The Captiva Spine SmartLOX Cervical Plate System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudoarthrosis or failed previous fusion. WARNING: The Captiva Spine SmartLOX Cervical Plate System is not intended for screw attachment or the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

Device Description

The Captiva Spine SmartLOX Cervical Plate system is intended for anterior screw fixation of the cervical spine. This system has been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system 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, spinal stenosis, deformity, tumor, pseudoarthrosis or failed previous fusion.

The Captiva Spine SmartLOX Cervical Plate System includes plates, screws, and a screwretaining rail lock. The plates are available in a variety of lengths ranging from 20 to 110mm. Screws are offered in two diameters, a primary screw diameter and a rescue diameter. Primary screws are available in self-drilling, and both screw diameters are available in fixed and variable versions. Screw lengths range from 12 to 18mm in 2mm increments. The rails are assembled with the plate during the manufacturing process and their configuration varies with the plate length.

The Captiva Spine SmartLOX Cervical Plate System is supplied with the instrumentation necessary for implantation of the system. The Captiva Spine SmartLOX Cervical Plate System is for single use only.

AI/ML Overview

This document is a 510(k) summary for the Captiva Spine SmartLOX Cervical Plate System. It details the device, its intended use, and its substantial equivalence to predicate devices, but it does not describe a study that uses acceptance criteria for device performance based on human reader evaluations or AI performance metrics.

Instead, the "acceptance criteria" and "study" described in the document refer to mechanical and material testing performed to demonstrate the device's safety and effectiveness compared to existing, legally marketed predicate devices.

Here's an breakdown based on the information provided:

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

The document does not provide a formal table with acceptance criteria and device performance in the way one might expect for an AI diagnostic device. Instead, it states that the device was evaluated against existing ASTM standards and engineering analyses.

Acceptance Criteria (Implied)	Reported Device Performance
Equivalence to predicate devices in static and dynamic loading.	"The worst-case implants were previously tested and performed equally to or better than the predicate devices in static compression, static torsion and dynamic compression in accordance with ASMT F1717."
Material corrosion resistance (ASTM F2129-08)	"Corrosion susceptibility was tested per ASTM F2129-08" (No specific performance values provided, but the statement implies it met the standard for acceptance).
Galvanic corrosion resistance (ASTM F3044-14)	"Galvanic Corrosion was tested per ASTM F3044-14." (No specific performance values provided, but the statement implies it met the standard for acceptance).
Design Failure Modes and Effect Analysis (FMEA)	"Engineering analysis of the proposed design changes included Design Failure Modes and Effect Analysis (FMEA)" (Implies analysis showed acceptable risk and performance for changes compared to predicate).
Comparative analysis (product code, indications, materials, dimensions)	"A tabulated comparison between Captiva Spine SmartLOX Cervical Plate System and the predicates. The comparative analysis included product code, indications for use, material and screw/plate dimensions." (Implies no significant differences that would raise new safety concerns).

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

This information is not applicable as the "test set" in this context refers to mechanical test samples, not a dataset of patient images or clinical data. The document mentions "worst-case implants" were tested, but not a specific sample size. No country of origin or retrospective/prospective data provenance is relevant here.

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)

This information is not applicable. The ground truth for mechanical testing is established by engineering standards (e.g., ASTM F1717) and physical measurements, not by experts reviewing clinical data.

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

This information is not applicable. Adjudication methods are relevant for subjective interpretations of data, typically in clinical studies or AI evaluations. For mechanical testing, results are objectively measured against predefined standards.

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, a multi-reader, multi-case comparative effectiveness study was not done. This device is a medical implant (cervical plate system), not a diagnostic AI software. Therefore, there is no concept of human readers or AI assistance in this context.

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

No, a standalone performance evaluation of an algorithm was not done. This is a physical medical device, not a software algorithm.

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

The "ground truth" for this device's performance is based on adherence to recognized mechanical and material testing standards (e.g., ASTM F1717, F2129-08, F3044-14) and engineering analyses (FMEA, comparative analysis). These standards define acceptable performance for spinal implant devices.

8. The sample size for the training set

This information is not applicable. There is no "training set" for this type of medical device. The design and manufacturing processes are informed by engineering principles, material science, and prior device designs, not by machine learning training data.

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

This information is not applicable as there is no training set.

Summary

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

June 11, 2015

Captiva Spine, Incorporated % Rich Jansen, Pharm. D Regulatory Consultant Silver Pine Consulting, LLC 13540 Guide Avenue Apple Valley, Minnesota 55124

Re: K141332

Trade/Device Name: Captiva Spine SmartLOX Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: May 14, 2015 Received: May 15, 2015

Dear Dr. Jansen:

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 - Rich Jansen, Pharm. D

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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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

K141332

Page 1 of 1

510(k) Number (if known) K141332

Device Name

Captiva Spine SmartLOX Cervical Plate System

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)

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:

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510(k) Summary

Date Prepared:Submitter Contact:	May 14, 2015Dale MitchellCaptiva Spine967 Alternate A1A #1Jupiter, FL 33477877-772-5571866-318-3224
Regulatory Contact:	Rich Jansen, Pharm. D.Silver Pine Consulting, LLC612-281-5505richj@s-pineconsulting.com
Trade Name:	Captiva Spine SmartLOX Cervical Plate System
Product Class:	Class II
Classification:	888.3060 Spinal Intervertebral Body Fixation Orthosis
Product Codes:	KWQ
Panel Code:	87

Reason for this Submission: This Traditional 510(k) involves several changes to the previously cleared Cervical Plate System that allow for:

1. Modifications to cervical plate configurations
1. Modifications to rail lock configuration
1. Modifications to screw design configurations
1. New or modified instrumentation

Indications for Use:

The Captiva Spine SmartLOX Cervical Plate System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system 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, spinal stenosis, deformity, tumor, pseudoarthrosis or failed previous fusion. WARNING: The Captiva Spine SmartLOX Cervical Plate System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

Device Descriptions:

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radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudoarthrosis or failed previous fusion.

Predicate Device(s):

The Captiva Spine SmartLOX Cervical Plate System is substantially equivalent to the previously cleared Precision Surgery Ltd. Fixed, Variable and Corpectomy Cervical Plate System found in both K032815 and K073708 (primary predicate) and Medtronic Sofamor Danek Orion Anterior Cervical Plate System cleared per K042499.

Performance Standards:

Captiva Spine SmartLOX Cervical Plate System was evaluated to demonstrate equivalence to the predicate device. The worst-case implants were previously tested and performed equally to or better than the predicate devices in static compression, static torsion and dynamic compression in accordance with ASMT F1717. Engineering analysis of the proposed design changes included Design Failure Modes and Effect Analysis (FMEA) as well as a tabulated comparison between Captiva Spine SmartLOX Cervical Plate System and the predicates. The comparative analysis included product code, indications for use, material and screw/plate dimensions. Based on the completed engineering analysis's it was determined that the modified implants have the same indication for use, are within the previously cleared device size ranges, made of the same materials and do not represent new worst case for mechanical testing and therefore no new performance testing was required. No clinical or animal studies were performed.

Corrosion susceptibility was tested per ASTM F2129-08 and Galvanic Corrosion was tested per ASTM F3044-14.

Substantial Equivalence:

Captiva Spine concludes that there are no significant differences between the Captiva Spine SmartLOX Cervical Plate System and the other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in intended use, indications for use, fundamental technology including design, materials, sterility and operational principles.

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.