(443 days)
No
The description focuses on patient-specific design based on imaging data and surgeon input, with no mention of AI or ML algorithms being used in the design process.
Yes
The device is intended for prescription use in oral and maxillofacial surgery, trauma, and reconstructive surgery to fixate bone, which aligns with the definition of a therapeutic device.
No
The device description clearly states its purpose is for "fixation to bone" and "mandibular reconstruction". It is a physical implant, not a tool for diagnosis. While it uses imaging data for design, it does not interpret or analyze that data to make a medical diagnosis.
No
The device description explicitly states that the device is a metal bone plate manufactured from commercially pure titanium, which is a hardware component. While software is used in the design process, the final device is a physical implant.
Based on the provided information, the MedCAD® AccuPlate® Patient-Specific Plate is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The MedCAD® AccuPlate® is a metal bone plate designed for surgical implantation to fixate bone in the mandible and maxilla. It is a physical implant used in vivo (within the body) during surgery.
- Intended Use: The intended use is for surgical reconstruction and fixation of bone, not for analyzing biological specimens to diagnose or monitor a condition.
- Input Data: While it uses patient anatomical data (CT, CBCT, MRI), this data is used for the design and manufacturing of the physical implant, not for in vitro analysis of a biological sample.
Therefore, the MedCAD® AccuPlate® falls under the category of a surgical implant or medical device used in vivo, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The MedCAD® AccuPlate® Patient-Specific Plate is intended for prescription use in oral and maxillofacial surgery, trauma and reconstructive surgery.
Specific Indications for Use:
Primary mandibular reconstruction with bone graft
Temporary bridging until delayed secondary reconstruction
Secondary mandibular reconstruction
Comminuted mandibular fractures
Fractures of edentulous and/or atrophic mandibles
Unstable mandibular fractures
Maxillary reconstruction with or without bone graft
Maxillary trauma
Product codes (comma separated list FDA assigned to the subject device)
JEY
Device Description
MedCAD® AccuPlate® Patient-Specific Plates are metal bone plates used in conjunction with commercially available metal bone screws for the fixation to bone, specifically in the areas of the mandible and maxilla. The design and dimensions of each plate within the envelope specification is based upon the patient’s anatomical data (CT scan, CBCT scan, or MRI), and the intended anatomy to be fixated as determined from input provided by the surgeon. The plates are designed by MedCAD in consultation with the surgeon and manufactured by MedCAD only. MedCAD® AccuPlate® Patient-Specific Plates are not intended to be bent or modified in surgery. The MedCAD® AccuPlate® Patient-Specific Plates are manufactured from commercially pure titanium, are provided non-sterilized prior to use, and are intended for single use only. Plates are fastened to bone using commercially available bone screws with diameters ranging from 2.0 mm to 2.7 mm and lengths ranging from 4.0 mm to 23.0 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scan, CBCT scan, or MRI
Anatomical Site
mandible and maxilla
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing was performed to demonstrate the MedCAD® AccuPlate® Patient-Specific Plates are substantially equivalent to other predicate / reference devices. The following comparative tests were performed:
- Static and dynamic 4 point bending per ASTM F382
- Screw pushout testing
The results of these studies show the subject MedCAD® AccuPlate® Patient-Specific Plates meets the performance of the predicate / reference devices, and the device was therefore found to be substantially equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 12, 2021
MedCAD % Linda Braddon President/CEO Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock. Georgia 30188
Re: K193280
Trade/Device Name: MedCAD® AccuPlate® Patient-Specific Plate Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: JEY Dated: January 11, 2021 Received: January 12, 2021
Dear Linda Braddon:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Actinclude 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Andrew Steen Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia. Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
Device Name
MedCAD® AccuPlate® Patient-Specific Plate
ndications for Use (Describe)
The MedCAD® AccuPlate® Patient-Specific Plate is intended for prescription use in oral and maxillofacial surgery, trauma and reconstructive surgery.
Specific Indications for Use:
- Primary mandibular reconstruction with bone graft
- Temporary bridging until delayed secondary reconstruction
- Secondary mandibular reconstruction
- Comminuted mandibular fractures
- Fractures of edentulous and/or atrophic mandibles
- Unstable mandibular fractures
- Maxillary reconstruction with or without bone graft
- Maxillary trauma
Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D) Subpart C)
□ Over-The-Counter Use (21 CFR 801
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
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FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services(301)443-6740 EF
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Image /page/3/Picture/0 description: The image shows the logo for MedCAD. The word "Med" is in a large, black serif font. The word "CAD" is in a smaller, white sans-serif font and is set against a blue background. There is a registered trademark symbol in the upper right corner of the blue background.
510(k) Summary MedCAD® AccuPlate® Patient-Specific Plates K193280
February 10, 2021
Sponsor
MedCAD 501 S 2nd Ave, Suite A-1000 Dallas. TX 75226 (214) 453-8864 x305
Contact
Secure BioMed Evaluations Linda Braddon, Ph.D. 7828 Hickory Flat Highway Suite 120 Woodstock, GA 30188 770-837-2681 Regulatory@SecureBME.com
Name of Device and Classification Name
Device Name: MedCAD® AccuPlate® Patient-Specific Plate Requlation Name: Bone Plate Regulation Number: 872.4760 Product Code: Primary - JEY Classification Panel: Dental
Predicate Device
Synthes Patient-Specific Plates (K122647)
Reference Devices
Stryker Customized Mandible Recon Plate Kit (K132519) Biomet Fracture/Reconstruction System Trauma One (K081067) MedCAD AccuShape™ PEEK Specific Cranial Implant (PSCI) (K110684)
Indication for Use:
The MedCAD® AccuPlate® Patient-Specific Plate is intended for prescription use in oral and maxillofacial surgery, trauma and reconstructive surgery.
Specific Indications for Use:
- Primary mandibular reconstruction with bone graft
- . Temporary bridging until delayed secondary reconstruction
- Secondary mandibular reconstruction
- Comminuted mandibular fractures
4
Image /page/4/Picture/0 description: The image shows the logo for MedCAD. The text "Med" is in a large, bold, serif font, and the text "CAD" is in a sans-serif font inside of a blue box. There is a line underneath the text that extends from the left side of the "M" to the right side of the "D" in CAD.
- Fractures of edentulous and/or atrophicmandibles .
- . Unstable mandibular fractures
- Maxillary reconstruction with or without bone graft
- . Maxillary trauma
Device Description
MedCAD® AccuPlate® Patient-Specific Plates are metal bone plates used in conjunction with commercially available metal bone screws for the fixation to bone, specifically in the areas of the mandible and maxilla. The design and dimensions of each plate within the envelope specification is based upon the patient's anatomical data (CT scan, CBCT scan, or MRI), and the intended anatomy to be fixated as determined from input provided by the surgeon. The plates are designed by MedCAD in consultation with the surgeon and manufactured by MedCAD only. MedCAD® AccuPlate® Patient-Specific Plates are not intended to be bent or modified in surgery. The MedCAD® AccuPlate® Patient-Specific Plates are manufactured from commercially pure titanium, are provided non-sterilized prior to use, and are intended for single use only. Plates are fastened to bone using commercially available bone screws with diameters ranging from 2.0 mm to 2.7 mm and lengths ranging from 4.0 mm to 23.0 mm.
Performance Data
Non-clinical testing was performed to demonstrate the MedCAD® AccuPlate® Patient-Specific Plates are substantially equivalent to other predicate / reference devices. The following comparative tests were performed:
- · Static and dynamic 4 point bending per ASTM F382
- · Screw pushout testing
The results of these studies show the subject MedCAD® AccuPlate® Patient-Specific Plates meets the performance of the predicate / reference devices, and the device was therefore found to be substantially equivalent.
Sterilization Validation
Sterilization validation was conducted in accordance with international standard ISO 17665-1 and FDA quidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling." to a sterility Assurance Level (SAL) of 1x10°. All test method acceptance criteria were met.
Biocompatibility Validation
Biocompatibility validation was conducted in accordance with international standard ISO 10993-1 and FDA guidance document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The results of the testing adequately address biocompatibility for the plates and their intended use.
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Image /page/5/Picture/0 description: The image shows the logo for MedCAD. The logo is composed of the word "Med" in a large, bold, black font, followed by "CAD" in a similar font but with the letters in white against a blue-green background. The "CAD" portion of the logo is contained within a rectangular shape.
Based on risk management , the following biocompatibility testing was conducted on the final, finished sterilized device:
- . Cytotoxicity per ISO 10993-5
- Scanning Electron Microscope (SEM) imaging and Energy Dispersive X-Ray . Spectroscopy (EDS) analysis for evaluation of the elemental analysis of the surface of the bone plate
6
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Substantial Equivalence
MedCAD® AccuPlate® Patient-Specific Plates are substantially equivalent to the identified predicate based on indications for use, principles of operation, material composition, and technological characteristics.
| COMPARISON OF TECHNOLOGICAL CHARACTERISITICS | ||||||
|---|---|---|---|---|---|---|
| Features | Subject Device | |||||
| MedCAD® | ||||||
| AccuPlate® Patient- | ||||||
| Specific Plate | ||||||
| (K193280) | Predicate Device | |||||
| Synthes Patient | ||||||
| Specific Plates | ||||||
| (K122647) | Reference Device | |||||
| Stryker Customized | ||||||
| Mandible Recon Plate | ||||||
| Kit | ||||||
| (K132519) | Reference Device | |||||
| Biomet | ||||||
| Fracture/Reconstruction | ||||||
| System (Traumaone) | ||||||
| (K081067) | ||||||
| Indications for | ||||||
| Use | The MedCAD® AccuPlate® | |||||
| Patient-Specific Plate | ||||||
| is | ||||||
| intended for prescription | ||||||
| use in oral and maxillofacial | ||||||
| trauma | ||||||
| surgery, | ||||||
| and | ||||||
| reconstructive surgery. | ||||||
| Specific Indications for Use: | ||||||
| Primary | ||||||
| ● | ||||||
| mandibular | ||||||
| reconstruction with | ||||||
| bone graft | ||||||
| Temporary | ||||||
| ● | ||||||
| bridging until | ||||||
| delayed secondary | ||||||
| reconstruction | ||||||
| Secondary | ||||||
| ● | ||||||
| mandibular | ||||||
| reconstruction | ||||||
| Comminuted | ||||||
| ● | ||||||
| mandibular | ||||||
| fractures | ||||||
| Fractures | ||||||
| of | ||||||
| ● | ||||||
| edentulous and/or | ||||||
| atrophic mandibles | ||||||
| Unstable | ||||||
| ● | ||||||
| mandibular | ||||||
| fractures | ||||||
| Maxillary | ||||||
| ● | ||||||
| reconstruction with | ||||||
| or without bone | ||||||
| graft | ||||||
| Maxillary trauma | ||||||
| ● | Synthes Patient Specific | |||||
| Plates are intended for | ||||||
| use in oral and | ||||||
| maxillofacial surgery, | ||||||
| trauma and | ||||||
| reconstructive surgery. | ||||||
| Specific Indications for | ||||||
| Use: | ||||||
| Primary | ||||||
| ● | ||||||
| mandibular | ||||||
| reconstruction | ||||||
| with bone graft | ||||||
| Temporary | ||||||
| ● | ||||||
| bridging until | ||||||
| delayed | ||||||
| secondary | ||||||
| reconstruction | ||||||
| Secondary | ||||||
| ● | ||||||
| mandibular | ||||||
| reconstruction | ||||||
| Comminuted | ||||||
| ● | ||||||
| mandibular | ||||||
| fractures | ||||||
| Fractures of | ||||||
| ● | ||||||
| edentulous | ||||||
| and/or atrophic | ||||||
| mandibles | ||||||
| Unstable | ||||||
| ● | ||||||
| mandibular | ||||||
| fractures | ||||||
| Maxillary | ||||||
| ● | ||||||
| reconstruction | ||||||
| with or without | ||||||
| bone graft | ||||||
| Maxillary trauma | ||||||
| ● | The Customized | |||||
| Mandible Recon Plate | ||||||
| Kit is indicated for | ||||||
| use in primary | ||||||
| mandibular | ||||||
| reconstruction with | ||||||
| bone graft, | ||||||
| temporary bridging until | ||||||
| delayed secondary | ||||||
| reconstruction | ||||||
| and secondary | ||||||
| mandibular | ||||||
| reconstruction. | Intended for use in the | |||||
| stabilization and fixation | ||||||
| of mandibular fractures | ||||||
| and mandibular | ||||||
| reconstructive surgical | ||||||
| procedures. | ||||||
| Material | Commercially Pure | |||||
| Titanium | Commercially Pure | |||||
| Titanium | Commercially Pure | |||||
| Titanium | Commercially Pure | |||||
| Titanium | ||||||
| Manufacturing | ||||||
| Method | Subtractive | Subtractive | Subtractive | Subtractive | ||
| Sterility | Provided non-sterile | Provided non-sterile | Provided non-sterile | Provided non-sterile |
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Image /page/7/Picture/0 description: The image shows the logo for MedCAD. The text "Med" is in a bold, black font, while "CAD" is in a white font inside of a blue-green box. There is a registered trademark symbol to the right of the box.
| COMPARISON OF TECHNOLOGICAL CHARACTERISITICS | ||||
|---|---|---|---|---|
| Features | Subject Device | |||
| MedCAD® | ||||
| AccuPlate® Patient- | ||||
| Specific Plate | ||||
| (K193280) | Predicate Device | |||
| Synthes Patient | ||||
| Specific Plates | ||||
| (K122647) | Reference Device | |||
| Stryker Customized | ||||
| Mandible Recon Plate | ||||
| Kit | ||||
| (K132519) | Reference Device | |||
| Biomet | ||||
| Fracture/Reconstruction | ||||
| System (Traumaone) | ||||
| (K081067) | ||||
| Physical | ||||
| Shape | Patient Specific Criteria | Patient Specific Criteria | Patient Specific Criteria | Generic Template that is |
| bent to patient specific | ||||
| criteria. | ||||
| Visual | ||||
| Appearance | Opaque | Opaque | Opaque | Opaque |
| Plate | ||||
| Thickness | 2.0 mm and 2.8 mm | 2.0 mm and 2.5 mm | 2.0 mm and 2.8 mm | 2.0 mm, 2.6 mm, 2.8 mm |
| Plate Height | 8.25 mm Minimum | 8.0 mm | 6.5 mm / 7.6 mm | 6.98 mm / 8.25 mm / 8.25 |
| mm | ||||
| Hole Spacing | ||||
| (minimum) | 7.5 mm for 2.0 mm Plate | |||
| 9.0 mm for 2.8 mm Plate | 5.5 mm | 7.6 mm for 2.0 mm Plate | ||
| 9.0 mm for 2.8 mm | ||||
| Plate | 7.5 mm | |||
| Plate Length | ||||
| Max length | ||||
| defined by | ||||
| patient | ||||
| anatomy | 30 mm – 490 mm | 24.5 mm – 490 mm | Not publicly disclosed | 30 mm – 251 mm |
| Plate Holes | Locking Threads Optional | Locking Threads Optional | Locking Threads | |
| Optional | Locking Threads Optional | |||
| Hole | ||||
| Angulation | 0° | 0-15° | 0-10° | 0-15° |
| Screw | ||||
| Diameter | 2.0 mm, 2.3 mm, | |||
| 2.4 mm, 2.7 mm | 2.4 mm or 2.9 mm | Not publicly disclosed. | 2.0 mm, 2.3 mm, 2.7 mm | |
| Shape Design | Mandible Hemi (L or R) | |||
| Mandible Angle to Angle, | ||||
| Mandible Condyle to | ||||
| Condyle, Maxilla | "During the plate design | |||
| process, surgeons will | ||||
| select the options for the | ||||
| plate design, which may | ||||
| include the following: | ||||
| Choose plate profile, | ||||
| Define plate trajectory" | "Full" or "Hemi" | Full Mandible (angle to | ||
| angle), Left & Right Hemi- | ||||
| mandible (angle to | ||||
| symphysis of chin), | ||||
| Straight Plate (no angle) | ||||
| Range of | ||||
| lengths for | ||||
| each shape | ||||
| design or | ||||
| model type | 30 mm – 490 mm | 24.5 mm – 490 mm | "Plate design is based | |
| upon a CT scan of the | ||||
| patient. Selecting | ||||
| specific plate design | ||||
| features like profile | ||||
| height, length, and run | ||||
| of the plate allow for the | ||||
| creation of patient | ||||
| specific solutions" | 30 mm – 251 mm | |||
| Maximum | ||||
| dimensions | ||||
| for each | ||||
| shape design | ||||
| or model type | Thickness: 2.0 mm and | |||
| 2.8 mm | ||||
| Length: 30 mm – 490 mm | Thickness: 2.0 mm – 2.5 | |||
| mm | ||||
| Length: 24.5 mm – 490 | ||||
| mm | Thickness: | |||
| 2.0 mm and 2.8 mm | ||||
| Length: | ||||
| Not publicly disclosed | Thickness: | |||
| 2.0 mm, 2.6 mm, 2.8 mm | ||||
| Length: 30 mm – 251 mm |
8
Comparison of Technological Characteristics with the Predicate Device
MedCAD® AccuPlate® Patient-Specific Plates are substantially equivalent to its predicate device (Synthes Patient Specific Plates - K122647).
Similarities to Predicate
The MedCAD® AccuPlate® Patient-Specific Plates has the same intended use and similar technological characteristics as the identified predicate device. The system employs similar fundamental technologies as the identified predicate / reference devices. The principals of operation and technological characteristics are either identical or substantially equivalent to the predicate / reference devices. The system has similar technological characteristics including:
- Materials: Commercially pure titanium (proposed device and the reference ● (K081067) are manufactured from Grade 2 commercially pure titanium).
- Plate thickness: The proposed device is offered in nominal thickness of 2.0 mm . and 2.8 mm. The thickness of the predicate / reference devices range from 2.0 mm to 2.8 mm.
- . Technical Characteristics: The proposed device and predicate / reference devices share similar technical characteristics including available lengths, thicknesses, heights, curvatures, hole spacing, and material. The proposed device and the predicate / reference devices have hole features that are geometrically the same to accommodate commercially available fixation screws.
- The proposed device and the reference (K110684) share the same fundamental . principles of processing the patient data (i.e. CT Scan) for use as input.
- The proposed device and the predicate / references are manufactured similarly via . CNC milling.
- . Sterility assurance level of 1x10-6
Differences to Predicate
The following differences exist between the subject and predicate / reference devices:
- The proposed subject device is manufactured to the planned patient anatomy ● whereas the reference device(s) (Biomet and Stryker) are first manufactured flat, and then bent to match patient anatomy. This manufacturing difference does not create a new risk since the end product of both processes are designed to fit the patient and the performance testing is equivalent.
- The proposed subject device is Grade 2 commercially pure titanium while the predicate device (K122647) utilize Grades 1,2,3,4, and 5 titanium. The differences in material do not create a risk for biocompatibility or mechanical performance.
Conclusion
Based on the indications for use, technological characteristics, performance testing, and comparison to predicate / reference devices, the subject MedCAD® AccuPlate® Patient-Specific Plates have been shown to be substantially equivalent to the predicate devices.