When used as a pedicle screw fixation system, the NuVasive SpheRx 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® 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 two 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® PPS System consists of a variety of polyaxial screws, 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.

AI/ML Overview

This document is a 510(k) summary for the NuVasive SpheRx® PPS System, a pedicle screw system. It focuses on the regulatory submission rather than a detailed study proving performance against specific acceptance criteria. Therefore, most of the requested information regarding detailed study design, sample sizes, ground truth establishment, and expert involvement is not present.

However, based on the provided text, we can infer some information:

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

Acceptance Criteria (Inferred from regulatory submission)	Reported Device Performance
Substantial Equivalence to Predicate Device	Achieved Substantial Equivalence to the SpheRx® II System.
Compliance with mechanical testing standards	Mechanical testing was performed and presented. (Specifics not detailed)
Intended Use as a pedicle screw fixation system	Device is intended to provide immobilization and stabilization for specific spinal conditions (as listed in Section E).

Explanation: The document does not explicitly state acceptance criteria in a quantitative manner (e.g., specific thresholds for tensile strength or fatigue life). Instead, the primary "acceptance criterion" for this regulatory submission is demonstrating substantial equivalence to a previously approved predicate device. This is achieved by showing that the new device has "indications for use identical to those of its predicate, and employs the same principles of operation." Mechanical testing is mentioned as supporting this claim, implying that the device met relevant performance standards, but the specifics are not provided.

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

Sample Size: Not applicable/Not provided. This document describes a 510(k) submission, not a clinical study with a "test set" in the context of algorithm performance. The "testing" referred to is primarily mechanical testing for the physical device.
Data Provenance: Not applicable.

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

Not applicable. This is not an AI/algorithm-focused study requiring expert-established ground truth on a test set.

4. Adjudication method for the test set:

Not applicable.

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. This is not an AI/algorithm study.

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

Not applicable. This is a physical medical device (pedicle screw system), not an algorithm.

7. The type of ground truth used:

Mechanical Testing: For the mechanical aspects, the "ground truth" would be established by validated test methods and established engineering standards for orthopedic implants.
Substantial Equivalence: For the regulatory aspect, the "ground truth" is the performance and indications for use of the predicate device (SpheRx® II System), against which the new device is compared.
Clinical Efficacy (Indirect): While no clinical studies were performed for this specific submission (as stated in Section H, "Summary of Clinical Tests (Not Applicable)"), the claim of substantial equivalence implies that the predicate device's clinical efficacy and safety data are being leveraged. The "ground truth" for the predicate device would have been established through clinical trials and post-market surveillance.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI study that uses a "training set."

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

Not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for "Nuvasive". The logo is in black and white and features a stylized "N" followed by the word "NUVASIVE" in all caps. Below the word "NUVASIVE" is the tagline "Creative Spine Technology" in a smaller font.

VII. 510(k) Summary

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

Submitted by: A.

Laetitia Cousin Sr. Director of Regulatory and Clinical Affairs and Quality Assurance NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-1868 Fax: (858) 909-2068

B. Device Name

Trade or Proprietary Name:	NuVasive SpheRx® PPS System
Common or Usual Name:	Pedicle Screw System
Classification Name:	Spinal Pedicle Screw Spinal System, Spinal InterlaminalFixation Orthosis, Spinal Intervertebral Body Fixationorthosis.
Device Class:	Class III
Classification:	§888.3050, §888.3060, §888.3070
Product Code:	KWP, MNI, MNH, KWQ, NKB

C. Predicate Devices

The subject SpheRx® PPS System is substantially equivalent to the SpheRx® II System currently distributed commercially in the U.S. by NuVasive.

D. Device Description

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GNUVASIVE

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. Degencrative spondylolisthesis with objective evidence of neurologic impaironent
1. Fracture
Dislocation ধ:
Scoliosis 5.
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
Pseudoarthosis 6.
Tumor resection and/or 7.
1. Failed previous fusion

F. Comparison to Predicate Devices

The subject device has indications for use identical to those of its predicate, and employs the same principles of operation.

G. Summary of Non-Clinical Tests

Mechanical testing was presented.

H. Summary of Clinical Tests (Not Applicable).
2 62

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

OCT 1 0 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nuvasive, Inc. % Ms. Laetitia Cousin Senior Director of Regulatory and Clinical Affair Specialist and Quality Assurance 7475 Lusk Boulevard San Diego, California 92121

Re: K082332

Trade/Device Name: SpheRx® PPS System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: III Product Code: NKB, KWP, KWQ, MNH, MNI Dated: September 11, 2008 Received: September 12, 2008

Dear Ms. Cousin:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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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Page 2 – Ms. Laetitia Cousin

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to I o(gally marketed predicate device results in a classification for your device and thus, permitts your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by refirence to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark M. Wilkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

KO82332 510(k) Number (if known):

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc 1. confirmed by patient history and radiographic studies)
Degenerative spondylolisthesis with objective evidence of neurologic impairment 2.
റ്റ് Fracture
1. Dislocation
ട്. Scoliosis
1. Kyphosis
1. Spinal tumor and/or
Failed previous fusion (pseudoarthrosis) 8.

The NuVasive SpheRx 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 sacuri), 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 deg 1. eneration of the disc confirmed by patient history and radiographic studies)
1. Spinal stenosis
Spondylolisthesis ల్లో
1. Spinal deformities
1. Fracture
Pseudoarthosis 6.
1. Tumor resection and/or
Failed previous fusion 8.

Aush n. Millerson

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K082332

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)

Page 1 of 1

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.