Properly used, this system is intended for anterior interbody screw fixation of the cervical spine. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The system is indicated for use in the temporary stabilization of the anterior spine from C2 to T1 during the development of cervical spinal fusions in patients with: 1.) Degenerative disc disease, DDD (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies); 2). Spondylolisthesis; 3.) Trauma (including fractures or dislocations); 4.) Spinal cord stenosis; 5.) Deformity or curvatures (i.e. kyphosis, lordosis or scoliosis); 6.) Tumors; 7.) Pseudarthrosis; and/or 8.) Failed previous fusions.

Device Description

The IRIS™ Anterior Cervical Plating System consists of a variety of shapes and sizes of bone 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.

The IRIS™ Anterior Cervical Plate System implant components are made from titanium alloy described by ASTM F136 and Nitonol per ASTM F2063. Stainless steel and titanium implant components must not be used together in a construct. LIFE SPINE expressly warrants that these devices are fabricated from the foregoing material specification. No other warranties express or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded. Do not use any of the IRIS™ Anterior Cervical Plate System components with the components from any other system or manufacturer.

AI/ML Overview

The provided document is a 510(k) Pre-market Notification for the IRIS™ Anterior Cervical Plate System, a medical device. This type of submission focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than on proving clinical effectiveness or generating new clinical performance data through studies typically associated with AI/ML algorithms.

Therefore, the information requested in your prompt, which pertains to AI/ML model validation (e.g., sample size for test set/training set, expert ground truth, adjudication methods, MRMC studies, standalone performance), is not present in this document. This filing is for a mechanical implant, not an AI medical device.

Here's why your request cannot be fully answered from this document:

No AI/ML Component: The IRIS™ Anterior Cervical Plate System is a physical spinal fixation implant. It does not involve any artificial intelligence, machine learning, or software algorithms that would require a test set, training set, or performance metrics like accuracy, sensitivity, or specificity.
Substantial Equivalence: The approval process for this device relies on demonstrating that it is as safe and effective as a predicate device already on the market. This is primarily done through:
- Technological Characteristics Comparison: Showing similar design, materials, and intended use to existing devices.
- Performance Data (Bench Testing): Conducting non-clinical (mechanical) tests to ensure the device meets established engineering standards, like ASTM F1717 for spinal instrumentation.

However, I can extract information related to the acceptance criteria and performance data for this mechanical device as described in the document, which are different from an AI/ML context:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical/Bench Testing)

Acceptance Criteria (Demonstrates Substantial Equivalency)	Reported Device Performance (Via Bench Testing)
Meets Static Compression per ASTM F1717 standards for spinal implants.	Static compression testing per ASTM F1717 was presented to demonstrate substantial equivalency. (Specific values not provided in summary, but implicitly met.)
Meets Static Torsion per ASTM F1717 standards for spinal implants.	Static torsion testing per ASTM F1717 was presented to demonstrate substantial equivalency. (Specific values not provided in summary, but implicitly met.)
Meets Dynamic Compression per ASTM F1717 standards for spinal implants.	Dynamic compression testing per ASTM F1717 was presented to demonstrate substantial equivalency. (Specific values not provided in summary, but implicitly met.)
Meets Screw Push-out testing standards (implicitly compared to predicate or established limits).	Screw Push-out testing was presented to demonstrate substantial equivalency. (Specific values not provided in summary, but implicitly met.)
Materials conform to ASTM F136 (Titanium Alloy) and ASTM F2063 (Nitinol).	The IRIS™ Anterior Cervical Plate System material is 6AL-4V-ELI titanium manufactured according to ASTM F136 and Nitonol manufactured according to ASTM F2063.

Regarding the other points you requested:

2. Sample size used for the test set and the data provenance: Not applicable. There's no "test set" in the context of an AI/ML model. The performance data refers to mechanical bench testing, where "samples" are physical units of the device tested in a lab, not data points. Data provenance would be from laboratory testing.
3. Number of experts used to establish the ground truth... and qualifications: Not applicable. "Ground truth" in this context is established by engineering standards and validated lab testing protocols, not human clinical experts reviewing images or data for diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This concept is relevant for human expert review in AI studies, not for mechanical testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done...: Not applicable. An MRMC study involves human readers interpreting cases, relevant for diagnostic AI. This device is an implant, not a diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This refers to AI algorithm performance.
7. The type of ground truth used: For a mechanical device, "ground truth" is defined by established engineering and material standards (e.g., ASTM F1717, ASTM F136, ASTM F2063) and the results of a predicate device.
8. The sample size for the training set: Not applicable. No "training set" for an AI/ML model.
9. How the ground truth for the training set was established: Not applicable.

In summary, this document is a regulatory submission for a physical medical implant, and the requested performance criteria and study details are specific to the validation of AI/ML algorithms, which are not part of this device.

Summary

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K130202 Page 1 of 2

510(k) Summary IRIS™ Anterior Cervical Plate System

APR 2 9 2013

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 Spine2401 W. Hassell Road, Suite 1535Hoffman Estates, IL 60169Telephone: 847-884-6117Fax: 847-884-6118
Date Prepared:	January 25th, 2013
Trade Name:	IRISTM Anterior Cervical Plate
Common Name:	Spinal Fixation System
Classification:	KWQ, CFR 888.3060, Class II
Predicate Device:	Life Spine Anterior Cervical Plate System (K070285)K2M Cervical Plate System (K113329)

Device Description:

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Intended Use of the Device:

Properly used, this system is intended for anterior interbody screw fixation of the cervical spine. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The system is indicated for use in the temporary stabilization of the anterior spine from C2 to T1 during the development of cervical spinal fusions in patients with: (1) Degenerative disc disease, DDD (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies): (2) Spondylolisthesis: (3) Trauma (including fractures or dislocations); (4) Spinal cord stenosis: (5) Deformity or curvatures (i.e. kyphosis, lordosis or scoliosis); (6) Tumors; (7) Pseudarthrosis; (8) Failed previous fusions.

Nota Bene: This device system is intended for anterior cervical interverterbral body fusions only.

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

Technological Characteristics:

The IRIS™ Anterior Cervical Plate System is substantially equivalent to the predicate system in terms of design, materials, indications for use and sizing.

Material:

The IRIS™ Anterior Cervical Plate System material is 6AL-4V-ELI titanium manufactured according to ASTM F136 and Nitonol manufactured according to ASTM F2063. The device is comprised of a variety of non-sterile, single use components.

Performance Data:

Static compression, static torsion and dynamic compression testing per ASTM F1717 as well as Screw Push-out testing were presented to demonstrate the substantial equivalency of the IRIS™ Anterior Cervical Plate System.

Conclusion:

The information presented demonstrates the substantial equivalency of the IRIS™ Anterior Cervical Plate System.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling a bird or a person with outstretched arms, composed of three curved lines.

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

April 29, 2013

Life Spine, Incorporated % Mr. Randy Lewis Director, RA/QA 2401-West-Hassell-Road, Suite-1-535 Hoffman Estates, Illinois 60169

Re: K130202

Trade/Device Name: IRISTM Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: February 27, 2013 Received: February 28, 2013

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 vour 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. Randy Lewis

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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Image /page/3/Picture/6 description: The image shows the name "Erin I.D. Keith" in a stylized font. The letters "Erin" and "ith" are in a standard bold font. The letters "I.D.Ke" are stylized with a pattern of lines and shapes.

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

K130202 Page 1 of 1

510(k) number (if known):

Device Name: IRISTM Anterior Cervical Plate System_

Nota Bene: This device system is intended for anterior cervical interverterbral body fusions only.

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

Prescription Use _ x (Part 21 CFR 801 Subpart D) And/Or

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

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

Anton E. Dmitriev, PhD Division of Orthopedic Devices

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.