ULTIMAX ANKLE FUSION ROD SYSTEM by ENCORE ORTHOPEDICS, INC.

The rod geometry features sharp flutes to obtain initial stability. The rod is bi-diameter to maximize strength in the distal region, tapering down 2mm to accommodate the tibial intramedullary canal. The rod is locked with one or two 5mm transfixing screws in the tibia proximally and are screwed distally in the calcaneous. Rods range in lengths from 150mm == 325mm (25mm increments) and diameters of 11mm and 13mm. Transfixing cortical screws are available in lengths ranging from 60-100mm in 2mm increments.

The rod also features a unique "compression slot" allowing up to 25mm of static or dynamic compression at the ankle joint. This is achieved with compression screws through the distal cannulation being driven against a distal transfixing screw. The compression screws are available in 12mm, 22mm, and 32mm lengths. The rod is fully cannulated for use with a small 2mm guide wire. The small cannulation maintains optimal strength while allowing traditional techniques for rodding.

AI/ML Overview

This looks like a 510(k) submission for a medical device (UltiMax Ankle Fusion Rod System). Unfortunately, the provided text does not contain details about acceptance criteria or a study proving the device meets them.

The document primarily describes:

Device Description: Materials, dimensions, features (e.g., flutes, bi-diameter, compression slot, cannulation).
Intended Use: Arthrodesis of the ankle joint.
Predicate Device Comparison: States that the device is "equivalent to the referenced legally marketed comparison devices" based on intended uses, design, testing, and manufacturing.
Test Results: A very brief, generic statement: "Testing was performed on the UltiMax Ankle Fusion System. Test results proved the device to be of sound design." This provides no specifics about the tests performed, the acceptance criteria, or the outcomes.
FDA Clearance Letter: This letter confirms the device's substantial equivalence to predicate devices and allows it to be marketed. It does not detail specific acceptance criteria or study results beyond the FDA's regulatory finding.

Therefore, I cannot populate the table or answer most of your specific questions related to acceptance criteria, study details, sample sizes, expert involvement, or ground truth.

Here's what I can extract from the provided text, and where I must state "Not Provided":

UltiMax Ankle Fusion Rod System

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (e.g., Specific Mechanical Strength, Biocompatibility Standard)	Reported Device Performance (Specific Test Result, Compliance Statement)
Not Provided in the document. The document only has a generic statement: "Test results proved the device to be of sound design."	Not Provided in the document.

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not Provided. The document only states "Testing was performed" without specifying the number of samples or specimens.
Data Provenance (e.g., country of origin, retrospective/prospective): Not Provided.

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

Not Applicable/Not Provided. The document describes mechanical testing, not a study involving expert assessment or ground truth establishment in a clinical or diagnostic context.

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

Not Applicable/Not Provided. This pertains to studies involving human interpretation or subjective assessment, which is not described here.

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:

No. This is a mechanical orthopedic implant, not an AI or imaging device that would involve human readers or AI assistance.

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

No. This is a mechanical orthopedic implant.

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

Not Applicable/Not Provided. The "testing" mentioned is almost certainly mechanical and biocompatibility testing against engineering standards or predicate device performance, not clinical ground truth in the sense of diagnosis or outcomes.

8. The sample size for the training set:

Not Applicable/Not Provided. This concept applies to AI/machine learning models, which is not relevant to this device.

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

Not Applicable/Not Provided.

Summary

{0}------------------------------------------------

K991790

Encore Orthopedics®, Inc. 9800 Metric Blvd Austin, TX 78758 512-832-9500

Trade Name: UltiMax Ankle Fusion Rod System

Common Name: Ankle Fusion Rod

Classification Name: Single/multiple component metallic bone fixation appliances and accessories 21 CFR 888.3030

Device Description: All components of the UltiMax Ankle Fusion Rod System are manufactured from titanium (6A1-4V ELI) per ASTM F136.

Intended Use: The UltiMax Ankle Fusion Rod System is indicated for single use for arthrodesis of the ankle joint.

Comparable Features to Predicate Device(s): Based on the intended uses, design, testing, and manufacturing, the UltiMax Ankle Fusion Rod System is equivalent to the referenced legally marketed comparison devices.

Test Results: Testing was performed on the UltiMax Ankle Fusion System. Test results proved the device to be of sound design.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract symbol that resembles an eagle or bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG -6 1999

Ms. Debbie De Los Santos Regulatory/Clinical Specialist Encore Orthopedics 9800 Metric Boulevard Austin, Texas 78758

Re: K991790

Trade Name: Ultimax Ankle Fusion Rod System Regulatory Class: II Product Code: HSB Dated: May 24, 1999 Received: May 26, 1999

Dear Ms. De Los Santos:

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 (QS) 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.

{2}------------------------------------------------

Page 2 – Ms. Debbie De Los Santos

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,

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

Enclosure

{3}------------------------------------------------

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

UltiMax Ankle Fusion Rod Indications For Use

The UltiMax Ankle Fusion Rod System is indicated for single use for arthrodesis of the ankle joint.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)_

töäeeef

(Division Sign-Off) Division of General Restorative Devices 12991790 510(k) Number

Regulation Number and Section

§ 888.3020 Intramedullary fixation rod.

(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.