The Reliance Interspinous Plate System is a supplemental fixation device intended as an adjunct to fusion of the thoracolumbar (T1- S1) spine by fixation to the spinous processes in skeletally mature patients, and is indicated for the following:

degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
spondylolisthesis
trauma (i.e., fracture or dislocation)
tumors

This device is not intended for stand-alone use.

Device Description

The Reliance Interspinous Plate System consists of an interspinous process spacer-plate and process lock plate assembly for posterior fixation of the spine in order to achieve fusion. The interspinous process spacer-plate and process lock plate are available in multiple sizes to accommodate various patient anatomies. The insert features a lateral plate with teeth to interface with the bone of the spinous processes. The process lock plate also features teeth which contact the bone of the spinous processes. The process lock plate is passed through the insert such that, in their final position, interspinous process spacer-plate and process lock plate surround the spinous processes on both sides, and fixation is achieved via compression of the two components onto the spinous processes.

AI/ML Overview

The provided submission is for the Reliance Interspinous Plate System, a medical device, not an AI/ML device. Therefore, the questions related to AI/ML device evaluation criteria such as sample size for test/training sets, data provenance, ground truth establishment, MRMC studies, and standalone performance are not applicable.

However, based on the provided text, I can infer the acceptance criteria and how the device claims to meet those criteria for a traditional medical device:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria / Test	Reported Device Performance
Mechanical Performance (Strength & Durability)	Static axial compression (per ASTM F1717-13)	Sufficient for intended use, substantially equivalent to predicate devices
	Static torsion (per ASTM F1717-13)	Sufficient for intended use, substantially equivalent to predicate devices
	Static axial pull-out (per ASTM F1717-13)	Sufficient for intended use, substantially equivalent to predicate devices
	Dynamic axial compression (per ASTM F1717-13)	Sufficient for intended use, substantially equivalent to predicate devices
	Static plate dissociation	Sufficient for intended use, substantially equivalent to predicate devices
Material Biocompatibility	Manufactured from medical grade Titanium (Ti 6Al-4V) per ASTM F136	Meets material standard, assumed biocompatible with predicate devices
Sterilization	Provided non-sterile with instructions for sterilization	Standard practice, similar to predicate devices
Indications for Use	Adjunct to fusion of thoracolumbar (T1-S1) spine in skeletally mature patients for degenerative disc disease, spondylolisthesis, trauma, tumors (not stand-alone use)	Similar to predicate devices' indications
Technological Characteristics	Material, structural support mechanism, sterilization, size options, design for compression fixation	Nearly identical to predicate devices; minor differences do not raise new safety/effectiveness issues

Regarding the AI/ML-specific questions (2-9), these are not applicable to this submission as it is for a physical medical device.

2. Sample size used for the test set and the data provenance: Not applicable (not an AI/ML device).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable (not an AI/ML device).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable (not an AI/ML device).
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 (not an AI/ML device).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable (not an AI/ML device).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable (not an AI/ML device). Ground truth for a physical device is typically based on engineering standards and mechanical testing results.
8. The sample size for the training set: Not applicable (not an AI/ML device).
9. How the ground truth for the training set was established: Not applicable (not an AI/ML device).

Summary of Acceptance Criteria and Study:

The acceptance criteria for the Reliance Interspinous Plate System are primarily based on mechanical performance testing against industry standards (ASTM F1717-13) and comparison of technological characteristics and indications for use to legally marketed predicate devices.

The study that proves the device meets the acceptance criteria is a series of non-clinical performance tests:

Static axial compression
Static torsion
Static axial pull-out
Dynamic axial compression
Static plate dissociation

The results of these tests demonstrated that the device's strength is sufficient for its intended use and is substantially equivalent to the predicate devices. The materials and design are also compared to predicate devices to establish substantial equivalence.

Summary

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

April 2, 2015

Reliance Medical Systems, LLC % Meredith L. May, MS, RAC Empirical Consulting, LLC 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K142217

Trade/Device Name: Reliance Interspinous Plate System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: PEK Dated: February 19, 2015 Received: February 20, 2015

Dear Ms. May:

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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Page 2 - Meredith L. May, MS, RAC

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" (21 CFR 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

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Indications for Use

510(k) Number (if known) K142217

Device Name Reliance Interspinous Plate System

Indications for Use (Describe)

degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
spondylolisthesis
trauma (i.e., fracture or dislocation)
tumors

This device is not intended for stand-alone use.

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

|X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Submitter's Name:	Reliance Medical Systems, LLC
Submitter's Address:	545 West 500 South Suite 100Bountiful, UT 84010
Submitter's Telephone:	(801) 295-3280
Contact Person:	Meredith L. May, MS, RACEmpirical Consulting, LLC719.337.7579
Date Summary was Prepared:	31 March 2015
Trade or Proprietary Name:	Reliance Interspinous Plate System
Common or Usual Name:	Spinous Process Plate
Classification:	Class II per 21 CFR §888.3050
Product Code:	PEK
Classification Panel:	Orthopedic (87)

5.510(K) SUMMARY

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

INDICATIONS FOR USE

Degenerative disc disease (defined as back pain of discogenic origin with ● degeneration of the disc confirmed by patient history and radiographic studies)
spondylolisthesis ●
trauma (i.e., fracture or dislocation) .
tumors ●

This device is not intended for stand-alone use.

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The indications for use for the Reliance Medical Interspinous Plate is similar to that of the predicates listed in Table 5-1 below.

TECHNOLOGICAL CHARACTERISTICS

The interspinous process spacer-plate and process lock plate are manufactured from medical grade Titanium (Ti 6Al-4V) per ASTM F136. The implants are provided non-sterile with instructions for sterilization. The interspinous plates are designed in interspinous heights of 18mm, total heights of 35-50mm, and widths of 25-30.

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

Indications for Use
Materials of manufacture ●
Structural support mechanism ●
Sterilization

Table 5-1 Predicate Devices

510k Number	Trade or Proprietary or Model Name	Manufacturer	Predicate Type
K133363	Interspinous Posterior Fixation System	InterBRIDGE	Additional
K073278,K131238	Affix Spinous Process Plate System	NuVasive®	Additional
K123093	StabiLink™ MIS Spinal Fixation System	Southern Spine	Additional
K100354	PrimaLOK™ Interspinous Fusion System	OsteoMed	Primary
K122509	Spinous Process Fixation Plate	VertiFlex®	Additional

Performance Data

The Reliance Interspinous Plate System has been tested in the following test modes:

Static axial compression per ASTM F1717-13
Static torsion per ASTM F1717-13
Static axial pull-out per ASTM F1717-13 ●
Dynamic axial compression per ASTM F1717-13 .
. Static plate dissociation

The results of this non-clinical testing show that the strength of the Reliance Medical Interspinous Plate is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

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CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the Reliance Interspinous Plate System is substantially equivalent to the predicate device.

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.