The RELIANCE CERVICAL IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level.

The RELIANCE CERVICAL IBF System is intended for use at one level in the cervical spine, from C3 to T1, for treatment of cervical degenerate disc disease (DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The RELIANCE CERVICAL IBF System is to be used in patients who have six weeks of nonoperative treatment.

Device Description

The Reliance Cervical IBF System is comprised of implant and instrument components. The implant component, the Reliance Cervical IBF device, is a spacer, which inserts between vertebral bodies in the anterior column of the Cervical spine. The spacer is made of PEEK Optima LT1 with Tantalum markers.

AI/ML Overview

The provided text describes the Reliance Cervical IBF System, an intervertebral body fusion device, and its a 510(k) submission (K120396). The submission focuses on demonstrating substantial equivalence to already marketed predicate devices through mechanical testing.

Here's an analysis of the acceptance criteria and study data:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Material Equivalence: PEEK Optima LT1 with Tantalum markers	The Reliance Cervical IBF System is comprised of implant and instrument components. The implant component, the Reliance Cervical IBF device, is a spacer which inserts between vertebral bodies in the anterior column of the cervical spine. The spacer is made of PEEK Optima LT1 with Tantalum markers, demonstrating material equivalence to predicate devices.
Intended Use Equivalence: Intervertebral body fusion of the spine in skeletally mature patients at one level (C3 to T1) for DDD, with autogenous bone graft and supplemental fixation.	The Indications for Use for the Reliance Cervical IBF System closely match the intended use of predicate devices: "The RELIANCE CERVICAL IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients... intended for use at one level in the cervical spine, from C3 to T1, for treatment of cervical degenerate disc disease (DDD)... used with autogenous bone graft to facilitate fusion... intended to be used with legally cleared supplemental spinal fixation."
Levels of Attachment Equivalence: C3-T1	The device is "intended for use at one level in the cervical spine, from C3 to T1," demonstrating equivalence in levels of attachment.
Size Range Equivalence	The document explicitly states equivalence to predicate devices in "size range." However, specific size ranges for the device or the predicate devices are not provided.
Use with Supplemental Fixation Equivalence	The device "implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level," indicating equivalence in this regard.
Static Compression Testing (ASTM F2077-03)	Performed on the "worst case Reliance Cervical IBF device." The device was found to be "substantially equivalent to the predicate devices." No specific numerical outcomes of the testing are provided.
Dynamic Compression Testing (ASTM F2077-03)	Performed on the "worst case Reliance Cervical IBF device." The device was found to be "substantially equivalent to the predicate devices." No specific numerical outcomes of the testing are provided.
Subsidence Testing (ASTM F2267-04)	Performed on the "worst case Reliance Cervical IBF device." The device was found to be "substantially equivalent to the predicate devices." No specific numerical outcomes of the testing are provided.
Static Push-out Testing (ASTM Draft F-04.25.02.02)	Performed on the "worst case Reliance Cervical IBF device." The device was found to be "substantially equivalent to the predicate devices." No specific numerical outcomes of the testing are provided.

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

Test Set Sample Size: The document refers to testing performed on "the worst case Reliance Cervical IBF device," implying a limited sample size, likely representative units for mechanical testing. No specific number of devices tested is provided.
Data Provenance: The mechanical testing was performed following ASTM Standards (F2077-03, F2267-04, and Draft F-04.25.02.02). The context suggests this was conducted by the manufacturer (Reliance Medical Systems, LLC) as part of their 510(k) submission, likely in a laboratory setting. The country of origin of the data is not explicitly stated but is implied to be within the United States, given the FDA submission. This is a prospective test in the sense that the testing was carried out specifically for this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This device, an intervertebral body fusion system, does not involve a test set for diagnostic accuracy or human interpretation. Therefore, there are no "experts" in the sense of clinicians establishing ground truth on patient data.
The determination of what constitutes "worst case" for mechanical testing would have been based on engineering principles and potentially input from mechanical engineers or materials scientists.

4. Adjudication Method for the Test Set

Not applicable. The study is mechanical testing, not a diagnostic study requiring adjudication of expert interpretations. The "adjudication" in this context would be the interpretation and comparison of the mechanical test results against the established ASTM standards and data from predicate devices.

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

No, an MRMC comparative effectiveness study was not done. This type of study is used for diagnostic devices to assess the performance of human readers with and without AI assistance. This submission is for a physical implantable medical device and relies on mechanical testing to demonstrate substantial equivalence, not diagnostic accuracy.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This isn't a software algorithm or AI-driven diagnostic device. The performance evaluated is the mechanical integrity of a physical implant.

7. Type of Ground Truth Used

The "ground truth" for this type of submission is defined by established engineering standards (ASTM Standards) for mechanical performance and the mechanical performance data of legally marketed predicate devices. The device's performance is compared against these benchmarks to demonstrate substantial equivalence.

8. Sample Size for the Training Set

Not applicable. This is not a study involving machine learning or AI, so there is no "training set." The device itself is the "product" being evaluated, not a system that needs to be trained on data.

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

Not applicable. As there is no training set, there is no ground truth established for one. The "truth" for the product's performance is established through adherence to mechanical testing standards and comparison to predicate device performance.

Summary

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K120396

510(k) Summary

MAY - 8 2012

Date: 6 April 2012

Reliance Medical Systems, LLC 545 West 500 South, Suite 100 Bountiful, UT 84010 Telephone: 801-295-3280 801-294-0079 Fax:

Bret M. Berry Contact: Member-Manager

510(k) Number: Common or Usual Name: Proposed Proprietary or Trade Name: Classification Name: Regulation Number: Product Code:

K120396 Intervertebral Body Fusion Device Reliance Cervical IBF System Intervertebral Body Fusion Device 21 CFR 888.3080 ODP

Substantial Equivalence

The Reliance Cervical IBF is substantially equivalent to the legally marketed Alphatec NOVEL Cervical System (K081730), the Pioneer Cervical IBF System (K073177), and the Zimmer BAK/C Cage (P980048). The Reliance Cervical IBF is equivalent to these commercially available devices in terms of material, intended use, levels of attachment, size range, and use with supplemental fixation.

Device Description

Intended Use/Indications for Use

Performance Data and Substantial Equivalence

Page 1 of 2

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Mechanical testing was performed on the worst case Reliance Cervical IBF device following ASTM Standards. Static and Dynamic Compression testing was performing following ASTM Standard F2077-03, Subsidence Testing was performed following ASTM F2267-04, and Static Push-out Testing was performed following ASTM Draft F-04.25.02.02. The Reliance Cervical IBF was found to be substantially equivalent to the predicate devices.

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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 stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

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

Reliance Medical Systems, LLC % Mr. Bret M. Berry Member-Manager 545 West 500 South, Suite 100 Bountiful. Utah 84010

MAY - 8 2012

Re: K120396

Trade/Device Name: Reliance CERVICAL IBF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: April 6, 2012 Received: April 9, 2012

Dear Mr. Berry:

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 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.

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Page 2 – Mr. Bret M. Berry

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

J 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): K120396

Device Name: Reliance CERVICAL IBF System

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Divi Jon Sien-Off) Division of Surgical, Orthopedic, and Restorative Devices

Page of

K120396 510ck ; 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.