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.

Summary

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991806

Summary of Safety and Effectiveness for VHS™ Supracondylar Plate System

This safety and effectiveness summary for the VHS™ Supracondylar Plate System is provided as required per Section 513(i)(3) of the Food, Drug and Cosmetic Act.

1. Submitter :	Contact Person :
Walter Abendschein, M.D.	Walter Abendschein, M.D.
5530 Wisconsin Avenue, Suite 705	5530 Wisconsin Avenue, Suite 705
Chevy Chase, Md. 20815	Chevy Chase, Md. 20815
	Telephone: (301) 656 4317

Date Prepared: May 26,1999

Telephone: (301) 656-4317

2. Tradename:	VHS TM Supracondylar Plate System
Common Name:	Supracondylar Plate System
Classification Name:	Single/ multiple component metallic bone fixation appliances and accessories(888.3030)

3. Predicate or legally marketed devices which are substantially equivalent:

Compression Hip Screw Supracondylar Compression Tube & Plate System ( Zimmer ) .
. AMBI Hip Screw System ( S &N Richards )
DHS / DCS Dynamic Hip and Condylar Screw System ( Synthes ) ●
Versa-Fx Femoral Fixation System ( Zimmer )
. Omega Plus Supracondylar Sideplates ( Howmedica )
Combination NoLok/ Keyed Compression Hip Screw System ( DePuy ) .
Medoff Supracondylar Plate System ( Wright Medical Technology ) ●
BMP Supracondylar Cable Plate System ( Biomet ) .

4. Description of the device :

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.

5. Intended Use:

The VHS™ Supracondylar Plate System is indicated for use in the treatment of supracondylar fractures and distal femoral fractures.

6. Comparison of the technological characteristics of the device to predicate and legally marketed devices :

There are no significant differences between the VHS™ Supracondylar Plate System and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, with flowing lines representing hair or movement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG -6 1999

Walter Abendschein, M.D. 5530 Wisconsin Avenue Suite 705 Chevy Chase, MD 20815

Re: K991806

Trade Name: VHS™ Supracondylar Plate System Regulatory Class: II Product Code: KTT/KTW Dated: May 26, 1999 Received: May 26, 1999

Dear Dr. Abendschein:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general control provisions of the Act. The general control provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General Regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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Page 2 - Dr. Walter Abendschein

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K991806

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The VHS™ Supracondylar Plate System is indicated for use in the treatment of supracondylar fractures and distal femoral fractures.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) /

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General Restorative Devices K991806

510(k) Number

Prescription Use (Per 21 CFR 801.109)	Y
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Over-The-Counter Use (Optional Format 1-2-96)	No
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Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.