The Reliance Posterior Cervical-Thoracic System is intended to promote fusion of the cervical spine and cervicothoracic junction (C1-T3), and is indicated for the following:
· ddd (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)

spondylolisthesis
· spinal stenosis
· fracture/dislocation
· revision of previous cervical spine surgery
tumors

The use of the mini polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

Hooks and Rods

The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

WARNING: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic (T4-T12), or lumbar spine. Pedicle screws are intended for placement only in T1-T3 as a means of anchoring the system.

Device Description

The Reliance Posterior Cervical-Thoracic System contains posterior spinal attachment elements in a variety of configurations based upon rod diameter. These include a Titanium alloy based Ø3.5mm rod configuration, a Titanium alloy based Ø4.0mm rod configuration and a Titanium alloy based 04.5mm rod configuration. All configurations, regardless of rod size, are available in 03.5mm, 04.0mm, and 04.5mm major screw diameters. These screw diameters are offered in lengths ranging from 10mm to 20mm, with the 04.0mm, and 04.5mm available up to 50mm. All of these screws are available in both mono-axial options. The polyaxial screws in all of these configurations have an internal taper bushing that circumferentially grasps the rod when the device is locked. Additionally, both the mono-axial and poly-axial screws have a double lead thread.

In addition to the screw sizes mentioned above, reduction-tabbed screws are also available. The reduction-tabbed screws are available in all of the previously mentioned sizes. The Reliance Posterior Cervical-Thoracic System also offers a series of crosslink connectors. Furthermore, the Reliance Posterior Cervical-Thoracic System includes a series of hooks for attaching to the posterior elements of the cervico-thoracic spine. All of the components discussed above are " fabricated from Titanium alloy and should not be used with implants of different materials.

AI/ML Overview

This document describes a spinal fixation device, not an AI or diagnostic medical device. Therefore, the requested information (acceptance criteria, study details including sample sizes, expert involvement, and ground truth establishment) is not applicable to this submission. The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing for mechanical properties.

Here's a breakdown of why the requested information cannot be provided based on the given input:

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

Not Applicable. The document states: "The Reliance Posterior Cervical-Thoracic System has undergone Non-Clinical Testing including Static Compressive, Static Torsion, Dynamic Compressive and Dynamic Torsion in accordance with ASTM F1717." It then concludes, "The Reliance Posterior Cervical-Thoracic System is substantially equivalent to the predicate devices."
While ASTM F1717 outlines test methods for spinal implant constructs, the document does not provide specific acceptance criteria values or the quantitative results of these tests for the Reliance system. It only states that the testing was performed and that the device is "substantially equivalent."

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. The "test set" in this context refers to the physical devices tested according to ASTM F1717. The document does not specify the number of devices (samples) tested for each non-clinical test (Static Compressive, Static Torsion, Dynamic Compressive, Dynamic Torsion).
Data provenance (country of origin, retrospective/prospective) is relevant for clinical studies, not for the non-clinical mechanical testing described here.

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. "Ground truth" and expert review are concepts associated with diagnostic performance studies, typically involving human interpretation of data (e.g., medical images). This document describes the mechanical testing of a physical implant. The "ground truth" for these tests would be the measured physical properties against a standard, not expert consensus.

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

Not Applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or diagnostic studies to resolve disagreements among human readers or expert reviewers. This is not pertinent to the non-clinical mechanical testing of a spinal implant.

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 explicitly an AI/diagnostic performance study question. The submission is for a physical medical device (spinal fixation system) and does not involve AI, human readers, or diagnostic interpretation.

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

Not Applicable. This question is also for AI/algorithm performance. The device is a physical implant.

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

Not Applicable. As explained in point 3, the concept of "ground truth" for a diagnostic or AI device is not applicable here. For the mechanical testing performed, the "truth" is established by the specifications and measurable performance outlined in the ASTM F1717 standard.

8. The sample size for the training set:

Not Applicable. "Training set" refers to data used to train an AI algorithm. This document is about a physical medical device and does not involve AI.

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

Not Applicable. Similar to point 8, this question is for AI algorithms and not relevant to the described device.

Summary of Device Performance and Acceptance Criteria (as much as can be inferred from the document):

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred/Stated)	Reported Device Performance
Mechanical Performance	Adherence to ASTM F1717 standards for:	Substantially equivalent to predicate devices (Medtronic Vertex Reconstruction System (K003780), Pioneer Surgical Posterior Cervical Thoracic System (K092295), Theken Atoll Cervico-Thoracic System (K083073), Alphatec Solanas Posterior Stabilization System (K052201)) based on non-clinical testing.
	- Static Compressive	Results not quantitatively provided.
	- Static Torsion	Results not quantitatively provided.
	- Dynamic Compressive	Results not quantitatively provided.
	- Dynamic Torsion	Results not quantitatively provided.
Material	Titanium alloy (consistent with predicate devices)	Fabricated from Titanium alloy.
Intended Use	Promote fusion of cervical spine and cervicothoracic junction (C1-T3) for specific conditions (ddd, spondylolisthesis, spinal stenosis, fracture/dislocation, revision surgery, tumors). Limited polyaxial screw placement (T1-T3).	Intended use matches claimed indications.
Levels of Attachment	C1-T3	C1-T3
Size Range	Rods: Ø3.5mm, Ø4.0mm, Ø4.5mm. Screws: Ø3.5mm, Ø4.0mm, Ø4.5mm; Lengths: 10mm-20mm (up to 50mm for Ø4.0mm, Ø4.5mm).	Available in specified sizes.
Strength	(Implied through ASTM F1717 testing and substantial equivalence)	Substantially equivalent to predicate devices.
Sterilization	(Implied to be equivalent to predicate devices)	Substantially equivalent to predicate devices.
Biocompatibility	(Implied to be equivalent to predicate devices)	Substantially equivalent to predicate devices.

Study Details:

Study Type: Non-clinical (benchtop) mechanical testing.
Testing Standard: ASTM F1717 (Standard Test Methods for Spinal Implant Constructs in a Corpectomy Model).
Sample Size (Test Set): Not specified in the document.
Data Provenance: Not applicable for non-clinical benchtop testing.
Ground Truth Establishment: Performance against parameters and criteria outlined in ASTM F1717.
Training Set Sample Size/Ground Truth: Not applicable as this is not an AI/algorithm-based device.
Expert involvement, adjudication, MRMC studies, standalone performance: Not applicable for this type of device submission.

Summary

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

K122-292

page 1 of 2

OCT 2 4 2012

510(k) Summary

08 October 2012

Reliance Medical Systems, LLC PO Box 1693 Bountiful, UT 84010 Telephone: 801-295-3280 Fax: 801-294-0079

Bret M. Berry Contact: Member-Manager

Common or Usual Name: Proposed Proprietary or Trade Name: Classification Name:

Spinal Fixation Device Reliance Posterior Cervical-Thoracic System Spinal Interlaminal Fixation Orthosis (per 21 CFR 888.3050) KWP, MNH, MNI

Product Code:

Substantial Equivalence

The Reliance Posterior Cervical-Thoracic System is substantially equivalent to the legally marketed Medtronic Vertex Reconstruction System (K003780), Pioneer Surgical Posterior Cervical Thoracic System (K092295), the Theken Atoll Cervico-Thoracic System (K083073), and the Alphatec Solanas Posterior Stabilization System (K052201). The Reliance Posterior Cervical-Thoracic System is equivalent to these commercially available devices in terms of material, intended use, levels of attachment, size range, and strength.

Device Description

Intended Use/Indications for Use

Page 21 of 35

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

page 2 of 2.

The Reliance Posterior Cervical-Thoracic System is intended to promote fusion of the cervical spine and cervicothoracic junction (C1-T3), and is indicated for the following:

· ddd (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)

spondylolisthesis
· spinal stenosis
fracture/dislocation
· revision of previous cervical spine surgery
tumors

The use of the polyaxial screws is limited to placement in the upper thoracic spine (TI-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

Hooks and Rods

The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Performance Data and Substantial Equivalence

The Reliance Posterior Cervical-Thoracic System has undergone Non-Clinical Testing including Static Compressive, Static Torsion, Dynamic Compressive and Dynamic Torsion in accordance with ASTM F1717. The Reliance Posterior Cervical-Thoracic System is substantially equivalent to the predicate devices. Additionally, the Reliance Cervical Plate System is substantially equivalent to the predicate devices in terms of sterilization and biocompatibility.

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

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.

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

Re: K122292

Trade/Device Name: Reliance Posterior Cervical-Thoracic System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP, MNH, MNI Dated: October 09, 2012 Received: October 10, 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

OCT
24 2012

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

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 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 yours,

Sincerely yours,

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

Enclosure

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

Indications for Use

510(k) Number (if known): K122292

Device Name: Reliance Posterior Cervical-Thoracic System

Indications for Use:

The Reliance Posterior Cervical-Thoracic System is intended to promote fusion of the cervical spine and cervicothoracic junction (C1-T3), and is indicated for the following: · ddd (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)

spondylolisthesis
· spinal stenosis
· fracture/dislocation
· revision of previous cervical spine surgery
tumors

The use of the mini polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

Hooks and Rods

The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

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)

Division Sign-Off

Page / of /

Sign-Off) Vision of Surgical, Orthopedic, /and Restorative Devices

K122292 510(k) Number_

Page 18 of 234

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.