(225 days)
METICULY Patient-specific titanium maxillofacial mesh implant is intended for bone fixation and reconstruction, restoration of bone defects and intended to provide continuity in regions where the bone is missing and/or to augment the bone by means of an onlay device in the maxillofacial skeleton and midface.
The METICUL Y Patient-specific titanium maxillofacial mesh implant is a device designed individually for each patient and intended for use in selective trauma of the maxillofacial skeleton, maxillofacial surgery, and reconstructive procedures. It is specifically designed with a focus on applications of non-bending related scenarios. The implant is made of titanium alloys produced via additive manufacturing (Laser Powder Bed Fusion) and is intended to be used with titanium screws. All additive manufacturing and other post-processing steps are only to take place under Meticuly manufacturing control. The device is not intended to substitute for bone reconstruction in clinical situations where bone is needed for support and stability of the maxillofacial skeleton under functional loading conditions. It is intended for adults only (at least 22 years of age). The surgeon approves the design of the mesh implant prior to fabrication of the implant device by the sponsor. The proposed FaciMesh models are intended to treat the maxillofacial region, while the OrbiMesh models treat the Orbital region. The device is not intended for reconstruction of the orbital roof defects or for any frontal bone defects, such as the supra-orbital ridge. Additionally, the FDA-cleared commercially available titanium screws that can be used with the subject devices include the TITANIUM MINIPLATE SYSTEM (K951690) and MICRO TITANIUM PLATE SYSTEM (K951688).
The METICULY Patient-specific titanium maxillofacial mesh implant underwent various performance tests to demonstrate its substantial equivalence to predicate devices.
1. Acceptance Criteria and Reported Device Performance:
The document broadly mentions compliance with various ASTM and ISO standards for material properties, manufacturing quality, biological evaluation, sterilization, and packaging. While specific quantitative acceptance criteria are not explicitly listed in a single table alongside reported values within the provided text, the conclusion states that "Verification and validation testing confirms that the product specifications have been met, demonstrating that the device will perform as intended. There were no unexpected results which indicate the suitable material used and manufacturing process compared to the standards for medical devices." This implies that the device met the requirements outlined in the referenced standards.
Here's a breakdown of the performance aspects and the reported methods/outcomes:
| Acceptance Criteria Category | Reported Device Performance/Testing Method | Implied Acceptance Criteria (based on standards compliance) |
|---|---|---|
| Material & Manufacturing | Evaluated maintained composition, particle size, flowability, density, and visual characteristics of recycled/reused powder. | |
| Density of printed samples consistently within acceptance criteria across build plate locations. | ||
| Dynamic fatigue strength testing to account for worst-case print orientation. | ||
| Patient-matched device form output consistently matches digital design and CT scan data inputs. | Virgin powder characteristics maintained after recycling. | |
| Consistent and acceptable density of printed implants. | ||
| Sufficient dynamic fatigue strength for intended use (meets ASTM F3001-14). | ||
| High fidelity between digital design, CT data, and fabricated implant (within specified tolerances). | ||
| Biocompatibility | Tested per ISO 10993-1, -3, -5, -6, -10, -11, -23, and USP-NF Pyrogen Test. | Non-toxic, non-sensitizing, non-irritating, non-genotoxic, no unacceptable local effects after implantation, and non-pyrogenic. |
| Sterilization | Validated using Overkill method for steam sterilization (135°C for 10 minutes) to achieve SAL of 10^-6. | |
| Tested per ANSI AAMI ST72, USP-NF , , , ISO 17665-1, ISO 11737-1, -2. | Achieves a Sterility Assurance Level (SAL) of 10^-6. | |
| Complies with bacterial endotoxin limits and sterility verification. | ||
| Packaging & Transportation | Tested per ASTM F88/F88M-15, D7386-16, F1886/F1886M-16, F1929-15. | Maintains sterility and device integrity during storage and transport. |
| Adequate seal strength, package performance, and seal integrity. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample sizes for the various performance tests conducted (e.g., number of powder samples, printed devices for fatigue testing, implants for biocompatibility).
The data provenance is also not explicitly stated beyond the tests being conducted by the manufacturer to support the 510(k) submission. It doesn't mention country of origin for data or if it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not provided in the document. The studies described are primarily engineering and laboratory-based performance tests for the device itself (materials, manufacturing, sterility), not clinical studies requiring expert ground truth for interpretation of medical images or patient outcomes.
4. Adjudication Method for the Test Set:
This information is not applicable as the described tests are laboratory-based device performance evaluations, not clinical studies requiring expert adjudication of results.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
An MRMC comparative effectiveness study was not done or reported in this document. The submission focuses on the chemical, physical, and mechanical properties of the device and its manufacturing process, not on its diagnostic or treatment efficacy as interpreted by human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
This information is not applicable. The device is a physical implant, not an algorithm or software that performs a diagnostic or treatment function on its own. While the design process involves digital input (CAD data from CT scans), the "performance" described is of the physical mesh implant, not a standalone algorithm.
7. Type of Ground Truth Used:
For the performance tests, the "ground truth" is largely established by recognized industry standards (ASTM, ISO, USP-NF). For instance:
- Material properties: Measured values compared against specified ranges in ASTM F3001-14.
- Biocompatibility: Results of biological tests (cytotoxicity, irritation, sensitization, etc.) are compared against established biological endpoints defined by ISO 10993 series and USP-NF.
- Sterilization: Achievement of a defined Sterility Assurance Level (SAL) and compliance with microbial limits as per ISO/ANSI/USP standards.
- Manufacturing accuracy: Comparison of the physical implant to the digital design and CT scan data inputs, with acceptable tolerances implied by "consistently matches."
No pathology, expert consensus on patient outcomes, or outcomes data is mentioned as ground truth for these device performance tests.
8. Sample Size for the Training Set:
This information is not applicable as the document describes a physical medical device, not an AI/ML algorithm that requires a training set. The device design process involves patient-specific CT data, but this is an input for individual device fabrication, not a training set in the context of AI/ML.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reasons as point 8.
§ 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.