The AddPlus™ is a vertebral body replacement device intended for use in the thoracolumbar spine (T1 - L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture).

The AddPlus™ is intended to be used with supplemental internal fixation systems that are cleared by FDA for use in the thoracic and lumbar spine. Such systems include posterior pedical screw and rod systems, anterior plate systems, and anterior screw and rod systems.

The use of bone grafting material with the AddPlus™ is optional.

Device Description

The AddPlus™ is a modification of the 12 mm diameter VBR™ device cleared under K012254. It is an adjustable (distractable) cylindrical cage with attached fixation plates that add supplemental bilateral spinal fixation to the design of the marketed VBR™ device. The device remains constructed from medical grade titanium alloy. In the case of resected vertebral bodies of the human spine, the AddPlus™ is used for bridging the intervertebral space and serves to lengthen the anterior column, realigning the spinal profile, to stabilize the anterior column, and to support the consolidation of inserted bone material.

The attached fixation plates serve to provide further fixation and stabilization and to prevent migration as well as possible sinking in of the implant. The device is available in one diameter (i.e., 12 mm), four expansion ranges (i.e., 13 - 18 mm, 17 - 26 mm, 25 - 41 mm, and 40 - 65 mm), and four angles (i.e., 0°, 6°, 12°, and 18°).

Available components to be used with the AddPlus™ include a locking screw, osmium™ screw. and cancellous bone screw. The locking screw is used to fix the height of the adjusted AddPlus™4. The osmium™ screw is used for monocortical fixation. It is available in lengths of 14, 16, and 18 mm, with a diameter of 5 mm. The cancellous bone screw is used for bicortical fixation. It is available in lengths of 12, 14, 16, 18, 20, 24, and 26 mm, with a diameter of 4 mm. In addition to these device components, a number of surgical instruments are available for use during implantation of the device.

AI/ML Overview

The provided document describes a medical device called AddPlus™, Anterior Distraction Device Plus, and its 510(k) summary for FDA clearance. The information focuses on its mechanical characteristics and intended use, rather than a clinical study evaluating diagnostic or prognostic performance. Therefore, many of the requested criteria cannot be directly addressed.

Here's the breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Equivalence to predicate devices in mechanical characteristics (withstanding anticipated in vivo loads)	Mechanical testing, in accordance with applicable recommendations of FDA guidance titled "Guidance for Industry and FDA Staff, Guidance for Spinal Systems 510(k)s," dated May 2004, was conducted to demonstrate equivalence to the predicate devices and demonstrated the subject device's capability to withstand anticipated in vivo loads.

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

Not Applicable. The document describes mechanical (bench) testing, not a clinical test set with human or animal subjects. The "test set" in this context refers to the physical devices subjected to mechanical stress.

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 this context, would typically refer to clinical diagnosis or outcomes. For mechanical testing, the "ground truth" is defined by established engineering standards and guidelines for spinal implants. The document does not specify human experts for establishing the "ground truth" of mechanical performance, as it relies on standardized testing methods.

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

Not Applicable. As this is mechanical testing, there is no human adjudication process described. Performance is measured against engineering specifications.

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 spinal implant, not an AI-based diagnostic tool. Therefore, an MRMC study and AI assistance are not relevant.

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

Not Applicable. The device is a physical spinal implant, not an algorithm.

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

The ground truth for the mechanical performance is implicitly defined by accepted scientific methods and FDA guidance for spinal systems 510(k)s, which specify the types of loads and conditions the device must withstand. This is a form of engineering standard ground truth.

8. The sample size for the training set

Not Applicable. This is not an AI/machine learning device, so there is no concept of a "training set" in the traditional sense.

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

Not Applicable. As there is no training set mentioned, this question is not applicable.

Summary

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

510(k) SUMMARY

This 510(k) summary is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.87

OCT - 5 2009

Establishment Registration Number:

9612420

Merle Symes

President and CEO ulrich medical USA 754 Spirit 40 Park Drive Chesterfield, MO 63005

28 September 2009

ulrich GmbH & Co. KG Buchbrunnenweg 12 89081 Ulm, Germany

Address of Manufacturer:

Contact Person:

Date Prepared:

Trade or Proprietary Name:

AddPlus™, Anterior Distraction Device Plus

Common or Usual Name:

Classification Name:

Spinal intervertebral body fixation orthosis (21 CFR 888.3060)

Vertebral body replacement device

Product code: MQP

Class II

Predicate Device Identification:

VBR™ (K012254)

Device Description:

Company Confidential

Page 13 of 84

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

of the human spine, the AddPlus™ is used for bridging the intervertebral space and serves to lengthen the anterior column, realigning the spinal profile, to stabilize the anterior column, and to support the consolidation of inserted bone material.

Intended use and comparison to predicate devices:

The use of bone grafting material with the AddPlus™ is optional.

Technological characteristics and comparison to predicate devices:

A comparison of the subject and predicate devices identified technical differences in geometrical configurations. Similarity was noted with regards to material of construction.

The differences in technological characteristics between the subject and predicate devices do not raise new types of safety or effectiveness questions. Accepted scientific methods, such as performance (bench) testing, do exist for assessing the effect of the differences in characteristics.

Summary of performance data:

Mechanical testing, in accordance with applicable recommendations of FDA guidance titled "Guidance for Industry and FDA Staff, Guidance for Spinal Systems 510(k)s," dated May 2004, was conducted to demonstrate equivalence to the predicate devices and demonstrated the subject device's capability to withstand anticipated in vivo loads.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Ulrich GmbH & Company KG % Ulrich Medical USA Mr. Merle Symes President and Chief Executive Officer 754 Spirit 40 Park Drive Chesterfield, Missouri 63005

OCT - 5 2009

Re: K090841

Trade/Device Name: AddPlus™, Anterior Distraction Device Plus Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MOP Dated: September 28, 2009 Received: September 29, 2009

Dear Mr. Symes:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

Page 2 - Mr. Merle Symes

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,
for

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use

510(k) Number (if known): K090841

Device Name: AddPlus™, Anterior Distraction Device Plus

Indications for Use:

The AddPlus™ is a vertebral body replacement device intended for use in the thoracolumbar spine (T1 - L5) to replace a collapsed, or unstable vertebral body due to tumor or trauma (i.e., fracture).

The use of bone grafting material with the AddPlus™ is optional.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: X (21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use: (21 CFR 807 Subpart C)

(Division Sign Off)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K090841

Company Confidential

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.