The NuVasive Sage Lateral Plate System is indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery.

Device Description

The NuVasive Sage Lateral Plate System is an anterior/anterolateral plate system that may be used in the thoracic, lumbar, and sacral spine (T1-S1). The Sage Lateral Plate System includes plates, screws, and spikes manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 or ISO 5832-3, as well as associated manual general surgical instruments. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.

AI/ML Overview

The NuVasive Sage Lateral Plate System is a medical device. The provided text describes the 510(k) summary for this device, which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific clinical acceptance criteria or through a standalone clinical study.

Here's an analysis based on your request, highlighting what information is and is not available in the provided text:

Based on the provided 510(k) summary, the device is a spinal implant system and the "study" conducted is a nonclinical performance testing to demonstrate substantial equivalence to predicate devices. There is no information about a clinical study with human subjects, acceptance criteria related to a specific performance metric (like accuracy, sensitivity, specificity, etc.), or expert ground truthing as would be typical for an AI/algorithm-based device.

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

Acceptance Criteria (Nonclinical)	Reported Device Performance
Substantial equivalence to predicate devices based on nonclinical testing.	The Sage Lateral Plate System was shown to be substantially equivalent to its predicate devices through comparison of design, intended use, material composition, and function.
Static and dynamic compression testing per ASTM F1717 meets predicate performance.	Results "demonstrate that the subject Sage Lateral Plate System presents no new worst-case for performance testing" compared to the predicate device, implying it met or exceeded the performance of the predicate in these tests.
Static torsion testing per ASTM F1717 meets predicate performance.	Results "demonstrate that the subject Sage Lateral Plate System presents no new worst-case for performance testing" compared to the predicate device, implying it met or exceeded the performance of the predicate in these tests.

Note: The acceptance criteria here are focused on mechanical performance and equivalence, not clinical performance metrics for an AI/software device.

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

Sample Size: Not applicable in the context of a "test set" for an AI/algorithm. The "testing" refers to mechanical and material tests of the physical implants. The number of samples/units tested is not specified, but it would involve a certain number of implant components (plates, screws, spikes) to conduct the ASTM F1717 tests.
Data Provenance: Not applicable. The "data" comes from engineering and material testing in a lab setting, not from patient data or clinical studies.

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 is not applicable as the ground truth here is based on engineering and material standards (ASTM F1717) and mechanical testing results, not expert interpretation of clinical data.

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

This is not applicable as there is no human interpretation or adjudication involved in establishing ground truth for mechanical testing.

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 AI/software devices that aid in interpretation or diagnosis, which is not the function of a spinal implant system.

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

No, a standalone study was not done. The device is a physical implant, not an algorithm.

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

The "ground truth" for this device, in the context of a 510(k) submission for a physical implant, is based on established engineering standards and mechanical test results (e.g., strength, durability, fatigue resistance as defined by ASTM F1717). The comparison is against predicate devices that have already been cleared, implying their safety and effectiveness have been established through a similar process or prior clinical use.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

Not applicable. There is no "training set" for this physical implant device.

In summary: The provided document is a 510(k) summary for a physical medical implant (spinal plate system). It demonstrates substantial equivalence to predicate devices through nonclinical mechanical testing. The concepts of "acceptance criteria," "test set," "ground truth," "experts," "adjudication," and "training set" as you typically define them for AI/software devices are not relevant or described in this context. The study outlined is a set of engineering performance tests to ensure the new device is as safe and effective as similar, already-approved devices.

Summary

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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.

Sheila Bruschi Associate Manager, Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 320-4515 Fax: (858) 320-4615

Date Prepared: August 24, 2012

B. Device Name

Trade or Proprietary Name:	Sage® Lateral Plate System
Common or Usual Name:	Spinal Implants
Classification Name:	Spinal Intervertebral Body Fixation orthosis

Device Class:	Class II
Classification:	21 CFR § 888.3060
Product Code:	KWQ

C. Predicate Devices

The subject Sage Lateral Plate System is substantially equivalent to the following predicate devices: NuVasive® Lateral Plate System (K061789), NuVasive Anterior Lumbar Plate (K072339) and Synthes Antegra-T System (K081568).

D. Device Description

Page 1 of 2

OCT 2 3 2012

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K121815

NUVASIVE
Speed of Innovation

K121815/S01 -- NuVasive® Sage® Lateral Plate System August 24, 2012

E. Intended Use

The NuVasive Sage Lateral Plate System is indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (LJ-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery.

F. Technological Characteristics

As was established in this submission, the subject Sage Lateral Plate 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, and function.

G. Performance Data

Nonclinical testing was performed to demonstrate that the subject Sage Lateral Plate 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 demonstrate that the subject Sage Lateral Plate System presents no new worstcase for performance testing, and the subject device was therefore found to be substantially equivalent to the predicate.

H. Conclusions

Based on the indications for use, technological characteristics, and comparison to predicate devices, the subject Sage Lateral Plate 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 logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the eagle. The eagle is depicted in black and white, and the text is also in black.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

NuVasive, Incorporated % Ms. Sheila Bruschi Associate Manager, Regulatory Affairs 7475 Lusk Boulevard San Diego, California 92121

OCT
23 2012

Re: K121815

Trade/Device Name: NuVasive® Sage® Lateral Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: October 16, 2012 Received: October 17, 2012

Dear Ms. Bruschi:

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 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

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Page 2 - Ms. Sheila Bruschi

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Daniel Keane

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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121815

Indications for Use

510(k) Number (if known): K121815

Device Name:

Indications For Use:

The NuVasive Sage Lateral Plate System is indicated for use via a lateral or anterolateral surgical above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, deqenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, spinal stenosis, or a failed previous spine surgery.

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)

Calisti

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

510(k) Number k/2/8/5

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.