111558
Page	1 of 1
Prescription Use	X
(Per 21 CFR 801.109)

Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).