The Eminent Spine Scoliosis Deformity Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion as a pedicle screw fixation system (T1-S2/Ilium). The system is intended for posterior, pedicle fixation in skeletally mature patients for the following acute and chronic instabilities or deformities: degenerative disc disease (DDD) (defined as back pain with discogenic origin with degeration of the disc confirmed by history and radiographophic studies), severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebrae, degenerative spondylolisthesis with objective evidence of neurologic imparment, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion.

When used for fixation to the ilium, the offset connectors of the Eminent System must be used in conjunction with pedicle screws placed at the S1 or S2 spinal level.

When used for posterior non-cervical pedicle screw fixation in pediatic patients, the Eminent Spinal Scoliosis Deformity Pedicle Screw System is indicated as an adjunct to treat progressive spinal deformities (i.e., scoliosis, kyhosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis. Additionally, the Eminent Spine Deformity Pedicle System is intents diagnosed with: spondylolisthesis / spondylolisthesis / spondylolysis, fracture caused by tumor and/or trauma, pseudoarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Device Description

The Eminent Spine Scoliosis Deformity Pedicle System consists of rods, polyaxial screws with set caps, and cross connectors with locking screws. Additionally, the system consists of rod connectors and iliac bolts with their respective locking screws. Rods are 5.5mm in diameter and are available either straight or pre-contoured. Straight and pre-contoured rods are each offered in lengths ranging from 40mm to various increments. Cannulated polyaxial screws are available in 6.0mm to 12.5mm diameters and in lengths ranging from 40mm to 110mm in 5mm increments. Set caps are used to fasten the rod and screw. Cross connectors are available in 3 length ranges: 32mm-42mm, 42mm-58mm, and 58mm-74mm. Cross connectors lock screws are used to fasten the cross connector together and fasten across the rods. Rod connectors are offered in 3 types and the iliac bolts are offered in 1 type. All of the components are available in a variety of sizes to match more closely to the patient's anatomy. All components are made from titanium alloy per ASTM F136.

AI/ML Overview

The provided document describes a medical device, the "Eminent Spine Scoliosis Deformity Pedicle Screw System," and its 510(k) premarket notification. The document focuses on establishing substantial equivalence to predicate devices, primarily through technological characteristics and mechanical testing.

However, the provided text does not contain information directly related to the acceptance criteria and study proving device performance in the context of an AI/software-based medical device. The device described is a physical implant (pedicle screw system), and the studies mentioned are mechanical tests, not clinical performance studies involving a test set, ground truth, experts, or AI algorithms.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI-powered device, as this information is not present in the provided text.

Specifically, the document lacks:

A table of acceptance criteria and reported device performance for an AI/software component.
Sample size and data provenance for a test set.
Number and qualifications of experts used to establish ground truth.
Adjudication method.
Multi-reader multi-case (MRMC) comparative effectiveness study results.
Standalone (algorithm-only) performance metrics.
Type of ground truth used (e.g., pathology, outcomes data) for an AI model.
Sample size and ground truth establishment method for a training set.

The document solely focuses on mechanical testing of the physical pedicle screw system to demonstrate its substantial equivalence to previously cleared devices.

Summary

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September 3, 2024

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Eminent Spine Stephen Courtney Chief Executive Officer 2004 Ventura Dr. Ste. 100 Plano, Texas 75093

Re: K242069

Trade/Device Name: Eminent Spine Scoliosis Deformity Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB Dated: August 15, 2024 Received: August 16, 2024

Dear Stephen Courtney:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Eileen
Digitally signed by
Eileen Cadel -S
Date: 2024.09.03
Cadel -S 11:13:15 -04'00'

Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

for

Enclosure

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Indications for Use

510(k) Number (if known) K242069

Device Name

Eminent Spine Scoliosis Deformity Pedicle Screw System

Indications for Use (Describe)

The Eminent Spine Scoliosis Deformity Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion as a pedicle screw fixation system (T1-S2/Lium). The system is intended for posterior, pedicle fixation in skeletally mature patients for the following acute and chronic instabilities or deformities: degenerative disc disease (DDD) (defined as back pain with discogenic origin with degeration of the disc confirmed by history and radiographophic studies), severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebrae, degenerative spondylolisthesis with objective evidence of neurologic imparment, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion.

When used for fixation to the ilium, the offset connectors of the Eminent System must be used in conjunction with pedicle screws placed at the S1 or S2 spinal level.

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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Image /page/3/Picture/0 description: The image shows a logo for "Eminent Spine". The logo features a golden sword with a spine-like structure in the middle of the blade. The sword is surrounded by a golden, crescent-shaped design. The text "EMINENT" is written in a bold, serif font above the word "SPINE", which is written in a smaller, lighter font.

510(k) Summary

Submitted By:	Eminent Spine, LLC2004 Ventura Dr. Suite #100Plano, TX 75093
Date:	08/20/2024
Contact Person:Contact Telephone:Contact Fax:	Stephen Courtney, CEO, Eminent Spine(972) 499-3593N/A
Device Trade Name:Common Name:Device Classification Name:Device Classification:Reviewing Panel:Product Code:Primary Predicate Device:Additional Predicate Devices:	Eminent Spine Scoliosis Deformity Pedicle Screw SystemPedicle Screw Spinal SystemOrthosis, spinal pedicle fixationClass II - 21 CFR 888.3070 - Thoracolumbarsacral Pedicle Screw SystemOrthopedicNKBEminent Spine Diamondback Pedicle Screw System (K100377)NEXXT Spine Inertia® Pedicle and Deformity Correxxion System (K153453)

Device Description:

Indications for Use:

The Eminent Spine Scoliosis Deformity Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion as a pedicle screw fixation system (T1-S2/Ilium). The system is intended for posterior, pedicle fixation in skeletally mature patients for the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (DD) (defined as back pain with discogenic origin with degeration of the disc confirmed by history and radiographophic studies), severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebrae, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudoarthrosis and failed previous fusion.

When used for fixation to the ilium, the offset connectors of the Eminent System must be used in conjunction with pedicle screws placed at the S1 or S2 spinal level.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Eminent Spinal Scoliosis Deformity Pedicle Screw System is indicated as an adjunct to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Eminent Spine Deformity Pedicle System is intended to treat pediatric patients diagnosed with: spondylolisthesis / spondylolysis, fracture caused by tumor and/or trauma, pseudoarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

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Image /page/4/Picture/1 description: The image shows a logo for "Eminent Spine". The logo features a stylized spine with a sword running through it, all encased within a golden, semi-circular frame. The word "EMINENT" is written in a bold, sans-serif font above the word "SPINE", which is written in a smaller, lighter font. The overall design is professional and suggests a focus on spinal health or surgery.

Technological Characteristics Comparison

The technological design features of the subject Eminent Spine Scoliosis Deformity Pedicle Screw System is substantially equivalent to the predicate devices (K100377 and K153453). The technological design features of the subject implants were compared to the predicates in intended use, indications for use, design, function, and technology and it was demonstrated that they are substantially equivalent

Mechanical Testing:

Substantial equivalence is supported by the results of mechanical testing. Construct tests were conducted according to ASTM F1717, including static torsion, static compression bending, and dynamic compression bending. Rod connector axial and torsional grip tests were conducted according to ASTM F1789. Results support the substantial equivalence of the subject device compared to predicate devices.

Conclusion:

Based on the indications for use, technological characteristics, and comparison with the predicate device, the subject device has demonstrated substantial equivalence for its intended use.

Regulation Number and Section

N/A