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 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 DBR II 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

The provided text describes a 510(k) premarket notification for a medical device called the NuVasive SpheRx DBR II System. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and reported device performance.

Therefore, many of the requested details about acceptance criteria, performance metrics, and study methodologies for proving device performance are not present in this type of regulatory submission. This document primarily focuses on equivalence to an already approved device.

Here's an analysis of the available information:

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

This information is not provided in the document. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, not on directly reporting performance against specific acceptance criteria for a new clinical or diagnostic capability. The mechanical testing mentioned (Section G) would have its own acceptance criteria, but these are not detailed in this summary.

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

This information is not applicable or not provided. Since no clinical performance study for an AI/diagnostic device is described, there's no "test set" in that context. The document mentions "Mechanical testing was presented" (Section G), but details about the samples used for these tests (e.g., number of implant components, types of forces applied) are not explicitly given in this summary, nor is the provenance.

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)

This information is not applicable or not provided. There is no "test set" requiring expert ground truth in the context of an AI/diagnostic device performance study described here.

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

This information is not applicable or not provided. There is no "test set" requiring adjudication in the context of an AI/diagnostic device performance study described here.

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

This information is not applicable or not provided. The device described is a spinal pedicle screw system, not an AI-assisted diagnostic tool.

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

This information is not applicable or not provided. The device is a physical implant, not a standalone algorithm.

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

This information is not applicable or not provided. As above, there is no "ground truth" establishment in the context of an AI/diagnostic device performance study described here.

8. The sample size for the training set

This information is not applicable or not provided. The device is a physical implant, not an AI model, so there's no "training set."

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

This information is not applicable or not provided. As above, there is no "training set" or "ground truth" establishment in this context.

Summary of the Device and Study (as presented in the document):

The NuVasive SpheRx DBR II System is a spinal pedicle screw system. The submission is a 510(k) premarket notification affirming its substantial equivalence to the predicate device, the SpheRx II System.

Acceptance Criteria for 510(k) Substantial Equivalence: The primary "acceptance criterion" for this type of submission is demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is achieved by showing that it has the same intended use, similar technological characteristics, and that any differences in technological characteristics do not raise new questions of safety or effectiveness.
Study Proving Acceptance Criteria: The study for this 510(k) submission was a comparison to a predicate device supported by non-clinical mechanical testing.
- Comparison to Predicate: The document states, "The subject SpheRx DBR II System is substantially equivalent to the SpheRx II System currently distributed commercially in the U.S. by NuVasive." It further notes, "The subject device has indications for use identical to those of its predicate, and employs the same principles of operation."
- Mechanical Testing: Section G states: "Summary of Non-Clinical Tests: Mechanical testing was presented." The specific results or methodologies of this testing are not detailed in this summary, but would have been included in the complete 510(k) submission to demonstrate that the new device's mechanical properties are suitable for its intended use and comparable to the predicate.
- Clinical Tests: Section H explicitly states: "Summary of Clinical Tests (Not Applicable)." This confirms that no clinical studies were performed to prove the device's performance because substantial equivalence was demonstrated through comparison to a predicate and non-clinical testing.

Summary

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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:

A. Submitted by:

Han Fan Regulatory Affairs Associate NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-1868 Fax: (858) 909-2068

NOV 1 3 2008

B. Device Name

Trade or Proprietary Name:	NuVasive SpheRx DBR II 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:	§888.3070, §888.3050, §888.3060
Product Code:	NKB, KWP, MNI, MNH, KWQ

C. Predicate Devices

The subject SpheRx DBR II 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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ONUVASIVE

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
1. Scoliosis
1. Kyphosis
1. Spinal tumor and/or
1. Failed previous fusion (pseudoarthrosis)

The Nu Vasive 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 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 spinc. 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. 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).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 3 2008

Re: K083028

Nuvasive, Inc. % Mr. Han Fan

Regulatory Affairs Associate

San Diego, California 92121

7475 Lusk Boulevard

Trade/Device Name: SphcRx® DBR II System Regulation Number: 21 CFR 888.3070 Regulation Names: Pedicle screw spinal system. Regulatory Class: III Product Code: NKB, KWQ, KWP, MNI, MWH Dated: October 07, 2008 Received: October 14, 2008

Dear Mr. Fan:

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 usc 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 classificd (see above) into cither 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 – Mr. Han Fan

This letter will allow you to begin marketing your device as described in your Scction 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits 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 reference 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 N Milliken

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

510(k) Number (if known): K083028

Device Name: SpheRx® DBR II System

Indications For 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)
Degenerative spondylolisthesis with objective evidence of neurologic impairment 2
1. Fracture
1. Dislocation
1. Scoliosis
1. Kyphosis
1. Spinal tumor and/or
Failed previous fusion (pseudoarthrosis) ರು.

The NuVasive SpheRx Spinal System is also indicated for the treatment of severe spondy/olisthesis (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:

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
အ Spondylolisthesis
1. Spinal deformities
1. Fracture
1. Pseudoarthosis
Tumor resection and/or 7.
Failed previous fusion 8.

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 ation (ODE)

Page 1 of 1

n of General. Restorative, and Neurological Devices

510(k) Number K093028

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.