The Unison-C Anterior Cervical Fixation System is indicated for stand-alone anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from C2 to T1. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Unison-C Anterior Cervical Fixation System is to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and is implanted via an anterior approach. The Unison-C Anterior Cervical Fixation System must be used with two of the provided bone screws. This cervical device is to be used in patients who have had six weeks of non-operative treatment.

Device Description

The Unison-C Anterior Cervical Fixation System is intended for stand-alone cervical interbody fusion procedures and does not require use of supplemental fixation. The Unison-C Anterior Cervical Fixation System is used to provide structural stability in skeletally mature individuals following discectomy. The Unison-C System implants consist of intervertebral body devices (with an integrated locking mechanism and radiographic pins) and screws. The intervertebral body device component is manufactured from a radiolucent polymer (PEEK-OPTIMA® LT1 polymer from INVIBIO® Biomaterial Solutions (polyether ether ketone), the radiographic markers consist of ASTM F560 tantalum, and the screws and locking mechanism are comprised of ASTM F136 Titanium Alloy. The Unison-C Anterior Cervical Fixation System is supplied with instrumentation that are necessary for use to facilitate the insertion and removal of the implants as well as general manual surgical instruments.

AI/ML Overview

This document describes the Unison-C Anterior Cervical Fixation System and its substantial equivalence to predicate devices, based on performance data from mechanical testing. It is a 510(k) summary, which typically focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than proving performance against specific acceptance criteria for a new clinical application.

Therefore, the requested information regarding acceptance criteria, device performance in clinical studies, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not available in the provided text. The document focuses on non-clinical mechanical testing.

Here's an analysis of what can be extracted and what is explicitly not available given the provided text:

1. A table of acceptance criteria and the reported device performance

Not available. The document states that the Unison-C Anterior Cervical Fixation System has been tested against several ASTM standards (F2077-11, F2267-04) for static and dynamic mechanical properties, and a locking mechanism disassociation and screw push-out test. However, it does not provide specific acceptance criteria values or the reported performance data against those criteria. It only states, "The results of this non-clinical testing show that the Unison-C Anterior Cervical Fixation System is substantially equivalent to legally marketed predicate devices."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable / Not available. The testing described is non-clinical mechanical testing, not a clinical study involving a "test set" of patient data. Therefore, concepts like data provenance or retrospective/prospective studies do not apply. The document does not specify the number of samples used for each mechanical test.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable / Not available. This information is relevant to clinical studies where expert consensus might establish ground truth for a diagnostic device. The provided document describes mechanical testing of an orthopedic implant, where "ground truth" as typically defined for AI/diagnostic studies is not relevant.

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

Not applicable / Not available. Adjudication methods are used in clinical studies, particularly for diagnostic devices, to resolve discrepancies in expert opinions. This is not mentioned as the study is mechanical.

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

No. An MRMC study is a type of clinical study, often used for diagnostic devices involving human readers (e.g., radiologists) and AI. This document pertains to mechanical testing of an intervertebral fusion device, not a diagnostic tool or AI assistance.

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

No. This question is also relevant to AI/diagnostic devices. The Unison-C system is a physical surgical implant, not an AI algorithm.

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

Not applicable / Not available. As discussed, the concept of "ground truth" in the context of clinical or diagnostic studies does not apply to the mechanical testing described. The "truth" in mechanical testing is typically measured physical properties against engineering specifications or established standards.

8. The sample size for the training set

Not applicable / Not available. This would be relevant for an AI device. The Unison-C is a physical medical implant.

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

Not applicable / Not available. This would be relevant for an AI device.

In summary, the provided document describes a 510(k) premarket notification for a physical medical device (an anterior cervical fixation system). The evidence presented for substantial equivalence is based on non-clinical mechanical testing against established ASTM standards. The document does not provide specific numerical acceptance criteria or performance results from these tests, nor does it involve clinical studies, AI, or human reader performance that would necessitate the other requested details.

Summary

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

January 19, 2016

Pioneer Surgical Technology, Incorporated dba RTI Surgical, Incorporated % Mr. Kenneth C. Maxwell II Regulatory and Quality Specialist Empirical Testing Corporation 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K152793

Trade/Device Name: Unison-C Anterior Cervical Fixation System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: December 18, 2015 Received: December 21, 2015

Dear Mr. Maxwell:

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" (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 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,

Lori A. Wiggins -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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Indications for Use

510(k) Number (if known) K152793

Device Name

Unison-C Anterior Cervical Fixation System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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☑ Prescription Use (Part 21 CFR 201 Subpart D)	☐ Over-The-Counter Use (21 CFR 201 Subpart C)
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Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(K) SUMMARY

Submitter's Name:	Pioneer Surgical Technology, Inc. DBA RTI Surgical, Inc.
Submitter's Address:	375 River Park CircleMarquette, MI 49855
Submitter's Telephone:	906.225. 5861
Company Contact Person:	Sarah PleaughRegulatory Affairs Specialist
Official Contact Person:	Kenneth C. Maxwell IIEmpirical Testing Corp.719.291.6874
Date Summary was Prepared:	12 January 2015
Trade or Proprietary Name:	Unison-C Anterior Cervical Fixation System
Common or Usual Name:	Intervertebral Fusion Device With Bone Graft, Cervical
Classification:	Class II per 21 CFR §888.3080 Device Classification
Product Code:	OVE
Classification Panel:	Division of Orthopedic Devices

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

INDICATIONS FOR USE

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TECHNOLOGICAL CHARACTERISTICS

The subject and predicate devices have similar technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically the following characteristics are similar between the subject and predicates:

. Indications for Use
. Materials of manufacture
Principle of operation .

Table 5-1 Predicate Devices

510k Number	Trade or Proprietary or Model Name	Manufacturer	Predicate Type
K121151	Pro-Link Cervical Spacer	Link Spine	Primary
K142079	STALIF C®	Centinel Spine, Inc.	Additional
K113796	Solitaire®-C Cervical Spacer System	Biomet Spine	Additional
K113559	Cervical Interbody Fusion System ROI-C	LDR Spine USA	Additional
K102606	AVS® Anchor-C Cervical Cage System	Stryker Spine	Additional
K142218	COALITION AGX	Globus	Additional

PERFORMANCE DATA

The Unison-C Anterior Cervical Fixation System has been tested in the following test modes:

Static axial compression per ASTM F2077-11 ●
Static compressive shear per ASTM F2077-11
Static torsion per ASTM F2077-11
Static Subsidence per ASTM F2267-04 ●
Dynamic axial compression fatigue per ASTM F2077-11 .
Dynamic compressive shear per ASTM F2077-11 ●
Dynamic torsion per ASTM F2077-11 ●
Locking Mechanism Disassociation Testing .
Screw Push-Out .

The results of this non-clinical testing show that the Unison-C Anterior Cervical Fixation System is substantially equivalent to legally marketed predicate devices.

CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the Unison-C Anterior Cervical Fixation System is substantially equivalent to the predicate device.

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.