The Bendini™ Spinal Rod Bending System is used to locate spinal implant system instrumentation (screws, hooks) to determine their relative location to one another to generate bend instructions to shape a spinal rod. A surgeon is able to use those instructions and bend a rod using the Bendini Bender, a mechanical rod bender,

Device Description

The NuVasive Bendini Spinal Rod Bending System consists of components that are used to locate spinal implant system instrumentation (screws, hooks), determine their relative location to one another, and generate bend instructions that are used along with the Bendini bender to accurately shape a rod for use in spinal surgery applications.

The Bendini Spinal Rod Bending System shares the following components with the predicate device: a computer with touch screen display, a 6DOF optical and electromagnetic localizer system, and localized pointers or styluses used to digitize intraoperative anatomical landmarks. Both the Bendini Spinal Rod Bending System and the predicate device intraoperatively digitize the relative location of anatomical landmarks with a localized pointer or stylus in order to acquire data that is then interpreted by a proprietary set of algorithms.

AI/ML Overview

The provided text describes the NuVasive Bendini™ Spinal Rod Bending System and its 510(k) submission. However, it does not contain a detailed study with specific acceptance criteria and reported device performance metrics in a tabular format. The document focuses on demonstrating substantial equivalence to a predicate device rather than providing quantitative performance data against predefined criteria.

Based on the available information, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the document. The text states:

"Nonclinical testing was performed to demonstrate that the Bendini Spinal Rod Bending System is substantially equivalent to a predicate device. This testing performed was determined to be necessary in establishing substantial equivalence and included evaluation of software performance per predetermined specifications outlined in the SRS, GUI functionality, error handling, system accuracy during data acquisition, verification of instrument performance in combination with the software, verification of software algorithms, and cadaver testing to demonstrate performance under anticipated clinical settings."

And:

"The results of the studies performed demonstrate that the subject Bendini Spinal Rod Bending System meets the performance of the predicate device, and the subject device was therefore found to be substantially equivalent."

This indicates that acceptance criteria were established ("predetermined specifications outlined in the SRS") and performance was demonstrated to meet those criteria and be equivalent to the predicate. However, the specific metrics and their numerical outcomes are not presented.

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "cadaver testing to demonstrate performance under anticipated clinical settings." This implies a test set using cadavers. However, the sample size for this test set is not specified. The data provenance would be cadaveric data, likely prospective in the context of this study. The country of origin is not specified but given NuVasive is in San Diego, California, it's likely US-based.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided. The document does not detail how "ground truth" was established for the cadaver testing.

4. Adjudication Method for the Test Set

This information is not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not mentioned or implied. The device is a tool to generate bend instructions for a surgeon to use with a mechanical rod bender, not an AI diagnostic or interpretive tool for human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device is described as generating "bend instructions that are used along with the Bendini bender to accurately shape a rod for use in spinal surgery applications" and "A surgeon is able to use those instructions and bend a rod using the Bendini Bender, a mechanical rod bender." This indicates that the algorithm generates instructions which are then used by a human (surgeon) with a mechanical device. Therefore, it is not a purely standalone algorithm a human is always in the loop, acting on the algorithm's output. The performance of the system as described appears to involve the algorithm providing instructions to a human operator.

7. The Type of Ground Truth Used

For the "cadaver testing," the ground truth would likely be physical measurements of the bent rods compared to the intended or prescribed bend instructions generated by the system, and potentially the accuracy of locating spinal implant system instrumentation within the cadaver. It would be an objective physical measurement rather than expert consensus or pathology in the conventional sense for a diagnostic device.

8. The Sample Size for the Training Set

This information is not provided. The document refers to "proprietary set of algorithms" and "verification of software algorithms," but does not detail their development or any training sets used.

9. How the Ground Truth for the Training Set Was Established

This information is not provided. Given the nature of the device (generating bending instructions based on relative location of hardware), the "ground truth" for any training of its algorithms would likely involve highly accurate spatial measurements of instrumentation and desired rod shapes, potentially from engineering specifications, cadaveric data, or simulated environments.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for Nuvasive. The logo consists of a stylized, abstract shape on the left, resembling a curved or partial circle with a small extension at the bottom. To the right of the shape is the word "NUVASIVE" in bold, sans-serif font. Below "NUVASIVE" is the tagline "Speed of Innovation" in a smaller font size.

510(k) Premarket Notification Bendini™ Spinal Rod Bending 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

Date Prepared: August 26, 2011

B. Device Name

Trade or Proprietary Name: NuVasive® Bendin™ Spinal Rod Bending System ' Common or Usual Name: Stereotaxic Instrument

Classification Name: Device Class: Classification: Product Code:

Instrument, Stereotaxic Class II 8882.4560 OLO

C. Predicate Devices

The subject Bendini Spinal Rod Bending System is substantially equivalent to the following device:

· K050438 - StealthStation® System, Medtronic, Inc.

D. Device Description

E. Intended Use

F. Technological Characteristics

As was established in this submission, the subject Bendini Spinal Rod Bending System is substantially equivalent to a predicate device cleared by the FDA for commercial distribution in the United States.

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Image /page/1/Picture/1 description: The image shows the logo for Nuvasive. The logo consists of a stylized black and white graphic to the left of the company name. Below the company name is the tagline "Speed of Innovation".

The main technological differences between the Bendini Spinal Rod Bending System and the predicate device is that the Bendini Spinal Rod Bending System does not integrate or overlay acquired data into patient data contained in radiographic images nor is it used to generate surgical intervention plans/approaches based on traiectories and/or other identified anatomical structures observed in radiographic images. Any differences in technology do not raise questions or issues regarding safety and effectiveness of the Bendini Spinal Rod Bending System.

Based on the comparison above, the subject device was shown to be substantially equivalent and have the same technological characteristics to its predicate device in areas including design, intended use, material composition, and function.

G. Performance Data

Nonclinical testing was performed to demonstrate that the Bendini Spinal Rod Bending System is substantially equivalent to a predicate device. This testing performed was determined to be necessary in establishing substantial equivalence and included evaluation of software performance per predetermined specifications outlined in the SRS, GUI functionality, error handling, system accuracy during data acquisition, verification of instrument performance in combination with the software, verification of software algorithms, and cadaver testing to demonstrate performance under anticipated clinical settings.

The results of the studies performed demonstrate that the subject Bendini Spinal Rod Bending System meets the performance of the predicate device, and the subject device was therefore found to be substantially equivalent.

H. Conclusions

Based on the indications for use, technological characteristics, performance testing, and comparison to a predicate device, the subject Bendini Spinal Rod Bending System has been shown to be substantially equivalent to a legally marketed predicate device.

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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 depiction of an abstract caduceus, which is a symbol often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

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

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

DEC - 5 2011

Re: K111811

Trade/Device Name: Nu Vasive® Bendini™ Spinal Rod Bending System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: November 11, 2011 Received: November 14, 2011

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

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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.ida.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/ReportalProblem/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 vours.

Sincerely yours,

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

KII/811 510(k) Number (if known):

Device Name: NuVasive® Bendini™ Spinal Rod Bending System

Indications For Use:

Prescription Use AND/OR Over-The-Counter Use X (Part 21 CFR 801 Subpart D) (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)

Nil R^Dolen for mxm

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

510(k) Number

Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).