The Ocata™ Anterior Cervical System is intended for anterior interbody screw fixation of the cervical spine from C2 to T1. The system is indicated for use in the temporary stabilization of the anterior spine as an adjunct to fusion for patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures and dislocations), tumors, spondylolisthesis, deformity (defined as kyphosis, lordosis, or scoliosis), spinal stenosis, pseudarthrosis, and/or failed previous fusions. This device system is intended for anterior cervical intervertebral body fusions only.
WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Device Description

The Ocata Anterior Cervical System components are temporary implants that are intended for anterior interbody screw fixation of the cervical spine during the development of a cervical spinal fusion.
The Ocata Anterior Cervical System consists of a variety of shapes and sizes of bone plates, screws (available in self-drilling or self-tapping, fixed or variable configurations), and associated instruments.
Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The Ocata™ Anterior Cervical System implant components are made from titanium alloy.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Ocata™ Anterior Cervical System.

Upon reviewing the provided document, it becomes clear that this is a 510(k) submission for a medical device (spinal implant), not an AI/ML software or diagnostic device. Therefore, the questions related to AI performance metrics, ground truth establishment, expert adjudication, multi-reader multi-case studies, and training/test set sample sizes for AI are not applicable to this submission.

The document primarily focuses on establishing substantial equivalence to previously marketed predicate devices based on non-clinical mechanical testing.

Here's the information extracted and adapted to the context of a medical implant:

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

For medical implants like the Ocata™ Anterior Cervical System, "acceptance criteria" and "reported device performance" are typically defined by recognized standards for mechanical and material properties. The submission states that tests were conducted according to ASTM standards. The acceptance criteria are implicitly that the device's performance meets or exceeds the requirements of these standards and is comparable to previously cleared predicate devices.

Acceptance Criteria (Proxy)	Reported Device Performance
Plates meet static and dynamic compression requirements per ASTM F1717	Performed. Results indicate equivalence to predicate devices. (Specific quantitative values are not provided in this summary.)
Plates meet torsion requirements per ASTM F1717	Performed. Results indicate equivalence to predicate devices. (Specific quantitative values are not provided in this summary.)
Screws meet torsional yield strength requirements per ASTM F543	Performed. Results indicate equivalence to predicate devices. (Specific quantitative values are not provided in this summary.)
Screws meet driving torque requirements per ASTM F543	Performed. Results indicate equivalence to predicate devices. (Specific quantitative values are not provided in this summary.)
Screws meet axial pullout strength requirements per ASTM F543	Performed. Results indicate equivalence to predicate devices. (Specific quantitative values are not provided in this summary.)
Material (Ti-6Al-4V ELI) conforms to ASTM F136	Stated that implants are made from Ti-6Al-4V ELI conforming to ASTM F136.
Instrument materials (17-4 H900 SS or 465 SS H950) conform to ASTM F899	Stated that system-specific instruments are made from either 17-4 H900 SS or 465 SS H950 conforming to ASTM F899.
Overall mechanical safety and performance equivalent to predicate devices	"The results of these evaluations indicate that the Ocata™ Anterior Cervical System is equivalent to predicate devices." This is the ultimate reported performance outcome relative to the primary predicate (Theken Surgical TetherTM ACFS – K010466) and additional predicates.

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

Sample Size for Test Set: Not explicitly stated in the summary for each specific test (e.g., how many plates were tested for compression). However, mechanical testing for medical devices typically involves a statistically relevant number of samples to demonstrate consistency.
Data Provenance: The tests are non-clinical, mechanical tests. This means the data is generated in a laboratory setting, not from human or animal subjects. The location of the testing facility is not specified, but it would have been performed by or for Kalitec Direct, LLC.
Retrospective or Prospective: Not applicable as these are laboratory-based mechanical tests.

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. "Ground truth" in the context of this device refers to the established mechanical properties and material standards (e.g., ASTM F1717, ASTM F543, ASTM F136). The "experts" involved are engineers and materials scientists who perform and interpret these tests according to recognized industry standards, rather than medical experts establishing diagnostic ground truth.

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

Not applicable. Mechanical testing results are objective measurements that are compared against predefined numerical criteria outlined in the relevant ASTM standards. There is no human adjudication process involved in assessing test results in the same way there would be for image interpretation by clinicians.

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 implant, not an AI/ML diagnostic or assistive tool.

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 (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is based on established engineering standards and material specifications (e.g., ASTM F1717 for static and dynamic compression and torsion, ASTM F543 for screw properties, ASTM F136 for implant material, ASTM F899 for instrument material). The device's performance is deemed acceptable if it meets these standards and is shown to be equivalent to the predicate devices which have already demonstrated safety and efficacy through their own testing and market history.

8. The sample size for the training set

Not applicable. This device is a physical implant, not an AI/ML model that requires a training set.

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

Not applicable. See point 8.

Summary

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

May 9, 2017

Kalitec Direct, LLC % Mr. J.D. Webb Official Correspondent The Orthomedix Group. Inc. 1001 Oakwood Boulevard Round Rock, Texas 78681

Re: K170342

Trade/Device Name: Ocata™ Anterior Cervical System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWO Dated: January 31, 2017 Received: February 3, 2017

Dear Mr. Webb:

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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.

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 Food and Drug Administration

Indications for Use

510(k) Number (if known)

K170342

Device Name

Ocata™ Anterior Cervical System

Indications for Use (Describe)

The Ocata™ Anterior Cervical System is intended for anterior interbody screw fixation of the cervical spine from C2 to T1. The system is indicated for use in the temporary stabilization of the anterior spine as an adjunct to fusion for patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures and dislocations), tumors, spondylolisthesis, deformity (defined as kyphosis, lordosis), spinal stenosis, pseudarthrosis, and/or failed previous fusions. This device system is intended for anterior cervical intervertebral body fusions only.

WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

ا Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary: Ocata™ Anterior Cervical System

Date Prepared	January 31, 2017
Submitted By	Scott WinnKalitec Direct, LLC618 E. South Street, Suite 500Orlando, FL 32801407-545-2063 Tele407-358-5441 Fax
Primary Contact	J.D. Webb1001 Oakwood BlvdRound Rock, TX 78681512-388-0199 Telee-mail: jdwebb@orthomedix.net
Secondary Contact	Keith Cannan1890 W. CR 419, Suite 2000Oviedo, FL 32765407-545-2063 Tele407-358-5441 Faxe-mail: quality@kalitecdirect.com
Trade Name	Ocata™ Anterior Cervical System
Common Name	Anterior Cervical Plate System
Classification Name	Appliance, Fixation, Spinal Intervertebral Body
Class	II
Product Code	KWQ
CFR Section	21 CFR section 888.3060
Device Panel	Orthopedic
Primary PredicateDevice	Theken Surgical TetherTM ACFS – K010466
Additional PredicateDevices	Integra Sonoma™ Cervical Plate System - K032368Stryker Reflex™ Anterior Cervical Plate System - K062310 and K040261Synthes CLSP Cervical Plate – K000536
Device Description	The Ocata Anterior Cervical System components are temporary implants that areintended for anterior interbody screw fixation of the cervical spine during the developmentof a cervical spinal fusion.The Ocata Anterior Cervical System consists of a variety of shapes and sizes of boneplates, screws (available in self-drilling or self-tapping, fixed or variable configurations),and associated instruments.Fixation is provided by bone screws inserted into the vertebral body of the cervical spineusing an anterior approach. The Ocata™ Anterior Cervical System implant componentsare made from titanium alloy.
Materials	Implants are made from Ti-6Al-4V ELI conforming to ASTM F136.System specific instruments are made from either 17-4 H900 SS or 465 SS H950conforming to ASTM F899.
Intended Use	Maintain adequate disc space until fusion occurs.
SubstantialEquivalence Claimedto Predicate Devices	The Ocata™ Anterior Cervical System is substantially equivalent to the predicatedevices in terms of intended use, design, materials used, mechanical safety andperformances.
Indications for Use	The Ocata ™ Anterior Cervical System is intended for anterior interbody screw fixation ofthe cervical spine from C2 to T1. The system is indicated for use in the temporarystabilization of the anterior spine as an adjunct to fusion for patients with degenerative discdisease (as defined by neck pain of discogenic origin with degeneration of the discconfirmed by patient history and radiographic studies), trauma (including fractures anddislocations), tumors, spondylolisthesis, deformity (defined as kyphosis, lordosis, orscoliosis), spinal stenosis, pseudarthrosis, and/or failed previous fusions. This devicesystem is intended for anterior cervical intervertebral body fusions only.WARNING: This device is not approved for screw attachment to the posterior elements(pedicles) of the cervical, thoracic, or lumbar spine.
Non-clinical TestSummary	The following analyses were conducted:Plates were tested for static and dynamic compression and torsion per ASTM F1717 Screws were tested for torsional yield strength, driving torque, and axial pullout strength per ASTM F543 The results of these evaluations indicate that the Ocata™ Anterior Cervical System is equivalent to predicate devices.
Clinical TestSummary	No clinical studies were performed
Conclusions: Non-clinical and Clinical	Kalitec Direct, LLC considers the Ocata™ Anterior Cervical System to be equivalent to thepredicate devices listed above. This conclusion is based upon the devices' similarities inprinciples of operation, technology, materials and indications for use

In accordance with 21 CFR 807.92 of the Federal Code of Regulations

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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.