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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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