The Phusion Metal Cervical Cage is indicated for intervertebral body fusion of the spine in skeletally mature patients. The Phusion Metal Cervical Cage is intended for use at one level in the cervical spine, from C3 to C7, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The Phusion Metal Cervical Cage is to be used in patients who have had six weeks of non-operative treatment. Devices are intended to be implanted via an open, anterior approach and used with autogenous bone and supplemental fixation, such as an anterior plating system.

Device Description

The Phusion Metal Cervical Cage is an intervertebral fusion device intended to act as a disc spacer and hold bone graft to promote fusion in the cervical spine. The Phusion Metal Cervical Cage is anatomically shaped with two holes in the anterior end of the device each having a diameter of two millimeters extending to the inner cavity. The Phusion Metal Cervical Cage is manufactured from a porous titanium-nickel (Ti-Ni) intermetallic material. The Phusion Metal Cervical Cage is offered in a variety of shapes and sizes to accommodate variations in patient anatomy. The superior and inferior surfaces of the device has a pattern of teeth to provide increased stability and inhibit movement of the implants. Phusion Metal Cage implants are available in one lordotic configuration of 7°and heights ranging from 5 to 10 mm in 1 mm increments. The Phusion Metal Cage device is single-use only.

AI/ML Overview

The provided text describes the 510(k) summary for the PorOsteon Phusion Metal Cervical Cage, a medical device for intervertebral body fusion. It outlines performance data from various tests and studies a comparison with a predicate device.

Here's the information about acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Test/Characteristic	Acceptance Criteria	Reported Device Performance
Biomechanical tests (static and dynamic compressive, shear, and torsion strength per ASTM F2077-11)	Meet or exceed strength requirements for cervical spinal devices	Phusion Metal Cages met or exceeded the strength requirements for cervical spinal devices.
Subsidence characteristics (per ASTM F2267-04)	Typical of spinal fusion devices fabricated from permanent polymer or metallic materials	Possessed subsidence characteristics typical of spinal fusion devices fabricated from permanent polymer or metallic materials.
Expulsion characteristics (per ASTM F-04.25.02.02)	Comparable to a competitive PEEK device	Static expulsion testing of the worst-case device for the Phusion Metal Cage and a competitive PEEK device were measured and compared. (Implied that it met or was comparable, as device was deemed substantially equivalent).
Wear debris (per ASTM F1714-96)	(Not explicitly stated, but implied to be acceptable based on overall safety conclusion)	Collection and characterization of wear debris from dynamic testing was characterized.
Biocompatibility (per ISO 10993 standards)	Biocompatible and elicit no adverse reactions	The porous Ti-Ni intermetallic Phusion Metal material was shown to be biocompatible and elicit no adverse reactions.
Bone Apposition/Ingrowth/Fusion (ovine model)	No evidence of adverse tissue reaction, no evidence of migration or pseudoarthrosis, normal bone and soft tissue at fusion sites, 100% rate of fusion at 6 months, statistically equivalent fusion at 6 months to control devices, higher percentage of bone contact compared to PEEK control.	Histology, micro-CT, in-life radiography and CT, and biomechanical evaluation showed: - No evidence of adverse tissue reaction. - No evidence of migration or pseudoarthrosis. - Normal bone and soft tissue at the fusion sites. - 100% rate of fusion at 6 months (4 sheep, 2 devices/sheep). - Statistically equivalent fusion at 6 months to the control devices based on bone histology and biomechanical motion. - Statistically significant, higher percentage of bone contact of the superior and inferior surfaces of the devices at 4 and 6 months for the Phusion Metal devices as compared to the PEEK control devices (23.90% vs. 9.94% at 4 months and 56.09% vs. 27.31% at 6 months).
Nickel Levels (in ovo model)	Normal levels of nickel (Ni) with respect to control PEEK devices and scientific literature; no evidence of abnormal nickel levels.	Histopathology of major organs, blood work, ICP-MS of blood, and serum biochemistry showed normal levels of nickel (Ni) with respect to the control PEEK devices and the scientific literature; there was no evidence of abnormal nickel levels for all tissue, blood, and serum samples.

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

Biomechanical Tests: "Worst-case devices" for static and dynamic compressive, shear, and torsion strength, subsidence, and expulsion testing. Specific numerical sample sizes are not provided for these in vitro tests.
Biocompatibility Testing: Not specified, but performed per ISO 10993 standards.
Ovine Model (in vivo study):
- Sample Size: n = 8 sheep.
- Test Devices: Phusion Metal Cervical Cage devices were implanted in 2 non-contiguous levels (L2-L3 and L4-L5) in each sheep.
- Control Devices: Commercially available control devices of similar design fabricated from Zeniva PEEK material were also implanted.
- Data Provenance: The study was performed by the Preclinical Surgical Research Laboratory, Colorado State University, USA. It was a prospective study described as being performed "per Good Laboratory Practices (GLP)".

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

The document does not mention the use of human experts to establish ground truth for the in vitro biomechanical and biocompatibility tests. For the in vivo ovine model, the ground truth was based on objective measures:

Histology
Micro-CT
In-life radiography and CT
Biomechanical evaluation
Histopathology of major organs
Blood work (including ICP-MS for nickel levels)
Serum biochemistry

Therefore, the "experts" were the analytical methods and laboratory personnel performing these detailed assessments. Their specific qualifications are not detailed beyond "Preclinical Surgical Research Laboratory, Colorado State University, USA." No information regarding "number of experts" is provided in the context of human assessment for establishing ground truth for this device.

4. Adjudication method for the test set

Not applicable. The ground truth for the in vitro and in vivo studies was established through objective measurements and scientific analysis, not through human expert consensus requiring an adjudication method like 2+1 or 3+1.

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

No MRMC study was conducted or described. This submission is for a physical intervertebral body fusion device, not an AI-assisted diagnostic tool or imaging software.

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

This question is not applicable as the device is a physical implant, not an algorithm or AI system.

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

In vitro tests: Ground truth was based on engineering standards (ASTM) and ISO standards for material properties, biomechanical performance, and biocompatibility.
In vivo animal study (ovine model): Ground truth was established through a combination of pathology (histology, histopathology of organs), imaging data (micro-CT, in-life radiography and CT), laboratory analysis (blood analysis, serum biochemistry, ICP-MS), and biomechanical evaluation of the fused spinal segments.

8. The sample size for the training set

This is not applicable. The device is a physical implant, and the studies described are performance and safety evaluations, not machine learning model training.

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

Not applicable, as there was no training set for a machine learning model.

Summary

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

December 19, 2014

PorOsteon, Incorporated % BioVera. Incorporated Robert A. Poggie, PhD 100 Promenade Saint Louis Notre-Dame-de-L'Ile-Perrot, Quebec, J7V 7P2 Canada

Re: K142041

Trade/Device Name: PorOsteon Phusion Metal Cervical Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: November 21, 2014 Received: November 25, 2014

Dear Dr. Poggie:

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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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 yours,

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) K142041

Device Name

PorOsteon Phusion Metal Cervical Cage

Indications for Use (Describe)

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

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

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510(k) SUMMARY

PorOsteon, Inc. – Phusion Metal Cervical Cage

In accordance with 21 CFR 807.92 of the Federal Code of Regulations, the following information is a summary of safety and effectiveness PorOsteon's Phusion Metal Cervical Cage device.

A. SUBMITTERS INFORMATION

Submitter Name:	BioVera, Inc.
Submitter Address:	65 Promenade Saint-Louis, Notre-Dame-De-L'Ile-Perrot, Quebec,J7V 7P2, CANADA
Contact Person:	Robert A Poggie, PhD
Phone Number:	(514) 901-0796; (973) 738-6097
Fax Number:	(514) 901-0796
Date of Submission:	July 22, 2014

B. DEVICE IDENTIFICATION & MANUFACTURER

Manufacturer Name:	PorOsteon, Inc.
Manufacturer Address:	605 Cambridge Ave. Suite B
	Menlo Park, CA 94025 USA
Registration Number:	TBD
Contact Name:	Robert (Bob) Zider
Title:	President & CEO
Device Trade Name:	PorOsteon Phusion Metal Cervical Cage
Device Common Name:	Intervertebral body fusion device
Classification Name:	Intervertebral body fusion device - cervical
Classification Code:	ODP - Class II
Classification Panel:	Orthopedic
Regulation Number:	21 CFR section 888.3080

C. PREDICATE DEVICES

K103033 Trabecular Metal Fusion Device; manufactured by Zimmer Trabecular Metal Technology, Inc.

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D. DEVICE DESCRIPTION

Materials: Porous titanium-nickel (Ti-Ni) intermetallic material.

E. INTENDED USE

F. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

The subject Phusion Metal Cervical Caqe devices are machined from porous Titanium-Nickel intermetallic bar stock, and are intended for permanent implantation in the cervical spine. Phusion Metal Cervical Cage devices are designed to fit the anatomic profile of the cervical spine. Two size options (depth x width) are available, 12.5 x 14.5 mm and 14.5 x 16.5 mm. All devices are designed with seven (7) degrees of lordosis and are available in height options ranging between 5 and 10 mm in 1 mm increments.

The technological characteristics of PorOsteon Phusion Metal devices are the same as the cited predicate device excepting a change in the porous metal material used to machine the devices and slight variations in geometry. The subject PorOsteon Phusion Metal Cervical Cage devices are machined from porous Titanium-Nickel intermetallic material with nominal porosity of 63% and compressive elastic modulus of 1.0 GPa. The predicate Zimmer Trabecular Metal Fusion devices are machined from porous tantalum material. Both the predicate and subject devices are manufactured from porous metal materials and are indicated for use as an interbody spacer in the cervical spine. The technological characteristics of the PorOsteon Phusion Metal Cervical Cage devices are substantially equivalent to the cited predicate device.

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G. PERFORMANCE DATA

Characterization of Phusion Metal Cervical Cage devices was performed per the FDA Guidance Document entitled "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" issued on June 12, 2007. Biomechanical evaluation of the devices was performed per ASTM standards F2077-11, F2267-04, F1714-96, and draft standard F-04.25.02.02. Static and dynamic compressive, shear, and torsion strength of the worst-case devices were measured per ASTM F2077-11. The subsidence characteristics of the worst case device were measured per ASTM F2267-04. Static expulsion testing of the worst-case device for the Phusion Metal Cage and a competitive PEEK device were measured and compared per ASTM draft standard F-04.25.02.02. Collection and characterization of wear debris from dynamic testing was characterized per applicable sections of ASTM F1714-96. Biocompatibility testing of the porous Ti-Ni intermetallic material was performed per ISO 10993 standards.

Bone apposition, ingrowth, spinal fusion, large organs, blood, and serum were evaluated in an ovine model of lumbar spinal fusion of 2 non-contiguous levels (L2-L3 and L4-L5; n = 8 sheep), and sacrifice time points of 4 and 6 months. Blood analysis and serum biochemistry were performed pre-operatively, post-operatively, and weekly up to 6 weeks and monthly thereafter (N=88 total blood samples) through 6 months. The study was performed with commercially available control devices of similar design fabricated from Zeniva PEEK material; both the control and subject devices were implanted with autograft bone harvested from the illac crest. The ovine study was performed per Good Laboratory Practices (GLP) by the Preclinical Surgical Research Laboratory, Colorado State University, USA.

The results of the biomechanical tests showed to Phusion Metal Cages to meet or exceed the strength requirements for cervical spinal devices, and to possess subsidence and expulsion characteristics typical of spinal fusion devices fabricated from permanent polymer or metallic materials. ISO 10993 biocompatibility testing showed the porous Ti-Ni intermetallic Phusion Metal material to be biocompatible and elicit no adverse reactions. Histology, micro-CT, in-life radiography and CT, and biomechanical evaluation of Phusion Metal Cervical Cage devices in the ovine model showed no evidence of adverse tissue reaction, no evidence of migration or pseudoarthrosis, normal bone and soft tissue at the fusion sites, 100% rate of fusion at 6 months (4 sheep, 2 devices/sheep), statistically equivalent fusion at 6 months to the control devices based on bone histology and biomechanical motion, and a statistically significant, higher percentage of bone contact of the superior and inferior surfaces of the devices at 4 and 6 months for the Phusion Metal devices as compared to the PEEK control devices (23.90% vs. 9.94% at 4 months and 56.09% vs. 27.31% at 6 months). Histopathology of the major organs, blood work, ICP-MS of blood, and serum biochemistry showed normal levels of nickel (Ni) with respect to the control PEEK devices and the scientific literature; there was no evidence of abnormal nickel levels for all tissue, blood, and serum samples evaluated in the ovine study.

H. CONCLUSION

The PorOsteon Phusion Metal Cervical Cage system is substantially equivalent to the predicate device, the Zimmer Trabecular Metal Fusion 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.