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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 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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KLS Martin Individual Patient Solutions (IPS) is intended as a pre-operative software tool for simulating / evaluating surgical treatment options as a software and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The is processed by the IPS software and the result is an output data file that may then be provided as digital models or used as input in an additive manufacturing portion of the system that produces physical outputs including implants, anatomical models, guides, splints, and case reports for use in maxillofacial, midface, & mandibular surgery.

KLS Martin Individual Patient Solutions (IPS) implant devices are intended for use in the stabilization, fixation, and reconstruction of the maxillofacial / midface and mandibular skeletal regions in children (2 years of age), adolescents (12 years of age - 21 years of age), and adults.

KLS Martin Individual Patient Solutions (IPS) is comprised of a collection of software and associated additive manufacturing equipment intended to produce various outputs to support reconstructive and orthognathic surgeries. The system processes the medical images to produce various patient-specific physical and/or digital output devices which include implants, anatomical models, guides, splints, and case reports.

Patient-specific metallic bone plates are used in conjunction with metallic bone screws for internal fixation of maxillofacial, midface, and mandibular bones. The devices are manufactured based on medical imaging (CT scan) of the patient's anatomy with input from the physician during virtual planning and prior to finalization and production of the device. The physician provides input for model manipulation and interactive feedback by viewing digital models of planned outputs that are modified by trained KLS Martin engineers during the planning session. For each design iteration, verification is performed by virtually fitting the generated output device over a 3D model of the patient's anatomy to ensure its dimensional properties allow an adequate fit.

Implants are provided non-sterile and are manufactured using traditional (subtractive) or additive manufacturing methods from either CP Titanium (ASTM F67) or Ti-6AI-4V (ASTM F136). These patient-specific devices are fixated with previously cleared KLS Martin screws.

Here's a summary of the acceptance criteria and study information for the KLS Martin Individual Patient Solutions device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the KLS Martin Individual Patient Solutions device primarily revolve around demonstrating substantial equivalence to predicate devices and ensuring the safety and effectiveness of the device, particularly for the expanded pediatric population and new specifications. The performance is assessed through various non-clinical tests and a review of clinical literature.

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The Additive Orthopaedics 3D Printed Bone Segments are intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as:

*Cotton (opening wedge) osteotomies of the medial cuneiform *Evans lengthening osteotomies

The Additive Orthopaedics 3D Printed Bone Segments are intended for use with ancillary plating fixation.

The Additive Orthopaedics 3D Printed Bone Segments are not intended for use in the spine.

It is a patient specific device.

The Additive Orthopaedics Patient Specific 3D Printed Bone Segments is a simple one piece device constructed individually for each patient using CT image data. It is intended to be used for internal bone fixation for bone fractures or osteotomies in the foot and ankle. The segments are additively manufactured from medical grade titanium alloy (Ti-6AL-4V Eli). It is a patient specific device. The bone segments come in a variety of configurations that depend on the geometry of the application. The surgeon approves the design of the 3D Printed Bone Segments by comparing his/her design requirements to engineering drawings prior to the construction of the implant device.

This is a 510(k) premarket notification for a medical device, not an AI/ML device. Therefore, the requested information about acceptance criteria and studies (such as MRMC, standalone performance, ground truth, sample sizes for training/test sets, and expert qualifications) is not typically found in this type of document because it pertains to the evaluation of AI/ML algorithm performance.

Here's what can be extracted from the document regarding the device's evaluation, rephrased to align with the spirit of the request, focusing on how the device meets the regulatory requirements for "substantial equivalence":

Device Name: Additive Orthopaedics Patient Specific 3D Printed Bone Segments
510(k) Number: K180239

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a non-AI/ML device submission, there are no "acceptance criteria" in the traditional sense of performance metrics like AUC, sensitivity, or specificity. Instead, the "acceptance criteria" are related to demonstrating substantial equivalence to a predicate device. The "performance" is shown through comparative testing against that predicate.

Study Proving Device Meets Criteria (Substantial Equivalence Study):

The submission highlights a substantial equivalence study based on non-clinical evidence.

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

This information is not applicable and not provided in the document. The evaluation is based on demonstrating equivalence in materials, manufacturing, indications, and non-clinical performance characteristics (morphological, mechanical, biocompatibility) rather than a "test set" of patient data for an algorithm. The "data" here refers to test results from the device itself and the predicate.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not applicable. "Ground truth" in the context of an AI/ML device (e.g., expert consensus on medical images) is not relevant for this type of device submission. The verification of the patient-specific design is done by the surgeon.

4. Adjudication Method for the Test Set:

Not applicable. There is no "test set" in the sense of evaluating diagnostic performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, which doesn't apply to this 3D-printed bone segment device.

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

Not applicable. This device is a physical, patient-specific implant, not a standalone algorithm.

7. The type of ground truth used:

The concept of "ground truth" (e.g., pathology, outcomes data) as it applies to AI/ML diagnostic or prognostic devices is not relevant here. For device design, the "ground truth" for the patient-specific geometry is derived from the patient's CT image data and subsequently "verified by the surgeon."

8. The Sample Size for the Training Set:

Not applicable. There is no machine learning "training set" for this device. The device is custom-designed for each patient based on their CT scan data.

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

Not applicable, as there is no training set. The patient-specific designs are generated using individual patient CT image data, and the final design is approved by the surgeon.

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