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Materialise Personalized Guides for Craniomaxillofacial Surgery are intended to guide the marking of bone and or guide surgical instruments in facial surgery.

CMF Titanium Guides are used during bone repositioning/reconstruction surgical operations for orthognathic and reconstruction (including bone harvesting) indications.

CMF Titanium Guides are intended for children, adolescents and adults.

CMF Titanium Guides are intended for single use only.

CMF Titanium Guides are to be used by a physician trained in the performance of maxillofacial surgery.

Materialise Personalized Models for Craniomaxillofacial Surgery are intended for visualization of the patient's anatomy, preparation of surgical interventions and fitting or adjustment of implants or other medical devices such as osteosynthesis plates or distractors, in mandibular and maxillofacial surgical procedures.

CMF Plastic Models are intended for infants, children, adolescents and adults.

CMF Plastic Models are intended for single use only.

CMF Plastic Models are to be used by a physician trained in the performance of maxillofacial surgery.

Materialise Personalized Guides and Models for Craniomaxillofacial Surgery combines the use of 3D preoperative planning software with patient-matched guides and models to improve and simplify the performance of surgical interventions by transferring the pre-operative plan to surgery. Materialise Personalized Guides and Models for Craniomaxillofacial Surgery are used in the facial skeleton or in maxillofacial surgeries.

The surgical planning is based on medical images of the patient that are segmented in order to create a 3D representation of the patient's anatomy. The surgical treatment of the patient is simulated based on instructions provided by the surgeon and the patient-matched devices are tailored to the treatment and the patient's needs. The patient-matched devices are manufactured from commercially pure Titanium, polyamide, or clear acrylic by means of additive manufacturing technologies. The patient-matched devices are provided non-sterile.

Materialise Personalized Guides and Models for Craniomaxillofacial Surgery include CMF Titanium Guides and CMF Plastic Models.

The provided text is a 510(k) summary for the device "Materialise Personalized Guides and Models for Craniomaxillofacial Surgery." It details the device's indications for use, description, comparison to predicate and reference devices, and non-clinical performance data. However, it does not include information about AI/algorithm performance, acceptance criteria for such an algorithm, or a clinical study for proving the device meets those criteria. The document lists "non-clinical testing" and states that "no guide specific mechanical testing is performed but this is covered by mechanical analysis of CMF Titanium Plates."

Therefore, I cannot extract the information required for an AI device acceptance criteria and study from this document. The document primarily focuses on the substantial equivalence of the physical, patient-matched guides and models to existing devices, covering aspects like material compatibility, mechanical properties, biocompatibility, and sterilization.

To answer your request, the ideal information would be present in a document describing an AI/ML medical device, which would typically contain details regarding the algorithm's performance metrics (acceptance criteria), the dataset used for testing, ground truth establishment, and potential MRMC studies. This document does not describe such a device.

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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.

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The MedCAD® AccuPlate® 3DTi Patient-Specific Plating System is intended for use in the stabilization, fixation, and reconstruction of the maxillofacial / midface and mandibular skeletal regions in adolescents (greater than 12 to 21 years of age) and adults.

The MedCAD AccuPlate® 3DTi Patient-Specific Plating System is a metal bone plate used in conjunction with commercially available, non-locking metal bone screws for the fixation to bone in orbital, midface / maxillofacial, and non-continuity mandibular operations. The design and dimensions of each plate within the envelope specification is based upon the patient's anatomical data (CT scan, CBCT scan, or MRI), and the intended anatomy to be fixated as determined from input provided by the surgeon. The subject device is not intended to be bent or modified in surgery. If for any reason the surgeon chooses not to use the subject device in surgery, they may use any of the commercially available plates to complete the surgery. The subject device is additively manufactured from Ti-6AL-4V Extra Low Interstitial (ELI) titanium alloy, provided non-sterile, must be sterilized prior to use, and is intended for single use only. Plates are fastened to bone using commercially available non-locking bone screws with diameters ranging from 1.5mm to 2.7mm and lengths ranging from 3.5mm to 22mm.

Here's a summary of the acceptance criteria and study information for the MedCAD® AccuPlate® 3DTi Patient-Specific Plating System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance letter mentions the following non-clinical performance tests. The acceptance criteria are implied to be "equivalent" to identified reference devices.

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

The document does not explicitly state the sample sizes (number of devices or tests) for the non-clinical performance tests (bending, pushout, fit and form validation). It also does not specify the country of origin of the data or whether the studies were retrospective or prospective, as these are non-clinical (mechanical and material) performance tests rather than clinical studies with patient data.

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

This information is not explicitly provided in the document. For non-clinical performance tests, "ground truth" is typically established by engineering standards and validated testing procedures, not by human experts in the same way as clinical image interpretation. The "Fit and Form Validation" mentions alignment with an "approved surgical plan," which would involve surgical expertise in its creation, but the number and qualifications of individuals involved in approving these plans or assessing the fit are not detailed.

4. Adjudication Method for the Test Set

Not applicable for these types of non-clinical, objective performance tests. Adjudication methods like 2+1 or 3+1 are typically used for subjective clinical interpretations by multiple readers (e.g., radiologists) in diagnostic accuracy 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

No such study was mentioned. The MedCAD® AccuPlate® 3DTi Patient-Specific Plating System is a patient-specific surgical implant, not an AI-assisted diagnostic tool.

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

This concept is not directly applicable. The device itself is an implant. However, the "patient specific design process" for creating the implant is an "algorithm only" type of process in that it uses patient anatomical data to generate the device design. The "Fit and Form Validation" likely assessed the output of this design process against the intended surgical plan. The document states that the design process "was shown to produce devices that aligned with the approved surgical plan," indicating successful standalone performance of the design software.

7. The Type of Ground Truth Used

• Biocompatibility: Established by adherence to ISO 10993 standards and FDA guidance.
• Sterilization Validation: Established by adherence to ISO 17665 standards and FDA guidance, with a specific SAL target.
• Static and Dynamic Bending: Established by ASTM F382 standard, with comparison to a reference device's known performance.
• Axial Screw Pushout: Established by ASTM F543 standard, with comparison to a reference device's known performance.
• Fit and Form Validation: Established by alignment with an "approved surgical plan." This likely involves a comparison of the 3D-printed plate geometry with the virtual surgical plan derived from patient imaging data, which can be considered "design ground truth."

8. The Sample Size for the Training Set

The document does not describe the development or training of an AI algorithm in the traditional sense, so there is no mention of a training set sample size. The "patient-specific design software" is mentioned as being the same as a reference device (K192282), implying it's a previously validated system rather than a newly trained AI model.

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

As no training set for an AI algorithm is described, this information is not applicable.

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