The Innovasis Box PEEK IBF System is an intervertebral body fusion device intended to stabilize a spinal segment to promote fusion using bone graft, in order to restrict motion and decrease pain.

Indications for use are as follows:

The Innovasis Box 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 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 an anterior or anterolateral (A-Box) or lateral (L-Box) approach.

This device is intended to be used with internal supplemental spinal fixation systems such as the Innovasis Excella" Spinal System. The interior of the Box implants is intended to be packed with autograft.

Device Description

The Innovasis Box™ Peek IBF System consists of polyetheretherketone (PEEK) implants meant to be used with supplemental fixation and offered in a variety of different sizes, in order to accommodate the patient's anatomy and surgeon's preference for installation. The implants feature holes in the interior geometry in order to accommodate bone graft and maximize bone ingrowth. Tantalum (A-Box) or titanium (L-Box) radiographic markers are incorporated into the material to allow for visualization of the implant configuration during and after surgery. The surfaces of the implants have machined barbs meant to engage the vertebral endplates and prevent expulsion.

The A-Box device is an anatomically shaped IBF with two interior holes to allow for packed autograft. This device is designed to be inserted from an anterior or anterolateral approach.

The L-Box device is similar to the A-Box, but is longer and designed to be inserted from a lateral approach. It has a rounded nose which can be used to aid in placement.

Materials: The implants are machined from Medical Grade PEEK (Polyetheretherketone) Zeniva™ (Solvay) per ASTM F2026. Marker beads (A-Box) machined from implant grade Tantalum per ASTM F560. Marker pins (L-Box) machined from implant grade Titanium per ASTM F-67.

The system comes with reusable stainless steel surgical instruments designed to be cleaned and steam-sterilized between uses. These instruments aid in the preparation of the area and installation of the PEEK implants.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Box™ PEEK IBF System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test Name	Acceptance Criteria (Implicit)	Reported Device Performance
Static Axial Compression (F2077-11)	Performance comparable to legally marketed predicate devices and established acceptance criteria for the test.	"The worst-case implants performed substantially equivalent to the predicates for multiple modes of loading and met all of the acceptance criteria." "The Innovasis Inc. A-Box and L-Box IBF will adequately stabilize the lumbar spine for an interbody fusion indication as it demonstrated favorable mechanical performance compared to legally marketed predicate device."
Static Torsion (ultimate torque)	Performance comparable to legally marketed predicate devices and established acceptance criteria for the test.	"The worst-case implants performed substantially equivalent to the predicates for multiple modes of loading and met all of the acceptance criteria." "The Innovasis Inc. A-Box and L-Box IBF will adequately stabilize the lumbar spine for an interbody fusion indication as it demonstrated favorable mechanical performance compared to legally marketed predicate device."
Offset Yield Torque (F2077-11)	Performance comparable to legally marketed predicate devices and established acceptance criteria for the test.	"The worst-case implants performed substantially equivalent to the predicates for multiple modes of loading and met all of the acceptance criteria." "The Innovasis Inc. A-Box and L-Box IBF will adequately stabilize the lumbar spine for an interbody fusion indication as it demonstrated favorable mechanical performance compared to legally marketed predicate device."
Expulsion (in-house method)	Performance comparable to legally marketed predicate devices and established acceptance criteria for the test.	"The worst-case implants performed substantially equivalent to the predicates for multiple modes of loading and met all of the acceptance criteria." "The Innovasis Inc. A-Box and L-Box IBF will adequately stabilize the lumbar spine for an interbody fusion indication as it demonstrated favorable mechanical performance compared to legally marketed predicate device."
Subsidence (F2267-04)	Performance comparable to legally marketed predicate devices and established acceptance criteria for the test.	"The worst-case implants performed substantially equivalent to the predicates for multiple modes of loading and met all of the acceptance criteria." "The Innovasis Inc. A-Box and L-Box IBF will adequately stabilize the lumbar spine for an interbody fusion indication as it demonstrated favorable mechanical performance compared to legally marketed predicate device."
Biocompatibility (LAL and MEM Elution)	Tests passed below the established cutoff limit.	"All tests passed well below the cutoff limit."
Sterilization Validation	Sterility assurance level (SAL) of 10^-6 for both A-Box and L-Box systems (biological indicator overkill method).	"Pre-vacuum and gravity steam sterilization per parameters in the Innovasis IFU were validated to a sterility assurance level (SAL) of 10^-6 using the biological indicator overkill method for both the A-Box and L-Box systems."

Study Information:

The provided document describes non-clinical bench testing to demonstrate the substantial equivalence of the Box™ PEEK IBF System to predicate devices. It does not present a clinical study involving human patients or ground truth established by medical experts for diagnostic purposes.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Testing was conducted on "sterilized samples of the identified 'worst case' sizes from the Box™ PEEK IBF System (A-Box and L-Box)." The exact number of samples is not specified.
Data Provenance: The data is from non-clinical bench testing performed by Innovasis Inc. (or a third-party for sterilization) in a laboratory setting. It is not clinical data from patients or a specific country of origin, nor is it retrospective or prospective in a clinical sense.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable as the document describes non-clinical bench testing. There were no medical experts involved in establishing ground truth for a test set in the context of diagnostic accuracy or clinical outcomes. The "ground truth" here is defined by established engineering and biological standards.

4. Adjudication Method for the Test Set

This section is not applicable as the document describes non-clinical bench testing. Adjudication methods like 2+1 or 3+1 are used in clinical studies to establish a consensus ground truth among multiple readers/experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This document focuses on the mechanical and biological performance of an interbody fusion device, not on the diagnostic accuracy or interpretive capabilities of human readers with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This section is not applicable as the device is a physical intervertebral body fusion system, not an AI algorithm. Therefore, there is no "standalone" algorithm performance to report.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests was established by:

Recognized ASTM Standards: ASTM F2077-11 (for mechanical behavior like static axial compression, static torsion, offset yield torque) and ASTM F2267-04 (for subsidence).
In-house method: For expulsion testing.
Established biological cutoff limits: For Biocompatibility (LAL and MEM Elution).
Sterility Assurance Level (SAL) of 10^-6: For Sterilization Validation by biological indicator overkill method.

Essentially, the ground truth is adherence to these established engineering, safety, and sterilization standards.

8. The Sample Size for the Training Set

This section is not applicable. There is no "training set" in the context of an AI device. The testing described is for a physical medical device.

9. How the Ground Truth for the Training Set Was Established

This section is not applicable as there is no training set for an AI device.

Summary

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510(k) Summary Report Section 5 Box™ PEEK IBF System

September 12, 2012

September 12, 2012		OCT 17 2012
Company:	Innovasis Inc.614 East 3900 SouthSalt Lake City, UT 84107
Contact:	Marshall C. McCartyPhone: (801)261-2236Fax: (801) 261-0573
Trade Name:	Box™ PEEK IBF System
Common Name:	Interbody Fusion Device
Classification:	Product Code: MAXRegulation Number: 21 CRF 888.3080Classification Name: Intervertebral Body Fusion DevicePanel code: 87
SubstantiallyEquivalent Devices:	- K062151 - Box PEEK VBR System—Innovasis, Inc.- P960025 - Jaguar Lumbar I/F Cage System—DePuy Spine, Inc.

Intended Use: The Innovasis Box PEEK IBF System is an intervertebral body fusion device intended to stabilize a spinal segment to promote fusion using bone graft, in order to restrict motion and decrease pain.

Indications for use are as follows:

Device Description:

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ingrowth. Tantalum (A-Box) or titanium (L-Box) radiographic markers are incorporated into the material to allow for visualization of the implant configuration during and after surgery. The surfaces of the implants have machined barbs meant to engage the vertebral endplates and prevent expulsion.

The A-Box device is an anatomically shaped IBF with two interior holes to allow for packed autograft. This device is designed to be inserted from an anterior or anterolateral approach.

The L-Box device is similar to the A-Box, but is longer and designed to be inserted from a lateral approach. It has a rounded nose which can be used to aid in placement.

Performance Data-Non-clinical (Bench):

The standard ASTM F2077 is recognized by FDA and internationally as a uniform method for testing Intervertebral Body Fusion Devices, and the results can be compared to other devices. Testing to this standard can assess the mechanical behavior of the device.

This method simulates the loads that will be seen in an implant application, i.e. compressive loads are parallel to the axis of the spine and torsional loads rotate around the axis of the spine.

The standard ASTM F2267 is a recognized standard method to determine subsidence of an IVBFD for comparison purposes.

Testing protocols and acceptance criteria were defined prior to testing in various documents filed in the Design History Files for these products.

Performance bench testing has been conducted on sterilized samples of the identified "worst case" sizes from the Box™ PEEK IBF System (A-Box and L-Box). Worst case was determined using Finite Element Analysis. The testing included: Static Axial Compression, Static Torsion (ultimate torque), Offset Yield Torque (all per F2077-11), Expulsion (per in-house method) and Subsidence (per F2267-04).

Biocompatibility

PEEK has a substantial history and laboratory evidence of biocompatibility. In order to verify that the processing at Innovasis does not introduce new biocompatibility issues, Limulus Amebocyte Lysate (LAL) and MEM Elution tests have been performed on representative A-Box and L-Box devices. The devices were manufactured per Innovasis specifications and procedures, then were submitted for testing. All tests passed well below the cutoff limit.

Sterilization Validation

Autoclave (steam) sterilization was performed by an independent contractor on the A-Box IBF and Instruments in the carrying case. This is the worst case configuration for the Box

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IBF products, because all instruments and implants are included in one case, presenting a large mass and heat sink.

Pre-vacuum and gravity steam sterilization per parameters in the Innovasis IFU were validated to a sterility assurance level (SAL) of 10th using the biological indicator overkill method for both the A-Box and L-Box systems.

Conclusion

The Box PEEK IBF implants, the L-Box and A-Box, were substantially equivalent to predicate devices and met the acceptance criteria for each test. The worst-case implants performed substantially equivalent to the predicates for multiple modes of loading and met all of the acceptance criteria. The Innovasis Inc. A-Box and L-Box IBF will adequately stabilize the lumbar spine for an interbody fusion indication as it demonstrated favorable mechanical performance compared to legally marketed predicate device.

Performance testing indicates that the Box™ Peek IBF System is capable of performing in accordance with its intended use.

Basis for Substantial Equivalence:

The Box™ Peek IBF System has been subjected to risk analysis and engineering analysis including recognized ASTM standard testing and has been shown to be substantially equivalent to the predicates:

K062151 Box Peek VBR System-Innovasis, Inc.
P960025 Jaguar Lumbar I/F Cage System (Brantigan Cage)-DePuy Spine, Inc.

Summary of Safety and Effectiveness:

The Innovasis Box™ Peek IBF System is shown to be substantially equivalent for use as a intervertebral body fusion device and in the indications associated with device product code MAX.

For the new additions to the product line, the worst-case implants performed substantially equivalent to the predicates for multiple modes of loading and met all of the acceptance criteria. The Innovasis Inc. A-Box and L-Box IBF will adequately stabilize the lumbar spine for an interbody fusion indication as it demonstrated favorable mechanical performance compared to legally marketed predicate device.

Analysis of the intended use, design, materials and physical characteristics has shown the Box™ PEEK IBF System to be substantially equivalent when compared to the predicate devices. Based on feature comparisons, performance testing, indications for use, and adherence to good laboratory practice, Innovasis believes the Box™ PEEK IBF System to be substantially equivalent to existing legally marketed devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is a stylized image of an eagle.

Public Health Service

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

Innovasis, Incorporated % Mr. Marshall C. McCarty Manager, Regulatory Affairs 614 East 3900 South Salt Lake City, Utah 84107

stan 84107

Re: K121581

Trade/Device Name: Box ™ PEEK IBF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: September 11, 2012 Received: September 14, 2012

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

CT 17 2012

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Page 2 - Mr. Marshall C. 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 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/Resourcesfor You/Industry/default.htm.

Sincerely yours

Mark N. Melkerson

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

Enclosure

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Image /page/5/Picture/0 description: The image shows the word "INNOVASIS" in a bold, sans-serif font. The letters are black and have a slightly distressed or textured appearance. Below the main word, there is a smaller line of text that reads "INNOVATE / INVOLVE / INVENT" in a simpler font. The overall design is clean and straightforward, with a focus on the company name.

Indications for Use Statement Section 4

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Device Name: Box™ PEEK IBF System

Indications for use are as follows:

The Innovasis Box 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-SI). 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 Grade 1 monds of non operative a the involved level(s). These implants are used to facilitate spond) in the lumbar spine and are placed via either an anterior or anterolateral (A-Box) or lateral (L-Box) approach.

This device is intended to be used with internal supplemental spinal fixation systems such as the I movasis Excella" Spinal System. The interior of the Box implants is intended to be packed with autograft.

X Prescription Use (21 CFR 801 Subpart D)

Over-The-Counter-Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IE NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Cal-Rf
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

. 510(k) Number k/2/58/

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.