(139 days)
The Stryker CMF MEDPOR® Customized Implant is intended for the augmentation or restoration of bony contour in craniofacial defects.
The Stryker CMF MEDPOR® Customized Implant is sold as a kit of two identical implants plus one host bone model. The Stryker CMF MEDPOR Customized Implants are molded from porous high density polyethylene (HDPE) to the specific reconstruction boundaries indicated by the surgeon via submission of CT scans and a customized implant request. The porous structure of the MEDPOR material allows for tissue ingrowth. The implant is fixed into place using compatible Stryker fixation systems. The implants and host bone model are provided sterile for single use only.
This document describes a 510(k) premarket notification for the Stryker CMF MEDPOR® Customized Implant. The submission focuses on adding two additional surgeon design options to an already cleared predicate device (K121315). As such, the information provided primarily addresses the differences and similarities to the predicate device rather than a comprehensive, standalone performance study for the original device.
Here's an analysis based on the provided text, addressing your points where possible:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in a quantitative numerical format typically found in performance studies for new algorithms or devices with new functionalities. Instead, the "acceptance" for this 510(k) hinges on demonstrating substantial equivalence to the predicate device.
The performance data supplied is for the modifications to the device and demonstrates that the modifications do not negatively impact the device's equivalence to the predicate.
| Performance Data Category | Description | Reported Device Performance / Assessment |
|---|---|---|
| Biocompatibility | Assessment of biological compatibility of materials. | Not required; no change in material, duration/location of contact, or sterilization method from predicate. |
| Performance Bench Testing | ||
| - Screw Pullout Testing | Testing the strength of screw fixation in the modified implant. | Completed (implied successful as no issues raised for substantial equivalence). |
| - End user validation testing | Validation by end-users (surgeons) for the modified design options. | Completed (implied successful as no issues raised for substantial equivalence). |
| Software Verification and Validation | Verification and validation of software used in the design process. | Software is used in the design process, but the addition of design options doesn't change manufacturing process, and internal control systems remain unchanged from predicate (K121315). Therefore, the existing software validation from the predicate is deemed sufficient. |
| Animal Testing | Testing conducted on animal models. | Not required; no change in material, duration/location of contact, or sterilization method from predicate. |
| Clinical Testing | Human clinical trials. | Not required; no change in intended use/indications for use or fundamental technological characteristics. |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a "test set" in the context of typical AI algorithm validation (e.g., a dataset of images with ground truth). The performance data cited are primarily bench tests and software/material assessments against the predicate device.
- Screw Pullout Testing: The specific sample size for this test is not mentioned.
- End User Validation Testing: The number of end-users or cases involved is not specified.
- Data Provenance: Not applicable in the context of this 510(k) where clinical dataset provenance is not the focus. The documentation comes from Stryker Leibinger (Germany and USA).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This 510(k) is not for an AI algorithm that requires expert-established ground truth on a test set. The validation revolves around maintaining safety and effectiveness equivalent to a predicate device.
4. Adjudication Method for the Test Set
Not applicable. No test set requiring adjudication of ground truth is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a customized implant, not an AI diagnostic algorithm, so such a study would not be relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This device is a physical customized implant, not an AI algorithm, and therefore does not have a "standalone" or "human-in-the-loop" performance in the sense of AI. While software is used in its design process, the 510(k) states that the addition of design options does not change the manufacturing process or internal control systems, implying that the existing software validation (from the predicate K121315) is sufficient, and no new standalone software performance study was required.
7. The Type of Ground Truth Used
The concept of "ground truth" as typically applied to AI algorithms (e.g., pathology, expert consensus) is not directly applicable here. The "ground truth" for this 510(k) is the established safety and effectiveness of the predicate device (K121315). The aim of the submission is to demonstrate that the proposed modifications do not alter this established safety and effectiveness.
8. The Sample Size for the Training Set
Not applicable. This 510(k) is not for an AI algorithm developed using a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This 510(k) is not for an AI algorithm.
§ 878.3550 Chin prosthesis.
(a)
Identification. A chin prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the chin.(b)
Classification. Class II.