The Innovasis PFX™ Posterior Spinous Fixation System is a posterior, non-pedicle supplemental fixation device intended for use in the posterior non-cervical spine (T1-S1) of skeletally mature patients. It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion. The PFX Posterior Spinous Fixation System is intended for use at one level, with bone graft material. The PFX Posterior Spinous Fixation System is indicated for use as an aid in immobilization and stabilization of spinal segments as an adjunct to fusion for treatment of the following conditions:

· Degenerative disc disease: Back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
· Trauma: fracture or dislocation
· Spondvlolisthesis
Tumor

Device Description

The Innovasis® PFX™ Posterior Spinous Fixation System consists of plates, struts and screws that are used to build a construct to provide supplemental stabilization of spinal segments to support fusion. The components are available in a range of sizes to fit the anatomical needs of a variety of patients. PFX™ implants are composed of titanium alloy (per ASTM F136).

AI/ML Overview

The provided document describes the Innovasis PFX™ Posterior Spinous Fixation System, a medical device, and its testing for substantial equivalence to predicate devices. The study conducted is a non-clinical performance study focused on mechanical testing rather than a clinical study involving human subjects or AI performance.

Therefore, many of the requested criteria related to clinical studies, AI performance, and human expert review are not applicable to the information provided.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Applicable Standards)	Reported Device Performance (Tests Conducted)
ASTM F1798-97(Reapproved 2008) Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants	Tests Performed: Axial Pushoff, Lock Post Dissociation, Torque to Failure Results: "Testing demonstrates substantial equivalence to the predicates." and "The PFX Posterior Spinous Fixation device when tested using recognized standardized testing performed comparably to the predicates in all modes of loading and also exceeded the in vivo force tolerances of the human spine."
ASTM F1717-12 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model (This standard is generally for devices replacing a vertebral body. Its application here implies testing the construct's ability to provide stability akin to what would be needed after a vertebrectomy, even though this device is for spinous process fixation.)	Tests Performed: Static Compression Bending, Static Torsion, Dynamic Compression Bending Results: "Testing demonstrates substantial equivalence to the predicates." and "The PFX Posterior Spinous Fixation device when tested using recognized standardized testing performed comparably to the predicates in all modes of loading and also exceeded the in vivo force tolerances of the human spine."
Overall Substantial Equivalence to Predicate Devices (CD HORIZON® SPIRE™ Z Spinal System, Aspen™ Spinous Process Fixation System, Affix Spinous Process Plate System)	Comparability: - "The PFX Posterior Spinous Fixation device when tested using recognized standardized testing performed comparably to the predicates in all modes of loading and also exceeded the in vivo force tolerances of the human spine." - "The materials utilized (titanium alloy) are substantially equivalent to the predicates." - "The mode of operation (clamping mechanism utilizing wings and spikes, center post and set screw) is substantially equivalent to the predicates." - "The indications for use are substantially equivalent."

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

Sample Size for Test Set: Not explicitly stated as a number of physical devices. The "tests" section implies multiple tests were conducted (e.g., Axial Pushoff, Static Compression Bending, etc.), each likely on a sample of devices. However, the exact sample size for each specific test (e.g., how many devices for axial pushoff) is not detailed.
Data Provenance: The tests are non-clinical (mechanical testing). There is no "data provenance" in terms of patient data or country of origin for such data. The tests were performed to ASTM standards, which are internationally recognized.

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 was a non-clinical mechanical performance study, not a study evaluating diagnostic accuracy or clinical outcomes that would require expert-established ground truth.

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

Not Applicable. As a mechanical performance study, there was no need for adjudication by human experts. The "ground truth" was derived from the physical testing measurements against engineering standards.

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 document describes a medical device's physical performance, not an AI or imaging diagnostic tool. Therefore, MRMC studies and AI assistance are irrelevant to this submission.

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

Not Applicable. This is not an AI algorithm. It is a physical spinal fixation device.

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

The "ground truth" for this non-clinical study was the performance parameters defined by recognized industry standards (ASTM F1798 and ASTM F1717) and comparative performance to predicate devices. The device was deemed to have met the acceptance criteria if its mechanical performance was comparable to, and ideally exceeded, that of the predicate devices under standardized test conditions.

8. The sample size for the training set

Not Applicable. This is a physical device, not a machine learning model; therefore, there is no "training set."

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

Not Applicable. There is no training set for this type of device submission.

Summary

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K132765 Page 1 of 3

JUL 1 4 2014

510(k) Summary

PFX™ Posterior Spinous Fixation System

Date Prepared:	July 8, 2014
Company:	Innovasis, Inc.614 E. 3900 SouthSalt Lake City, UT 84107
Contact:	Marshall C. McCartyPhone: (801) 261-2236mmccarty@innovasis.com
Trade Name:	PFX™ Posterior Spinous Fixation System
Common Name:	Posterior Spinous Fusion Device
Classification:	Regulation No.: 21 CFR 888.3050 Spinal InterlaminalFixation OrthosisClass IIProduct Code: PEKReview Panel: Orthopedic/87Posterior Spine Devices Branch (PSDB)

Substantially

CD HORIZON® SPIRE™ Z Spinal Equivalent Device: K032037, K123246 System K090252 Aspen™ Spinous Process Fixation System K133052 Affix Spinous Process Plate System

Device Description: The Innovasis® PFX™ Posterior Spinous Fixation System consists of plates, struts and screws that are used to build a construct to provide supplemental stabilization of spinal segments to support fusion. The components are available in a range of sizes to fit the anatomical needs of a variety of patients. PFX™ implants are composed of titanium alloy (per ASTM F136).

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Performance Data:

Applicable Standards:

. ASTM F1798-97(Reapproved 2008) Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
. ASTM F1717-12 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model

Tests:

Axial Pushoff Lock Post Dissociation Torque to Failure Static Compression Bending Static Torsion Dynamic Compression Bending

Testing demonstrates substantial equivalence to the predicates.

Indications for Use: The Innovasis PFX™ Posterior Spinous Fixation System is a posterior, non-pedicle supplemental fixation device intended for use in the posterior non-cervical spine (T1-S1) of skeletally mature patients. It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion. The PFX Posterior Spinous Fixation System is intended for use at one level, with bone graft material. The PFX Posterior Spinous Fixation System is indicated for use as an aid in immobilization and stabilization of spinal segments as an adjunct to fusion for treatment of the following conditions:

· Degenerative disc disease: Back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
· Trauma: fracture or dislocation
· Spondvlolisthesis
Tumor

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K132765 Page 3 of 3

Basis for Substantial Equivalence:

The PFX Posterior Spinous Fixation device when tested using recognized standardized testing performed comparably to the predicates in all modes of loading and also exceeded the in vivo force tolerances of the human spine.

The materials utilized (titanium alloy) are substantially equivalent to the predicates.

The mode of operation (clamping mechanism utilizing wings and spikes, center post and set screw) is substantially equivalent to the predicates.

The indications for use are substantially equivalent.

Summary of Safety

And Effectiveness

And Effectiveness: The PFX when used as posterior supplemental fixation to a fusion site is substantially equivalent to the identified predicate devices.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

July 14, 2014

Innovasis, Incorporated Mr. Marshall C. McCarty Director, QA/RA 614 East 3900 South Salt Lake City, Utah 84107

Re: K132765

Trade/Device Name: PFX™ Posterior Spinous Fixation System Regulation Number: 21 CFR 888,3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: PEK Dated: June 16, 2014 Received: June 17, 2014

Dear Mr. McCarty:

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

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Page 2 - Mr. Marshall C. McCarty

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.

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 10

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/dcfault.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,

Ronald P. Jean -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

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

510(k) Number (if known) K132765

Device Name

PFXTM Posterior Spinous Fixation System

Indications for Use (Describe)

The Innovasis PFX™ Posterior Spinous Fixation System is a posterior, non-pedicle supplemental fixation device intended for use in the posterior non-cervical spine (T)-S1) of skeletally mature patients. It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion. The PFX Posterior System is intended for use at one level, with bone graft material. The PFX Posterior System is indicated for use as an aid in immobilization and stabilization of spinal segments as an adjunct to fusion for treatment of the following conditions:

· Degenerative disc disease: Back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies
· Trauma: fracture or dislocation
· Spondylolisthesis
· Tumor

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY FOR FOR . 、 . . . . . .

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Division of Orthopedic Devices

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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.