When used as an intervertebral fusion device, the MOBIS® II devices are intended for use at one or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had six months of non-operative treatment. Patients with previous nonfusion spinal surgery at the involved level may be treated with the device. The devices are intended for use with a supplemental internal fixation system and with autograft to facilitate fusion.

Device Description

The basic shape of the MOBIS® II devices is a hollow structural frame having a rounded, tapered leading face. The upper and lower aspects of the implant are open. Surface spikes assist in the positive anchorage and seating of the implant between the vertebral bodies. The device is available in a variety of sizes and two angulations thereby enabling the surgeon to choose the size best suited to the individual pathology and anatomical condition.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided text, focusing on what's available and noting what's not explicitly stated:

Based on the provided 510(k) summary for the MOBIS® II intervertebral fusion device, the acceptance criteria and study details are primarily focused on mechanical performance testing to demonstrate substantial equivalence to predicate devices, rather than clinical efficacy or AI performance.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria for MOBIS® II (Implicit from substantial equivalence claim):
The device's mechanical performance, specifically for static and dynamic compression and subsidence properties, must be equivalent to or better than previously cleared predicate devices (MOBIS®, PEEK TETRIS™, and Python) when tested according to relevant ASTM standards.

Test Parameter	Acceptance Criteria (Implied)	Reported Device Performance
Static Compression	Performance substantially equivalent to predicate devices	Meets or exceeds predicate device performance in ASTM F2077
Dynamic Compression	Performance substantially equivalent to predicate devices	Meets or exceeds predicate device performance in ASTM F2077
Subsidence Properties	Performance substantially equivalent to predicate devices	Meets or exceeds predicate device performance in ASTM F2267

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated for each mechanical test. The text mentions "worst case MOBIS® II" was tested, implying a representative sample but not a specific number of units tested.
Data Provenance: The study was conducted by the device manufacturer, SIGNUS Medizintechnik GmbH, based in Alzenau, Germany. The testing was likely performed in a lab setting, not using patient data.

3. Number of Experts and Qualifications for Ground Truth

Not Applicable: This device is an intervertebral fusion device, not an AI or diagnostic imaging device. The "ground truth" for its performance is established through objective mechanical testing against engineering standards. Experts were not involved in establishing a "ground truth" in the way they would be for evaluating diagnostic accuracy or clinical outcomes.

4. Adjudication Method

Not Applicable: As this is a mechanical performance study, there's no "adjudication method" in the context of human expert review of cases. The results are quantitative measurements against predefined standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No: This is not an MRMC study. MRMC studies are typically performed for diagnostic imaging devices to assess how AI assistance impacts human reader performance.

6. Standalone (Algorithm Only) Performance Study

No: This device is a physical implant, not a software algorithm. Therefore, "standalone algorithm performance" is not relevant. The performance study focused on the mechanical integrity of the implant itself.

7. Type of Ground Truth Used

Mechanical Engineering Standards: The "ground truth" for the device's performance is objective mechanical measurements validated against established ASTM standards (ASTM F2077 for static and dynamic compression; ASTM F2267 for subsidence properties). The performance is then compared to accepted limits or to the performance of predicate devices that have already met regulatory requirements.

8. Sample Size for the Training Set

Not Applicable: There is no "training set" as this is a physical medical device undergoing mechanical validation, not a machine learning model.

9. How the Ground Truth for the Training Set Was Established

Not Applicable: (See point 8).

Summary

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K131372 Page 1 of 2

510(k) Summary

Date: Sponsor: 20 June 2013 SIGNUS Medizintechnik GmbH

Industriestrasse 2

JUL 0 2 2013

D-63755 Alzenau, GERMANY
Tel. + 49 (0) 6023 9166-136
Fax + 49 (0) 6023 9166-161
Url: http://www.signus-med.de
Contact Person:	Joachim Schneider, Quality Management/Regulatory Affairs
Trade Names:	MOBIS ® II
Device Classification	Class II
Classification Name:	Intervertebral fusion device with bone graft, lumbar
Regulation:	888.3080
Device ProductCode:	MAX
Device Description:	The basic shape of the MOBIS ® II devices is a hollow structuralframe having a rounded, tapered leading face. The upper and loweraspects of the implant are open. Surface spikes assist in the positiveanchorage and seating of the implant between the vertebral bodies.The device is available in a variety of sizes and two angulationsthereby enabling the surgeon to choose the size best suited to theindividual pathology and anatomical condition.
Intended Use:	When used as an intervertebral fusion device, the MOBIS ® IIdevices are intended for use at one or two contiguous levels in thelumbar spine, from L2 to S1, for the treatment of degenerative discdisease (DDD) with up to Grade I spondylolisthesis. DDD is definedas back pain of discogenic origin with degeneration of the discconfirmed by history and radiographic studies. The lumbar device isto be used in patients who have had six months of non-operativetreatment. Patients with previous nonfusion spinal surgery at theinvolved level may be treated with the device. The devices areintended for use with a supplemental internal fixation system andwith autograft to facilitate fusion.
Materials:	The MOBIS ® II devices are manufactured from polyetheretherketone(PEEK-OPTIMA ® LT1, Invibio ® ) as described by ASTM F2026.Integral marker pins used in the devices are manufactured fromtantalum as described by ASTM F560.
Predicate Devices:	MOBIS ® and PEEK TETRIS ™ (K111792)Python (K090064)
Performance Data:	Mechanical testing of the worst case MOBIS ® II was performedaccording to ASTM F2077 and included static and dynamiccompression. The subsidence properties were evaluated accordingto ASTM F2267.
The mechanical test results demonstrate that the MOBIS ® II deviceperformance is substantially equivalent to the predicate devices.

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Technological Characteristics:

MOBIS® II possesses the same technological characteristics as the predicate devices. These include:

. performance (as described above),
basic design (hollow structural frame), .
. material (PEEK polymer and tantalum), and
sizes (widths, lengths and heights are within the range(s) . offered by the predicate).

Therefore the fundamental scientific technology of the MOBIS® II device is the same as previously cleared devices.

The MOBIS® II devices possess the same intended use and technological characteristics as the predicate devices. Therefore the MOBIS® II is substantially equivalent for its intended use.

Conclusion:

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a semi-circular fashion around the top of the emblem.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

July 2, 2013

SIGNUS Medizintechnik GmbH % BackRoads Consulting, Incorporated Dr. Karen E. Warden Representative / Consultant P.O. Box 566 Chesterland. Ohio 44026

Re: K131372

Trade/Device Name: MOBIS® II Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: May 8, 2013 Received: May 13, 2013

Dear Dr. Warden:

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

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Page 2 – Dr. Karen E. Warden

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.

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

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address :

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

Sincerely yours,

For Erin L. Keith

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

Enclosure

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Section 7 - Indications for Use Statement

510(k) Number: K131372

Device Name: MOBIS® II

Indications for Use:

Prescription Use X

OR Over-the-Counter Use_

(Per 21 CFR 801.109)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anton E. Dmitriev, PhD Division of Orthopedic Devices

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.