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CranioMaxillofacial Fixation (CMF) System - CMF Visionare 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 subject device is a fixation system consisting of plates and screws in a variety of shapes and sizes. All plates are made of commercially pure titanium conforming to ASTM F67, and all screws are made of Ti-6Al-4V alloy conforming to ASTM F136. The subject device includes the following groups: 1.5 System Plate, 2.0 System Plates, 2.4 System Plates, Orthognathic Plates, Blocking Screws (for intermaxillary fixation, 2.0 mm diameter), and screws for use with the various plates ranging in diameter from 1.5 mm to 2.7 mm.

It looks like the provided text is a 510(k) Summary for a CranioMaxillofacial Fixation (CMF) System, which is a medical device. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study.

Therefore, the input request asking for:

1. A table of acceptance criteria and reported device performance
2. Sample sizes for test set and data provenance
3. Number and qualifications of experts for ground truth
4. Adjudication method
5. MRMC comparative effectiveness study results
6. Standalone performance
7. Type of ground truth
8. Sample size for training set
9. How ground truth for training set was established

cannot be fully answered from the provided text. The document describes non-clinical data (mechanical testing, dimensional analysis, biocompatibility) to show equivalence, not clinical study results with acceptance criteria.

Here's what can be extracted and inferred from the text:

1. A table of acceptance criteria and the reported device performance

There isn't a table of "acceptance criteria" for clinical performance. The "performance data" reported in the document is non-clinical, demonstrating mechanical and material properties. The acceptance criterion for the 510(k) submission itself is "substantial equivalence" to predicate devices.

Non-clinical Performance Data Reported:

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

This information is not provided as the submission relies on non-clinical engineering and laboratory testing, not a clinical test set.

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)

This information is not applicable/not provided as there was no clinical test set requiring expert ground truth for performance evaluation.

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

This information is not applicable/not provided for the same reason as above.

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

This information is not applicable/not provided. The device is not an AI-assisted diagnostic tool; it's a physical fixation system. No clinical comparative effectiveness study is mentioned, particularly an MRMC study.

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

This information is not applicable/not provided. The device is not an algorithm.

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

For the non-clinical tests, the "ground truth" implicitly refers to established engineering standards (ASTM, ISO) for mechanical properties, material composition, and sterilization. For the comparison to predicate devices, the "ground truth" is the design and performance characteristics of the legally marketed predicate devices.

8. The sample size for the training set

This information is not applicable/not provided as the device is not an AI/ML algorithm requiring a training set.

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

This information is not applicable/not provided for the same reason as above.

Summary of what the document focuses on instead:

The document describes a substantial equivalence claim for the CranioMaxillofacial Fixation (CMF) System - CMF Visionare. This means the manufacturer is asserting their device is as safe and effective as a legally marketed predicate device, and does not raise new questions of safety or effectiveness. This is primarily established through:

• Comparison of Indications for Use: The indications for use are reported as "identical" to the primary predicate device (K102641), with the only difference being the device names.
• Comparison of Technological Characteristics: Detailed tables (Tables 1-6) are provided comparing the subject device's plates (1.5 System, 2.0 System, 2.4 System, Orthognathic) and screws (Blocking, other screws) to those of the primary predicate device and several reference devices. These comparisons cover plate designs, dimensions (thickness, overall sizes, hole configurations), screw dimensions (diameter, threaded length), and material composition.
• Non-clinical Performance Data:
  • Sterilization validation: Conformed to ANSI/AAMI/ISO 17665-1 and ANSI/AAMI/ISO 14937.
  • Biocompatibility testing: Conformed to ISO 10993-5 and ISO 10993-12 (cytotoxicity testing).
  • Dimensional analysis: Engineering analysis of cross-sectional dimensions and bending moments of inertia "compared favorably" to predicate/reference devices.
  • Mechanical testing: Performed according to ASTM F382 (single cycle bending fatigue) and ASTM F543 (torsional properties, driving torque, axial pullout, self-tapping performance). The implication is that these tests demonstrate performance comparable to predicate devices.
• Material Equivalence: All subject device plates are CP titanium, and all screws are Ti-6Al-4V alloy, which are stated to be substantially equivalent to the materials of the primary predicate and most reference devices. A minor difference in screw alloy (Ti-6Al-7Nb) for some reference devices is identified but deemed not to affect intended use or raise new safety/effectiveness questions.

In essence, the study presented is a design and performance comparison against existing, cleared devices and recognized standards, rather than a clinical trial with specific performance acceptance criteria.

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For use in the stabilization and fixation of mandibular fractures and mandibular reconstructive surgical procedures.

The Biomet Microfixation PreBent Plates with Virtual Surgical Planning is comprised of a variety of titanium plates with shapes and sizes designed for internal fixation for mandible reconstruction procedures. The plates include variations of straight, angle, curved, Y-shape, double Y-shape, and matrix, options with various lengths and thickness. Plates are offered flat or pre-bent. Pre-bent plates are contoured by Biomet Microfixation per surgeon specifications or patient specific anatomical model and include patient specific guides and instruments, of the VSP System (K120956, cleared December 12, 2012). The VSP System is used by Medical Modeling to create the guides, instrumentation and a patient specific anatomical model from CT scans provided by a surgeon. Medical Modeling uses the surgeon information to create the anatomical patient specific model. The anatomical patient specific model is then used to aide in proper alignment and bending of the plates previously cleared under K063052 (cleared 01/12/07), K113152 (cleared 06/29/12), and K081067 (cleared 05/09/08). This bending process is conducted at Biomet Microfixation based on our process specification and inspection criteria previously cleared with K063052.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies:

Acceptance Criteria and Study for Biomet Microfixation PreBent Plates with Virtual Surgical Planning

Based on the provided 510(k) summary, the device submission does not include specific acceptance criteria or performance data for the "PreBent Plates with Virtual Surgical Planning" device itself. Instead, the submission relies on the substantial equivalence principle, arguing that the new device is essentially the same as previously cleared predicate devices, with an added option of using the VSP system for pre-bending.

The core argument is that the pre-bent plates are "100% verified to the Medical Modeling output, anatomical model, for every case," which implies that the accuracy of the bending process is continuously checked against a patient-specific anatomical model created by Medical Modeling.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document states that "no additional testing was conducted on the subject plates" because they "are identical" to cleared predicate devices, with the only difference being the method of shaping (using the VSP system and patient-specific guides/instruments). The acceptance criteria are, therefore, implicitly tied to the established safety and effectiveness of the predicate devices and the verification of the custom bending process.

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

• Sample Size for Test Set: Not applicable. No dedicated test set, clinical, or non-clinical testing was performed for the current submission. The justification for safety and effectiveness is based on substantial equivalence to predicate devices and a process specification for bending and inspection.
• Data Provenance: Not applicable, as no new testing data was generated for this submission. The "provenance" for the justification comes from the cleared status of the predicate devices and Biomet Microfixation's internal process specifications for plate bending and inspection.

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

• Number of Experts: Not applicable. No specific expert review of a test set for this submission is mentioned. The "ground truth" for the pre-bent plates is the patient-specific anatomical model generated by Medical Modeling from CT scans provided by the surgeon.
• Qualifications of Experts: The CT scans are provided by a "surgeon," and Medical Modeling creates the anatomical model. The document does not specify the qualifications of the surgeons or the personnel at Medical Modeling involved in creating the anatomical models.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No test set requiring expert adjudication was used. The verification process is described as "100% verified to the Medical Modeling output, anatomical model, for every case," implying a direct comparison rather than an adjudication process.

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

• Was an MRMC study done? No.
• Effect Size of Human Readers Improve with AI vs. without AI assistance: Not applicable. This device is a physical medical implant (bone plates) and a virtual surgical planning process for custom-bending these plates, not an AI diagnostic algorithm that assists human readers in interpreting images.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Was a standalone study done? No. This device is not an algorithm for standalone performance evaluation in the typical sense (e.g., diagnostic image analysis). The "Virtual Surgical Planning" aspect refers to the use of software (the VSP System) to create patient-specific models and guides that aid in the manual pre-bending of plates, which is then verified.

7. Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for the custom bending of the plates is the patient-specific anatomical model created by Medical Modeling from the patient's CT scans. This model dictates the precise contours to which the plates are bent.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device submission is for a physical implant (pre-bent plates) and a process, not a machine learning algorithm that requires a training set. The VSP system (K120956), which creates the anatomical model, would have had its own validation/verification at the time of its clearance, but details of its training set are not part of this submission.

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

• How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this device in the context of the current submission.

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