ASCOT® is intended for anterior cervical fixation (C2-C7) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis and/or lordosis), tumor, pseudarthrosis and failed previous fusion.

Device Description

ASCOT® is an anterior cervical plate and screw system. Plates offered in a variety of sizes to accommodate anatomic requirements. Fixed and variable angle screws are available in numerous length/diameter combinations. In addition, a center graft screw is offered.

AI/ML Overview

The provided text describes the 510(k) summary for the ASCOT® anterior cervical plate system. This is a medical device and not an AI or software-based diagnostic tool. Therefore, the questions related to AI performance, ground truth, sample sizes for training/test sets, expert adjudication, and MRMC studies are not applicable.

The "acceptance criteria" for this type of device are related to its mechanical performance and substantial equivalence to predicate devices, rather than diagnostic accuracy metrics.

Here's a breakdown of the relevant information from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical performance equivalent to predicate devices as per ASTM F1717 (static & dynamic compression bending, static torsion)	"The mechanical test results demonstrate that the ASCOT® device performance is substantially equivalent to the predicate devices."

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

Not Applicable. This is a hardware medical device; performance was evaluated through mechanical testing, not a diagnostic test set with patient data.

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 the context of diagnostic performance, is not relevant for this mechanical device.

4. Adjudication method for the test set

Not Applicable.

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 device.

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

Not Applicable. This is not an AI device.

7. The type of ground truth used

Not Applicable. The "ground truth" for this device would be the physical properties and mechanical stability under specified loads, measured against established engineering standards (ASTM F1717) and compared to predicate devices. This isn't a diagnostic ground truth.

8. The sample size for the training set

Not Applicable.

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

Not Applicable.

Summary of Relevant Information Regarding Device Acceptance:

The acceptance of the ASCOT® device for 510(k) clearance was based on demonstrating substantial equivalence to existing legally marketed predicate devices (TOSCA®, TOSCA® II, VERTEBRON SCP™, Uniplate™). This was primarily achieved by showing:

Mechanical Testing: According to ASTM F1717, static and dynamic compression bending, and static torsion tests were performed on the "worst case" ASCOT® configuration. The results showed performance "substantially equivalent" to the predicate devices.
Technological Characteristics: The device possesses the "same technological characteristics" as the predicates, including:
- Performance (as described by mechanical testing).
- Basic design (plate and screw system).
- Material (titanium alloy - Ti-6Al-4V ELI, ASTM F136).
- Sizes (component dimensions are within the ranges offered by the predicates).
Intended Use: The intended use for anterior cervical fixation (C2-C7) for specific indications (degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, deformities/curvatures, tumor, pseudarthrosis, failed previous fusion) is the same as the predicate devices.

The FDA's decision letter (K132310) confirms the determination of substantial equivalence, allowing the device to be marketed.

Summary

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K132310 page 1 of 2

510(k) Summary		DEC 2 3 2013
Date:	24 July 2013
Sponsor:	SIGNUS Medizintechnik GmbHIndustriestrasse 2D-63755 Alzenau, GERMANYTel. + 49 (0) 6023 9166-136Fax + 49 (0) 6023 9166-161Url: http://www.signus-med.de
Contact Person:	Joachim Schneider, Quality Management/Regulatory Affairs
Trade Names:	ASCOT®
Device Classification	Class II
Common Name:	Anterior cervical plate system
Classification Name:	Appliance, fixation, spinal intervertebral body
Regulation:	888.3060
Device ProductCode:	KWQ
Device Description:	ASCOT® is an anterior cervical plate and screw system. Platesoffered in a variety of sizes to accommodate anatomic requirements.Fixed and variable angle screws are available in numerouslength/diameter combinations. In addition, a center graft screw isoffered.
Intended Use:	ASCOT® is intended for anterior cervical fixation (C2-C7) for thefollowing indications: degenerative disc disease (as defined by neckpain of discogenic origin with degeneration of the disc confirmed bypatient history and radiographic studies), spondylolisthesis, trauma(i.e., fracture or dislocation), spinal stenosis, deformities orcurvatures (i.e., scoliosis, kyphosis and/or lordosis), tumor,pseudarthrosis and failed previous fusion.
Materials:	The ASCOT® implant components are manufactured from titaniumalloy (Ti-6Al-4V ELI) as described by ASTM F136.
Predicate Devices:	TOSCA® (K043082)TOSCA® II (K080815)VERTEBRON SCP™ (K051815 & K062110)Uniplate™ (K042544)
Performance Data:	Mechanical testing of the worst case ASCOT® was performedaccording to ASTM F1717 and included static and dynamiccompression bending and static torsion.The mechanical test results demonstrate that the ASCOT® deviceperformance is substantially equivalent to the predicate devices.

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K132310 page 2 of 2

Technological Characteristics:

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

. performance (as described above),
. basic design (plate and screw system),
. material (titanium alloy), and
sizes (component dimensions are within the ranges offered . by the predicates).

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

Conclusion:

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. 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 symbol that resembles an abstract human figure or a caduceus, which is a symbol often associated with healthcare. The image is in black and white.

Public Health Service

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

December 23, 2013

SIGNUS Medizintechnik GmbH % Karen E. Warden, Ph.D. BackRoads Consulting, Incorporated 8202 Sherman Road Chesterland, Ohio 44026

Re: Ki32310

Trade/Device Name: ASCOT® Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: November 13, 2013 Received: November 19, 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Karen E. Warden, Ph.D.

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" (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/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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Ronald P. Jean -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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Section 7 - Indications for Use Statement

510(k) Number: K132310

Device Name: ASCOT®

Indications for Use:

らいくなり、

ASCOT® is intended for anterior cervical fixation (C2-C7) for the following indications: degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis and/or lordosis), turnor, pseudarthrosis and failed previous fusion.

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 ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ Division of Orthopedio Devices

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.