When Optio-C Anterior Cervical Plate is used with structural allograft it is intended for one-level anterior screw fixation of the cervical spine (C2-T1). The implant has been designed for use with structural allograft to provide stabilization as an adjunct to cervical fusion. Indications for use of the Optio-C Anterior Plate with structural allograff/ autograft include degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or failed previous fusion. The Optio-C Anterior Cervical Plate is intended to be used with a structural allograft and with three Optio-C bone screws.

When Optio-C Anterior Cervical Plate is used with an Optio-C PEEK IBF Spacer it becomes an Optio-C Anterior Cervical Intervertebral Body Fusion Device (IBFD), indicated for stand-alone anterior cervical interbody fusion procedures in skeletally mature patients with cervical degenerative disc disease at one level from C2 to T1. Degenerative disc disease (DDD) is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Optio-C IBFD is comprised of one Optio-C PEEK IBF Spacer, one Optio-C Anterior Cervical Plate and three Optio-C bone screws.

The Optio-C IBFD is to be used with autograft and implanted via an open, anterior approach in patients who have had six weeks of non-operative treatment.

Device Description

The Optio-C Anterior Cervical System consists of two different configurations, an Optio-C Anterior Cervical PEEK Intervertebral Body Fusion Device (IBFD) (K132894, SE on January 16, 2014) and the subject of this submission, the Optio-C Anterior Cervical Plate System. Both configurations share the same cervical plate, bone screws and instrumentation and are used only in anterior surgical procedures and at the same spinal level of C2 to T1.

The subject cervical plate and bone screws of this submission are designed for use with structural allograft or autograft and is supplied sterile to the end user. The bone screws and instrumentation are supplied non-sterile and are intended to be sterilized by the end user.

The cervical plate with an Optio-C PEEK IBF Spacer or an allograft/autograft is placed in the cervical disc space, flush with the adjacent vertebral bodies. Bone screws pass through the screw holes of the plate and affix to bone to help prevent implant migration. The implant construct can be implanted in two orientations: Standard orientation, two screws cephalic and one screw caudal or Inverted orientation, one screw cephalic and two screws caudal.

The Optio-C Anterior Cervical Plate System is a stand-alone system designed to provide structural stability in skeletally mature individuals following discectomy. The implants are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Screws are inserted through the anterior titanium portion of the implant into adjacent vertebral bodies for bony fixation. The Optio-C Anterior Cervical Plate System is used with structural bone graft material and is manufactured from Titanium with Titanium bone screws that allow intradiscal fixation to the vertebral body. The superior and inferior surfaces of the implant have a pattern of ridges that provide increased stability and help prevent migration of the device.

The Optio-C Anterior Cervical System is provided for single use only.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Optio-C Anterior Cervical System, which is a medical device. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a clinical study with detailed performance metrics. Therefore, many of the requested elements for describing acceptance criteria and a study proving device performance are not applicable or cannot be extracted from this type of document.

However, I can extract information related to the device description, indications for use, and a summary of performance testing that aims to establish substantial equivalence.

Here's a breakdown of the information that can be extracted, and where the requested details are not applicable:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria in terms of specific performance targets (e.g., accuracy, sensitivity, specificity, or clinical outcomes) for the Optio-C Anterior Cervical System as would be found for a diagnostic or AI-based device. Instead, it describes performance testing conducted to demonstrate substantial equivalence to predicate devices. The reported device performance is qualitative, indicating acceptability for intended use and substantial equivalence to predicates.

Acceptance Criteria (General Goal)	Reported Device Performance (as demonstrated by testing)
Acceptable performance for intended use (mechanical stability)	Bench Testing (ASTM 1717 for Static Torsion, Static and Dynamic Compression Bending) confirmed performance is acceptable for intended use, similar to predicate devices.
Acceptable performance for intended use (clinical application)	Design Validation / Cadaver Testing confirmed performance is acceptable for intended use and substantial equivalence to predicate(s). Biomechanical cadaveric testing conducted.
Sterility of sterile implant components	Gamma Sterilization conducted per ISO 11137 and ISO 11737.
Maintenance of sterile barrier by packaging materials	Packaging Sterility Testing conducted per ISO 11607.
Sterilization for end-user facility (non-sterile components)	Sterilization conducted per ISO 17665 and AAMI TIR12 to ensure equivalence to predicate devices. Dry time and cleaning instructions assessed to be similar.
Biocompatibility of materials	Biocompatibility Assessment per ISO 10993-1 conducted, confirming materials are biocompatible and similar to predicate devices.
Technological characteristics similar to predicate devices	Design, dimensions, intended use, materials, and performance characteristics are similar to predicate devices.
Implant construct design does not change stabilization fixation	The implant construct design does not change the stabilization fixation of the cervical vertebra found in the predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. The document describes bench testing (mechanical tests) and cadaveric testing (biomechanical tests), but not a patient-based "test set" in the context of clinical data for an AI/diagnostic device.

3. 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. The ground truth for this type of device (spinal implant) is related to mechanical and biocompatibility standards, and biomechanical performance, not expert assessment of clinical images or data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This concept is relevant for studies involving human interpretation or clinical endpoints, not for the engineering and biological tests described for this spinal implant.

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 is a spinal implant, not an AI-assisted diagnostic device or a system for human readers to interpret.

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

Not applicable. This is a physical medical device (spinal implant), not an algorithm.

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

The "ground truth" for the performance testing of this device is based on:

Engineering standards: ASTM 1717 for mechanical properties.
Biomechanical principles: Used in cadaveric testing.
Biological safety standards: ISO 11137, ISO 11737, ISO 11607, ISO 17665, AAMI TIR12 for sterilization and packaging; ISO 10993-1 for biocompatibility.
Comparison to predicate devices: The ultimate "standard" for substantial equivalence.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" as it is not an AI/machine learning model.

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

Not applicable, as there is no "training set."

Summary of the Study that Proves the Device Meets Acceptance Criteria (as interpreted for this device type):

The "study" described in the document is a series of non-clinical performance tests designed to demonstrate that the Optio-C Anterior Cervical System is substantially equivalent to legally marketed predicate devices and is safe and effective for its intended use.

Components of the Study:

Bench Testing: Performed according to ASTM 1717 for Static Torsion, Static and Dynamic Compression Bending. This tested the mechanical properties of the cervical plate. The results concluded that its performance is "acceptable for its intended use" and comparable to the predicate devices (Synthes CSLP and Trinica devices).
Design Validation / Cadaver Testing: This type of testing assesses the biomechanical performance and confirms the device's acceptability for its intended use, ensuring substantial equivalence to the predicate(s).
Biomechanical Cadaveric Testing: Conducted to evaluate the device's performance in a more realistic anatomical setting.
Sterilization Validation:
- Gamma Sterilization: Performed for sterile implant components under international standards ISO 11137 and ISO 11737.
- Packaging Sterility Testing: Conducted per ISO 11607 to ensure the packaging maintains a sterile barrier.
- End-user Sterilization: Validated for non-sterile components (instrumentation and bone screws) under ISO 17665 and AAMI TIR12 to ensure equivalence to predicate devices, including dry time and cleaning instructions.
Biocompatibility Assessment: Conducted per ISO 10993-1 to ensure the materials used in the Optio-C System are biocompatible and similar to those of the predicate devices.

Conclusion of the Study:

The document explicitly states: "The test results conclude the Optio-C™ Anterior Cervical Plate System to be substantially equivalent to the predicate devices listed above." It further notes that "The Optio-C Anterior Cervical Plate System performance, intended use and fundamental scientific technology remain unchanged from the predicate devices. The implant construct design does not change the stabilization fixation of the cervical vertebra found in the predicate devices. The Optio-C Anterior Cervical Plate is substantially equivalent to the predicate devices, a traditional anterior cervical plate."

In essence, the "acceptance criteria" for this 510(k) submission are met by demonstrating that the device performs mechanically, biologically, and functionally in a manner that is substantially equivalent to already approved predicate devices for the same indications for use.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines connecting them. The profiles are arranged in a way that suggests unity and connection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

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

September 23, 2014

Zimmer Spine, Incorporated Ms. Donna M. Semlak Senior Regulatory Affairs Specialist 7375 Bush Lake Road Minneapolis, Minnesota 55439

Re: K141500

Trade/Device Name: Optio-CTM Anterior Cervical System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWO. OVE Dated: August 12, 2014 Received: August 13, 2014

Dear Ms. Semlak:

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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Page 2 - Ms. Donna M. Semlak

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/ResourcesforYou/Industry/default.htm. Also, please note the regulation 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/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.

Ronald#Alean -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

510(k) Number (if known) K141500

Device Name Optio-CTM Anterior Cervical System

Indications for Use (Describe)

The Optio-C IBFD is to be used with autograft and implanted via an open, anterior approach in patients who have had six weeks of non-operative treatment.

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)

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Image /page/3/Picture/1 description: This image is a 510(k) summary for the Optio-C™ Anterior Cervical System. The summary was prepared on September 16, 2014, by Zimmer Spine, Inc. located in Minneapolis, MN. The document includes the establishment registration number, company contact information for Donna M. Semlak, trade name, device names, device classification as Class II, and regulation number and product codes.

This submission is for the Optio-C Anterior Cervical Plate System, which is a component of the Optio-C Anterior Cervical System.

Predicate Devices:

Optio-C Anterior Cervical Plate System predicates were identified to address the intended uses, mechanical functions and performance attributes of each system. The predicate information is listed in the following table:

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Optio-C Anterior Cervical SystemPredicate Device Name	Product Code	FDA 510k NumberClearance Date
Synthes® Spine Anterior CSLP SystemSynthes Spine	KWQ21 CFR§ 888.3060	K031276Cleared July 2, 2003K030866Cleared April 18, 2003K971883Cleared Oct 16, 1997
Trinica® Anterior Cervical Plate SystemZimmer Spine, Inc.	KWQ21 CFR§ 888.3060	K012305Cleared August 22, 2001

General Device Description:

The Optio-C Anterior Cervical System is provided for single use only.

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Indications for Use:

The Optio-C Anterior Cervical System includes the following Indications for Use.

Optio-C Anterior Cervical System

When Optio-C Anterior Cervical Plate is used with structural allograft/autograft it is intended for one-level anterior screw fixation of the cervical spine (C2-T1). The implant has been designed for use with stuctural allograft/autograft to provide stabilization as an adjunct to cervical fusion. Indications for use of the Optio-C Anterior Plate with structural allograft/autograft include degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or failed previous fusion. The Optio-C Anterior Cervical Plate is intended to be used with a structural allograft and with three Optio-C bone screws.

The Optio-C IBFD is to be used with autograft and implanted via an open, anterior approach in patients who have had six weeks of non-operative treatment.

Summary of Technological Characteristics:

The technological characteristics for the Optio-C Anterior Cervical Plate System are similar to the predicate devices in terms of design, dimensions, intended use, materials, and performance characteristics.

Summary of Performance Testing:

Non-clinical testing of the components comprising each configuration of the subject Optio-C"" Anterior Cervical Plate System were assessed and tested appropriately to design controls; i.e. design verification. The test results conclude the Optio-C™ Anterior Cervical Plate System to be substantially equivalent to the predicate devices listed above.

Bench Testing for the cervical plate was conducted per ASTM 1717 for Static ● Torsion, Static and Dynamic Compression Bending, confirming the Optio-C Anterior Cervical Plate System performance is acceptable for its intended use; the same intended use as the predicate Synthes CSLP and Trinica devices.
Design Validation / Cadaver Testing was conducted to ensure the Optio-C ● Anterior Cervical Plate System performance is acceptable for its intended use and to ensure substantial equivalence to the predicate(s).
Biomechanical cadaveric testing was conducted. ●

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트 Gamma Sterilization was conducted for sterile implant components under ISO 11137 and ISO 11737.
. Packaging Sterility Testing was conducted per ISO 11607 to ensure packaging materials maintain a sterile barrier.
Sterilization was conducted for sterilizing at the end user facility under ISO 17665 . and AAMI TIR12 to ensure equivalent to the predicate devices. Dry time and cleaning instructions will be assessed and yield similar (substantially Equivalent) to the predicate devices.
. Biocompatibility Assessment per ISO 10993-1 was conducted to ensure the Optio-C System materials are biocompatible based with the same type materials to the predicate devices.

The Optio-C Anterior Cervical Plate System performance, intended use and fundamental scientific technology remain unchanged from the predicate devices. The implant construct design does not change the stabilization fixation of the cervical vertebra found in the predicate devices. The Optio-C Anterior Cervical Plate is substantially equivalent to the predicate devices, a traditional anterior cervical plate.

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.