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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 traCMF 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 rapid prototyping portion of the system that produces physical outputs including anatomical models, surgical guides, and dental splints for use in maxillofacial and mandibular surgery. The surgical guides and dental splints are intended to the maxillofacial and mandibular bone in mandibular surgery. The tmCMF Solution is also intended as a preoperative software tool for simulating/evaluating surgical treatment options.

The TechMah CMF (tmCMF) Solution is a family of personalized product solutions for trauma and reconstruction procedures in the mandible and midface. The solution is comprised of Surgeon Review Tool (SRT) software, and maxillofacial and mandibular surqical instruments (surgical quides, anatomical models, and dental splints). The surqical instruments are patient-specific devices and are designed utilizing CT and dental scan patient image data.

Surgical guides are patient-specific devices or templates that are based on preoperative software planning and are 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 of bone for plate fixation screws and the position of the osteotomy marking slots. Surgical guides are available for treatment (maxilla and mandible) and harvesting (fibula, iliac crest, and scapula). Guides can be used in conjunction with anatomical models to verify anatomical positioning and fit.

Anatomical models are patient-specific models that are based on pre-operative anatomy and surgical planning specific to a patient. These models are used to assist a surgeon in transferring the pre-operative plan to the surgery by representing preoperative, intra-operative, and post-operative anatomical models as guidance. Anatomical models are available for treatment (maxilla and mandible), and harvesting (fibula, iliac crest, and scapula) anatomy. Anatomical models can be used to check quide fit.

Dental splints are patient-specific devices or templates that are based on preoperative software surgical planning and are designed to fit a specific patient. Dental splints are available as single splint desired occlusions or combined splint-in-splint option. 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.

The Surgeon Review Tool (SRT) software is used by surgeons for the review and approval of surgical plans and surgical instrument designs. The SRT software is accessed through a web interface from a surgeon's device.

The tmCMF Solution's acceptance criteria and the study proving it meets these criteria are detailed below.
1. A table of acceptance criteria and the reported device performance:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Cadaveric Benchtop Performance Testing" as part of the benchtop performance evaluation. However, it does not specify the sample size (number of cadavers or cases) used for this test set, nor does it explicitly state the country of origin or whether the data was retrospective or prospective. It only states that a comparison of pre-operative surgical plan to post-operative CT measurements was performed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document does not provide information on the number of experts used to establish the ground truth for the test set or their specific qualifications. It mentions that the "Surgeon Review Tool (SRT) software is used by surgeons for the review and approval of surgical plans and surgical instrument designs," implying surgeon involvement in the process but not specifically for ground truth establishment for a test set in the regulatory submission context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not describe any specific adjudication method (such as 2+1 or 3+1) used for establishing ground truth or evaluating the test set.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size related to human reader improvement with or without AI assistance. The tmCMF Solution is described as a software system for image segmentation, surgical planning, and the production of physical outputs, with the Surgeon Review Tool (SRT) facilitating surgeon review and approval, but not explicitly as an AI assistance tool for human readers in a diagnostic setting that would typically involve a MRMC study.

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

While the document describes the tmCMF Solution as a "software system and image segmentation system," it also highlights the "Surgeon Review Tool (SRT) software is used by surgeons for the review and approval of surgical plans and surgical instrument designs" and "Physician Interaction with Planning and Physician Model / Guide Approval." This indicates that the device is intended for human-in-the-loop performance, with the surgeon involved in the review and approval process. A standalone algorithm-only performance is not explicitly described as a primary evaluation method.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the "Cadaveric Benchtop Performance Testing," the ground truth was established by "Comparison of pre-operative surgical plan to post-operative CT measurements." This suggests that the ground truth for accuracy was based on direct measurement from CT scans after the surgical plan was implemented on cadavers, rather than expert consensus, pathology, or long-term outcomes data.

8. The sample size for the training set

The document does not provide any information regarding the sample size used for the training set of the tmCMF Solution's "software system and image segmentation system."

9. How the ground truth for the training set was established

The document does not disclose how the ground truth for the training set was established.

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The OsteoPlan™ System 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 OsteoPlan™ System and the result is an output data file that may then be provided as digital models or used as input to the additive manufacturing portion of the system that produces physical outputs including anatomic models and splints for use in maxillofacial surgery. The OsteoPlan System is also intended as a pre-operative software tool for simulating / evaluating surgical treatment options.

OsteoMed uses computer aided modeling to assist the physician with planning complex maxillofacial surgeries. Specifically, the OsteoPlan™ System provides patient-specific anatomical models, splints, and patient-specific surgical plans and digital files of the surgical plan to assist physicians with maxillofacial surgeries. Outputs of the OsteoPlan™ System are designed with physician input and reviewed by the physician prior to finalization and distribution. All outputs are manufactured by OsteoMed using additive manufacturing (SLS and SLA), only with direct physician involvement to reduce the criticality of the outputs.

The system uses electronic medical images of the patient anatomy (CT and CBCT) with input from the physician to create the plan and splints for executing surgery. Off-the-shelf (OTS) software is used for surgical planning.

The outputs of the system include Orthognathic Occlusal Splints, Case Reports, and Anatomic models. The splints are offered in commonly used forms, in both intermediate and final positioning, and some are available with ligature holes.

Case reports are digital and physical documents created to lay out the surgical plan, dictated by the surgeon, and show outputs of the OsteoPlan™ system that will be used to translate the plan during surgery.

Anatomic models are tools provided to physicians for complex anatomy visualization or to preplan surgery with an accurate physical representation of patient anatomy. Anatomic models may include maxilla, mandible, or skull models.

This Premarket Notification (510(k)) summary for the OsteoPlan System does not include specific details on acceptance criteria and device performance in the format requested. The document focuses on establishing substantial equivalence to predicate devices through a comparison of technological characteristics and a summary of non-clinical testing.

Here's what can be extracted and what information is not present based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the given text in a quantifiable table format for the OsteoPlan System's primary functions (e.g., accuracy of segmentation, precision of surgical planning). The document generally states that "All testing passed" or "all acceptance criteria being met" for various validations, but doesn't detail what those criteria were nor the specific performance metrics achieved.

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

This information is not explicitly provided for the software's core functionality (image segmentation, surgical planning).

• For the "Cadaver Study," a "simulated use" study was conducted, indicating a test set was used, but its size and specific provenance (e.g., number of cadavers, country of origin) are not mentioned. The study is prospective in nature as it verified the functionality of the design.

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

This information is not provided. The document states that "Outputs of the OsteoPlan™ System are designed with physician input and reviewed by the physician prior to finalization and distribution," implying expert involvement in the design and review process, but it doesn't specify how many experts or their qualifications for establishing ground truth in a formal validation test set.

4. Adjudication Method for the Test Set

This information is not provided.

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

This information is not mentioned. There is no indication of a comparative effectiveness study comparing human readers with and without AI assistance.

6. Standalone Performance

The document mentions "Software Validation and documentation for software of moderate level of concern was provided per the FDA Guidance Document 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices' and 'Off-The-Shelf Software Use in Medical Devices.' All software verification/validation passed." This indicates that standalone testing of the software was performed, but the specific standalone performance metrics (e.g., accuracy, precision) are not detailed. It states "The OsteoPlan™ System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner... The input data file is processed by the OsteoPlan™ System and the result is an output data file," implying standalone operation.

7. Type of Ground Truth Used

For the software's core functions (segmentation, planning), the specific type of ground truth (e.g., expert consensus on anatomies, pathology reports) used for validation is not explicitly stated. Given the pre-operative planning nature, it would likely involve expert consensus or established anatomical landmarks.

8. Sample Size for the Training Set

This information is not provided. The document doesn't mention a training set, which is typical for AI/ML models. However, the OsteoPlan System is described as using "Off-the-shelf (OTS) software used for surgical planning," suggesting it might be an adaptation or integration of existing tools rather than a completely novel AI model requiring extensive de novo training data for its core algorithms.

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

This information is not provided, as no training set is mentioned.

Summary of available information regarding acceptance criteria and performance:

The document broadly states that various non-clinical tests were conducted and "all acceptance criteria being met" or "All testing passed." These tests cover:

• Equipment/Process Qualification (IQ/OQ/PQ)
• Software Validation (for moderate level of concern)
• Cleaning Validations
• Steam Sterilization Validation
• Biocompatibility testing (cytotoxicity, sensitization, irritation, acute toxicity, pyrogenicity, subchronic toxicity, implantation) for worst-case splint and anatomical model
• Packaging Validation
• Shelf Life (functional testing)
• Cadaver Study (simulated use to verify design functionality)

Crucially, the document does not provide the specific quantifiable acceptance criteria or the numerical results of performance tests for the software's primary functions of image segmentation or surgical planning accuracy. Instead, it relies on a general statement of "all testing passed" and "performance equivalence was shown through the verification comparison to the predicate device" to establish substantial equivalence.

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