Search Results

The tmCMF Solution is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT-based system. The input data file is processed by the tmCMF Solution, and the result is an output data file that may then be provided as digital models or used as input to a manufacturing portion of the system that produces physical outputs, including anatomical models, surgical guides, dental splints, and implants for use in maxillofacial, midface, and mandibular surgery. Implants are 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, mandible, and chin in adolescents (greater than 12 to 21 years of age) and adults. The tmCMF Solution is also intended as a preoperative software tool for simulating/ evaluating virtual surgical treatment options.

TechMah CMF (tmCMF) Solution is a family of personalized product solutions for Reconstructive, Orthognathic, Trauma, and Augmentation procedures in the mandible and midface (including orbital floor, medial and lateral orbital walls). The solution is comprised of Surgeon Review Tool (SRT) software and maxillofacial and mandibular surgical instruments (surgical guides, anatomical models, and dental splints) and implants. The surgical instruments and implants are patient-specific devices and are designed utilizing CT and dental scan patient image data.

Surgical guides are patient-specific devices or templates based on pre-operative software planning designed to fit a specific patient. These guides are used to assist a surgeon in transferring the pre-operative plan to the surgery by guiding the marking/drilling of bone for plate fixation screws and the position of the osteotomy marking/cutting slots. Guides can be used in conjunction with anatomical models to verify anatomical positioning and fit. Surgical guides can be used with either tmCMF Solution patient-specific implants or compatible off-the-shelf DePuy Synthes implants.

Anatomical models are patient-specific models that are based on pre-operative anatomy and surqical planning specific to a patient. These models are used to assist a surgeon in transferring the pre-operative plan to the surgery by representing pre-operative, intra-operative, and post-operative anatomical models as quidance. Anatomical models can be used to check quide fit and facilitate the pre-bending of a non-patient-specific off-the-shelf plate.

Dental splints are patient-specific devices or templates based on pre-operative software planning designed to fit a specific patient. These templates are used to assist a surgeon in transferring the pre-operative plan to the surgery by guiding the dental alignment of bone and teeth.

Implants are patient-specific devices that are based on pre-operative software planning designed to fit a specific patient. These implants are integral components for CMF (craniomaxillofacial) procedures, facilitating bone repositioning, fixation, reconstruction, and the restoration of bone defects. They are designed according to the pre-operative surgical plan to ensure continuity in regions where bone is absent and to provide structural integrity to the maxillofacial skeletal components, midface, mandible, and chin. This could include stabilizing fractured or intraoperatively cut bone, fixating harvested graft segments, or augmenting bone defects. Implants can be used in conjunction with surgical guides and anatomical models to assist with anatomical positioning and fit.

The Surgeon Review Tool (SRT) software is used by surgeons for the review of surgical plans, surgical instruments, and implant designs. The SRT software is accessed through a web interface.

tmCMF Solution supports the following maxillofacial, midface (including orbital floor, lateral and medial orbital wall), and mandibular surgical procedures:

• . Reconstructive
• Orthognathic
• Trauma
• Augmentation ●

The provided text describes the tmCMF Solution device and its substantial equivalence to predicate devices, but it does not contain the specific acceptance criteria or the study details proving the device meets those criteria, particularly for performance metrics like accuracy, sensitivity, or specificity for the software components.

The "Benchtop Performance" section mentions that "Testing demonstrated that the tmCMF Solution and substantial equivalence with the predicate device" and lists several "Performance verification" items, but these are high-level statements rather than detailed acceptance criteria and reported performance values. For example, "Testing demonstrated that the surgical guide and implants meets the predetermined acceptance criteria" indicates that acceptance criteria exist but doesn't provide them or the specific performance results.

Therefore, I cannot fulfill all parts of your request with the given input. I will extract the information that is present and indicate where information is missing.

Here's a summary of what can be extracted based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly provided with specific numerical acceptance criteria or reported performance values in the document. The document generally states that "Testing demonstrated that... meets the predetermined acceptance criteria" for various aspects.

Note: The document only states that the device "meets" or is "compliant" with predetermined acceptance criteria, without providing the specific quantitative or qualitative criteria themselves, nor the specific performance values (e.g., accuracy percentages, error margins).

2. Sample Size for the Test Set and Data Provenance

This information is not provided in the document. The document refers to "testing" but does not specify the sample size for any test set or the provenance (country of origin, retrospective/prospective) of data used for performance validation.

3. Number of Experts and Qualifications for Ground Truth

This information is not provided in the document.

4. Adjudication Method

This information is not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not provided in the document. The document focuses on the device's technical specifications and substantial equivalence to predicate devices, not on comparative effectiveness with human readers.

6. Standalone (Algorithm Only) Performance Study

The document does not explicitly present a standalone performance study with specific metrics (e.g., accuracy, sensitivity, specificity) for the imaging or segmentation algorithms. It mentions tmCMF Solution is "a software system and image segmentation system," and that "Software Verification and Validation Testing was conducted," but focuses on compliance with software standards (IEC 62304) and general system functionality rather than detailed standalone performance metrics against ground truth for clinical tasks.

7. Type of Ground Truth Used

The specific type of ground truth (e.g., expert consensus, pathology, outcomes data) used for the software's performance assessment is not explicitly stated in the document. It generally refers to "predetermined acceptance criteria" for various verification items.

8. Sample Size for the Training Set

This information is not provided in the document.

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

This information is not provided in the document.

Ask a specific question about this device

DePuy Synthes MatrixWAVE MMF System (originally cleared per K141165)
The DePuy Synthes MatrixWAVE MMF System is indicated for the temporary treatment of mandibular and maxillary fractures and osteotomies in adults and adolescents (age 12 and higher) in whom permanent teeth have erupted.

DePuy Synthes MatrixMANDIBLE Plate and Screw System (originally cleared per K121574)
The DePuy Synthes MatrixMANDIBLE Plate and Screw System is intended for oral, maxillofacial surgery:

• Trauma
• Reconstructive surgery
• Orthognathic surgery (surgical correction of dentofacial deformities)

DePuy Synthes MatrixMANDIBLE Plate and Screw System (originally cleared per K113567)
The DePuy Synthes MatrixMANDIBLE Plate and Screw System is intended for oral, maxillofacial surgery:

• Trauma
• Reconstructive surgery
• Orthognathic surgery (surgical correction of dentofacial deformities)

DePuy Synthes Dentoalveolar Bone Fixation System (originally cleared per K102656)
The DePuy Synthes Dentoalveolar Bone Fixation System is intended for use in non-load bearing applications for maintaining the relative position of and/or containing bony fragments, bone grafts (autograft or allograft), or bone graft substitutes in reconstruction of maxillary and/or mandibular areas, including the dentoalveolar ridge.

DePuy Synthes MatrixMANDIBLE Subcondylar Plates (originally cleared per K091233)
The DePuy Synthes MatrixMANDIBLE Subcondylar Plates are intended for oral, maxillofacial surgery; trauma and reconstructive surgery, specifically for fractures of the subcondylar region of the mandible and fractures of the condylar basis region of the mandible.

DePuy Synthes MatrixMANDIBLE Preformed Reconstruction Plates (originally cleared per K091144)
The DePuy Synthes MatrixMANDIBLE Preformed Reconstruction Plates are intended for use in oral and maxillofacial surgery, trauma and reconstructive surgery. This includes primary mandibular reconstruction, comminuted fractures and temporary bridging pending delayed secondary reconstruction, including fractures of edentulous and/or atrophic mandibles, as well as unstable fractures.

DePuy Synthes MatrixORTHOGNATHIC Plating System (originally cleared per K083388)
The DePuy Synthes MatrixORTHOGNATHIC Plating System is intended for use in selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla, mandible and chin in adolescents (greater than 12 to 21 years of age) and adults. Specific Indications for Use:

• Fractures of the midface and maxillofacial skeleton
• LeFort I osteotomies, sagittal split osteotomies and genioplasties
• Orthognathic surgery including reconstructive procedures

DePuy Synthes MatrixMANDIBLE Plate and Screw System (originally cleared per K082335)
The DePuy Synthes MatrixMANDIBLE Plate and Screw System is intended for oral, maxillofacial surgery; trauma; reconstructive surgery; and orthognathic surgery (surgical correction of dentofacial deformities).

DePuy Synthes Craniofacial Plate and Screw System (originally cleared per K080331)
The DePuy Synthes Craniofacial Plate and Screw System is intended for use in selective trauma of the midface and maxillofacial skeleton, maxillofacial surgery, reconstructive procedures and selective orthognathic surgery of the maxilla and chin.

DePuy Synthes MatrixMANDIBLE Plate and Screw System (originally cleared per K063790)
The DePuy Synthes MatrixMANDIBLE Plate and Screw System is intended for oral, maxillofacial surgery; trauma; reconstructive surgery; and orthognathic surgery (surgical correction of dentofacial deformities).

DePuy Synthes Craniofacial Plate and Screw System (originally cleared per K050608)
The DePuy Synthes Craniofacial Plate and Screw System is intended for use in selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

DePuy Synthes Neuro Plate and Screw System (originally cleared per K042365)
The DePuy Synthes Neuro Plate and Screw System is intended for use in selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

DePuy Synthes 1.3 & 1.5 mm Contourable Titanium (Ti.) Mesh Plates (originally cleared per K033121)
The DePuy Synthes 1.3 & 1.5 mm Contourable Titanium (Ti.) Mesh Plates are intended for use in selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

DePuy Synthes Orbital Plates (originally cleared per K031761)
The DePuy Synthes Orbital Plates are intended for use in selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

DePuy Synthes Low Profile Neuro System (originally cleared per K022012)
The DePuy Synthes Low Profile Neuro System is intended for use in selective trauma of the midfacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

DePuy Synthes Midface Distractor (Originally cleared per K022005)
The DePuy Synthes Midface Distractor is intended for use in adult and pediatic populations for the treatment of midface conditions for which reconstructive osteotomy and segment are indicated. This includes conditions such as midfacial retrusion. The device is intended to provide temporary stabilization and gradual lengthening of the midfacial bones.

DePuy Synthes Translating Maxillary Distractor (Originally cleared per K020505)
The DePuy Synthes Translating Maxillary Distractor is intended for use in maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla. Specifically it is intended for distraction of the maxilla utilizing a LeFort I osteotomy in adult and pediatric populations.

DePuy Synthes Midface Distractor (Originally cleared per K010499)
The DePuy Synthes Midface Distractor is intended for use in adult and pediatic populations for the treatment of midface conditions for which reconstructive osteotomy and segment are indicated. This includes conditions such as midfacial retrusion. The device is intended to provide temporary stabilization and gradual lengthening of the midfacial bones.

DePuy Synthes Maxillary Distractor (Originally cleared per K003393)
The DePuy Synthes Maxillary Distractor is intended for use in maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla. Specifically it is intended for distraction of the maxilla utilizing a LeFort I osteotomy in adult and pediatric populations.

DePuy Synthes Orbital Mesh Plates (Originally cleared per K001311)
The DePuy Synthes Orbital Mesh Plates for the Midfacial System are indicated for selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

DePuy Synthes 2.0 mm Locking Plate System (2.0 LPS) (originally cleared per K974555)
The DePuy Synthes 2.0 LPS is intended for oral, maxillofacial surgery: trauma; reconstructive surgery; and orthognathic surgery (surgical correction of dentofacial deformities).

DePuy Synthes 2.4 mm Universal Locking Plate System (originally cleared per K961421)
The DePuy Synthes 2.4 mm Universal Locking Plate and screw system, that is intended for mandible trauma and reconstruction procedures.

DePuy Synthes Mandibular Modular Fixation System (originally cleared per K954385)
The DePuy Synthes Mandibular Modular Fixation System is a plate and screw system, manufactured from commercially pure titanium, and is intended for use in:

• Oral, maxillofacial surgery: trauma; surgical correction of dentofacial deformities; reconstructive surgery; and maxillofacial surgery

DePuy Synthes Maxillofacial Titanium Micro Set (originally cleared per K912932)
General indications:

• Maxillofacial surgery

DePuy Synthes MatrixWAVE MMF is a bone-borne maxillomandibular fixation (MMF) system that consists of wave shaped plates (made from commercially pure Titanium) that are attached to the dental arches with self-drilling locking screws (made from Titanium alloy, Ti-6Al-7Nb). The system is intended for temporary stabilization of mandibular and maxillary fractures and osteotomies to maintain proper occlusion during intraoperative bone fixation and postoperative bone healing (approximately 6-8 weeks). The dental arches are brought into occlusion by wiring around the plate hooks and/or accessible screw heads.

The DePuy Synthes MatrixMANDIBLE Plate and Screw System consists of a variety of plates offered in multiple shapes and a variety of screws offered in multiple diameters and lengths to meet the anatomical needs of the patient. System implants are manufactured in either titanium or titanium alloy and are intended for single use only. The DePuy Synthes MatrixMANDIBLE screws that are the subject of this premarket notification are made from titanium alloy (Ti-6A1-7Nb) and are available in a diameter of 2.0 mm and lengths ranging from 4 mm to 8 mm, and have a thread pitch of 0.5 mm. These screws work with all plates within the DePuy Synthes MatrixMANDIBLE Plate and Screw System. These devices are offered, non-sterile and must be sterilized prior to use. DePuy Synthes MatrixMANDLBLE screws are intended for single use.

The DePuy Synthes MatrixMANDIBLE Plate and Screw System consists of a variety of plates offered in multiple shapes and a variety of screws offered in multiple diameters and lengths to meet the anatomical needs of the patient. This submission pertains to 1.5 mm thick MatrixMANDIBLE Reconstruction Plates, which are available as left and right single angle reconstruction plates and in three sizes of double angle reconstruction plates. These plates are made from pure titanium and may be offered sterile or non-sterile (non-sterile implants must be sterilized prior to use). DePuy Synthes MatrixMANDIBLE 1.5 mm thick reconstruction plates are intended for single use only.

The DePuy Synthes Dentoalveolar Bone Fixation System is a plate, mesh, and screw system intended to be implanted intraorally for use in non-load bearing applications for maintaining the relative position of and/or containing bony fragments, bone grafts (autograft or allograft), or bone graft substitutes in reconstruction of maxillary and/or mandibular areas, including the dentoalveolar ridge. Screws: The System includes 1.3 mm, 1.5 mm, and 2.0 mm diameter cortex screws in lengths from 3 mm to 20 mm. Screws are offered with both self-tapping and self drilling tips. Screws are manufactured from titanium alloy (Ti-6A1-7Nb). Plates and Meshes: The System includes plates and meshes that come in a variety of configurations to accommodate various dentoalveolar defect sites. The plates attach to bone via titanium cortex screws. Plates and meshes are manufactured from commercially pure titanium.

The DePuy Synthes MatrixMANDIBLE Subcondylar Plates are designed specifically to match the anatomy of the subcondylar region of the mandible. These plates are designed for use with DePuy Synthes MatrixMANDIBLE screws that come in multiple diameters and lengths to meet the anatomical needs of the patient. System components are manufactured in either titanium or titanium alloy and are intended for single use only.

The DePuy Synthes MatrixMANDIBLE Preformed Reconstruction Plates are anatomically contoured to match the body and angle regions of the mandible in most patients. These plates are designed for use with DePuy Synthes MatrixMANDIBLE screws that come in multiple diameters and lengths to meet the anatomical needs of the patient. System components are manufactured in either titanium alloy and are intended for single use only.

The DePuy Synthes MatrixORTHOGNATHIC Plating System consists of a variety of plates that come in a variety of shapes and sizes to meet the anatomical needs of the patient. This system is designed for use with DePuy Synthes Matrix screws. System components are manufactured in either titanium or titanium alloy and are intended for single use only.

The DePuy Synthes MatrixMANDIBLE Plate and Screw System incorporates small, medium and large plates designed so all plates accept all system screws. The plates are available in various shapes and thicknesses and accept self-tapping and self-drilling cortex and locking screws. The implants are manufactured from titanium.

The DePuy Synthes Orbital Plates, components of the Synthes Craniofacial Plate and Screw System, consist of anatomically shaped orbital plates that come in various sizes and configurations to fit the patient anatomy. These devices are designed for use with DePuy Synthes craniofacial bone screws commercially available in the U.S. System components are manufactured in titanium and are intended for single use only.

The DePuy Synthes MatrixMANDIBLE Plate and Screw System is the next generation of Synthes (USA) fixation systems for the mandible. The system incorporates small, medium, and large plates designed so that all plates accept all system screws. The plates are available in various shapes and thicknesses, and accept self-tapping cortex and locking screws. The implants are manufactured from CP titanium and titanium alloy.

The DePuy Synthes Craniofacial Plate and Screw System consist of plates and meshes that come in a variety of shapes and sizes to meet the anatomical needs of the patient. This system is designed for use with 1.8 mm screws and 2.1 mm emergency screws. The screws will be used with Synthes 1.8 mm hexagonal screwdriver blades. System components are manufactured in either titanium or titanium alloy and are intended for single use only.

DePuy Synthes Neuro Plate and Screw System consists of plates, burr hole covers, and meshes that come in a variety of shapes and sizes to meet the anatomical needs of the patient. This system is designed for use with 1.8 mm screws and 2.1 mm emergency screws. The screws will be used with Synthes 1.8 mm hexagonal screwdriver blades. System components are manufactured in either titanium or titanium alloy and are intended for single use only.

The DePuy Synthes 1.3 & 1.5 mm Contourable Ti. Mesh Plates come in a variety of shapes and sizes to meet the anatomical need of the patient. The plates are sterile and for single use only.

The DePuy Synthes Orbital Plates come in a variety of shapes and sizes to meet the anatomical need of the patient. The plates are sterile/non-sterile and for single use only.

The DePuy Synthes Low Profile Neuro System consists of titaniurn plates, meshes, and screws in a variety of shapes and sizes designed for various maxillofacial procedures.

The DePuy Synthes Midface Distractor is a maxillofacial distraction device consisting of two telescoping components with attached footplates. The device is intended to be placed subcutaneously with an anterior footplate fastened to the lateral orbital rim, extending down to the maxilla and spanning the zygomaticomaxillary suture; and a posterior footplate fastened to the temporal region of the cranium. The plates are fixed to the bone through unthreaded screw holes using 1.5 mm or 2.0 mm Cortex screws.

The DePuy Synthes Translating Maxillary Distractor is an intra-oral distraction device. It features a distractor body with two adjustable footplate components, each with contourable legs having screw holes that are fixed to the bone via 2.0 mm or 2.4 mm cortex screws.

The DePuy Synthes Midface Distractor is a maxillofacial distraction device consisting of two telescoping components with attached footplates. The device is intended to be placed subcutaneously with an anterior footplate fastened to the lateral orbital rim, extending down to the maxilla and spanning the zygomaticomaxillary suture; and a posterior footplate fastened to the temporal region of the cranium. The plates are fixed to the bone through unthreaded screw holes using 1.5 mm or 2.0 mm Cortex screws.

The DePuy Synthes Maxillary Distractor is an intra-oral distraction device. It features two telescoping components, with contourable legs having screw holes, that are fixed to the bone via 2.0 mm or 2.4 mm cortex screws.

The DePuy Synthes Orbital Mesh Plates have a semi-circular shape with a radially designed mesh pattern. Orbital Mesh Plates are available in 0.2, 0.3 and 0.4 mm profile thickness. Standard 1.0 mm screw holes positioned along the outer arc of the Orbital Mesh Plate accept 1.0 mm selftapping bone screws and 1.2 mm emergency screws. Synthes Orbital Mesh Plates for the Midfacial System are provided nonsterile.

The DePuy Synthes 2.0 Locking Plate System consists of five different types of plates and two screws, as follows: 2.0 Straight Locking Plates, 2.0 Crescent Locking Plates, 2.0 Atrophic Locking Plates, 2.0 Reconstruction Locking Plates, 2.0 Specialty Plates (Y- and 1.5 mm and 2.0 mm Self-drilling Locking Screws. The plates feature a threaded screw hole which accepts a locking screw with a mating external thread on the screw head. Engaging these screw threads fixes the screw to the plate thereby reducing the likelihood of screw loosening and improving the screw to plate stability of the implant system.

The DePuy Synthes 2.4 mm Universal Locking Plate System plates are designed to accept the 2.4 mm – 3.0 mm diameter locking/non-locking screws.

The DePuy Synthes Mandibular Fixation System is a plate and screw system manufactured from titanium. The plates are available in a variety of shapes and sizes, and attach to bone via 2.0 mm, 2.4 mm or 2.7 mm screws.

The DePuy Synthes Maxillofacial Titanium Micro set consists of titanium bone plates (shapes include L,Y,H,T, Double-Y, Mesh and Straight) and self-tapping screws.

The provided document, K192655, is a 510(k) Premarket Notification for DePuy Synthes Maxillofacial Portfolio - MR Conditional. This type of submission is a declaration from the manufacturer to the FDA that their device is substantially equivalent to a legally marketed predicate device, and it does not typically involve clinical performance studies with acceptance criteria as one would find for novel AI/ML medical devices.

Instead, the provided document focuses on demonstrating MR Conditional safety for a portfolio of existing maxillofacial bone plates and screw systems that were previously cleared by the FDA. The "acceptance criteria" and "study" described herein relate to non-clinical electromagnetic compatibility (EMC) testing in an MR environment, not clinical performance for diagnostic or therapeutic accuracy of an AI/ML algorithm.

Therefore, the requested information elements related to AI/ML device performance (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this specific submission.

Here's a breakdown of the information that is available and relevant to the document's purpose:

Acceptance Criteria and Study for MR Conditional Safety (Non-Clinical)

The submission aims to add "MR Conditional" labeling to a portfolio of maxillofacial devices. This requires demonstrating that the devices are safe for use in a specified MR environment under defined conditions. The "acceptance criteria" for this type of submission are typically based on recognized international consensus standards for testing the MR compatibility of medical devices.

1. Table of Acceptance Criteria and Reported Device Performance

The document consistently references the following ASTM standards for non-clinical testing to support MR Conditional safety across all listed devices:

Note: The document states that "Non-clinical testing is provided to support the conditional safety..." for each of these parameters. While it doesn't provide specific quantitative results (e.g., exact temperature rise in °C, or N/A for displacement/torque if deemed safe), the acceptance of the 510(k) by the FDA implies that the results of these tests met the predefined safety thresholds for an MR Conditional designation as per the referenced ASTM standards. The specific numerical results (e.g., maximum temperature rises, displacement forces, etc.) would be detailed in the full test reports submitted to the FDA, which are not part of this public summary.

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

• Sample Size: For non-clinical MR compatibility testing, the "sample size" refers to the number of device units tested. The document does not specify the exact number of physical devices or models tested for each parameter. However, standard practice for such assessments involves testing representative samples of each device type (plates, screws, meshes, distractors) and material compositions (titanium, titanium alloy) to ensure the portfolio's MR safety.
• Data Provenance: The data is "non-clinical testing" conducted by the manufacturer (Synthes - DePuy Synthes). The country of origin for the testing itself is not explicitly stated in this summary, but it would typically be conducted in a laboratory setting compliant with relevant international standards. This is retrospective in the sense that the studies were performed specifically to characterize the existing devices for MR compatibility.

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

• Not Applicable. This is a non-clinical evaluation of physical device properties in an MR environment, not a clinical study involving expert interpretation of medical images or patient outcomes. The "ground truth" for MR safety is established by adherence to recognized ASTM testing standards and the physical properties of the materials and device in situ within the MR scanner, not by human expert consensus or annotations on medical data.

4. Adjudication Method for the Test Set

• Not Applicable. As this is non-clinical testing of physical device characteristics, there is no "adjudication" in the sense of resolving discrepancies between human readers or AI outputs. The test results are objective measurements against standard-defined thresholds.

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

• Not Applicable. This submission is not for an AI-powered device.

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

• Not Applicable. This submission is not for an AI-powered device.

7. The Type of Ground Truth Used

• Physical Measurements against ASTM Standard Thresholds: The "ground truth" for MR Conditional safety is determined by rigorous physical measurements (e.g., temperature changes, displacement forces, torque, observable image artifacts) obtained through standardized testing protocols (ASTM F2052-14, F2213-06, F2182-11a, F2119-07) and comparison against acceptance limits defined by these standards or applicable regulatory guidance. It's about validating the device's behavior in an MR field, not diagnosing a condition. The "DUKE model" for RF heating indicates a high-fidelity computational human body model used for simulating temperature distributions due to RF fields.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/ML device. There is no "training set" in the context of machine learning.

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

• Not Applicable. As there is no training set for AI/ML, this question doesn't apply.

Ask a specific question about this device

MCI - CMF System is intended for use in selective trauma of the midface, maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla, mandible and chin.

The bone plates are made from commercially pure titanium (ASTM F67) and the bone screws are manufactured from titanium alloy - Ti-6AI-4V (ASTM F136) and are available in different sizes and shapes, according the site of the implantation and the extension of the fracture. The surface of plates and screws are colored-anodized. MCI - CMF System implant devices are for single use. The devices are provided non-sterile and must be properly cleaned, disinfected and sterilized before use, according the recommendations provided in the Instructions for Use.

I am sorry, but the provided text describes a 510(k) premarket notification for a medical device called the "MCI - CMF System," which consists of bone plates and screws. This document focuses on demonstrating substantial equivalence to existing predicate devices, primarily through comparison of design, materials, indications for use, and a limited set of mechanical and biocompatibility tests.

There is no mention of an AI/algorithm-driven device, nor are there any acceptance criteria or studies related to AI model performance, accuracy, or human-in-the-loop studies involving expert readers.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study that proves a device meets acceptance criteria in the context of an AI/algorithm. The provided text simply does not contain this information.

To elaborate on why I cannot answer based on the provided text:

• No AI/Algorithm: The "MCI - CMF System" is a physical medical implant (bone plates and screws). It is not software, an algorithm, or an AI system.
• No Diagnostic Claims: The device is for "selective trauma of the midface, maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla, mandible and chin." These are surgical indications, not diagnostic. There's no AI that would be "reading" images or assisting in diagnosis.
• No Acceptance Criteria for AI Performance: Since it's a physical implant, the "performance" data refers to mechanical testing (e.g., bending fatigue of plates, pullout strength of screws) and biocompatibility, not AI metrics like sensitivity, specificity, AUC, or reader studies.
• No Test Set Details: There's no test set of patient data, as there's no AI to evaluate on such data.
• No Expert Ground Truth or Adjudication: These concepts are relevant for evaluating AI in diagnostic imaging or clinical decision support, which is not the function of this device.
• No MRMC or Standalone AI Study: These are types of studies specifically for AI performance evaluation.
• No Training Set Information: Again, training sets are for machine learning models, which are not described in this document.

The 510(k) summary concludes that the device is substantially equivalent based on engineering principles, material science, and the stated indications for use, compared to predicate devices already on the market.

Ask a specific question about this device

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.

Ask a specific question about this device