The Innovasis Px™ PEEK IBF System is an intervertebral body fusion device for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to a Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These implants are used to facilitate fusion in the lumbar spine and are placed via either a posterior (PLIF) or modified transforaminal (T-PLIF) approach.

This device is intended to be used in pairs and with internal supplemental spinal fixation systems such as the Innovasis Excella® Spinal System. The interior of the Px implant is intended to be packed with autograft.

Device Description

The Innovasis Px™ PEEK IBF is designed for use in a posterior (PLIF) approach to the lumbar spine. Manufactured by Innovasis from implant grade polyetheretherketone (PEEK) conforming to ASTM F2026, the Px has excellent strength, stiffness and dimensional stability, with a modulus of elasticity similar to human vertebral bone. The device is radiolucent allowing straightforward assessment of the fusion process, while tantalum spheres are located around the periphery of the device to allow implant visualization during the procedure.

The single use implant devices feature an open cavity in the interior geometry to accommodate bone graft and maximize bone in-growth, as well as a convex shape with anti-migration teeth to engage the vertebral endplates and prevent expulsion. The implants are offered in a variety of different sizes to fit the anatomical needs of a wide variety of patients. Reusable instruments to support the PLIF surgery are provided with the implants in custom sterilization trays.

AI/ML Overview

Based on the provided text, the device in question is the Innovasis Px™ PEEK IBF System, an intervertebral body fusion device. The text describes non-clinical performance testing for this device, not a study involving human subjects or AI. Therefore, most of the requested information regarding AI acceptance criteria, human reader studies, and ground truth establishment (as typically applied to AI/imaging diagnostics) is not applicable to this document.

However, I can extract the relevant information concerning the device's acceptance criteria and the study that proves it meets them, based on the non-clinical performance data presented.

Here's the breakdown:

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

The document highlights performance testing against specific ASTM standards. These standards implicitly set the "acceptance criteria" through their methodologies for demonstrating capability for intended use.

Acceptance Criteria (Measured Performance Aspect)	Standard	Reported Device Performance
Static Axial Compression	ASTM F2077-11	Capable of performing in accordance with its intended use.
Dynamic Axial Compression	ASTM F2077-11	Capable of performing in accordance with its intended use.
Subsidence	ASTM F2267-04	Capable of performing in accordance with its intended use.
Expulsion	ASTM F2077-11	Capable of performing in accordance with its intended use.

Note: The document states that "Performance testing per ASTM F2077-11 and F2267-04 for Static Axial Compression, Dynamic Axial Compression, Subsidence and Expulsion, indicates that the Px™ PEEK IBF is capable of performing in accordance with its intended use." It does not provide specific numerical results of these tests, but a qualitative statement of meeting the standard's requirements.

2. Sample size used for the test set and the data provenance

Sample Size: Not explicitly stated. For mechanical testing of medical devices per ASTM standards, the sample size is usually determined by statistical requirements of the specific test method and regulatory guidelines, but not detailed here.
Data Provenance: The data is from "Performance testing" conducted by Innovasis as part of their 510(k) submission. It is non-clinical (ex-vivo/in-vitro) testing rather than collected from human subjects. The country of origin of the data is implied to be the US, where Innovasis is based. It is prospective testing designed to demonstrate device performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. This is non-clinical mechanical testing of a physical device, not an imaging or diagnostic study requiring expert human interpretation or "ground truth" establishment in the context of clinical accuracy for AI. The "ground truth" for these tests is the physical performance measured against the parameters defined by the ASTM standards.

4. Adjudication method for the test set

Not Applicable. As this is mechanical testing, there's no "adjudication" in the sense of reconciling expert opinions. Test results are measured objectively against defined criteria within the ASTM 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 the performance testing of an intervertebral body fusion device, not a diagnostic imaging AI algorithm. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted or is relevant here.

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

Not Applicable. This is a physical medical device, not a software algorithm.

7. The type of ground truth used

Mechanical Performance Standards. The "ground truth" is defined by the requirements and methodologies outlined in the referenced ASTM standards (ASTM F2077-11, ASTM F2267-04). These standards specify the mechanical properties and behaviors that the device must exhibit to be considered suitable for its intended use. This is a form of engineering or performance 'ground truth'.

8. The sample size for the training set

Not Applicable. There is no "training set" as this is not an AI/machine learning study.

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

Not Applicable. There is no "training set" or associated ground truth establishment for a training set in this context.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, resembling a bird-like shape.

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

June 19, 2015

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

Re: K150500

Trade/Device Name: Px™ PEEK IBF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: May 19, 2015 Received: May 20, 2015

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 – Mr. Marshall McCarty

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

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Indications for Use

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

K150500

Page 1 of 1

510(k) Number (if known) K150500

Device Name Px™ PEEK IBF System

Indications for Use (Describe)

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)

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."

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Image /page/3/Picture/0 description: The image shows the logo for Innovasis. The logo is in black and features the word "INNOVASIS" in a bold, sans-serif font. Below the main wordmark are the words "INNOVATE / INVOLVE / INVENT" in a smaller font size. The logo has a modern and clean design.

510(k) Summary Report:

Px™ PEEK IBF System

Company:	Innovasis, Inc.614 E. 3900 SouthSalt Lake City, UT 84107
Contact:	Marshall C. McCartyPhone: (801) 261-2236mmccarty@innovasis.com
Trade Name:	Px™ PEEK IBF System
Common Name:	Intervertebral body fusion device
Classification:	Regulation No.: 21CFR 888.3080Class 2Product Code: MAXReview Panel: Orthopedic ASDBApplicable Standards:
	• ASTM F560-13	Standard Specification for Unalloyed Tantalum forSurgical Implant Applications
	• ASTM F983-86	(Reapproved 2013) Standard Practice forPermanent Marking of Orthopedic ImplantComponents
	• ASTM F2026-12	Standard Specification for Polyetheretherketone(PEEK) Polymers for Surgical ImplantApplications
	• ASTM F2077-11	Test Methods for Intervertebral Body FusionDevices
	• ASTM F2267-04	(Reapproved 2011) Standard Test Method forMeasuring Load Induced Subsidence ofIntervertebral Body Fusion Device Under StaticAxial Compression
	• ISO 17665-1: 2006	(Reapproved 2013) Sterilization of HealthcareProducts - Moist Heat - Part 1 Requirements forthe Development, Validation and Routine Controlof a Sterilization Process for Medical Devices
	The Innovasis Px™ PEEK IBF is designed for use in a posterior(PLIF) approach to the lumbar spine. Manufactured by Innovasisfrom implant grade polyetheretherketone (PEEK) conforming toASTM F2026, the Px has excellent strength, stiffness anddimensional stability, with a modulus of elasticity similar to humanvertebral bone. The device is radiolucent allowing straightforwardassessment of the fusion process, while tantalum spheres arelocated around the periphery of the device to allow implantvisualization during the procedure.
	The single use implant devices feature an open cavity in theinterior geometry to accommodate bone graft and maximize bonein-growth, as well as a convex shape with anti-migration teeth toengage the vertebral endplates and prevent expulsion. Theimplants are offered in a variety of different sizes to fit theanatomical needs of a wide variety of patients. Reusableinstruments to support the PLIF surgery are provided with theimplants in custom sterilization trays.
Performance Data:	(Non-clinical)—Performance testing per ASTM F2077-11 andF2267-04 for Static Axial Compression, Dynamic AxialCompression, Subsidence and Expulsion, indicates that the PxPEEK IBF is capable of performing in accordance with its intendeduse.
Materials:	The implants are machined from medical grade Solvay Zeniva ZA-500 and Evonik VESTAKEEP i4R polyetheretherketone per ASTMF2026. The radiographic markers meet ASTM F560 for unalloyedTantalum.
Intended Use:	The Innovasis Px PEEK IBF System is an intervertebral bodyfusion device intended to stabilize a spinal segment to promotefusion using bone graft, in order to restrict motion and decreasepain.
	Users of these products are limited to physicians trained inorthopedic surgery. Clinical locations include hospitals andsurgery sites equipped to perform spinal surgery.
Indications for Use:	The Innovasis Px™ PEEK IBF System is an intervertebral bodyfusion device for use in patients with degenerative disc disease(DDD) at one or two contiguous levels of the lumbar spine (L2-S1). DDD is defined as discogenic back pain with degeneration ofthe disc confirmed by history and radiographic studies. These

Primary Predicate: K073177 Pioneer Bullet Tip IBF This predicate has not been subject to a design-related recall.

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Image /page/4/Picture/0 description: The image shows the logo for Innovasis. The logo is black and features the word "INNOVASIS" in all caps. Below the word is the phrase "INNOVATE / INVOLVE / INVENT".

Add'I Predicate: P960025 Jaguar IF / Brantigan Cage

Device Description: $Px^{TM}$ PEEK IBF System

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Image /page/5/Picture/0 description: The image shows the logo for Innovasis. The logo is black and features the company name in a bold, sans-serif font. The "V" in Innovasis is stylized to look like a check mark. Below the company name is the tagline "Innovate / Involve / Invent."

patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to a Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These implants are used to facilitate fusion in the lumbar spine and are placed via either a posterior (PLIF) or modified transforaminal (T-PLIF) approach.

Basis for Substantial Equivalence:

The Px PEEK IBF System has been subjected to risk analysis, engineering analysis and testing to recognized standards and has been shown to be substantially equivalent to the predicate device, K073177 Pioneer Surgical Technology Interbody Fusion Bullet Tip IBF and reference device P960025 Depuy Spine Jaguar IF/Brantigan Cage.

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Conclusion:

The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe and as effective, and performs as well as or better than the legally marketed predicate device.

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.