(144 days)
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 in mandibular and maxillofacial surgical procedures.
SurgiCase Guides are intended for single use only.
The SurgiCase Guides are patient specific devices or templates that are based on a preoperative 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.A standardized design and manufacturing process with detailed procedures and work instructions allows manufacturing patient-specific templates that consistently perform in a safe and effective way during surgery.
The SurgiCase Guides are based on a software planning generated using the previously cleared SurgiCase software (K073449).
SurgiCase is software for pre-operative simulation and evaluation 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.
The provided text does not contain detailed information about specific acceptance criteria with quantifiable metrics, a formal study demonstrating the device meets these criteria, or granular details about test sets, ground truth establishment, or multi-reader multi-case studies typically associated with AI/ML device evaluations.
The document describes a 510(k) submission for "SurgiCase Guides," which are patient-specific surgical templates based on pre-operative software planning. The performance data section broadly mentions "non-clinical tests such as quantitative validation using bone models and cadaveric specimens" were performed and "verified that the accuracy and performance of the system is adequate to perform as intended." However, it does not provide the specific acceptance criteria or the results of these tests in a quantifiable manner.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Quantitative) | Reported Device Performance |
|---|---|
| Not specified in document | "accuracy and performance of the system is adequate to perform as intended." (No quantitative metrics provided) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not specified. The document mentions "bone models and cadaveric specimens" but does not give the number of models or specimens used.
- Data provenance: Not specified.
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/Not specified. The term "ground truth" as typically used in AI/ML evaluation referring to expert-annotated data is not mentioned. The device is a surgical guide system, and its validation involves physical accuracy on models/cadavers, not interpretation of images by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified. Adjudication methods are typically relevant for cases where multiple experts provide annotations that need to be reconciled to establish a ground truth for a test set in AI/ML contexts. This is not described for a physical device validation.
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. This type of study is usually conducted for AI-powered diagnostic or assistive tools where human readers are involved in interpreting data with and without AI. The SurgiCase Guides are physical surgical tools, not AI for human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The document implies that the "quantitative validation using bone models and cadaveric specimens" focused on the physical accuracy of the guides themselves, which could be considered a form of standalone performance of the device. However, it's not an "algorithm only" performance because the device itself is a physical object designed to guide surgical instruments. The software used to design the guides (SurgiCase software K073449) was previously cleared and is not the subject of this 510(k) submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" in this context would likely refer to the actual surgical plan (as transferred to the models/cadavers) or ideal anatomical positioning, against which the guided surgical actions were compared for accuracy. The document mentions "quantitative validation," suggesting objective measurements of accuracy were taken, but the specific nature of this "ground truth" (e.g., precise measurements of osteotomy planes or screw placement from a gold standard) is not detailed.
8. The sample size for the training set
- Not applicable/Not specified. Surgical guides are precisely manufactured to a patient's anatomy based on imaging and a pre-operative plan. There is no "training set" in the sense of machine learning model development mentioned for the SurgiCase Guides themselves. The underlying SurgiCase software (K073449) generates the plan, but its "training" details are not part of this submission.
9. How the ground truth for the training set was established
- Not applicable/Not specified. As there is no "training set" described for the SurgiCase Guides, the establishment of ground truth for such a set is not discussed.
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K103.136
p
MAR 1 8 20i1
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 affairs officer |
| Contact e-mail address | alexandra.razzhivina@materialise.be |
Submission date
The date of the Traditional 510(k) submission is 215 October 2010.
Submission information
| Trade Name | SurgiCase Guides |
|---|---|
| Common Name | Bone plate |
| Classification Name | Bone plate |
| Product code | JEY, MQN (21 CFR 872.4760) |
Predicate devices
Manufacturer
| Trade or proprietary or model name | Zimmer Patient Specific Instruments System 2.0 |
|---|---|
| 510(k) number | K093533 |
| Decision date | 2010/02/17 |
| Product code | MBH, JWH |
| Manufacturer | Materialise N.V. |
| Trade or proprietary or model name | Smith and Nephew Patient Matched Cutting Blocks |
| 510(k) number | K082358 |
| Decision date | 2008/11/25 |
| Product code | JWH, MBH |
Smith and Nephew, Inc.
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Device Information
Description and functioning of the device
The SurgiCase Guides are patient specific devices or templates that are based on a preoperative 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.A standardized design and manufacturing process with detailed procedures and work instructions allows manufacturing patient-specific templates that consistently perform in a safe and effective way during surgery.
The SurgiCase Guides are based on a software planning generated using the previously cleared SurgiCase software (K073449).
SurgiCase is software for pre-operative simulation and evaluation 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
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 in mandibular and maxillofacial surgical procedures.
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, materials and performance characteristics to the predicate device.
Performance data
Non-clinical tests
Non-clinical tests such as quantitative validation using bone models and cadaveric specimens, biocompatibility test, sterilization dimensional stability test and packaging and shipment test were performed to assess the safety and effectiveness of the device. Testing verified that the accuracy and performance of the system is adequate to perform as intended.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle, with its wings spread and head turned to the left.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Alexandra Razzhivina Regulatory Affairs Officer Materialise NV Technologielaan 15 Leuven, Belgium 3001
MAR 1 8 2011
Re: K103136
Trade/Device Name: SurgiCase Guides Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: March 10, 2011 Received: March 16, 2011
Dear Mr. Razzhivina:
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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Page Mr. Razzhivina
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 /ucm 115809.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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
h for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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181
Indications for Use
510(k) Number (if known): K103136
Device Name: SurgiCase Guides
Indications for Use:
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 in mandibular and maxillofacial surgical procedures.
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)
Susan Pusser
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of 1
510(k) Number: K103136
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.