The Octane Elevate Spinal Implant is an intervertebral body fusion device intended for spinal fusion procedures at one or two contiguous levels in the lumbar spine from L2 to S 1 in patients with Degenerative Disc Disease (DDD,) with up to Grade 1 spondvlolisthesis 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 six (6) months of nonoperative treatment. The device is intended for use with autogenous bone graft, and with supplemental internal fixation systems (i.e. posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems) cleared for use in the lumbosacral spine.

Device Description

This submission proposes a new lumbar interbody fusion system. The Octane Elevate Spinal Implant is designed to provide stability during intervertebral body fusion in the lumbrosacral spine.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (Exactech® Octane® Elevate™ Spinal Implant System) seeking clearance from the FDA. This type of document focuses on demonstrating substantial equivalence to existing legally marketed devices, primarily through engineering and performance testing, rather than clinical studies involving human patients or complex AI algorithms.

Therefore, many of the requested categories for AI/clinical study evaluation do not apply to this specific submission.

Here's an analysis based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on demonstrating "substantial equivalence" in performance characteristics to predicate devices. This is achieved through mechanical testing.

Acceptance Criteria	Reported Device Performance
Mechanical Performance: - Static compression - Dynamic compression - Static compressive shear - Dynamic compression shear - Subsidence yield force	Demonstrated substantially equivalent performance characteristics compared to cited predicates based on testing per ASTM F2077 and ASTM F2267 for all listed mechanical tests. The document states: "Mechanical testing results summarized in this 510(k) premarket notification demonstrate Octane Elevate devices have substantially equivalent performance characteristics compared to cited predicates."
Intended Use	Substantially equivalent to predicate devices (intervertebral fusion for DDD at L2-S1 with bone graft and supplemental fixation).
Materials	Substantially equivalent to predicate devices (PEEK-Optima and tantalum materials with demonstrably safe and effective use).
Dimensions	Substantially equivalent to predicate devices (similar size ranges).
Sterilization processes	Substantially equivalent to predicate devices (sterilized using processes conforming to recognized industry standards).

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

Test set sample size: Not applicable in the context of clinical patient data. The "test set" here refers to the actual physical devices (exact number not specified but implied to be sufficient for ASTM testing standards).
Data provenance: Not applicable for patient data. The data provenance is from mechanical testing performed on the devices themselves, adhering to recognized ASTM standards (F2077 and F2267). This is engineering data, not clinical or human subject data.

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

Not applicable. "Ground truth" in this context is established by engineering standards and validated mechanical testing protocols, not by expert medical review of patient data. The "experts" would be engineers and scientists familiar with mechanical testing and relevant ASTM standards.

4. Adjudication method for the test set

Not applicable. There is no adjudication method in the sense of reviewing disagreements among human readers for image interpretation or patient outcomes. The "adjudication" is inherent in the standardized mechanical testing protocols and their interpretation by qualified engineers.

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 device is a physical spinal implant, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and the concept of human readers improving with AI assistance are irrelevant.

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

Not applicable. This device is a physical implant, not an algorithm.

7. The type of ground truth used

The "ground truth" for demonstrating substantial equivalence is based on established engineering standards and performance specifications for intervertebral body fusion devices, as defined by ASTM F2077 (Standard Test Method for Static and Dynamic Axial Interbody Fusion Device Compression Fatigue) and ASTM F2267 (Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression). The performance of the Octane Elevate system is compared directly to the physical performance characteristics of the predicate devices under these standardized tests.

8. The sample size for the training set

Not applicable. This is not an AI algorithm requiring a training set.

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

Not applicable. This is not an AI algorithm.

Summary

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Exactech® Octane® Elevate™ Spinal Implant System Traditional 510(k)

510(k) Summary

APR 2 5 2014

Exactech®, Inc Company: 2320 Northwest 66th Court Gainesville, FL 32653-1630 Date: April 21, 2014 Contact Person: Patrick Hughes Senior Regulatory Affairs Specialist Phone: 352-327-4762 Fax: 352-378-2617 E-mail: patrick.hughes@exac.com Exactech® Octane® Elevate™ Spinal Implant Proprietary Name: Common Name: Intervertebral body fusion system

Classification Name:

Intervertebral Fusion Device - Lumbar (21 CFR 888.3080, Class II, Product Code MAX)

Legally Marketed Devices to Which Substantial Equivalence Is Claimed

Spinal Elements Lucent (#K071724) Innesis PEEK Cage System (#K120464) AccuLiF TL-PEEK Cage (#K112095 & #K123281)

Device Description

This submission proposes a new lumbar interbody fusion system. The Octane Elevate Spinal Implant is designed to provide stability during intervertebral body fusion in the lumbrosacral spine.

Indications for Use

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Summary of Technological Characteristics

The rationale for substantial equivalence is based on consideration of the following characteristics:

. Intended Use
Proposed Octane Elevate devices and cited predicates are intended to be used with bone graft and supplemental fixation systems (i.e. posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems) for intervertebral fusion for treatment of degenerative disc disease at the levels of L2-S1.

Materials .

Octane Elevate devices and cited predicate devices are made from the same PEEK-Optima and tantalum materials having demonstrable histories of safe and effective use in medical applications. per internationally recognized consensus standards.

. Dimensions

Octane Elevate devices and cited predicate devices have substantially equivalent dimensions and are available in substantially equivalent size ranges.

. Sterilization processes

Octane Elevate devices are provided sterile. These devices are sterilized using sterilization processes conforming to recognized industry standards.

Performance specifications .

Mechanical testing results summarized in this 510(k) premarket notification demonstrate Octane Elevate devices have substantially equivalent performance characteristics compared to cited predicates based on testing per ASTM F2077 and ASTM F2267:

Static compression .
. Dynamic compression
Static compressive shear .
Dynamic compression shear .
. Subsidence vield force

Substantial Equivalence Conclusion

The Octane Elevate Spinal Implant System is substantially equivalent to cited predicates per intended use, materials, dimensions, sterilization processes, and performance characteristics.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing and tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

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

April 25, 2014

Exactech®. Incorporated Mr. Patrick Hughes Senior Regulatory Affairs Specialist 2320 Northwest 66th Court Gainesville, Florida 32653

Re: K123607

Trade/Device Name: Exactech® Octane® Elevate™ Spinal Implant Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: April 21. 2014 Received: April 23, 2014

Dear Mr. Hughes:

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 cither 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 is 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. Patrick Hughes

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/ResourcesforYou/Industry/default.htm. Also, please note the requlation entitled. "Misbranding by reference to premarket notification" (21 CFR 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/Reportal?roblem/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.

Ronald P. Jean -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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Exactech® Octane® Elevate™ Spinal Implant System Traditional 510(k)

Indications for Use Statement

510(k) Number: K123607

Device Name: Exactech® Octane® Elevate™ Spinal Implant

INDICATIONS FOR USE:

The Octane Elevate Spinal Implant is an intervertebral body fusion device intended for spinal fusion procedures at one or two contiguous levels in the lumbar spine from L2 to S 1 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 six (6) months of nonoperative treatment. The device is intended for use with autogenous bone graft, and with supplemental internal fixation systems (i.e. posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems) cleared for use in the lumbosacral spine.

Prescription Use X and/or (Part 21 CFR 801 Subpart D)

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

Please do not write below this line - use another page if needed.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anton E. Dmitriev. PhD Division of

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.