(61 days)
The Universal Mesh is indicated for reconstruction, stabilization, and/or rigid fixation subsequent to craniotomy, craniectomy, cranioplasty, and cranial fractures in adults and adolescents (age 12 and higher).
The Universal Mesh is indicated for non-load-bearing reconstruction in the maxillofacial skeleton of patients in whom skeletal growth is complete.
The Universal Mesh - Sterile consists of an assortment of titanium meshes with different dimensions (small 60x60, medium 90x90, and large 120x120 mm) within the framework of the predicate Stryker Universal Mesh. The design of the meshes is not changed. The only addition is to provide the meshes sterile in a suitable packaging system. These meshes are sterilized by exposure to Ethylene Oxide. The intended use, the principles of operation, and the materials of construction have not changed.
This document describes the Stryker Universal Mesh - Sterile, a device that has received 510(k) clearance from the FDA. The 510(k) submission primarily focuses on the change from a non-sterile to a sterile presentation of an already cleared device.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with numerical target values for each test. Instead, it lists the performance bench tests conducted and states that the device "met all pre-defined acceptance criteria and standards." The reported performance is a simple "Passed" for each test.
| Characteristic | Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | EtO Residuals Test | Must pass ETO Residuals test | Passed |
| Biocompatibility | Cytotoxicity | Must pass Cytotoxicity test | Passed |
| Biocompatibility | Endotoxin Testing | Must pass Endotoxin test | Passed |
| Biocompatibility | Sterilization Validation | Must pass Sterilization Validation | Passed |
| Biocompatibility | Bioburden Verification | Must pass Bioburden Verification | Passed |
| Packaging Performance | Transportation Test | Must pass Transportation test | Passed |
| User Validation | System Handling Test | Must pass System Handling test | Passed |
2. Sample Size for the Test Set and Data Provenance
The document does not specify the sample sizes used for the individual bench tests. It only states that these tests were performed.
The data provenance is from bench testing conducted by Stryker Leibinger GmbH & Co. KG and Steris as part of the overall 510(k) submission process. There is no information regarding the country of origin of the data beyond the company's location in Germany and the testing occurring at Steris. The data is retrospective in the sense that it was generated for the purpose of the 510(k) submission, not from a prospective clinical trial.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This section is not applicable as the studies performed were bench tests, not clinical studies requiring expert interpretation or ground truth establishment in a diagnostic context. The "ground truth" for these tests are the established standards and methodologies for biocompatibility, sterilization, and packaging tests.
4. Adjudication Method for the Test Set
This section is not applicable as the studies performed were bench tests. Adjudication methods are typically relevant for clinical studies where multiple expert opinions on a diagnosis or outcome are reconciled.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a physical mesh for surgical reconstruction; therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone "algorithm only" study was not done. The device is a physical medical implant, not an AI software or diagnostic algorithm.
- The Type of Ground Truth Used
The "ground truth" for the bench tests conducted is based on established industry standards and regulatory requirements for biocompatibility, sterilization, and packaging. For example, for "EtO Residuals Test," the ground truth would be that the residual levels of ethylene oxide must be below a specified regulatory limit. Similarly, for "Sterilization Validation," the ground truth is that the sterilization process achieves a predefined sterility assurance level (SAL).
8. Sample Size for the Training Set
This section is not applicable. This device is a physical implant, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable as there is no training set for this device.
§ 882.5320 Preformed alterable cranioplasty plate.
(a)
Identification. A preformed alterable cranioplasty plate is a device that is implanted into a patient to repair a skull defect. It is constructed of a material, e.g., tantalum, that can be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).