(239 days)
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, which is the brand name of the subject device, consists of mesh implants in different sizes (40x40mm, 90x90mm, 120x120mm, 200x200mm), thicknesses (0.3mm, 0.6mm and 0.8mm), and perforation patterns, which include the 1.2mm and 1.5/ 1.7mm Dynamic Mesh pattern and Hybrid Mesh pattern. The meshes can be modified with trimming and bending instruments for an anatomical fit and are malleable for threedimensional adaptations. The mesh can be fixated to the bone with screws from the previously marketed Stryker CMF implant systems. In addition, the necessary instrumentation for mesh modification and storage is included with the system.
The implants of the Universal Mesh are provided non-sterile and are for single use only. The instrumentation and storage system is reusable.
The provided text describes a 510(k) premarket notification for the "Stryker Universal Mesh," which is a bone plate intended for non-load-bearing reconstruction in the maxillofacial skeleton. This is not an AI/ML device, and as such, the requested information pertaining to AI/ML device studies (such as sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) is not applicable and hence not present in the provided document.
However, I can extract information related to the acceptance criteria and the studies performed to demonstrate the device's substantial equivalence to a predicate device, as applicable to this medical device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility Testing | Compliance with ISO 10993-1, ISO 10993-5, ISO 10993-18 | Tests supported the biocompatibility of the device. |
| Lifetime Reprocessing | Internal acceptance criteria met | Internal acceptance criteria were met; tests were passed. |
| Cleaning Validation | Compliance with ISO 17664, AAMI TIR 30, AAMI TIR 12 | Method validated. |
| Sterilization Validation | Compliance with ISO 14937, ISO 17664, ISO 17665, AAMI TIR 12, AAMI ST 81, AAMI ST79 | Method validated. |
| Mechanical Performance Testing | Compliance with ASTM F382 against Primary Predicate Device | Acceptance criteria were met; tests were passed. |
| Corrosion Testing | Internal acceptance criteria met | Acceptance criteria were met; test was passed. |
| MR Compatibility | Compliance with FDA guidance for industry ("Assessment of Radiofrequency - Induced Heating" and "Establishing Safety and Compatibility of Passive Implants") | Labeled as MR Conditional based on evaluations. |
Note: The document explicitly states that the "Subject device met all pre-defined acceptance criteria and standards and was found to not represent a new worst case."
2. Sample size used for the test set and the data provenance:
- Not applicable (N/A). This device is a physical medical implant (bone mesh), not an AI/ML software. The provided document details bench testing, not a clinical study involving a "test set" of patient data in the context of AI/ML evaluation. The tests were performed on the device itself or its materials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. As this is not an AI/ML device, the concept of "ground truth" established by experts for a test set of data does not apply in the same manner. Safety and effectiveness are demonstrated through adherence to recognized standards and comparative performance against a predicate device.
4. Adjudication method for the test set:
- N/A. This is not relevant to the type of device and studies conducted.
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:
- N/A. This device is not an AI system, so no MRMC study was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- N/A. This device is not an algorithm.
7. The type of ground truth used:
- N/A. For this physical device, "ground truth" is established through adherence to engineering standards (e.g., ASTM F67, ASTM F382), biocompatibility standards (e.g., ISO 10993 series), and validated reprocessing/sterilization methods (e.g., ISO 17664, AAMI standards). The predicate device's established safety and effectiveness also serve as a comparative "ground truth" for substantial equivalence.
8. The sample size for the training set:
- N/A. This is not an AI/ML device, hence no training set.
9. How the ground truth for the training set was established:
- N/A. This is not an AI/ML device, hence no training set and no associated ground truth establishment method.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study that proves the device meets the acceptance criteria is a series of non-clinical performance bench tests and biocompatibility evaluations. These studies were conducted to demonstrate the substantial equivalence of the Universal Mesh to its primary predicate device (Universal CMF System - K022185).
The performance data included:
- Biocompatibility Testing: Conducted according to FDA guidance and international standards (ISO 10993-1, ISO 10993-5, ISO 10993-18) to ensure the material (titanium conforming to ASTM F67) is safe for implantation.
- Performance Bench Testing:
- Lifetime Reprocessing: Verified the ability of the device, instruments, and storage container to withstand reprocessing cycles per internal standards.
- Cleaning Validation: Verified the cleaning process as per ISO 17664, AAMI TIR 30, and AAMI TIR 12.
- Sterilization Validation: Validated sterilization instructions using standards like ISO 14937, ISO 17664, ISO 17665, AAMI TIR 12, AAMI ST 81, AAMI ST79.
- Mechanical Performance Testing: Included 4-point bending static and dynamic load tests according to ASTM F382, compared against the Primary Predicate Device, to ensure structural integrity and mechanical properties.
- Corrosion Testing: Verified the corrosion behavior of the subject device and associated components.
- MR Compatibility: Tested according to FDA guidance documents (e.g., "Assessment of Radiofrequency - Induced Heating" and "Establishing Safety and Compatibility of Passive Implants") to determine safe use in an MR environment.
The document explicitly states: "The Subject device met all pre-defined acceptance criteria and standards and was found to not represent a new worst case. Overall, the results of the performance bench tests support the substantial equivalence of the Subject device."
Neither animal testing nor clinical testing was required as a basis for substantial equivalence for this particular device submission.
§ 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.