The MIS Anterior Cervical Plating System is intended for anterior fixation to the cervical spine. This system is indicated for use in temporary stabilization of the anterior spine from C2 to T1 during the development of a cervical spinal fusion in patients with:

Degenerative disc disease, DDD (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies);
Spondylolisthesis
Trauma (including fractures or dislocations);
Spinal cord stenosis;
Deformity or curvatures (i.e. kyphosis, lordosis and/or scoliosis);
Tumors;
Pseudarthrosis;
Failed previous fusions.

Device Description

The MIS Anterior Cervical Plating System components are temporary implants that are intended for anterior fixation to the cervical spine during the development of a cervical spinal fusion.

The MIS Anterior Cervical Plating System consists of a variety of sizes of plates, screws, and associated instruments. Fixation is provided by bone screws inserted through the plates and into the vertebral body of the cervical spine using an anterior approach.

Manufactured from medical grade titanium alloy as described by ASTM F136.

AI/ML Overview

The provided text describes the "MIS Anterior Cervical Plating System," a medical device, and its acceptance criteria, which are primarily based on mechanical testing and substantial equivalence to predicate devices. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Meets "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model (ASTM 1717)" for:- Dynamic Compression- Static Compression and Torsion	All mechanical test results are presented in Appendix E (though Appendix E is not provided in the input text). The conclusion states: "The test results demonstrate that the MIS Anterior Cervical Plate is substantially equivalent to the predicate devices, Nuvasive Helix-Mini ACP (K073275) and NEO SL Anterior Cervical Plate (K070285)."
Substantial Equivalence to Predicate Devices (Nuvasive Helix-Mini ACP (K073275) and NEO SL Anterior Cervical Plate (K070285)) in:- Indications for Use- Design- Function- Materials Used	The device is claimed to be substantially equivalent to the predicate devices in these aspects. This is the primary "performance" metric for a 510(k) submission where direct comparative clinical or performance metrics are often not required if substantial equivalence can be demonstrated through other means (like mechanical testing and design comparison).

2. Sample Size Used for the Test Set and the Data Provenance

The provided text does not specify a sample size for a test set in the context of clinical data or patient data. The "test set" refers to mechanical tests performed on the device itself.

Sample Size for Mechanical Testing: Not explicitly stated (e.g., number of plates or screws tested).
Data Provenance: The mechanical testing was performed by an "independent third party test facility." The country of origin for the data is not specified, but the submission is to the U.S. FDA. The testing is not described as retrospective or prospective clinical data; it is laboratory-based mechanical testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This section is not applicable to this type of device submission. Ground truth, in the context of expert consensus, is typically relevant for studies involving diagnostic accuracy or clinical outcomes where human interpretation is involved. For this mechanical device, the "ground truth" for the test set is established by adherence to a standardized test method (ASTM 1717) and engineering principles, not expert clinicians establishing a "diagnosis."

4. Adjudication method for the test set

This is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical trials or studies to resolve discrepancies in expert opinions or interpretations of data. The "test set" here refers to mechanical tests, which are objective measurements, not subject to human interpretation requiring adjudication.

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

This is not applicable. An MRMC study is relevant for AI-powered diagnostic or screening devices where the performance of human readers (e.g., radiologists, pathologists) is being evaluated, often with or without AI assistance. The "MIS Anterior Cervical Plating System" is a physical implant, not an AI diagnostic tool, and therefore, no such study was performed or described.

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

This is not applicable. This question pertains to AI algorithms. The device is a physical medical implant.

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

The "ground truth" for the performance of this device is based on mechanical engineering standards (ASTM F136 for material, ASTM 1717 for testing methods) and the established performance of legally marketed predicate devices. The primary "ground truth" is that the device's mechanical properties meet the established benchmarks for safety and effectiveness as demonstrated by the predicate devices. There is no biological or diagnostic "ground truth" in the clinical sense mentioned (e.g., pathology slide, patient outcome).

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of machine learning or AI for this mechanical medical device submission.

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

This is not applicable for the same reasons as point 8.

Summary

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510(k) Summary

MIS Anterior Cervical Plating System

Submitted By:	Life Spine, Inc.2401 W. Hassell Road, Suite 1535Hoffman Estates, IL 60169Telephone: 847-884-6117Fax: 847-884-6118
510(k) Contact:	Randy LewisLife Spine, Inc.2401 W. Hassell Road, Suite 1535Hoffman Estates, IL 60169Telephone: 847-884-6117Fax: 847-884-6118
Date Prepared:	November 19th, 2010
Trade Name:	MIS Anterior Cervical Plating System
Product Code:	CFR 888.3060 - Spinal Intervertebral Body FixationOrthosisClass II
Classification:	KWQ
Predicate Device:	Nuvasive Helix-Mini ACP (K073275)NEO SL Anterior Cervical Plate (K070285)

Device Description:

The MIS Anterior Cervical Plating System components are temporary implants that are intended for anterior fixation to the cervical spine during the development of a cervical spinal fusion.

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Intended Use of the Device:

1. Degenerative disc disease, DDD (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies);
1. Spondylolisthesis
1. Trauma (including fractures or dislocations);
1. Spinal cord stenosis;
1. Deformity or curvatures (i.e. kyphosis, lordosis and/or scoliosis);
1. Tumors:
1. Pseudarthrosis;
1. Failed previous fusions.

Material:

Manufactured from medical grade titanium alloy as described by ASTM F136.

Test Data:

Dynamic Compression as well as Static Compression and Torsion was performed on the MIS Anterior Cervical Plate as described in ASTM 1717, Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model. The testing was performed by an independent third party test facility. All mechanical test results are presented in Appendix E.

Testing Conclusions:

The test results demonstrate that the MIS Anterior Cervical Plate is substantially equivalent to the predicate devices, Nuvasive Helix-Mini ACP (K073275) and NEO SL Anterior Cervical Plate (K070285).

Substantial Equivalence:

The MIS Anterior Cervical Plating System is substantially equivalent to previously cleared devices in indications for use, design, function, and materials used.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure, with its wings spread and head turned to the right. The bird is rendered in a simple, bold black line. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

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

JUN - 1 2011

Life Spine, Inc. % Mr. Randy Lewis 2401 West Hassell Road Suite 1535 Hoffman Estates, Illinois 60169

Re: K103423

Trade/Device Name: MIS Anterior Cervical Plating System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: April 26, 2011 Received: April 27, 201-1

Dear Mr. Lewis:

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

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Page 2 - Mr. Randy Lewis

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 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

cc
Ds De

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Indications for Use:

K 103423

Device Name:	MIS Anterior Cervical Plating System
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1. Degenerative disc disease, DDD (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies);
1. Spondylolisthesis
1. Trauma (including fractures or dislocations);
1. Spinal cord stenosis;
ડ. Deformity or curvatures (i.e. kyphosis, lordosis and/or scoliosis);
1. Tumors;
1. Pseudarthrosis;
1. Failed previous fusions.

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (DDE)
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(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

KID3423 510/k) Numher

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.