The Innovasis C-Box PEEK Cervical IBF device is indicated for cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. This device is to be used in patients who have had six weeks of non-operative treatment. The C-Box device is to be used with supplemental fixation, such as the Innovasis Opteryx® Cervical Plate System. The C-Box device is intended to be used with autograft bone and is to be implanted via an open, anterior approach.

Device Description

AI/ML Overview

The provided documentation describes a 510(k) premarket notification for the C-Box® PEEK Cervical IBF System, a medical device. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than explicit acceptance criteria and performance statistics from a clinical study for the new device.

Therefore, many of the requested elements regarding acceptance criteria, device performance, sample sizes, and expert validation are not applicable or explicitly stated in this type of regulatory document. Instead, the focus is on demonstrating that the new device is as safe and effective as a previously cleared device.

Here's an analysis based on the provided text:

Acceptance Criteria and Study Details for C-Box® PEEK Cervical IBF System

This submission is a 510(k) premarket notification, which establishes substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study of the new device itself.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission, there are no explicit "acceptance criteria" in the sense of predefined thresholds for clinical performance (e.g., sensitivity, specificity) for the new device. Instead, the acceptance is based on demonstrating substantial equivalence to legally marketed predicate devices, primarily through non-clinical performance data and material equivalency.

Acceptance Criteria (Demonstrated Equivalency to Predicate Devices)	Reported Device Performance (Non-Clinical)
Design configurations are substantially equivalent.	The C-Box® PEEK Cervical IBF has a rectangular shape with rounded corners, proportional sizing for the cervical spine, 6º lordosis, large central window for bone autograft, radiolucent body with tantalum markers, and custom position instruments. These features are implicitly presented as substantially equivalent to the predicate devices.
Applied mechanical loads are substantially equivalent.	Performance testing per ASTM F2077-11 (Test Methods for Intervertebral Body Fusion Devices) and ASTM F2267-04 (Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression) was performed. These tests cover: Static Compression, Static Compression Shear, Static Torsion, Dynamic Compression, Dynamic Compression Shear, Dynamic Torsion, Subsidence, and Expulsion. The results "indicate that the C-Box PEEK Cervical IBF is substantially equivalent to the predicate device."
Product sizes and shapes are substantially equivalent.	The device is offered in a variety of different heights and features 6º lordosis, described as "proportional sizing for the cervical spine". This is presented as substantially equivalent to predicate devices.
Materials used are equivalent.	Implants are machined from medical grade polyetheretherketone (Invibio PEEK Optima®) per ASTM F-2026. Radiographic markers meet ASTM F-560 for unalloyed Tantalum. These materials are explicitly stated as equivalent to those used in predicate devices.
Biocompatibility requirements have been demonstrated.	Implicitly demonstrated through the use of Invibio PEEK Optima® (per ASTM F-2026) and Tantalum (per ASTM F-560), which are well-established biocompatible materials for surgical implants, and likely by direct comparison to the predicate devices which use similar materials. The document states "Biocompatibility requirements have been demonstrated."
Manufacturing and processing methods are substantially equivalent.	Not explicitly detailed, but stated as a conclusion: "Manufacturing and processing methods are substantially equivalent."
Shelf life is equivalent.	Not explicitly detailed, but stated as a conclusion: "Shelf life is equivalent."

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

Test Set Sample Size: Not applicable. The "testing" referred to is non-clinical performance testing on the device itself (e.g., mechanical tests), not a clinical trial on a patient population. The sample size for these non-clinical tests (e.g., number of devices tested for mechanical properties) is not specified.
Data Provenance: The mechanical performance data is generated in a laboratory setting per ASTM standards. This is not clinical data, so country of origin of patient data or retrospective/prospective status is not applicable.

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

Not applicable. As this is a 510(k) for an intervertebral fusion device, the "ground truth" for demonstrating substantial equivalence is based on engineering analyses, material science, and comparison to predicate devices, not on expert adjudication of clinical outcomes or images in a test set.

4. Adjudication Method for the Test Set

Not applicable. There is no clinical test set requiring adjudication in this type of submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This type of study is not relevant for a mechanical implant device 510(k) submission, which focuses on physical and material equivalency rather than software or imaging diagnostic performance.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

Not applicable. This device is a mechanical implant, not an algorithm or an AI-powered diagnostic tool.

7. Type of Ground Truth Used

The "ground truth" for this submission is based on adherence to recognized ASTM standards for material properties and mechanical performance, and documented similarities in design, materials, and intended use with already-cleared predicate devices. The clinical ground truth for the predicate devices' safety and effectiveness was established when they received clearance or approval.

8. Sample Size for the Training Set

Not applicable. This device does not involve machine learning or AI, so 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 device.

Summary

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FEB 1 2 2014

510(k) Summary Report:

C-Box® PEEK Cervical IBF System

Company:	Innovasis, Inc.614 E. 3900 SouthSalt Lake City, UT 84107
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Contact: Marshall C. McCarty Phone: (801) 261-2236 mmccarty@innovasis.com

Trade Name: C-Box® PEEK Cervical IBF

Common Name: Intervertebral fusion device with bone graft, cervical

Classification:	Regulation No.: 21CFR 888.3080
	Class 2
	Product Code: ODP
	Review Panel: Orthopedic ASDB
	Applicable Standards:
	• ASTM F560-08 Standard Specification for UnalloyedTantalum for Surgical Implant Applications
	• ASTM F983-86 Standard Practice for Permanent Markingof Orthopedic Implant Components
	• ASTM F2026-12 Standard Specification forPolyetheretherketone (PEEK) Polymersfor Surgical Implant Applications
	• ASTM F2077-11 Test Methods for Intervertebral BodyFusion Devices
	• ASTM F2267-04 (Reapproved 2011) Standard Test Methodfor Measuring Load Induced Subsidenceof Intervertebral Body Fusion DeviceUnder Static Axial Compression
	• ISO 17665-1:2006 Sterilization of Healthcare Products –Moist Heat - Part 1 Requirements for theDevelopment, Validation and RoutineControl of a Sterilization Process forMedical Devices

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K132991 page 2 of 4

Substantially

Phantom™ Plus Cage System (US Spine)
Aleutian Spinal System	(K2M)
AVS AS PEEK Spacer	(Stryker)
Breckenridge Cervical IBF	(Lanx)

Device Description: C-Box® PEEK Cervical IBF

The single use devices are rectangular in shape with rounded corners and are offered in a variety of different heights to accommodate patient anatomy. The design features include: · Proportional sizing for the cervical spine · 6º lordosis · Manufactured with Invibio PEEK OPTIMA® polyetheretherketone · Large central window for bone autograft material • Radiolucent · Tantalum markers to facilitate and verify device placement · Custom position instruments to facilitate proper implant placement · Proud tooth design on superior and inferior surfaces to resist migration Performance Data: (Non-clinical)-Performance testing per ASTM F2077-11 and F2267-04 for Static Compression, Static Compression Shear, Static Torsion, Dynamic Compression, Dynamic Compression Shear, Dynamic Torsion, Subsidence and Expulsion, indicates that the C-Box PEEK Cervical IBF is substantially equivalent to the predicate device. Materials: The implants are machined from medical grade polyetheretherketone (Invibio PEEK Optima®) per ASTM F-2026. The radiographic markers meet ASTM F-560 for unalloyed Tantalum. Intended Use: The C-Box PEEK Cervical IBF device is intended for use in Anterior Cervical Discectorny and Fusion (ACDF) procedures. Users of these products are limited to physicians trained in orthopedic surgery. Clinical locations include hospitals and surgery sites equipped to perform spinal surgery.

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Indications for Use: The Innovasis C-Box PEEK Cervical IBF device is indicated for cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies.

This device is to be used in patients who have had six weeks of non-operative treatment. The C-Box device is to be used with supplemental fixation, such as the Innovasis Opteryx® Cervical Plate System. The C-Box device is intended to be used with autograft bone and is to be implanted via an open, anterior approach.

Contraindications (Exclusions for Use):

Use of this system is contraindicated when there is active systemic infection, infection localized to the site of the proposed implantation, or when the patient has demonstrated allergy or foreign body sensitivity to any of the implant materials.

Severe osteoporosis may prevent adequate fixation and thus preclude the use of this or any other orthopedic implant.

Conditions that may place excessive stress on the bone and implant, such as severe obesity or degenerative diseases are relative contraindications. The decision whether to use these devices under these conditions must be made by the physician taking into account the risks versus the benefits to the patient.

Use of these implants is relatively contraindicated in patients whose activity, mental capacity, mental illness, alcoholism, drug abuse, occupation, or lifestyle may interfere with their ability to follow postoperative restrictions and who may place undue stresses on the implant during bone healing and may be at a higher risk of implant failure.

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Basis for Substantial Equivalence:

The C-Box PEEK Cervical IBF has been subjected to risk analysis, engineering analysis and testing to recognized standards and has been shown to be substantially equivalent to the predicate devices, K082801 Phantom™ Plus Cage System, K130699 Aleutian Spinal System, K120486 AVS AS PEEK Spacer, and K103660 Breckenridge Cervical IBF.

· Design configurations are substantially equivalent.
· Applied mechanical loads are substantially equivalent.
· Product sizes and shapes are substantially equivalent.
· Materials used are equivalent.
· Biocompatibility requirements have been demonstrated.
· Manufacturing and processing methods are substantially equivalent.
· Shelf life is equivalent.

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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

February 12, 2014

Innovasis, Incorporated Mr. Marshall McCarty Director Quality Affairs/Regulatory Affairs 614 East 3900 South Salt Lake City, Utah 84107

Re: K132991

Trade/Device Name: C-Box® PEEK Cervical IBF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: January 16, 2014 Received: January 22, 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. Ilisting 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

VATO

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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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 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,

Vincent Devlin -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 Statement 1.0

K132991 510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Device Name: C-Box® PEEK Cervical IBF System

INDICATIONS FOR USE are as follows:

This device is to be used in patients who have had six weeks of non-operative treatment. The C-Box device is to be used with supplemental fixation, such as the Innovasis Opteryx® Cervical Plate System. The C-Box device is intended to be used with autograft bone and is to be implanted via an open, anterior approach.

x Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart D)

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

(PLEASE DO NOT WRITE BELOW THIS LINE_CONTINUE_ON ANOTHER PAGE IF_ NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anton E. Dmitriev, PhD

Division of Orthopedic Devices

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.