RHAUSLER PLAGE ANTERIOR CERVICAL FUSION SYSTEM by RHAUSLER, INC.

Intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone. This device is to be used in patients who have had at least 6 weeks of nonoperative treatment.

Device Description

The Rhausler Plage Anterior Cervical Fusion System consists of titanium plage (one piece cervical plate and cage) implants, titanium locking bone screw implants, and instruments. Implants are provided in a variety of dimensions. The Plage is designed with slots for bone screw placement. The Plage center lower cage portion is open to allow the opening to be filled with autogenous bone. The Plage System is provided nonsterile.

AI/ML Overview

This document is a 510(k) premarket notification for the Rhausler Plage™ Anterior Cervical Fusion System, which is an intervertebral body fusion device. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets clinical performance acceptance criteria through a specific study with human subjects.

Therefore, many of the requested categories regarding clinical study design, sample sizes, expert ground truth, and AI performance metrics are not applicable to this type of submission. The performance testing here refers to mechanical testing, not clinical performance.

Here's a breakdown of the information that can be extracted or that is not applicable:

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Meets ASTM F2077 (static and dynamic compression and torsion) standards.	Mechanical testing performed per ASTM F2077 (static and dynamic compression and torsion). Results of performance testing are "substantially equivalent to the predicate devices." (No specific numerical results provided in this summary).
Meets ASTM F2267 (subsidence testing) standards.	Subsidence testing performed per ASTM F2267. Results of performance testing are "substantially equivalent to the predicate devices." (No specific numerical results provided in this summary).
Meets ASTM F1877 (wear testing) standards.	Wear testing performed per ASTM F1877. Results of performance testing are "substantially equivalent to the predicate devices." (No specific numerical results provided in this summary).
Substantially equivalent in safety and effectiveness to predicate devices.	Performance test results confirm that design differences do not pose new issues of safety or effectiveness. Conclusion: "Based upon the design, technology, performance, and intended use, Rhausler Plage Anterior Cervical Fusion System is substantially equivalent to the predicate device currently marketed under the Food, Drug and Cosmetic Act."

Sample size used for the test set and the data provenance:
- N/A. This document describes mechanical component testing, not a clinical study on a patient test set. The testing was done on the device components themselves.
- The provenance is Rhausler Inc., located in San Carlos, CA, USA, where the device was developed and tested.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. No human experts were used to establish ground truth for this type of mechanical engineering test. The "ground truth" for mechanical testing is adherence to established ASTM standards.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A. This is not a clinical study involving human assessment. The "adjudication" is based on whether the device's mechanical properties meet the specified ASTM standards and are comparable to predicate devices.
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:
- N/A. This device is a physical implant, not an AI or imaging diagnostic device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- N/A. This device is a physical implant, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" in this context is adherence to recognized ASTM mechanical testing standards (F2077, F2267, F1877) and demonstrating substantial equivalence to existing predicate devices based on these mechanical properties.
The sample size for the training set:
- N/A. This is not a machine learning or AI study, so there is no "training set." The mechanical tests are performed on a sample of the manufactured devices. The specific number of physical units tested is not provided in this summary, but would be detailed in the full test reports.
How the ground truth for the training set was established:
- N/A. As there is no training set in the AI/ML sense, this question is not applicable.

Summary

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NOV 2 9 2011

Abbreviated 510(k) Rhausler Plage Anterior Cervical Fusion System

Section 5: 510(k) Summary

Assigned 510(k) number: K11272 Company: Rhausler Inc. 837 Industrial Road, Unit E San Carlos, CA 94070 USA Phone: 650-631-4515 Fax: 650-631-4555 Contact: Barbara DeBiase Phone: 303-537-3311 Email: barbdebiase@mac.com November 28, 2011 Date Prepared: Rhausler Plage™ Anterior Cervical Fusion System Proprietary Names: Classification Name: Intervertebral body fusion device 21 CFR 888.3080, Class II, Product Code ODP Classification: K071833 Mosaic™ by Spinal Elements Inc. Predicate Devices: K092521 Zuma-CTM by Seaspine Inc. Device Description: The Rhausler Plage Anterior Cervical Fusion System consists of titanium plage (one piece cervical plate and cage) implants, titanium locking bone screw implants, and instruments. Implants are provided in a variety of dimensions. The Plage is designed with slots for bone screw placement. The Plage center lower cage portion is open to allow the opening to be filled with autogenous bone. The Plage System is provided nonsterile. Intended for spinal fusion procedures at one level (C3-C7) in Intended Use: skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone. This device is to be used in patients who have had at least 6 weeks of nonoperative treatment. Technological Comparison to Predicate Device: The Rhausler Plage Anterior Cervical Fusion System is similar to the predicate device. Both are intervertebral body fusion devices

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that attach to the anterior portion of the cervical spine during the development of spinal fusion. Additionally, both use the same fundamental scientific technology, principle of operation, and materials. Performance test results confirm that design differences do not pose new issues of safety or effectiveness.

Mechanical testing has been performed on the Rhausler Plage Performance Testing: Anterior Cervical Fusion System per ASTM F2077 (static and dynamic compression and torsion). Subsidence testing has been performed per ASTM F2267, and wear testing has been performed per ASTM F1877. Results of performance testing are substantially equivalent to the predicate devices.
Based upon the design, technology, performance, and intended use, Conclusion: Rhausler Plage Anterior Cervical Fusion System is the substantially equivalent to the predicate device currently marketed under the Food, Drug and Cosmetic Act.

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

NOV 29 2011

Rhausler, Inc. % Ms. Barbara DeBiase 837 Industrial Road, Unit E San Carlos, California 94070

Re: K111272

Trade/Device Name: Rhausler Plage ** Anterior Cervical Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: October 10, 2011 Received: October 11, 2011

Dear Ms. DeBiase:

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

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Page 2 - Ms. Barbara DeBiase

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.

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/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.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

ely yours,

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

Enclosure

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Indications for Use

510(k) Number (if known): K111272

Device Name: Rhausler Plage™ Anterior Cervical Fusion System

Indications for Use:

Intended for spinal fusion procedures at one level (C3-C7) in skcletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone. This device is to be used in patients who have had at least 6 weeks of nonoperative treatment.

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

. . .

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

2לייו א 510(k) Number_

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.