(378 days)
Optimus CMF System is implantable bone screws for maxillofacial and mandible surgery procedures including: 1. Fractures - 2. Osteotomies - 3. Reconstructive procedures - 4. Revision procedures where other treatments or devices have failed.
The OPTIMUS CMF SYSTEM comprises plates and screws. The plate thickness sizes range from 0.4 to 2.6mm. They are made of unalloyed Titanium (ASTM F67) and anodized in four colors (silver, blue, green, and gold). The diameters of the screws range from 1.3 to 2.7mm, while lengths range from 3.0 to 20.0mm. They are made of Ti-6A1-4V ELI titanium alloy (ASTM F136) and anodized in six colors (light blue, silver, purple, blue, gold and green). The plates and screws are single use only, non-sterile products. They must be sterilized before use.
The provided document is a 510(k) premarket notification for the Optimus CMF System, which is a medical device consisting of implantable bone plates and screws for maxillofacial and mandible surgery. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a comparative study with a ground truth.
Therefore, many of the requested details about acceptance criteria and a study proving their attainment are not directly available in this type of regulatory submission. The document primarily describes non-clinical testing performed to show the device's performance and safety.
Here's an analysis based on the provided document, highlighting what is (and isn't) present:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" for clinical performance metrics (like sensitivity, specificity, accuracy) alongside reported device performance in a clinical setting. Instead, it details non-clinical testing to demonstrate the device's physical and biocompatibility performance against established standards.
Acceptance Criteria (Implied by Standards) & Reported Device Performance:
| Acceptance Criteria (Implied by Standard) | Reported Device Performance (Summary) |
|---|---|
| Mechanical Performance: | |
| - ASTM F382-99(2008)e1 (4-Point Bending) | Test results supported substantial equivalence to predicate devices. |
| - ASTM F543-13e1 (Torsion and Axial Pullout Strength) | Test results supported substantial equivalence to predicate devices. |
| Biocompatibility: | |
| - ISO 10993-5 (Cytotoxicity) | Test results supported substantial equivalence to predicate devices. |
| - ISO 10993-10 (Sensitization) | Test results supported substantial equivalence to predicate devices. |
| - ISO 10993-3 (Genotoxicity) | Test results supported substantial equivalence to predicate devices. |
| - ISO 10993-6 (Implantation) | Test results supported substantial equivalence to predicate devices. |
| Sterilization Validation: | |
| - ANSI/AAMI ST79, ISO 17665-1, ISO 11737-1, USP 30-NF25 (Microbial Limited Test) | Test results supported substantial equivalence to predicate devices. |
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 in the document. The testing described is non-clinical (mechanical, biocompatibility, sterilization) and typically involves samples of the device components, not human subjects or clinical data sets in the way an AI diagnostic device would.
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 and not provided. The device is an implantable bone plate and screw system, not an AI diagnostic tool that requires expert-established ground truth from clinical data. The performance is assessed through standardized engineering and biological tests, not expert interpretation of images or other data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. As explained above, this is not an AI diagnostic study where adjudication of expert opinions would be necessary.
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 and not provided. The Optimus CMF System is a physical implantable device, not an AI software for diagnostic assistance. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. This device is not an algorithm or AI system, so standalone performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The concept of "ground truth" as it applies to diagnostic accuracy studies is not applicable to this device. For the non-clinical tests performed, the "ground truth" is established by the accepted scientific and engineering principles underpinning the ASTM and ISO standards (e.g., precise measurement of force, observation of cellular reactions, sterility checks). The performance is compared against the requirements of these standards and against predicate devices.
8. The sample size for the training set
This information is not applicable and not provided. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable and not provided for the same reasons as point 8.
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.