The MOBIS®II ST Spinal Implant is indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). MOBIS®II ST Spinal Implants are to be used with autogenous bone graft and implanted via an open posterior or transforaminal approach. The MOBIS®II ST Spinal Implant is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

Device Description

The MOBIS®II ST Spinal implants have a hollow, slightly curved frame with areas of an open-pore titanium grid structure. Restoration of the intervertebral space can be achieved by the large selection of implants that, at the same time, offers a high degree of intraoperative flexibility. In addition to straight implants, the MOBIS®II ST cage is also available with a 5° lordotic angle. Due to its design, the implant can be aligned with the anterior curvature of the intervertebral body and so is suited for unilateral, dorsal access (TLIF) in the L2 to S1 region of the spine.

AI/ML Overview

This document is a 510(k) summary for the MOBIS®II ST Spinal Implant. It does not describe a study involving an AI/ML powered device, but rather a medical device (spinal implant). As such, many of the requested categories in the prompt are not applicable.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Not directly applicable in the terms of typical AI system performance metrics (e.g., sensitivity, specificity, AUC). For this medical device, acceptance criteria are based on mechanical safety and performance, demonstrating equivalency to predicate devices.

Acceptance Criterion (Type of Test)	Reported Device Performance
Static compression per ASTM F2077	Met (equivalent to predicate devices)
Dynamic compression per ASTM F2077	Met (equivalent to predicate devices)
Static compression-shear per ASTM F2077	Met (equivalent to predicate devices)
Dynamic compression-shear per ASTM F2077	Met (equivalent to predicate devices)
Subsidence per ASTM F2267	Met (equivalent to predicate devices)
Expulsion	Met (equivalent to predicate devices)

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

Not applicable as this is a mechanical engineering study, not a study involving a "test set" of data in the AI/ML sense. The "sample size" would refer to the number of devices tested, which is not specified but would typically follow ASTM standards for such tests.

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 refers to the physical properties and performance measured by standardized tests, not expert interpretation of data.

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

Not applicable. Mechanical tests have objective outputs based on engineering principles and standards, not adjudication among human observers.

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. This is not an AI-powered device, and no human reader study was conducted.

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

Not applicable. This is a physical spinal implant, not an algorithm.

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

Not applicable. The "ground truth" for mechanical testing is established by the specified ASTM (American Society for Testing and Materials) standards and the physical measurements obtained during the tests.

8. The sample size for the training set

Not applicable. There is no training set for a physical medical device.

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

Not applicable. There is no training set.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right, with flowing lines above them that resemble a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.

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

September 16, 2014

SIGNUS Medizintechnik GmbH % Mr. J.D. Webb The OrthoMedix Group, Incorporated 1001 Oakwood Boulevard Round Rock, Texas 78681

Re: K141405

Trade/Device Name: MOBIS®II ST Spinal Implant Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: June 12, 2014 Received: June 18, 2014

Dear Mr. Webb:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours.

Ronald DAJean -S for

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

Enclosure

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Form Approved: OMB No. 0910-0120

Expiration Date: December 31, 2013

See PRA Statement on last page.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K141405

Device Name

MOBIS®II ST Spinal Implant

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X | Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary for the MOBIS®II ST Spinal Implant

In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the MOBIS®II ST Spinal Implant

GENERAL INFORMATION 1.

Date Prepared:	June 12, 2014
Trade Name:	MOBIS®II ST Spinal Implant
Common Name:	Interbody spacer
Classification Name:	Intervertebral body fusion device - lumbar
Class:	II
Product Code:	MAX
CFR section:	21 CFR section 888.3080
Device panel:	Orthopedic
Legally Marketed	MOBIS® Spinal Implant (K131372)
Predicate Device:	T-PAL Spacer (K100089)Lucent Straight Cage (K071724/K081968)
Submitter:	SIGNUS Medizintechnik GmbHIndustriestrasse 2D - 63755 AlzenauGERMANYJoachim Schneider+49(0)6023-9166-213
Contact:	J.D. Webb1001 Oakwood BlvdRound Rock, TX 78681e-mail: jdwebb@orthomedix.net

2. DEVICE DESCRIPTION

Materials:

Titanium alloy (Ti6AI4V) (ASTM F136)

Function:

Maintain adequate disc space until fusion occurs.

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3. SUBSTANTIAL EQUIVALENCE CLAIMED TO PREDICATE DEVICES

The MOBIS®II ST Spinal Implant is substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety and performances.

4. INTENDED USE

The MOBIS®II ST Spinal Implant is indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). MOBIS®II ST Spinal Implants are to be used with autogenous bone graft and implanted via an open posterior or transforaminal approach. The MOBIS®I ST Spinal Implant is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

5. NON-CLINICAL TEST SUMMARY

The following tests were conducted:

. Static and dynamic compression per ASTM F2077
Static and dynamic compression-shear per ASTM F2077 ●
Subsidence per ASTM F2267 ●
Expulsion ●

The results of this testing indicate that the MOBIS®II ST Spinal Implant is equivalent to predicate devices.

CLINICAL TEST SUMMARY 6.

No clinical studies were performed

7. CONCLUSIONS NONCLINICAL AND CLINICAL

SIGNUS Medizintechnik considers MOBIS®II ST Spinal Implant to be equivalent to the predicate devices listed in section 1. 'General Information'. This conclusion is based upon the device's similarities in principles of operation, technology, materials and indications for use.

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.