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 Reliance Cervical IBF and Reliance Cervical IBF-HA 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 disc disease (defined at 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 non-operative treatment.

Device Description

The Reliance Cervical IBF System is comprised of implants 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 may be made of PEEK Optima LT1 or PEEK Optima LT1-HA with Tantalum markers. The Reliance Cervical IBF System may also include bone screws to secure the device to the vertebral body.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "Reliance Cervical IBF System." This document primarily focuses on demonstrating substantial equivalence to a predicate device through mechanical testing and an animal study, rather than establishing acceptance criteria and detailed performance against those criteria in a clinical study with human subjects.

Therefore, many of the specific details requested in your prompt (such as acceptance criteria, sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and detailed training set information) are not directly present in this regulatory submission.

However, I can extract and infer some information based on the provided text:

Key Takeaway from the Document:

The submission focuses heavily on substantial equivalence to previously cleared devices (K120396, K131429, and K142026) through mechanical testing and an animal study. It does not present detailed clinical efficacy or diagnostic performance data against specific acceptance criteria for a human clinical trial.

Here's the breakdown of what can be extracted and what cannot:

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

Acceptance Criteria: Not explicitly stated as pass/fail criteria in terms of clinical outcomes for human subjects. However, the document mentions adherence to specific ASTM standards for mechanical testing. These standards implicitly define acceptance criteria for the mechanical performance of intervertebral body fusion devices.
Reported Device Performance:
- Mechanical Testing: Performed per ASTM F-2077 (Static and dynamic compression, static torsion, dynamic torsion), ASTM F-2267 (Expulsion), and ASTM Draft F-04.25.02.02 (Subsidence). The document states the device "was found to be substantially equivalent to itself" based on this testing, implying it met the performance expectations relative to its own prior clearance or the predicate devices. Specific quantitative results (e.g., maximum load, displacement) are not provided in this summary.
- Animal Study: An "ovine fusion study was performed." No specific performance metrics or outcomes from this study are detailed in the provided text.

Acceptance Criteria Category (Inferred from ASTM Standards)	Reported Device Performance (Inferred/Summarized)
Static Compression Strength (ASTM F-2077)	Met, demonstrating substantial equivalence
Dynamic Compression Endurance (ASTM F-2077)	Met, demonstrating substantial equivalence
Static Torsion Strength (ASTM F-2077)	Met, demonstrating substantial equivalence
Dynamic Torsion Endurance (ASTM F-2077)	Met, demonstrating substantial equivalence
Expulsion Resistance (ASTM F-2267)	Met, demonstrating substantial equivalence
Subsidence Resistance (ASTM Draft F-04.25.02.02)	Met, demonstrating substantial equivalence
Fusion in Animal Model (Ovine Fusion Study)	Performed, result implies positive outcome for substantial equivalence

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

Test Set Sample Size:
- Mechanical Testing: Not specified in the summary. ASTM standards often specify the number of samples to be tested (e.g., n=6 for certain tests), but the exact count for this device is not here.
- Animal Study: Not specified.
Data Provenance: Not specified, but generally, studies for U.S. FDA submissions are conducted under appropriate Good Laboratory Practice (GLP) standards, which implies a controlled testing environment, likely in the US or a country with equivalent regulatory oversight. The animal study would be prospective in nature, as would the mechanical testing.

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: This information is not relevant to the type of studies described (mechanical testing and animal fusion study). These studies do not involve human expert interpretation for "ground truth" in the way a diagnostic AI device would. Mechanical tests rely on objective physical measurements and engineering analysis. Animal studies have veterinary pathologists or researchers assess outcomes.

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

Not Applicable: No adjudication method is mentioned or relevant for mechanical testing or a preclinical animal study as described.

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: This is a mechanical device (cervical interbody fusion system), not an AI/diagnostic software. Therefore, an MRMC comparative effectiveness study for human readers with and without AI assistance is not applicable and was not performed.

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

No: As this is a mechanical medical device, there is no "algorithm" or standalone AI performance to evaluate.

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

Mechanical Testing: The "ground truth" is defined by the physical/mechanical properties and thresholds specified in the ASTM standards. Measurements are objective.
Animal Study: The "ground truth" for fusion in the ovine study would typically be established through methods like histological analysis (pathology), radiographic evidence (e.g., CT scans), and potentially biomechanical testing of explanted specimens. The document does not specify which methods were used, but pathology/imaging are standard for fusion assessment.

8. The sample size for the training set

Not Applicable: This is not an AI/machine learning device. Therefore, there is no "training set" in the context of algorithm development.

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

Not Applicable: There is no training set for this device.

In summary, the provided document is a 510(k) summary for a cervical interbody fusion device, showcasing substantial equivalence primarily through non-clinical (mechanical) testing and a pre-clinical animal study. It does not include the types of clinical performance data, acceptance criteria, or study designs typically associated with AI/diagnostic devices that would involve human readers, ground truth consensus, or large human clinical cohorts.

Summary

{0}------------------------------------------------

Image /page/0/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 an abstract symbol resembling an eagle or a bird in flight, formed by three stylized human profiles facing to the right. The profiles are layered, creating a sense of depth and movement.

June 9, 2015

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

Reliance Medical Systems, LLC Mr. Bret M. Berry Owner P.O. Box 1693 Bountiful, Utah 84011

Re: K142269

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, OVE Dated: May 15, 2015 Received: May 14, 2015

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

{1}------------------------------------------------

Page 2 - Mr. Bret M. Berry

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 vours.

Mark N. Melkerson -S

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

Enclosure

{2}------------------------------------------------

K142269

Page 1 of 1

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K142269

Device Name Reliance Cervical IBF System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary

26 October 2014

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

Contact: Bret M. Berry Member-Manager

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

Intervertebral Body Fusion Device Reliance Cervical IBF System Class II. Intervertebral Body Fusion Device 21 CFR 888.3080 OVE, ODP

Substantial Equivalence

The Reliance Cervical IBF is substantially equivalent to the legally marketed Reliance Cervical IBF (K120396 and K131429). The primary predicate is the Reliance Cervical IBF (K120396). Arena-C® HA PEEK Cervical Intervertebral Body Fusion Device cleared in K142026 is an additional predicate device. The Reliance Cervical IBF is substantially equivalent to itself in terms of material, strength, intended use, levels of attachment, size range, and use with supplemental fixation. Mechanical testing was performed on the Reliance Cervical IBF System following ASTM F-2077, ASTM F-2267, and ASTM Draft F-04.25.02.02. The mechanical testing included static compression, dynamic compression, static torsion, dynamic torsion, expulsion, and subsidence testing. Additionally, and ovine fusion study was performed.

Device Description

Intended Use/Indications for Use

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 Reliance Cervical IBF and Reliance Cervical IBF-HA 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 disc disease (defined at neck pain of discogenic origin with

K142269 Page 1 of 2

{4}------------------------------------------------

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 non-operative treatment.

Performance Data and Substantial Equivalence

Mechanical testing was performed on the Reliance Cervical IBF System following ASTM F-2077, ASTM F-2267, and ASTM Draft F-04.25.02.02. The mechanical testing included static compression, dynamic compression, static torsion, dynamic torsion, expulsion, and subsidence testing. Additionally, and ovine fusion study was performed. The Reliance Cervical IBF System was found to be substantially equivalent to itself. Additionally, the Reliance Cervical IBF System is substantially equivalent to itself in terms of sterilization and biocompatibility.

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.