(134 days)
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."
§ 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.