Search Results

Optimus CMF System is implantable bone plates and 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 system is comprised of plate and screw. The range of subject device plate's sizes is from 0.6 to 1.5mm thick. It is made of unalloyed Titanium (ASTM F67) and anodized in 4 colors (silver, blue, green and gold). The range of screw's diameters is from 1.3 to 2.0mm in lengths of 6.0 to 12mm. The screws are made of Ti-6AI-4V ELI titanium alloy (ASTM F136) and anodized in 3 colors (light blue, silver and gold).

The device is packed separately in a PE bag.The plate and screw aresingle use only, nonsterile products. The devices must be sterilized before use.

The screws are anodized in different colors to prevent confusion. The colors are selected for each model by diameter and so on. The devices are used as a pair (O-plate & O-screw, Fplate & F-screw) but sold individually (Not a kit or a set).

The IMF screw is for maxillomandibular fixation. The head has a relief groove in which wire or elastic bands can be wrapped around the screws which are temporarily implanted in the maxilla and mandible. It is intended for use as a bone screw in temporary fixation of the maxilla and mandible, providing indirect stabilization of fractures of the maxilla and/or the mandible. It is used independently, not with the plates.

This document is a 510(k) premarket notification for a medical device called the "Optimus CMF System," which consists of implantable bone plates and bone screws for maxillofacial and mandible surgery. As such, it primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving a device meets specific clinical performance acceptance criteria in the way an AI/ML device would.

Therefore, the requested information elements related to AI/ML device studies (such as sample size for test/training sets, experts for ground truth, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable to this submission. This document describes a physical medical implant, not a diagnostic or interpretative AI/ML system.

However, I can extract information related to the device's performance testing as a substitute for "acceptance criteria and reported performance" in the context of this device type.

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

The document describes non-clinical tests performed to evaluate the performance of the Optimus CMF System compared to predicate devices. The "acceptance criteria" here implicitly refer to demonstrating comparable or superior mechanical strength to legally marketed predicate devices, thereby establishing substantial equivalence.

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

• Sample Size: The document does not explicitly state the number of samples (plates/screws) used for each mechanical test. Standard ASTM testing methods usually specify a minimum number of samples, but this information is not detailed in this summary.
• Data Provenance: The tests were performed to support a submission by Osteonic Co., Ltd. (located in Seoul, Korea) to the FDA in the USA. The specific location where the testing was physically conducted is not mentioned. These are prospective engineering tests performed on the manufactured devices.

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)

Not applicable, as this is a non-AI physical device. Ground truth, in the context of these mechanical tests, is established by measurement instruments according to standardized ASTM protocols.

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

Not applicable, as this is a non-AI physical device.

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

Not applicable, as this is a non-AI physical device.

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

Not applicable, as this is a non-AI physical device.

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

The "ground truth" for the mechanical tests consists of objective measurements (e.g., force, displacement) obtained from standardized engineering tests (ASTM F382-14, ASTM F543-13) using calibrated equipment. For biocompatibility and sterilization, the ground truth is established by adherence to recognized standards and validated reports, often involving laboratory analyses.

8. The sample size for the training set

Not applicable, as this is a non-AI physical device and does not involve a training set.

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

Not applicable, as this is a non-AI physical device and does not involve a training set.

Ask a specific question about this device

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:

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.

Ask a specific question about this device