The Life Spine Foot and Ankle Plating System is indicated for use in stabilization and fixation of fractures or osteotomies; intra and extra articular fractures, joint depression, and multifragmentary fractures, joint fusions, and reconstruction of the bones of the toes, feet and ankles including the distal tibia, talus, and calcaneus. The system can be used in both adult and pediatric patients.

Device Description

The Life Spine Foot and Ankle Plating System is system of plates and screws for fixation and reconstruction of the foot and ankle. The implant is fabricated and manufactured from the following:

Titanium (Ti 6A1-4V ELI)
Stainless Steel (316L)
All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Foot and Ankle Plating System components with components from any other system or manufacturer. The Foot and Ankle Plating System components should never be reused under any circumstances.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Life Spine Foot and Ankle Plating System. This type of FDA submission is focused on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria for device performance. Therefore, many of the requested data points related to clinical study design, AI performance, and ground truth establishment are not applicable to this document.

However, I can extract information related to the engineering and bench testing performed to support substantial equivalence.

Here is the information that can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Analysis performed	Reported Device Performance
Mechanical Strength	Torsional strength (Bench Top Validations)	Demonstrated substantial equivalency to predicate devices.
Mechanical Strength	Bending strength (Bench Top Validations)	Demonstrated substantial equivalency to predicate devices.
Mechanical Strength	Axial pullout (Bench Top Validations)	Demonstrated substantial equivalency to predicate devices.
Structural Integrity	Finite Element Analysis (FEA)	Included to demonstrate substantial equivalency to predicate devices.
Design Equivalence	Engineering Rationale	Included to demonstrate substantial equivalency to predicate devices.

2. Sample size used for the test set and the data provenance

Sample Size: Not specified for individual bench tests (e.g., number of plates tested for torsional strength). The document generally refers to "Bench Top Validations" without providing specific numbers of samples.
Data Provenance: The tests are "Bench Top Validations," meaning they were conducted in a laboratory setting. There is no information regarding country of origin or whether the tests were retrospective or prospective, as these terms are not applicable to bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. This device is hardware and does not involve AI or a diagnostic interpretation that would require human expert ground truth. The "ground truth" for the performance data is the physical measurement of mechanical properties compared against established engineering standards or predicate device performance.

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

Not Applicable. See point 3.

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 is a hardware device (bone plating system) and does not involve AI.

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

Not Applicable. This is a hardware device (bone plating system) and does not involve an algorithm.

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

For the performance data (e.g., torsional strength, bending strength, axial pullout), the "ground truth" is established by standard engineering testing methodologies and comparison to similar predicate devices, and likely against internal specifications derived from mechanical requirements for bone fixation. It is not expert consensus, pathology, or outcomes data.

8. The sample size for the training set

Not Applicable. This is a hardware device and does not involve an AI system requiring a training set.

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

Not Applicable. See point 8.

Summary

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December 21, 2017

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Life Spine Inc. Randy Lewis General Manager 13951 S Quality Drive Huntlev, Illinois 60142

Re: K172973

Trade/Device Name: Life Spine Foot and Ankle Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: October 20, 2017 Received: November 8, 2017

Dear Randy Lewis:

We have reviewed vour 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 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.

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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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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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Indications for Use

510(k) Number (if known) K172973

Device Name

Life Spine Foot and Ankle Plating System

Indications for Use (Describe)

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 Life Spine Foot and Ankle Plating System

Submitted By:	Life Spine, Inc.13951 S. Quality DriveHuntley, IL 60142Telephone: 847-884-6117Fax: 847-884-6118
510(k) Contact:	Randy LewisLife Spine13951 S. Quality DriveHuntley, IL 60142Telephone: 847-884-6117Fax: 847-884-6118
Date Prepared:	September 22nd, 2017
Trade Name:	Life Spine Foot and Ankle Plating System
Common Name:	Plate, Fixation, Bone
Regulation Name:	Single/multiple component metallic bone fixation appliances andaccessories
Classification:	HRS, CFR 888.3030, Class IIHWC, CFR 888.3040, Class II
Primary Predicate:	Paragon 28 Paralock Plating System / Tuffnek Screw (K140397)
Secondary Predicate:	Depuy ALPS Small Bone Locked Plating System (K101240)Ortho Solutions Extremity Fixation Implants for osteosynthesis (K111678)Life Spine Opening Base Wedge (K161037)

Device Description:

The Life Spine Foot and Ankle Plating System is system of plates and screws for fixation and reconstruction of the foot and ankle. The implant is fabricated and manufactured from the following:

1. Titanium (Ti 6A1-4V ELI)
1. Stainless Steel (316L)

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All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Foot and Ankle Plating System components with components from any other system or manufacturer. The Foot and Ankle Plating System components should never be reused under any circumstances.

Indications for Use of the Device:

The Life Spine Foot and Ankle Plating System is indicated for use in stabilization and fixation of fractures or osteotomies; intra and extra articular fractures, joint depression, and multifragmentary fractures; revision procedures, joint fusion and reconstructions of small bones of the toes, feet, and ankles including the distal tibia, talus, and calcaneus. The system can be used in both adult and pediatric patients.

Technological Characteristics:

The Life Spine Foot and Ankle Plating System are comparable in design and technological characteristics to one or more predicate devices. All plates utilize a plurality of screw holes to fixate the plate to bone using screws.

Material:

The Life Spine Foot and Ankle Plating System is Ti-6AL-4V-ELI titanium manufactured according to ASTM F136 and Stainless Steel 316L manufactured according to ASTM F138. Devices are single use implants.

Performance Data:

Finite Element Analysis, Engineering Rationale and Bench Top Validations were included to demonstrate the substantial equivalency of the Life Spine Foot and Ankle Plating System with respect to: torsional strength, bending strength and axial pullout.

Conclusion:

The information presented demonstrates the substantial equivalency of the Life Spine Foot and Ankle Plating System.

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.