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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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