Search Results

The Stryker Customized Mandible Recon Plate Kit is intended to be used for rigid internal fixation of primary and secondary mandibular reconstructions.
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.

The Subject Device, CMRP Kit (CMRP) is intended to be used for rigid internal fixation of primary and secondary mandibular reconstructions and is indicated for use in primary mandibular reconstruction with bone graft, temporary bridging until delayed secondary reconstruction and secondary mandibular reconstruction. The CMRP was cleared in K132519 and serves as an identical cleared Predicate Device, which shows the implant design software and design process, implant compatibility with the anatomical model, and the utilization of customized Guides which are similar to those offered for use with the Subject Device Stryker Customized Mandible Recon Plate Kit.

The Subject Device plate(s) are manufactured patient-specific plates, and the patient-specific 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 the Design Proposal, an Instruction for Use (IFU), and an optional Anatomical Model. Additionally, the Subject Device is compatible with a separately provided Guides accessory.

This 510(k) summary describes the Stryker Customized Mandible Recon Plate Kit, a device intended for surgical reconstruction of the mandible. The submission focuses on demonstrating substantial equivalence to a predicate device already on the market, particularly given a software update and compatibility with another system.

Here's an analysis of the acceptance criteria and supporting studies as presented in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a specific table of acceptance criteria and reported device performance in the format requested. Instead, it states that the "subject device met all pre-defined acceptance criteria as the primary predicate device," indicating that the acceptance criteria are implicitly linked to the performance of the predicate device.

The reported device performance is described generally: "the results of the tests support the substantial equivalence of the subject device to the primary predicate device." More specifically, the cadaver lab testing "showed that the subject device is performing as intended in the specified use conditions."

2. Sample Size Used for the Test Set and Data Provenance:

The document mentions "performance testing in the cadaver lab." However, it does not specify the sample size (i.e., number of cadavers) used for this test set nor does it explicitly state the provenance of the data (e.g., retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

The document does not specify the number of experts used or their qualifications for establishing ground truth in the cadaver lab testing. It simply refers to "end-user test validation."

4. Adjudication Method for the Test Set:

The document does not describe any adjudication method used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

An MRMC comparative effectiveness study was not performed or mentioned in this submission. The device is a physical bone plate kit and not an AI-assisted diagnostic tool that would typically involve such a study.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

A standalone performance study in the context of an algorithm without human-in-the-loop performance is not applicable or described for this physical device. The software update mentioned is related to design and visualization, not an autonomous diagnostic algorithm.

7. Type of Ground Truth Used:

For the cadaver lab testing, the ground truth was likely established through direct observation and assessment by surgical end-users of the device's performance in physically reconstructing the mandible. This would involve evaluating how well the customized plates fit, the stability of the fixation, and ease of use in a realistic surgical environment.

8. Sample Size for the Training Set:

The concept of a "training set" in the context of machine learning is not applicable here as this is a physical medical device. While software updates are mentioned for automated bone thickness measurements and visualization, the document does not detail any machine learning models that would require a distinct training set. The software was subject to "Software Verification and Validation testing."

9. How the Ground Truth for the Training Set Was Established:

As mentioned above, the concept of a training set is not directly applicable. For the software verification and validation, the "ground truth" would be established through predefined software requirements and specifications, and the validation would verify that the software outputs (e.g., bone thickness measurements, visualization) accurately reflect the design intent and input data. These tests were performed "according to internal procedures and IEC 62304."

Ask a specific question about this device

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.

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.

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.

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.

Ask a specific question about this device