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The Omni Foot Plaing System is internal fixation of arthrodeses, osteotomies, fractures and nonunions of the small bones of the foot & ankle including the fore-, mid-, and hind foot and ankle applications.

The Omni Foot Plating System is a bone fixation system consisting of unalloyed Titanium plates and Titanium Alloy (Ti-6AL-4V) locking and non-locking plate screws, which meet ASTM F67 and ASTM F136, and a set of instruments used for implant site preparation and delivery. The plates are available in various configurations, essentially differing by the lengths and number of holes. The plate screws are provided in diameters of 2.8mm and 3.5mm in lengths from 8mm to 50mm. The System offers 3.5mm cannulated screws in various lengths to be used as adjunctive fixation. The 3.5mm cannulated screw can also be used with a specialized locking screw ("Post") which contains a locking feature at the distal end for compression/stabilization.

This document is a 510(k) premarket notification for the Omni Foot Plating System, a medical device. It does not describe an AI/ML device or present data from a study to prove a device meets acceptance criteria related to AI/ML performance. Instead, it demonstrates substantial equivalence to predicate devices through engineering analysis and materials comparison.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving device performance for an AI/ML system, as this document pertains to a traditional metallic bone fixation system.

Specifically:

1. Table of acceptance criteria and reported device performance: Not applicable. This document is about a mechanical device, not an AI/ML system with performance metrics like sensitivity, specificity, etc.
2. Sample size for test set and data provenance: Not applicable. No test set for AI/ML performance. The engineering analysis compares mechanical properties.
3. Number of experts and qualifications for ground truth: Not applicable. Ground truth as typically defined for AI/ML (e.g., disease diagnosis) is not relevant here.
4. Adjudication method for test set: Not applicable.
5. MRMC comparative effectiveness study: Not applicable. This is not an AI-assisted diagnostic device.
6. Standalone (algorithm only) performance: Not applicable. This is a physical device, not an algorithm.
7. Type of ground truth used: Not applicable for AI/ML. The "ground truth" for this device's performance would be engineering standards and material properties, confirmed by engineering analysis.
8. Sample size for training set: Not applicable. There is no AI/ML model to train.
9. How ground truth for training set was established: Not applicable.

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The Omni Foot Plating System is intended for use in internal fixation, reconstruction, or arthrodesis of the 1st Metatarsalphalangeal joint.

The Omni Foot Plating System is a bone fixation system consisting of unalloyed Titanium plates and Titanium Alloy (Ti-6AL-4V) locking and non-locking plate screws, which meet ASTM F67 and ASTM F136, and a set of instruments used for implant site preparation and delivery. The plates are available in various configurations, essentially differing by the lengths and number of holes. The plate screws are provided in diameters of 2.8mm and 3.5mm in lengths from 8mm to 50mm. The System offers 3.5mm cannulated screws in various lengths to be used as adjunctive fixation. The 3.5mm cannulated screw can also be used with a specialized locking screw ("Peg") which contains a locking feature at the distal end for compression/stabilization.

The provided document is a 510(k) premarket notification for the Omni Foot Plating System, which is a metallic bone fixation device. This type of device is classified as a Class II medical device. For such devices, clinical performance studies using patient data (like those involving AI-powered diagnostic tools) are typically not required, as substantial equivalence is often demonstrated through technological comparison, engineering analysis, and non-clinical bench testing.

Therefore, the requested information regarding acceptance criteria and studies proving the device meets those criteria, particularly aspects like sample size for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth for training data, is not applicable to this type of device submission.

The document explicitly states under "Clinical Testing": "No clinical testing was performed."

Instead, the acceptance criteria and proof of meeting them for the Omni Foot Plating System are based on:

1. Technological Comparison: Demonstrating that the design, materials, and principle of operation are substantially equivalent to legally marketed predicate devices.
2. Engineering Analysis: Detailed analysis of the device's design and function.
3. Mechanical/Bench Testing: Physical tests conducted in a laboratory setting to verify performance specifications.

Here's a breakdown of the relevant information provided for the Omni Foot Plating System in relation to its acceptance criteria:

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

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

• Not Applicable. No human subjects test set or clinical data was used for this submission. The "test set" primarily refers to the physical samples of the device components used for bench testing. The document does not specify the exact number of samples tested for each bench test (e.g., how many screws were tested for pullout strength).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. Ground truth, in the context of clinical studies with human data, is not relevant here. Device equivalence was established through engineering principles and mechanical testing, which would involve qualified engineers and technicians performing the tests.

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

• Not Applicable. Adjudication methods apply to the interpretation of clinical data by multiple experts. Not relevant for this type of device submission.

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. The device is a physical implant, not an AI-powered diagnostic tool. MRMC studies are not relevant.

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

• Not Applicable. This is a physical medical device, not an algorithm.

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

• Not Applicable. For this device, the "ground truth" for demonstrating safety and effectiveness is primarily established through adherence to engineering design specifications, material standards (ASTM), and the results of validated mechanical bench tests demonstrating properties (like pullout strength, torque, static bend) that are equivalent to or meet the requirements of predicate devices.

8. The sample size for the training set:

• Not Applicable. "Training set" refers to data used to train algorithms, which is not relevant for this physical device.

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

• Not Applicable. As per point 8, there is no training set in the context of this device submission.

In summary, the 510(k) submission for the Omni Foot Plating System relies on non-clinical data (engineering analysis and mechanical bench testing) to demonstrate substantial equivalence to predicate devices, rather than clinical studies with human data. Therefore, many of the questions related to clinical study design and data analysis are not applicable.

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