The NILE Alternative Fixation Spinal System is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures.

The indications for use include the following applications:

Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques;
Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, kyphosis, and spondylolisthesis;
Spinal degenerative surgery, as an adjunct to spinal fusions.

The NILE Alternative Fixation Spinal System may also be used in conjunction with other medical implants made of similar metals whenever 'wiring' may help secure the attachment of other implants.

Device Description

The Nile Alternative Fixation System implants are comprised of bands, clamps and set screws designed to attach to titanium or cobalt chrome rods. The band is manufactured from polyethylene terephthalate (PET) and the clamps and set screws are made from titanium alloy in accordance with ASTM F136. Once the bands are secured the stainless steel tips are detached and are not intended to be implanted.

Function: The Nile Alternative Fixation system is a band (tether) and clamp device that is designed to be used in conjunction with spinal rods for attachment to the posterior vertebral structures.

AI/ML Overview

I apologize, but the provided text is a 510(k) summary for a medical device (Nile Alternative Fixation Spinal System) and does not contain the information requested in your prompt regarding acceptance criteria and a study proving a device meets them in the context of an AI/ML-based medical device.

The document describes:

The device name, its intended use, and indications for use.
Its classification and predicate devices.
A brief description of its components and function.
A comparison to predicate devices.
A mention of non-clinical mechanical performance evaluation.

However, it does not discuss:

A table of acceptance criteria and reported device performance for an AI/ML system.
Sample sizes for test sets, data provenance, or training sets in the context of AI/ML.
Number of experts, qualifications, or adjudication methods for establishing ground truth for AI/ML.
MRMC studies, effect sizes for human readers with/without AI assistance.
Standalone algorithm performance.
Type of ground truth used for AI/ML models.

The "Non-clinical Performance Evaluation" section simply states that the device "performed equally to or better than these systems in static tensile strength, static and dynamic compression, dynamic tension/band pull-through, static band pull-through, axial gripping capacity and rotational gripping capacity." This refers to biomechanical testing of a physical implant, not the evaluation of an AI/ML algorithm.

Summary

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

February 25, 2015

K2M, Incorporated Ms. Nancy Giezen Manager, Regulatory Affairs 751 Miller Drive Southeast Leesburg, Virginia 20175

Re: K143350

Trade/Device Name: Nile Alternative Fixation Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: Class II Product Code: OWI Dated: January 26, 2015 Received: January 27, 2015

Dear Ms. Giezen:

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. Nancy Giezen

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" (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 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

510(k) Number (if known) K143350

Device Name Nile Alternative Fixation

Indications for Use (Describe)

The indications for use include the following applications:

Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques;
Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, and spondy lolisthesis;
Spinal degenerative surgery, as an adjunct to spinal fusions.

The NJLE Alternative Fixation Spinal System may also be used in conjunction with other medical implants made of similar metals whenever 'wiring' may help secure the attachment of other implants.

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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510(k) SUMMARY Nile Alternative Fixation

Submitter

K2M, Inc. 751 Miller Drive SE Leesburg, VA 20175 Contact Person: Nancy Giezen Telephone: 703-777-3155 Date Prepared: 1/26/2015

Classification

Trade Name:	Nile Alternative Fixation
Common Name:	Bone Fixation Cerclage
Regulatory Class:	Class II

Classification Name(s): Bone Fixation Cerclage (21 CFR 888.3010, Product Code OWI)

Predicate Device(s)

Primary Predicate:

. Universal Clamp Spinal Fixation System (K110348, K091190, K081622, K060009)
Additional Predicates:
SILC Fixation System (K133482)
LigaPASS (K132395, K112736)
Jazz System (K121541) ●
Range/Mesa/Denali Spinal System (K120099) ●

Device Description

Function: The Nile Alternative Fixation system is a band (tether) and clamp device that is designed to be used in conjunction with spinal rods for attachment to the posterior vertebral structures.

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Intended Use

The indications for use include the following applications:

Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques;
Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, kyphosis, and spondylolisthesis;
Spinal degenerative surgery, as an adjunct to spinal fusions.

The NILE Alternative Fixation Spinal System may also be used in conjunction with other medical implants made of similar metals whenever 'wiring' may help secure the attachment of other implants.

Technological Comparison to Predicate(s)

The Nile Alternative Fixation system implants were compared to predicate systems and the design features, materials and intended uses were found to be substantially the same as these systems.

Non-clinical Performance Evaluation

The Nile Alternative Fixation system implants were mechanically tested and compared to predicate devices. The Nile Alternative Fixation system implants performed equally to or better than these systems in static tensile strength, static and dynamic compression, dynamic tension/band pull-through, static band pull-through, axial gripping capacity and rotational gripping capacity.

Conclusion

There are no significant differences between the Nile Alternative Fixation system implants and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and performance.

Regulation Number and Section

§ 888.3010 Bone fixation cerclage.

(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.