(102 days)
The Stryker Surgeon iD Mandible Recon Plate is intended to be used for rigid internal fixation of primary and secondary mandibular reconstructions.
The Stryker Surgeon iD Mandible Recon Plate is indicated for use in primary mandibular reconstruction with bone graft, temporary bridging until delayed secondary reconstruction and secondary mandibular reconstruction.
The Subject Device, the Stryker Surgeon iD Mandible Recon Plate is intended to be used for rigid internal fixation of primary and secondary mandibular reconstructions.
The Surgeon iD Mandible Recon Plate is a surgeon-specific plate which is designed based on an average mandible model. The plate is designed per surgeon's preference within the following design envelope. The Surgeon iD Mandible Recon Plate is offered in hemi and full shapes and three different sizes (Small, Medium, and Large). The plate can be designed with a profile height of 2.0 mm or 2.8 mm, with a number of screw holes between 4 and 50, and bar widths between 5.5 mm and 6.5 mm. The plate is made of commercially pure titanium.
The provided text describes the Stryker Surgeon iD Mandible Recon Plate and its acceptance criteria, but it primarily focuses on establishing substantial equivalence to a predicate device rather than presenting a standalone study showing device performance against specific, quantifiable acceptance criteria in the manner typically expected for AI/software devices. The acceptance criteria in this document relate more to the validation process rather than direct performance metrics against a clinical standard.
Here's an attempt to extract and interpret the requested information based on the provided text. It's important to note that many sections of your request are not directly applicable or explicitly stated in this type of 510(k) summary for a physical medical device. This summary focuses on materials, design, and comparison to a predicate, not AI performance.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, the "acceptance criteria" are related to the successful completion of verification and validation (V&V) activities and the functional demonstration that the device performs as intended and is compatible with its packaging.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Performance Bench Testing: | |
| Analysis of Functional Interfaces | Met all pre-defined acceptance criteria |
| Evaluation of the Models | Met all pre-defined acceptance criteria |
| Compatibility (e.g., fasteners, instruments) | Met all pre-defined acceptance criteria |
| Packaging (integrity, sterility maintenance) | Met all pre-defined acceptance criteria |
| Cleaning and Sterilization Validation | Equivalent to the Predicate Device |
| Biocompatibility Testing | Referenced in the Predicate Device (implying equivalence) |
| Sterilization | Referenced in the Predicate Device (implying equivalence) |
| Substantial Equivalence (Overall Conclusion) | Concluded that the information supports substantial equivalence, meaning it performs as safely and effectively as the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The text mentions "Verification and Validation activities" and "performance testing" but does not specify sample sizes for these tests or the provenance of any data beyond indicating that existing predicate device data was referenced for some aspects. Given this is a physical implantable device, the "test set" would likely refer to the number of plates or components tested, not a dataset in the AI sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable as presented. The concept of "ground truth" established by experts, particularly for an AI/software device, is not discussed in this 510(k) summary for a bone plate. Ground truth for a physical device like this is typically established through engineering specifications, material testing standards, and ultimately, clinical outcomes (though clinical trials were not required here).
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving interpretation (e.g., radiology reads) to resolve discrepancies among experts. This 510(k) summary describes bench testing and equivalence to a predicate device, not expert adjudication of a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI or diagnostic imaging devices comparing human reader performance with and without AI assistance. This document is for a physical medical device (a bone plate), not an AI diagnostic tool. Clinical testing was explicitly stated as "not required as a basis for substantial equivalence."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This device is a physical bone plate, not an algorithm.
7. The Type of Ground Truth Used
For this physical device, the "ground truth" for the performance bench testing would be defined by engineering specifications, material science standards, and the expected mechanical behavior of such a plate. For aspects like biocompatibility and sterilization, the ground truth is established by regulatory standards and established test methods that were either performed or referenced from the predicate device. Clinical outcomes data was not a basis for this submission.
8. The Sample Size for the Training Set
This information is not applicable and not provided. The device is a physical bone plate, not an AI model that requires a training set. The design of the plate is based on an "average mandible model" and "surgeon's preference," which are design inputs, not a 'training set' in the machine learning sense.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided. As the device is not an AI algorithm, there is no "training set" or corresponding ground truth to be established in that context.
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June 28, 2019
Stryker Zainab Amini Regulatory Affairs Specialist 750 Trade Centre Way - Suite 200 Portage, Michigan 49002
Re: K190696
Trade/Device Name: Stryker Surgeon iD Mandible Recon Plate Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: JEY Dated: May 29, 2019 Received: May 30, 2019
Dear Zainab Amini:
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 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 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 Advice (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 Srinivas Nandkumar, Ph.D. Acting 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
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Indications for Use
510(k) Number (if known) K190696
Device Name
Stryker Surgeon iD Mandible Recon Plate
Indications for Use (Describe)
The Stryker Surgeon iD Mandible Recon Plate is intended to be used for rigid internal fixation of primary and secondary mandibular reconstructions.
The Stryker Surgeon iD Mandible Recon Plate is indicated for use in primary mandibular reconstruction with bone graft, temporary bridging until delayed secondary reconstruction and secondary mandibular reconstruction.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Section 5. 510(k) Summary
This section provides a summary of 510(k) information in accordance with the requirements of 21 CFR 807.92.
- SUBMITTER [§807.92(a)(1)] I.
- 510(k) Owner: Stryker Leibinger GmbH & Co. KG Boetzinger Strasse 41 79111 Freiburg, Germany
- Submitter/ Zainab Amini Contact Person: Regulatory Affairs Specialist Stryker Craniomaxillofacial 750 Trade Centre Way Portage, MI 49002 Phone: 269-389-8349 Fax: 877-648-7114
- Date prepared: June 28, 2019
- DEVICE [§807.92(a)(2)] II.
| Trade Name: | Stryker Surgeon iD Mandible Recon Plate | |
|---|---|---|
| Common orUsual name: | Bone Plate | |
| Classificationname: | Bone Plate, 21 CFR §872.4760 | |
| RegulatoryClass: | Class II | |
| Product Code: | JEY |
PREDICATE DEVICE [§807.92(a)(3)] III.
Predicate: Stryker Customized Mandible Recon Plate Kit - K132519
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DEVICE DESCRIPTION [§807.92(a)(4)] IV.
The Subject Device, the Stryker Surgeon iD Mandible Recon Plate is intended to be used for rigid internal fixation of primary and secondary mandibular reconstructions.
The Surgeon iD Mandible Recon Plate is a surgeon-specific plate which is designed based on an average mandible model. The plate is designed per surgeon's preference within the following design envelope. The Surgeon iD Mandible Recon Plate is offered in hemi and full shapes and three different sizes (Small, Medium, and Large). The plate can be designed with a profile height of 2.0 mm or 2.8 mm, with a number of screw holes between 4 and 50, and bar widths between 5.5 mm and 6.5 mm. The plate is made of commercially pure titanium.
- V. REFERENCE DEVICE
K014263, Stryker Universal Mandible System
The Stryker Universal Mandible System is intended for stabilization and rigid fixation of mandibular fractures and mandibular reconstruction and cleared in K014263. The Reference Device and the Subject Device has similar fixation system and accessories and therefore, serves as the Reference Device for this submission.
INDICATIONS FOR USE [§807.92(a)(5 )] VI.
TABLE 1 SUBJECT AND PREDICATE DEVICE'S INDICATION FOR USE.
| Subject Device: Stryker Surgeon iDMandible Recon Plate (SMRP) | Predicate Device: StrykerCustomized Mandible Recon Plate(CMRP), K132519 | |
|---|---|---|
| IntendedUse/Indicationfor Use | The Stryker Surgeon iD MandibleRecon Plate is intended to be usedfor rigid internal fixation of primaryand secondary mandibularreconstructions. | The Customized Mandible ReconPlate Kit is intended to be used forrigid internal fixation of primaryand secondary mandibularreconstructions. |
| The Stryker Surgeon iD MandibleRecon Plate is indicated for use inprimary mandibular reconstructionwith bone graft, temporary bridginguntil delayed secondaryreconstruction and secondarymandibular reconstruction. | The Customized Mandible ReconPlate Kit is indicated for use inprimary mandibular reconstructionwith bone graft, temporary bridginguntil delayed secondaryreconstruction and secondarymandibular reconstruction. |
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VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE [§807.92(a)(6)]
The Subject Device has an identical principle of operation, and technological characteristics as the Predicate Device. However, the Subject Device Surgeon iD Mandible Recon Plate is surgeon-specific, the plates are designed per surgeon's preferences and offered in three sizes (Small, Medium, and Large). The plates may be modified intra-operatively to fit a specific patient's anatomy (e.g., by cutting or bending). The Subject Device Stryker Surgeon iD Mandible Recon Plate is based on the following criteria:
- A. Principle of Operation
- B. Technological Characteristics
A. Principle of Operation
The basic operational principle of the Subject and the Predicate Device is rigid internal fixation of primary and secondary mandibular reconstructions.
B. Technological and Operational Characteristics
The technological and operational characteristics of the Subject and the Predicate Device is to reconstruction or bridging of mandible resection, and area of the application is mandible.
VIII. PERFORMANCE DATA [§807.92(b)(1)]
The Subject Device is equivalent to the Predicate Device for cleaning and sterilization validation, the Subject Device's biocompatibility testing and sterilizations are referenced in the Predicate Device.
Performance Bench Testing
Verification and Validation activities were assessed on the Subject Device Surgeon iD Mandible Recon Plate, the V&V activities are referenced in the Predicate Device and Reference Device. Additionally, the following performance testing were completed for the Subject Device:
- Analysis of Functional Interfaces -
- -Evaluation of the Models
- Compatibility -
- -Packaging
The results of the activities showed that the Subject Device met all pre-defined acceptance criteria. Therefore, the Subject Device is substantially equivalent to the Predicate and Reference Devices.
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Animal Testing
Animal testing was not required as a basis for substantial equivalence.
Clinical Testing [§807.92(b)(2)]
Clinical testing was not required as a basis for substantial equivalence.
IX. CONCLUSIONS [§807.92(b)(3)]
The results of the non-clinical data demonstrate the Subject Device will perform as intended in the specified use conditions. According to the comparison based on the requirements of 21 CFR 807.92 and the information provided herein, it is concluded that the information included in this submission supports substantial equivalence.
§ 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.