When used as a pedicle screw fixation system, the NuVasive Reline 4.5-5.0 System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spine:

Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
Degenerative spondylolisthesis with objective evidence of neurologic impairment
Fracture
Dislocation
Scoliosis
Kyphosis
Spinal tumor and/or
Failed previous fusion (pseudoarthrosis)

The Nu Vasive Reline 4.5-5.0 System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the LS-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants of a solid fusion.

When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the NuVasive Reline 4.5-5.0 System is also intended for the following indications:

Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
Spinal stenosis
Spondylolisthesis
Spinal deformities
Fracture
Pseudoarthosis
Tumor resection and/or
Failed previous fusion

When used for posterior non-cervical screw fixation in pediatric patients, NuVasive Reline 4.5-5.0 System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the Nu Vasive Reline 4.5-5.0 System is intended to treat pediatric patients diagnosed with the following conditions: spondylolysis, and fracture caused by tumor and/or trauma. Pediatric pedicle screw fixation is limited to a posterior approach and is intended to be used with autograft and/or allograft.

In order to achieve additional levels of fixation, the NuVasive Reline 4.5-5.0 System rods may be connected to the Armada System.

Device Description

The NuVasive Reline 4.5-5.0 System is a pedicle screw system that consists of a variety screws, hooks, rods, lock screws, transverse connectors, rod-to-rod connectors, iliac connectors and associated general instruments. Implant components are available in a variety sizes and can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient. The purpose of this submission is to introduce design changes to the modular screws of the previously cleared Reline 4.5-5.0 System.

AI/ML Overview

The provided document is a 510(k) summary for the NuVasive® Reline® 4.5-5.0 System, a medical device for spinal fixation. It outlines the device's intended use, technological characteristics, and performance data used to demonstrate substantial equivalence to predicate devices. However, the document does not contain the level of detail requested regarding acceptance criteria and a study that proves the device meets those criteria in the context of an AI/ML medical device.

Specifically, the document discusses performance data in terms of nonclinical testing for mechanical properties, not performance metrics typically associated with AI/ML systems (e.g., sensitivity, specificity, accuracy). It also does not involve human readers, ground truth establishment by experts, or training/test set sample sizes in the context of an AI/ML algorithm.

Therefore, many of the requested categories cannot be filled from the provided text.

Here's a breakdown of what can and cannot be answered based on the document:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Mechanical Performance (implied)	The results from Dynamic Flexion-Extension Moment Testing per ASTM F1798 demonstrate substantial equivalence to the predicate. (Specific numerical criteria or performance values are not provided, only the conclusion of substantial equivalence).

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable / Not provided. The "test set" in this context refers to physical device components undergoing mechanical testing, not a dataset for an AI/ML model. The document does not specify the number of samples tested for the Dynamic Flexion-Extension Moment Testing, nor does it refer to data provenance in the context of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable / Not provided. This document describes a traditional medical device (spinal hardware) and its mechanical testing, not an AI/ML device that requires expert-established ground truth from medical imaging or clinical data.

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

Not applicable / Not provided. Adjudication methods are relevant for establishing ground truth in human-AI studies or for resolving discrepancies in expert interpretations, which is not the subject of this document.

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 / Not provided. This document is for a spinal fixation system, not an AI-assisted diagnostic or interpretative device that would involve human readers.

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

Not applicable / Not provided. The device is a physical pedicle screw system, not an algorithm.

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

Not applicable / Not provided. The "ground truth" for this device's performance is its mechanical integrity and strength as evaluated by a standardized test (ASTM F1798) to demonstrate substantial equivalence to a predicate device. There is no biological or interpretative ground truth in the AI/ML sense.

8. The sample size for the training set

Not applicable / Not provided. This device does not involve a training set for an AI/ML model.

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

Not applicable / Not provided. This device does not involve a training set for an AI/ML model.

In summary: The provided 510(k) summary is for a physical medical device (spinal fixation system) and details its mechanical performance testing to establish substantial equivalence. It does not provide information about acceptance criteria or a study design relevant to an AI/ML medical device as implied by the detailed questions.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

October 19, 2019

NuVasive, Incorporated Ms. Ivanna Lopez Specialist, Regulatory Affairs 7475 Lusk Boulevard San Diego, California 92121

Re: K190636

Trade/Device Name: NuVasive® Reline® 4.5-5.0 System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB, KWP, KWQ Dated: September 16, 2019 Received: September 17, 2019

Dear Ms. Lopez:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 (QS) 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,

Ronald P. Jean, Ph.D. Director (Acting) 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) K190636

Device Name NuVasive® Reline® 4.5-5.0 System

Indications for Use (Describe)

Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)

1. Degenerative spondylolisthesis with objective evidence of neurologic impairment
1. Fracture
1. Dislocation
1. Scoliosis
1. Kyphosis
1. Spinal tumor and/or
1. Failed previous fusion (pseudoarthrosis)

When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the NuVasive Reline 4.5-5.0 System is also intended for the following indications:

Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)

1. Spinal stenosis
1. Spondylolisthesis
1. Spinal deformities
1. Fracture
1. Pseudoarthosis
1. Tumor resection and/or
1. Failed previous fusion

In order to achieve additional levels of fixation, the NuVasive Reline 4.5-5.0 System rods may be connected to the Armada System.

Type of Use (Select one or both, as applicable)

X 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/1 description: The image shows the logo for Nuvasive. The logo consists of a stylized leaf shape in purple and gray, followed by the company name "NUVASIVE" in gray sans-serif font. The logo is clean and modern, with a focus on the company name.

510(k) Summary

In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR §807.92, the following summary of information is provided:

Submitted by: A.

Ivanna Lopez Specialist, Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-1878

Date Prepared: March 11, 2019

B. Device Name

Trade or Proprietary Name:	NuVasive® Reline® 4.5-5.0 System
Common or Usual Name:	Pedicle Screw System
Classification Name:	Thoracolumbosacral pedicle screw system

Device Class:	Class II
Classification:	21 CFR § 888.3070
Product Code:	NKB, KWP, KWQ

C. Predicate Devices

The subject device is substantially equivalent to the primary predicate device NuVasive Reline 4.5-5.0 System (K170126) and additional predicate device, DePuy Spine Expedium Spine System (K090230).

D. Device Description

E. Intended Use

When used as a pedicle screw fixation system, the NuVasive Reline 4.5-5.0 System is 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 posterior thoracic, lumbar, and sacral spine:

1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
1. Degenerative spondylolisthesis with objective evidence of neurologic impairment
3.Fracture
1. Dislocation

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Image /page/4/Picture/1 description: The image shows the logo for Nuvasive. The logo consists of a stylized leaf shape on the left, with the word "NUVASIVE" in gray letters to the right of the leaf. The leaf is split into two colors, with the top half being purple and the bottom half being gray.

Scoliosis 6. Kyphosis 7. Spinal tumor and/or 8. Failed previous fusion (pseudoarthrosis)

The NuVasive Reline 4.5-5.0 System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants after attainment of a solid fusion.

When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the NuVasive Reline 4.5-5.0 System is also intended for the following indications:

1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
1. Spinal stenosis
3.Spondylolisthesis
1. Spinal deformities
5.Fracture
1. Pseudoarthosis
1. Tumor resection and/or
1. Failed previous fusion

When used for posterior non-cervical screw fixation in pediatric patients. NuVasive Reline 4.5-5.0 System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the NuVasive Reline 4.5-5.0 System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis, spondylolysis, and fracture caused by tumor and/or trauma. Pediatric pedicle screw fixation is limited to a posterior approach and is intended to be used with autograft and/or allograft.In order to achieve additional levels of fixation, the NuVasive Reline 4.5-5.0 System rods may be connected to the Armada System.

F. Technological Characteristics

As was established in this submission, the subject NuVasive Reline 4.5-5.0 System is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent and have equivalent technological characteristics to its predicate device through comparison in areas including design, labeling/intended use, material composition, and function.

G. Performance Data

Nonclinical testing was performed to demonstrate that the subject NuVasive Reline 4.5-5.0 System is substantially equivalent to the predicate device. The following testing was performed:

Dynamic Flexion-Extension Moment Testing per ASTM F1798
The results demonstrate that the subject NuVasive Reline 4.5-5.0 System is substantially equivalent to the predicate.

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Image /page/5/Picture/1 description: The image shows the logo for Nuvasive. The logo consists of a stylized purple and gray leaf-like shape on the left, followed by the word "NUVASIVE" in gray sans-serif font. The logo is simple and modern, with a focus on the company name.

H. Conclusions

The subject NuVasive Reline 4.5-5.0 System has been shown to be substantially equivalent to legally marketed predicate devices for its intended use.

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.