When used as a pedicle screw fixation system, the NuVasive SpheRx MAS Deformity Spinal 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:

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 NuVasive SpheRx MAS Deformity Spinal 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 SpheRx Spinal 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

Device Description

The NuVasive SpheRx II-Pedicle Screw System consists of a variety of polyaxial screws, reduction screws, offset connectors, rods, locking nuts, and transverse connectors. Implant components can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient. This 510(k) is for the additional sizes of screw shanks, tulips, lock screws, load rings, and split rings that have been added to the SpheRx II-Pedicle Screw System platform and are designated as SpheRx II - MAS Deformity Spinal System.

AI/ML Overview

This document describes a 510(k) premarket notification for the NuVasive SpheRx II - MAS Deformity Spinal System, an orthopedic implant. The information provided focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving enhanced clinical performance or an AI-driven analysis. Therefore, many of the typical acceptance criteria and study details for AI/software as a medical device are not applicable here.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For this particular device submission (a 510(k) for an orthopedic implant), the "acceptance criteria" are related to demonstrating substantial equivalence in terms of mechanical performance and technological characteristics to an already marketed predicate device.

Acceptance Criteria (Performance)	Reported Device Performance (as stated in the document)
Biomechanical Performance:
Static Compression Strength (per ASTM F1717)	"meets or exceeds the performance of the predicate device"
Dynamic Compression Strength (per ASTM F1717)	"meets or exceeds the performance of the predicate device"
Static Torsion Strength (per ASTM F1717)	"meets or exceeds the performance of the predicate device"
Technological Characteristics:
Design, Intended Use, Material Composition, Function, Range of Sizes	"substantially equivalent and have the same technological characteristics to its predicate devices"

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

The document does not specify a "test set" in the context of clinical data or AI model evaluation. The performance data is derived from non-clinical mechanical testing.

Sample size for mechanical testing: Not explicitly stated in the document. ASTM F1717 standards would typically define the minimum number of samples for such tests.
Data provenance: Not applicable in the context of country of origin for clinical data or retrospective/prospective study design, as this refers to bench testing.

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

This information is not applicable as the "test set" refers to mechanical testing, not a dataset requiring expert annotation for ground truth.

4. Adjudication method for the test set

This information is not applicable as the "test set" refers to mechanical testing, not data requiring expert adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not the focus of this 510(k) submission for an orthopedic implant.

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

No, a standalone algorithm performance study was not done. This submission is for a physical medical device (spinal system), not a software algorithm.

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

The "ground truth" for this device's performance is established by validated mechanical testing standards (ASTM F1717), not expert consensus, pathology, or outcomes data. The "ground truth" essentially reflects the physical properties and performance characteristics defined by these standards.

8. The sample size for the training set

This information is not applicable. This document describes a physical medical device, not an AI/ML algorithm that requires a training set.

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

This information is not applicable. As above, there is no AI/ML training set mentioned in this document.

Summary

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NUVASIVE
Creative Spine Technology"

K102-514- Page I of 2 510(k) Premarket Notification SpheRx® II - MAS Deformity Spinal System

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:

A. Submitted by:

Elias Ketchum Regulatory Affairs Associate NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 320-4588 Fax: (858) 320-4688

DEC 1-2010

Date Prepared: August 17, 2010

B. Device Name

Trade or Proprietary Name: NuVasive® SpheRx II – MAS Deformity Spinal System Common or Usual Name: Pedicle Screw System Classification Name: Pedicle Screw Spinal System, Spinal Interlaminal Fixation Orthosis, Spinal Intervertebral Body Fixation orthosis Device Class: Class III $888.3050, $888.3060, $888.3070 Classification: Product Code: NKB, KWP, MNI, MNH, KWQ

C. Predicate Devices

The subject SpheRx II - MAS Deformity Spinal System is substantially equivalent to the SpheRx II-Pedicle Screw System (K091502) currently distributed commercially in the U.S. by NuVasive.

D. Device Description

E. Intended Use

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
1. Fracture
1. Dislocation

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Image /page/1/Picture/0 description: The image shows the Nuvasive logo. The logo consists of a stylized "N" with a dot above it, followed by the word "NUVASIVE" in all caps. Below the word "NUVASIVE" is the tagline "Creative Spine Technology" in a smaller font.

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

F. Technological Characteristics

As was established in this submission, the subject SpheRx II - MAS Deformity Spinal 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 the same technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, function, and range of sizes.

G. Performance Data

Nonclinical testing was performed to demonstrate that the subject SpheRx II - MAS Deformity Spinal System is substantially equivalent to other predicate devices. The following testing was performed:

. Static and dynamic compression testing per ASTM F1717
Static torsion testing per ASTM F1717 ●

The results of these studies showed that the subject SpheRx II - MAS Deformity Spinal System meets or exceeds the performance of the predicate device, and the device was therefore found to be substantially equivalent.

H. Conclusions

Based on the indications for use, technological characteristics, performance testing, and comparison to predicate devices, the subject SpheRx II-Pedicle Screw System has been shown to be substantially equivalent to legally marketed predicate devices, and safe and effective for its intended use.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

NuVasive Inc. % Mr. Elias Ketchum Associate, Regulatory Affairs 7475 Lusk Boulevard San Diego, California 92121

Re: K102514

Trade/Device Name: NuVasive® SpheRx® II MAS Deformity Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH, KWP, KWQ Dated: October 29, 2010 Received: November 01, 2010

Dear Mr. Ketchum:

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. 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

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Page 2 -- Mr. Elias Ketchum

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 (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,
Mark A. Milken

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

DEC 1 2010

510(k) Number (if known): K102514

Device Name:

Indications For Use:

When used as a pedicle screw fixation system, the NuVasive SpheRx MAS Deformity Spinal System is intended to provide immobilization 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
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 SpheRx MAS Deformity Spinal 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
Spondylolisthesis ကဲ
Spinal deformities ধ
1. Fracture
1. Pseudoarthosis
1. Tumor resection and/or
1. Failed previous fusion

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

KID 251 4 510(k) Number_

Page 1 of 1

Regulation Number and Section

N/A