The Invictus Spinal Fixation System is intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. Fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Invictus Spinal Fixation System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, lyphosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Invictus Spinal Fixation System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis / spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. Pediatic pedicle screw fixation is limited to a posterior approach.

The Invictus Spinal Fixation System is intended to be used with autograft and/or allograft.

Device Description

The Invictus Spinal Fixation System is a thoracolumbosacral pedicle screw system designed to be implanted through a posterior surgical approach. The implants are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136, commercially pure titanium (CP Ti Grade 2) per ASTM F67 and cobalt chromium (Co-28Cr-6Mo) alloy per ASTM F1537. The Invictus System consists of a variety of shapes and sizes of screws, hooks, rods, connectors, and cross-connectors to create a rigid construct as an adjunct to fusion for temporary internal fixation and stabilization of the thoracic. Iumbar and sacral spine.

The purpose of this submission is to add modular pedicle screws and rod connectors to the Invictus Spinal Fixation System.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Invictus™ Spinal Fixation System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance data, rather than clinical performance studies typically associated with AI/software devices. Therefore, the information requested regarding acceptance criteria, study design for proving it, sample sizes, expert ground truth, MRMC studies, standalone performance, and training data for AI/software is not applicable to this specific document.

The document pertains to a Class II medical device, specifically a thoracolumbosacral pedicle screw system, which is a physical implant. The approval is based on demonstrating the device's substantial equivalence to existing legally marketed predicate devices through material testing and mechanical performance, not through clinical or AI-based performance metrics.

Specifically addressing your numbered points based on the provided text:

A table of acceptance criteria and the reported device performance

Acceptance Criteria: The acceptance criteria are implicitly based on demonstrating performance comparable to the predicate devices as per industry standards for spinal fixation systems. The relevant ASTM (American Society for Testing and Materials) standards provide the framework for these criteria.

Reported Device Performance:

Test Type	Standard	Reported Performance
Static and dynamic axial compression	ASTM F1717	"The results demonstrate that the subject Invictus Spinal Fixation System is substantially equivalent to other predicate devices for nonclinical testing."
Static torsion	ASTM F1717	"The results demonstrate that the subject Invictus Spinal Fixation System is substantially equivalent to other predicate devices for nonclinical testing."
Static tulip pull-off (Fx)	ASTM F1798	"The results demonstrate that the subject Invictus Spinal Fixation System is substantially equivalent to other predicate devices for nonclinical testing."

Note: The document does not provide specific numerical results of these tests, but rather states that the results demonstrate substantial equivalence.

Sample size used for the test set and the data provenance
- Sample Size: Not specified in the document. For mechanical testing, sample sizes are typically determined by the relevant ASTM standard and statistical requirements for demonstrating equivalence, but not explicitly stated here.
- Data Provenance: The data is generated from non-clinical laboratory testing of the physical device components. Not applicable to country of origin in the way it would be for patient data, nor is it retrospective or prospective in the clinical sense.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth as typically understood in AI/software evaluation (e.g., expert consensus on medical images) is not relevant for this type of mechanical device testing. The "ground truth" for these tests are the established scientific principles of material strength and mechanical integrity as defined by the ASTM standards.
Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. This is not a clinical study involving human judgment.
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 non-clinical submission for a physical medical device, not an AI or software device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a non-clinical submission for a physical medical device, not an AI or software device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For this mechanical device, the "ground truth" is defined by the physical properties and mechanical performance requirements as per the relevant ASTM standards (F1717, F1798) to demonstrate safety and effectiveness comparable to predicate devices. There is no expert consensus on clinical data, pathology, or outcomes data used for the substantial equivalence determination for this device's performance.
The sample size for the training set
- Not applicable. This is a physical medical device, not an AI/software device that requires a "training set."
How the ground truth for the training set was established
- Not applicable. This is a physical medical device, not an AI/software device that requires a "training set."

Summary

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December 12, 2019

Alphatec Spine, Inc. Ms. Cynthia Adams Project Manager, Regulatory Affairs 5818 El Camino Real Carlsbad, California 92008

Re: K192938

Trade/Device Name: Invictus™ Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screws Regulatory Class: Class II Product Code: NKB, KWP Dated: October 17, 2019 Received: October 18, 2019

Dear Ms. Adams:

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. 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 located 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.

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

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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) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-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,

Colin O'Neill Acting Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K192938

Device Name InvictusTM Spinal Fixation System

Indications for Use (Describe)

The Invictus Spinal Fixation System is intended to be used with autograft and/or allograft.

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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K192938 510k Summary

This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.

I.	SUBMITTER:	Alphatec Spine, Inc.5818 El Camino RealCarlsbad, CA 92008Phone: (760) 431-9286Fax: (760) 431-0289
	Contact Person:	Cynthia AdamsProject Manager, Regulatory AffairsContact Phone: (760) 494-6740
	Date Summary Prepared:	October 16, 2019

II. DEVICE

Name of Device:	Invictus TM Spinal Fixation System
Common or Usual Name:	Thoracolumbosacral pedicle screw system
Classification Name:	Thoracolumbosacral pedicle screw system(21 CFR 888.3050, 888.3070)
Regulatory Class:	Class II
Product Code:	NKB, KWP

LEGALLY MARKETED PREDICATE DEVICES III.

510(k)	Product Code	Trade Name	Manufacturer
Primary Predicate Device
K181677	NKB, KWP	Kodiak Spinal Fixation System	Alphatec Spine
Additional Predicate Devices
K180210	NKB, KWP,KWQ	CREO Stabilization System	Globus Medical
K161363	NKB, OSH, MNI,MNH, KWP	Arsenal Spinal Fixation System	Alphatec Spine
K152968	NKB, OSH, MNI,MNH, KWP	Arsenal Spinal Fixation System	Alphatec Spine
K191311	MAX, OVD,PHM	ATEC Lateral Interbody System	Alphatec Spine

IV. DEVICE DESCRIPTION

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titanium (CP Ti Grade 2) per ASTM F67 and cobalt chromium (Co-28Cr-6Mo) alloy per ASTM F1537. The Invictus System consists of a variety of shapes and sizes of screws, hooks, rods, connectors, and cross-connectors to create a rigid construct as an adjunct to fusion for temporary internal fixation and stabilization of the thoracic. Iumbar and sacral spine.

The purpose of this submission is to add modular pedicle screws and rod connectors to the Invictus Spinal Fixation System.

V. INDICATIONS FOR USE

The Invictus Spinal Fixation System is intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. Fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Invictus Spinal Fixation System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Invictus Spinal Fixation System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis / spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. Pediatric pedicle screw fixation is limited to a posterior approach.

The Invictus Spinal Fixation System is intended to be used with autograft and/or allograft.

VI. TECHNOLOGICAL COMPARISON TO PREDICATES

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.

VII. PERFORMANCE DATA

Nonclinical testing performed on the Invictus Spinal Fixation System supports substantial equivalence to other predicate devices. The following testing was performed:

Static and dynamic axial compression testing per ASTM F1717 ●
Static torsion testing per ASTM F1717 .
. Static tulip pull-off (Fx) testing per ASTM F1798

The results demonstrate that the subject Invictus Spinal Fixation System is substantially equivalent to other predicate devices for nonclinical testing.

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Clinical Information

Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data.

VIII. CONCLUSION

Based upon the information provided in this 510(k) submission, it has been determined that the subject devices are substantially equivalent to legally marketed devices in regards to indications for use, intended use, design, technology, and performance.

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.