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The VHS™ Supracondylar Plate System is a compression fixation system used for the treatment of distal femoral fractures. It consists of adjustable plates, lag screws, compression screws and bone screws.

Materials: The devices are manufactured from 316 LVM or 22-13-5 stainless steel per ASTM standards.

Function: The system functions to provide immediate stability and temporary fixation during the natural healing process following fractures of the distal femur.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the VHS™ Supracondylar Plate System, a device used for treating distal femoral fractures. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring a detailed study proving the device meets specific performance acceptance criteria through clinical trials or extensive standalone AI performance evaluations.

Therefore, many of the requested categories are not applicable to a 510(k) submission for a medical device that isn't an AI/ML product. The document focuses on demonstrating that the new device has "no significant differences" to existing predicate devices in terms of design, function, material, and intended use, rather than presenting a performance study with specific acceptance criteria and detailed results from a test set.

Here's an attempt to address the points based on the provided text, indicating "Not Applicable" where the information is not present or relevant to a 510(k) for this type of device:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) submission for a mechanical implant (supracondylar plate system) and not an AI/ML diagnostic device, there are no specific numerical acceptance criteria (e.g., sensitivity, specificity, AUC) for the device's performance in the way an AI algorithm would be evaluated. The "acceptance criteria" for a 510(k) submission like this are met by demonstrating substantial equivalence to predicate devices. The "reported device performance" is essentially the finding of substantial equivalence.

Acceptance Criteria (for 510(k) Approval)	Reported Device Performance (as determined by FDA)
Device is substantially equivalent to legally marketed predicate devices in design, function, material, and intended use, with no significant differences that would adversely affect use.	The FDA reviewed the 510(k) notification and determined the device is substantially equivalent to devices marketed prior to May 28, 1976, or to reclassified devices. The FDA found "no significant differences... which would adversely affect the use of the product."

2. Sample size used for the test set and the data provenance: Not Applicable.
This is not an AI/ML diagnostic device. The substantial equivalence determination is based on a comparison of device characteristics to predicate devices, not on a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not Applicable.
No test set requiring expert ground truth was used for this type of submission.

4. Adjudication method for the test set: Not Applicable.
No test set or adjudication process for ground truth was involved.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not Applicable.
This device is a surgical implant, not an AI-assisted diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not Applicable.
This is not an algorithm.

7. The type of ground truth used: Not Applicable.
For a 510(k) for a medical device like this, the "ground truth" for substantial equivalence is regulatory comparison to existing devices and standards, rather than clinical outcomes or pathology data from a new study.

8. The sample size for the training set: Not Applicable.
This is not an AI/ML device.

9. How the ground truth for the training set was established: Not Applicable.
This is not an AI/ML device.

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