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The TruMatch CMF Titanium 3D Printed Implant is a patient specific implant and 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, midface and chin.

The TruMatch CMF Titanium 3D Printed Implant is a patient specific implant and 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, midface and chin.

The implants feature a mesh-like structure. The mesh-like structures are designed with the same elementary pattern. This pattern was designed to obtain implants with mechanical properties close to those of bone and to allow for osseointegration.

The TruMatch CMF Titanium 3D Printed Implant can be used in combination with TruMatch CMF Titanium 3D Printed Accessories (patient-specific guides), cleared as SurgiCase guides (K103136) and TruMatch CMF Titanium 3D Printed Implant System (K170272). The guides are intended to aid with implant positioning.

The TruMatch CMF Titanium 3D Printed Implant provides surgeons with a patient-specific implant solution for plastic and reconstructive surgery. The device is constructed based on the patient's CT imaging data.

The TruMatch CMF Titanium 3D Printed Implant is designed to fit the patient's anatomy and is not contoured manually by the surgeon. The TruMatch CMF Titanium 3D Printed Implant is designed and manufactured with integrated screw holes to fixate the bone using: MatrixMIDFACE (K050608), MatrixMANDIBLE (K063790, K121574), MatrixORTHOGNATHIC (K083388), MatrixNEURO screws (K123723, K042365), and Synthes Craniofacial Screw System (K050608).

The TruMatch CMF Titanium 3D Printed Implant contains the following applications:

Reconstruction applications: Orbital
Brand name: TruMatch CMF Ti 3D-Printed Implants
Material: Commercially pure titanium
Type of design: Patient Specific
Type of application: Implant thickness: 0.4-1.5mm
Patient specific associated instrument: Orbital guide

Reconstruction applications: Mandible, midface
Brand name: TruMatch CMF Ti 3D-Printed Implant
Material: Commercially pure titanium
Type of design: Patient Specific
Range of length: 10-294mm
Curvature: 0°-12°/mm length
Type of application: Range of shapes:
Midface reconstruction: Mesh-shaped, contoured to the patient's anatomy One/multi piece One/multi layered
Implant thickness: 0.8-10mm
Patient specific associated instrument: Midface guide
Mandibular reconstruction: Mesh-shaped, contoured to patient's anatomy Single/double strut Straight Curved/crescent Subcondylar Plated extensions One/multi layered Combinations of the above
Implant thickness: 1.2-10mm
Patient specific associated instrument: Mandibular guide

This is a 510(k) summary for a medical device called the "TruMatch CMF Titanium 3D Printed Implant" (K173039). The document focuses on demonstrating that this new device is substantially equivalent to existing, legally marketed predicate devices.

Let's break down the information regarding acceptance criteria and the supporting study, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission, the "acceptance criteria" are primarily based on demonstrating performance equivalent to or non-inferior to predicate devices, rather than strict pre-defined numerical thresholds for a novel diagnostic accuracy claim. The performance data presented is focused on various engineering and biological tests.

• Sensitization: In compliance with ISO 10993-10 guidelines.
• Intra-cutaneous reactivity: In compliance with ISO 10993-10 guidelines.
• Systemic toxicity: Test passed and considered negative.
• Chemical characterization: As per report.
• Leachable substances: No toxicological concern remains, further biological testing not justified. |

2. Sample Size Used for the Test Set and Data Provenance

The provided document describes testing for a physical implant, not an AI/ML device that would typically have a "test set" of data. Therefore, the concepts of "sample size used for the test set" and "data provenance (e.g., country of origin of the data, retrospective or prospective)" are not applicable in this context. The "test set" here refers to the physical devices (implants, packaging, materials) that were subjected to the various engineering and biological tests. The document does not specify the exact number of implants or material samples tested for each category (e.g., how many implants for mechanical testing).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable as the document describes a physical medical device (implant) and its performance through engineering and biological testing, not a diagnostic or AI/ML device requiring expert-established ground truth. The "ground truth" for these types of tests is generally defined by the standards themselves (e.g., ASTM F382, ISO 10993 series), which specify acceptable performance limits.

4. Adjudication Method for the Test Set

This is not applicable for the same reasons as points 2 and 3. Adjudication methods like 2+1 or 3+1 are used in scenarios where multiple human readers assess a case and their interpretations need to be reconciled, typically in AI/ML performance studies.

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

An MRMC comparative effectiveness study is not applicable as this document describes a physical medical implant, not an AI medical device.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

A standalone performance study of an algorithm is not applicable as this document describes a physical medical implant, not an AI medical device.

7. The Type of Ground Truth Used

The "ground truth" for the tests performed on the TruMatch CMF Titanium 3D Printed Implant is based on:

• Established Industry Standards and Specifications: For mechanical properties (ASTM F382) and biocompatibility (ISO 10993 series), the acceptance criteria are defined by these internationally recognized standards.
• Sterility Assurance Levels (SAL): For sterilization, the ground truth is a demonstrated SAL of 10^-6, which is a standard regulatory requirement.
• Functional Compatibility: For compatibility with fixation systems, the ground truth is that the device works with the specified Synthes systems.

8. The Sample Size for the Training Set

This is not applicable as the document describes a physical medical implant, not an AI medical device that requires a "training set." The implants are patient-specific and manufactured based on individual patient CT scan data, but this is a manufacturing process, not a machine learning training process.

9. How the Ground Truth for the Training Set was Established

This is not applicable for the same reasons as point 8.

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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.

• 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.

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