Stryker Facial iD Plating System

• K Number: K193143
• Device Name: Stryker Facial iD Plating System
• Manufacturer: Stryker
• Date Cleared: 2020-03-26 ( 134 days)
• Product Code: JEY
• Regulation Number: 872.4760
• Type: Special
• Panel: DE
• Reference & Predicate Devices: K192192 , K182305

Intended Use

The Stryker Facial iD Plating System is intended for osteotomy, stabilization of maxillofacial fractures and reconstruction in adults and adolescents (age 12 and higher).

Specific Indications for Use:
-Orthognathic surgery
-Reconstructive maxillofacial surgery
-Mandible and maxillofacial trauma surgery.

Device Description

The Stryker Facial iD Plating System is intended for osteotomy, stabilization and rigid fixation of maxillofacial fractures and reconstruction in adults and adolescents (age 12 and higher), with the specific Indications for Use in orthognathic surgery, reconstructive maxillofacial surgery, and mandible and maxillofacial trauma surgery.

The Subject Device plate(s) are additively manufactured patient-specific plates, and the patientspecific design of the plates allows certain features to be configured to meet the individual needs of each patient. The Subject Device plate(s) are provided with a Design Proposal, an electronic Instruction for Use (IFU) and an optional Anatomical Model.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information based on the provided text, focusing on what is present and what is not:

Acceptance Criteria and Device Performance (Based on provided text)

The document primarily states that the subject device (Stryker Facial iD Plating System, K193143) is substantially equivalent to its primary predicate device (Stryker Facial iD Plating System, K182305). The core of the acceptance criteria lies in demonstrating that the subject device performs as intended and is comparable to the predicate device, especially after software updates.

Acceptance Criteria Category	Reported Device Performance (K193143 vs. K182305)
Intended Use/Indications for Use	Identical
Principle of Operation	Identical
Fixation Method	Identical
Material	Identical
Non-Sterilization Method	Identical
Patient-Specific Offering	Identical
Design	Identical (bone plating system is identical)
Cleaning and Sterilization Validation	Identical (testing for K182305 is valid for K193143)
Biocompatibility Testing	Not necessary (no changes in material/process from K182305)
Performance Bench Testing (Mechanical Strength/Durability)	Performance test data shows substantial equivalence. Testing done for K182305 is valid.
End-User Performance	Performed as intended in specified use conditions (cadaver lab testing).
Software Verification and Validation	Performed according to internal procedures and IEC 62304. Met all predefined acceptance criteria.
Shipping and Handling	Testing done for K182305 is valid for K193143.

---

Detailed Study Information (Based on provided text)

1. A table of acceptance criteria and the reported device performance: See above table.

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

   • Test Set Sample Size:
     • For "Performance Bench Testing," "Cleaning and Sterilization," and "Shipping and Handling," the document states that data from the Primary Predicate Device (K182305) are "valid for the Subject Device." This implies that the sample sizes from the predicate device's testing were utilized, but the specific numbers are not provided in this document.
     • For the "end-user test validation in a cadaver lab," no specific sample size (number of cadavers or test cases) is mentioned.
   • Data Provenance: Not specified for any of the inherited or new testing. The manufacturing facility is in Freiburg, Germany, which might imply the origin of some data, but it's not explicitly stated for any of the studies. The studies are essentially "retrospective" for the predicate device's data being applied to the new device. The cadaver lab testing would be "prospective" for the specific evaluation.

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):

   • The document mentions "end-user test validation of the Subject Device in a cadaver lab." This implies evaluation by medical professionals. However, the number of experts, their qualifications, or how a "ground truth" was established from their feedback is not provided.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not specified. The document vaguely refers to "end-user test validation" but offers no details on assessment or adjudication methods for this or any other performance evaluation.

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 was not done. The device is a "Facial iD Plating System" (physical plates and associated software for design), not an AI-assisted diagnostic or interpretative system in the context of human "readers." The "software updates" mentioned are for "automated bone thickness measurements and visualization" and "plate design process improvements," aiding in the design of the physical plates, not directly assisting human "readers" in interpreting medical images or data for diagnosis.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • The document states "Software Verification and Validation testing were performed for the software updates" according to internal procedures and IEC 62304. This implies standalone testing of the software components. The new features like "automated bone thickness measurements and visualization" and "plate design process improvements" would have undergone testing in a standalone capacity to ensure they met their specified requirements. However, the specific metrics and results of this standalone testing are not detailed beyond the statement that they "met all predefined acceptance criteria."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the inherited bench testing from the predicate device, the ground truth would have been based on engineering specifications and established mechanical test standards.
   • For the "end-user test validation in a cadaver lab," the ground truth likely involved expert assessment of surgical handling, fit, and intended performance by the medical professionals using the system, although how this "ground truth" was formally established (e.g., expert consensus) is not specified.
   • For the software verification and validation, the ground truth would be against defined software requirements and expected outputs/behaviors.

8. The sample size for the training set:

   • This device is a physical plating system with associated design software, not a machine learning or AI algorithm that requires a "training set" in the conventional sense of supervised learning. Therefore, a "training set" as understood in AI/ML model development is not applicable here and is not mentioned in the document. The software updates are described as process improvements and automation of measurements, suggesting a rule-based or calculative approach rather than a learning algorithm trained on data.

9. How the ground truth for the training set was established:

   • As a "training set" is not applicable, this question is not relevant to the information provided.

Regulation Number and Section

§ 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.