The Octane® Straight Intervertebral Fusion Device, Ti Coated is intended for spinal fusion procedures at one or two contiguous levels in the lumbar spine from L2 to S1 in patients with Degenerative Disc Disease (DDD,) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature, and have had at least 6 months of non-operative treatment. The device is intended for use with autogenous graft, and with supplemental fixation systems cleared for use in the lumbosacral spine.

Device Description

The Exactech® Octane® Straight Spinal Implant is an implant constructed of medical grade Polyetheretherketone, (PEEK-OPTIMA® LT1). The implant incorporates ridges on the superior and inferior surfaces to resist expulsion. The device is open in the transverse plane to allow insertion of bone graft prior to placement, and fenestrated along the sides. The radiolucent PEEK-OPTIMA® material allows visualization of the defect site on radiography to assess bone growth, and incorporates tantalum markers to permit verification of position. The device is plasma coated with commercially pure titanium. The Octane Straight Spinal Implant is provided sterile for single use.

The purpose of this submission is the addition of a CP-Ti coating on a previously cleared lumbar intervertebral fusion device.

AI/ML Overview

This document is a 510(k) premarket notification for the Octane® Straight Intervertebral Fusion Device, Ti Coated. The purpose of this submission is not for a medical imaging AI device, but for an intervertebral fusion device (a spinal implant). Therefore, many of the requested categories related to acceptance criteria, AI performance, ground truth, and expert evaluation are not applicable to this type of medical device submission.

However, I can extract the relevant information regarding the performance data and the conclusion of substantial equivalence.

Here's the breakdown of the information that can be extracted:

A table of acceptance criteria and the reported device performance

This document does not specify quantitative acceptance criteria in a table format with corresponding performance metrics. Instead, it lists the types of non-clinical tests performed and states a general conclusion.

Acceptance Criteria Category Reported Device Performance
Mechanical Strength "sufficient for its intended use"
Substantial Equivalence "substantially equivalent to legally marketed predicate devices"
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The tests performed are non-clinical (mechanical/material tests on the device itself), not studies on patient data.
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 is not an AI/diagnostic device that requires expert ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable.
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 is not an AI device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable directly as "ground truth" for a diagnostic finding. The "ground truth" for this device's performance would be the specifications and requirements defined by the ASTM standards and the predicate device's performance, against which the subject device's mechanical and material properties are compared.
The sample size for the training set

Not applicable. This is not an AI device.
How the ground truth for the training set was established

Not applicable. This is not an AI device.

Acceptance Criteria Category	Reported Device Performance
Mechanical Strength	"sufficient for its intended use"
Substantial Equivalence	"substantially equivalent to legally marketed predicate devices"

Study that proves the device meets the acceptance criteria:

The study proving the device meets the acceptance criteria essentially refers to the performance data from the non-clinical testing. The document states:

Tests Performed:
- Static axial compression per ASTM F2077
- Static compressive shear per ASTM F2077
- Dynamic axial compression per ASTM F2077
- Dynamic compressive shear per ASTM F2077
- Percent Porosity per ASTM F1854-09
- Coating Thickness per ASTM F1854-09
- Static Shear per ASTM F1044-05
- Static Tensile per ASTM F1147-05
- Shear Fatigue per ASTM F1160-05
- Abrasion per ASTM F1978-00
Conclusion: "The results of this non-clinical testing show that the strength of the Octane® Straight Intervertebral Fusion Device, Ti Coated is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."

The predicate devices used for comparison are:

Primary Predicate: Octane® Straight Intervertebral Fusion Device, Manufacturer: Exactech, Inc. (K130434) - Note: This suggests the current device is an iteration (addition of Ti coating) of a previously cleared device from the same manufacturer.
Reference Predicate: Calix™ PC Spinal Implant System, Manufacturer: X-Spine (K112036)

In summary, for this particular medical device (a spinal implant), the "study" consists of a series of non-clinical, bench-top mechanical and material property tests conducted according to recognized ASTM standards. The "acceptance criteria" are implied by these standards and the equivalence to the predicate devices, ensuring the device has "sufficient" strength for its intended use. There are no elements related to AI performance, human reader studies, or diagnostic accuracy in this submission.

Summary

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

May 11, 2015

Exactech, Incorporated % Mr. Kenneth C. Maxwell Regulatory and Quality Specialist Empirical Testing Corporation 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K150152

Trade/Device Name: Octane Straight Intervertebral Fusion Device, Ti Coated Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: April 13, 2015 Received: April 14, 2015

Dear Mr. Maxwell:

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

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Page 2 - Mr. Kenneth C. Maxwell

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES	Form Approved: OMB No. 0910-0120
Food and Drug Administration	Expiration Date: January 31, 2017See PRA Statement on last page.
Indications for Use
510(k) Number (if known)
K150152
Device Name
Octane® Straight Intervertebral Fusion Device, Ti Coated
Indications for Use (Describe)
The Octane® Straight Intervertebral Fusion Device, Ti Coated is intended for spinal fusion
procedures at one or two contiguous levels in the lumbar spine from L2 to S1 in patients with
Degenerative Disc Disease (DDD,) with up to Grade 1 spondylolisthesis or retrolisthesis at the
involved level(s). DDD is defined as back pain of discogenic origin, with degeneration of the
disc confirmed by history and radiographic studies. Patients should be skeletally mature, and
have had at least 6 months of non-operative treatment. The device is intended for use with
autogenous graft, and with supplemental fixation systems cleared for use in the lumbosacral
spine.
Type of Use (Select one or both, as applicable)
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)
FORM FDA 3881 (9/13)Page 1 of 2	PSC Publishing Services (301) 443-6740 EF

Exactech Octane® Straight Intervertebral Fusion Device, Ti Coated

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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."

FORM FDA 3881 (9/13)

Page 2 of 2

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510(K) SUMMARY

Submitter's Name:	Exactech, Inc.
Submitter's Address:	2320 NW 66th CourtGainesville, FL 332653
Submitter's Telephone:	352.377.1140
Contact Person:	Kenneth C. MaxwellEmpirical Testing Corp.719.291.6874
Date Summary was Prepared:	16-Jan-15
Trade or Proprietary Name:	Octane® Straight Intervertebral Fusion Device,Ti Coated
Common or Usual Name:	Intervertebral Fusion Device With Bone Graft, Lumbar
Classification:	Class II per 21 CFR §888.3080
Product Code:	MAX
Classification Panel:	Orthopedic

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The purpose of this submission is the addition of a CP-Ti coating on a previously cleared lumbar intervertebral fusion device.

INDICATIONS FOR USE

The indications for use for the Octane® Straight Intervertebral Fusion Device. Ti Coated is similar to that of the predicate devices listed in Table 5-1.

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TECHNOLOGICAL CHARACTERISTICS

The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness.

510kNumber	Trade or Proprietary or Model Name	Manufacturer	Type
K130434	Octane® Straight Intervertebral FusionDevice	Exactech, Inc.	Primary
K112036	Calix™ PC Spinal Implant System	X-Spine	Reference

Table 5-1 Predicate Devices

PERFORMANCE DATA

The Octane® Straight Intervertebral Fusion Device, Ti Coated has been tested in the following test modes:

Static axial compression per ASTM F2077 ●
Static compressive shear per ASTM F2077 ●
Dynamic axial compression per ASTM F2077 ●
Dynamic compressive shear per ASTM F2077
Percent Porosity per ASTM F1854-09
Coating Thickness per ASTM F1854-09
Static Shear per ASTM F1044-05 ●
Static Tensile per ASTM F1147-05
Shear Fatigue per ASTM F1160-05
Abrasion per ASTM F1978-00

The results of this non-clinical testing show that the strength of the Octane® Straight Intervertebral Fusion Device, Ti Coated is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the Octane® Straight Intervertebral Fusion Device, Ti Coated is substantially equivalent to the 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.