(190 days)
The TruMatch CMF Titanium 3D Printed Implant System is intended for bone repositioning, fixation and reconstruction of the maxillofacial skelon, midface, mandible and chin in adolescents (greater than 12 to 21 years of age) and adults.
Specific indications for use:
- 0 Orthognathic surgery.
- 0 Reconstructive mandible and maxillofacial surgery.
- O Mandible and maxillofacial trauma surgery.
The TruMatch CMF Titanium 3D Printed Implant System is intended for bone repositioning, fixation and reconstruction of the maxillofacial skeleton, midface, mandible and chin.
The TruMatch CMF Titanium 3D Printed Implant System provides a solution with patient-specific plates and patient-specific osteotomy and drill accessories, for the accurate transfer of the surgical plan to the operating room.
The provided FDA 510(k) summary for the Materialise TruMatch CMF Titanium 3D Printed Implant System (K170272) describes performance data from non-clinical testing and a review of clinical performance data. However, it does not explicitly define acceptance criteria as typically seen for specific sensitivity, specificity, accuracy, or other performance metrics for a diagnostic or AI-driven device.
Instead, the performance data aims to demonstrate substantial equivalence to predicate devices in terms of mechanical properties, biocompatibility, and clinical outcomes based on literature review rather than a direct, head-to-head clinical study powered to show superiority or non-inferiority against a predefined statistical endpoint for this specific device.
Based on the provided information, here's an attempt to structure the requested points, acknowledging the limitations in the original document regarding explicit acceptance criteria and a dedicated study for the device's human-in-the-loop or standalone performance:
Acceptance Criteria and Study for TruMatch CMF Titanium 3D Printed Implant System (K170272)
1. Table of Acceptance Criteria and Reported Device Performance
As explicit quantitative acceptance criteria (e.g., minimum accuracy, sensitivity, specificity) for the device's diagnostic or AI performance are not defined in this 510(k) summary (as it's a patient-specific implant system, not a diagnostic AI device), the "acceptance criteria" can be inferred from the "Results" section of the non-clinical tests. Clinical performance is supported by a literature review, not a specific study with predefined performance metrics for the device itself.
| Category | Assumed (Inferred) Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Testing | Superior or equivalent static bending strength and fatigue bending properties compared to predicate devices. | The subject device has a higher static bending strength and comparable fatigue bending properties compared to the predicate devices (ASTM F382: static and fatigue four-point plate bending). |
| Compatibility | Compatibility with the Synthes fixation system. | The subject device is compatible with the Synthes fixation system (Combination of user need validation lab and engineering rationale). |
| Sterilization | Sterilizable to a Sterility Assurance Level (SAL) of 10^-6. | Can be sterilized to a SAL of 10^-6 using recommended steam sterilization instructions (according to ISO 17665-1:2006, ISO 11737-2:2009 and ISO 14161:2009). |
| Biocompatibility | No cytotoxic effect, in compliance with ISO 10993 guidelines for sensitization, intra-cutaneous reactivity, and systemic toxicity. No toxicological concern from leachable substances. | - No cytotoxic effect. |
- In compliance with ISO 10993-10 guidelines for sensitization and intra-cutaneous reactivity.
- Systemic injection test passed (considered negative based on ISO 10993-11).
- No toxicological concern remains from leachable substances. |
| Clinical Performance (Inferred) | Acceptable clinical outcomes in terms of accuracy in transferring surgical plans, predictability of positioning, and minimization of complications (based on literature for patient-specific devices and standard bone plates). | Li et al. 2017 (Patient-specific bone plate fixation): Maximum positional and orientational differences between planned and post-operative positions were within 1.1 mm and 3°. No complications reported.
Heufelder et al. 2017 (Subject device): All operations performed successfully, without unexpected incidence. High predictability of maxillary positioning by CAD/CAM fabricated customized surgical guides and patient-specific osteosynthesis plates. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set (for non-clinical testing): Not specified in terms of patient numbers. The "test set" here refers to the device units and materials subjected to mechanical, sterilization, and biocompatibility testing. The number of samples for each test (e.g., number of plates tested for mechanical strength) is not detailed in this summary.
- Data Provenance (for clinical performance):
- Country of Origin: Not explicitly stated for all cited literature. "Li et al. 2017" is likely Asian (given the names), and "Heufelder et al. 2017" involves German researchers (Rana M. often associated with Germany). "Schendel et al. 1978" and "Precious et al. 1985" are likely from Western countries (e.g., USA, Canada) given the names and publication years.
- Retrospective/Prospective: The nature (retrospective/prospective) of each cited clinical study (Schendel et al. 1978, Precious et al. 1985 (1&2), Li et al. 2017, Heufelder et al. 2017) is not specified in this summary. These are generally published clinical studies, not specific studies conducted by Materialise for this 510(k) in a controlled test set format.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Experts for Non-Clinical Tests: Not applicable in the sense of clinical experts establishing ground truth for device performance. These tests follow standardized protocols (ASTM, ISO).
- Experts for Clinical Literature Review: The clinical performance relies on previously published literature. The experts involved in establishing "ground truth" (i.e., patient outcomes) for those studies would be the clinicians/surgeons who performed the original treatments and assessed the outcomes. Their specific qualifications are not detailed in this 510(k) summary, but implicitly they are medical professionals specializing in maxillofacial surgery.
4. Adjudication Method for the Test Set
- Non-Clinical Testing: Not applicable. Performance is measured objectively according to standard test methods (e.g., force, displacement during mechanical testing; bacterial counts for sterilization).
- Clinical Literature Review: Not applicable. This is a review of existing publications, not a new study requiring adjudication of outcomes for a specific device test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not explicitly reported or conducted for this 510(k) submission. The device is an implant system, not an imaging or AI-assisted diagnostic tool that would typically involve human readers. The clinical evidence relies on a literature review comparing the outcomes of patient-specific plate fixation (which the device provides) to standard bone plate fixation.
- Effect Size of Human Readers Improvement: Not applicable, as no MRMC study was done, and the device's function is not to assist human readers in a diagnostic task.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- The TruMatch CMF Titanium 3D Printed Implant System is a physical implant and associated guides, requiring a human surgeon for implantation. It's not an AI algorithm that functions standalone.
- The system enables patient-specific planning and manufacturing, which could be considered an "algorithm" component in the sense of CAD/CAM processes. The clinical studies (Li et al. 2017, Heufelder et al. 2017) indirectly assess the performance of this patient-specific approach in conjunction with human surgeons, noting high predictability and accurate transfer of surgical plans. However, this is not a "standalone algorithm" in the context of typical AI device evaluation.
7. Type of Ground Truth Used
- Non-Clinical Testing: Ground truth is established by objective measurements based on recognized standards (e.g., mechanical properties conforming to ASTM F382; sterility conforming to ISO standards; biocompatibility conforming to ISO 10993).
- Clinical Performance Review: Ground truth is based on reported patient outcomes from published clinical studies (e.g., "skeletal stability," "little morbidity and few complications," "maximum positional and orientational differences," "high predictability of maxillary positioning," "operations performed successfully without any unexpected incidence"). This could be categorized as outcomes data and expert assessment of clinical success/complications.
8. Sample Size for the Training Set
- Not applicable. This device is not an AI/ML algorithm that requires a "training set" in the traditional sense. It's a medical implant system.
- The patient-specific nature means each implant is "designed" based on an individual patient's CT scan data, but this is a design and manufacturing process, not a machine learning training process.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no AI/ML training set, there is no ground truth established for such a set.
§ 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.