The Life Spine Lumbar Fixation System (SENTRY®) is intended for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolisthesis, scoliosis, lordotic deformities of the spine, spinal stenosis, or a failed previous spine surgery.

Device Description

Anterior Lumbar: The SENTRY Anterior Lumbar Fixation System consists of a variety of plates and screws to suit the individual pathology and anatomical conditions of the patient. All components are fabricated and manufactured from titanium alloy 6AL-4V-ELI per ASTM F-136. The plates are manufactured in a variety of configurations with options including different lengths and curvature. The screws are manufactured in variable and fixed configurations with diameters of and lengths. Fixation is provided by bone screws inserted through the plates and into the vertebral body of the Lumbar spine using an anterior approach. The responsible surgeon will determine the correct size of the implant in accordance with the size of the individual patient. The SENTRY Anterior Lumbar Fixation System also utilizes a variety of standard orthopedic instruments to assist in the placement of the devices.

Lateral Lumbar: The SENTRY Lateral Plating System consists of a variety of plates and screws to suit the individual pathology and anatomical conditions of the patient. All components are fabricated and manufactured from titanium alloy 6AL-4V-ELI per ASTM F-136. The plates are manufactured in a variety of configurations with options including different lengths. The screws are manufactured in a variable configuration with different diameters and lengths. Fixation is provided by bone screws inserted through the plates and into the vertebral body of the Lumbar spine using an Lateral approach. The responsible surgeon will determine the correct size of the implant in accordance with the size of the individual patient. The SENTRY Lateral Plating System also utilizes a variety of standard orthopedic instruments to assist in the placement of the devices.

All implants are provided non-sterile and intended for SINGLE USE ONLY and should not be reused under any circumstances. Do not use any of the Life Spine Lumbar Fixation System (SENTRY®) components with components from any other system or manufacturer.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "Life Spine Lumbar Fixation System (SENTRY®)". This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than proving its safety and effectiveness through clinical trials with specific acceptance criteria as would be the case for a novel device or one requiring a PMA.

Therefore, the information you're requesting regarding acceptance criteria, study details, expert qualifications, and ground truth establishment, which are typical for studies evaluating diagnostic or AI-driven devices, is not present in this document.

The "Performance Data" section mentions "Axial Static and Dynamic compression. Bending and Static Torsion Testing to ASTM F1717, was presented to demonstrate the substantial equivalency of the Life Spine Lumbar Fixation System (Sentry)." This indicates that the performance criteria are related to the mechanical properties of the device and its ability to withstand certain forces, aligning with a mechanical engineering assessment rather than a clinical study with diagnostic accuracy metrics.

Here's how to address your request based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in the format of a clinical study or diagnostic performance metrics. Instead, it refers to mechanical testing standards.

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical performance according to ASTM F1717 to demonstrate substantial equivalence to predicate devices (Life Spine Sentry 2 (K172131) and Life Spine Presidio (K132589)).	Axial Static and Dynamic compression, Bending, and Static Torsion Testing performed to ASTM F1717. The document states this testing demonstrated the substantial equivalency of the Life Spine Lumbar Fixation System (SENTRY®).

Missing Information from the Document:

The following information is not present in the provided text, as it describes a 510(k) submission focused on substantial equivalence through mechanical testing, not a clinical study on diagnostic accuracy or AI performance:

Sample size used for the test set and the data provenance: Not applicable in this context, as the "test set" refers to mechanical samples of the device components, not patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is based on engineering specifications and physical measurements, not expert clinician consensus.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 device is a spinal fixation system, not an AI-driven diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is its mechanical integrity and adherence to engineering standards for spinal implants, as evaluated through physical testing.
The sample size for the training set: Not applicable. There is no training set for a mechanical device like this.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) clearance letter and summary for a spinal implant, which relies on demonstrating mechanical equivalence to previously cleared devices. It does not involve the types of clinical studies, data analysis, or AI performance metrics that your questions typically address.

Summary

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June 22, 2018

Image /page/0/Picture/1 description: The image contains two logos. The logo on the left is the Department of Health & Human Services-USA logo, which features a stylized human figure. The logo on the right is the FDA U.S. Food & Drug Administration logo, with the FDA acronym in a blue square and the full name of the administration in blue text.

Life Spine, Inc. Angela Batker RA/QA Specialist 13951 S Quality Drive Huntley, Illinois 60142

Re: K180166

Trade/Device Name: Life Spine Lumbar Fixation System (SENTRY®) Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWO Dated: May 18, 2018 Received: May 21, 2018

Dear Ms. Batker:

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 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,

Brent Showalter -S

for

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)

K180166

Device Name

Life Spine Lumbar Fixation System (SENTRY®)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X 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 Lumbar Fixation System (SENTRY®)

Submitted By:	Life Spine, Inc.13951 S. Quality DriveHuntley, IL 60142Telephone: 847-884-6117Fax: 847-884-6118
510(k) Contact:	Angela BatkerLife Spine, Inc.13951 S. Quality DriveHuntley, IL 60142Telephone: 847-884-6117Fax: 847-884-6118
Date Prepared:	May 17th, 2018
Trade Name: Common	Life Spine Lumbar Fixation System (SENTRY®)
Name:	Spinal Intervertebral Body Fixation Orthosis
Classification:	KWQ, 21 CFR 888.3060, Class II
Primary Predicate :	Life Spine Sentry 2 (K172131)
Secondary Predicate:	Life Spine Presidio (K132589)

Device Description:

Anterior Lumbar

The SENTRY Anterior Lumbar Fixation System consists of a variety of plates and screws to suit the individual pathology and anatomical conditions of the patient. All components are fabricated and manufactured from titanium alloy 6AL-4V-ELI per ASTM F-136.

The plates are manufactured in a variety of configurations with options including different lengths and curvature. The screws are manufactured in variable and fixed configurations with diameters of and lengths. Fixation is provided by bone screws inserted through the plates and into the vertebral body of the Lumbar spine using an anterior approach. The responsible surgeon will determine the correct size of the implant in accordance with the size of the individual patient.

The SENTRY Anterior Lumbar Fixation System also utilizes a variety of standard orthopedic instruments to assist in the placement of the devices.

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Lateral Lumbar

The SENTRY Lateral Plating System consists of a variety of plates and screws to suit the individual pathology and anatomical conditions of the patient. All components are fabricated and manufactured from titanium alloy 6AL-4V-ELI per ASTM F-136.

The plates are manufactured in a variety of configurations with options including different lengths. The screws are manufactured in a variable configuration with different diameters and lengths. Fixation is provided by bone screws inserted through the plates and into the vertebral body of the Lumbar spine using an Lateral approach. The responsible surgeon will determine the correct size of the implant in accordance with the size of the individual patient. The SENTRY Lateral Plating System also utilizes a variety of standard orthopedic instruments to assist in the placement of the devices.

Indications for Use:

The Life Spine Lumbar Fixation System (SENTRY®) is intended for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, spondylolisthesis, scoliosis, lordotic deformities of the spine, spinal stenosis, or a failed previous spine surgery.

Technological Characteristics:

The Life Spine Lumbar Fixation System (SENTRY®) is substantially equivalent to the predicate systems in terms of design, materials, indications for use and sizing.

Performance Data:

Axial Static and Dynamic compression. Bending and Static Torsion Testing to ASTM F1717, was presented to demonstrate the substantial equivalency of the Life Spine Lumbar Fixation System (Sentry).

Substantial Equivalence:

The Life Spine Lumbar Fixation System (SENTRY®) was shown to be substantially equivalent to the predicate devices in indications for use, design, function, materials used and mechanical performance.

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Conclusion:

The information presented demonstrates the substantial equivalency of the Life Spine Lumbar Fixation System (SENTRY®).

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.