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 instruments (manufactured from stainless steel and polycarbonate) and software 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 shape a rod for use in spinal surgery applications.

The Bendini System consists of three main components:

IR Stylus composed of a sterile handle with integrated IR markers, and non-sterile shaft options (solid or offset), that helps obtain the location of the implants,
Software provided on a Bendini System control unit, converts the implant locations to a series of bend instructions, and
Mechanical Rod Bender tool used by the surgeon to execute the bend instructions.

AI/ML Overview

The provided text describes the 510(k) Premarket Notification for the NuVasive® Bendini® Spinal Rod Bending System. It outlines the device, its intended use, and substantial equivalence to a predicate device, which usually implies that the new device meets the same performance criteria as the predicate. However, detailed acceptance criteria and the specific results of a study proving the device meets those criteria, as you've requested, are not explicitly described in this summary.

The document 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, and verification of software algorithms using anatomical models."

And concludes:
"The results of the studies performed show 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 a study was performed, but the specific acceptance criteria (e.g., "accuracy of X +/- Y mm") and the exact numerical performance results are not detailed in this 510(k) summary. The summary focuses on demonstrating substantial equivalence rather than presenting detailed performance data against explicit acceptance criteria in a quantitative format.

Therefore, I cannot populate all the sections of your request with information directly from the provided text. I will indicate where information is not available.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Not Explicitly Stated for this Device)	Reported Device Performance (Implied from Substantial Equivalence)
Software performance per predetermined specifications outlined in the SRS	Met (results showed substantial equivalence)
GUI functionality	Met (results showed substantial equivalence)
Error handling	Met (results showed substantial equivalence)
System accuracy during data acquisition	Met (results showed substantial equivalence; performed as well as predicate)
Verification of instrument performance in combination with the software	Met (results showed substantial equivalence)
Verification of software algorithms using anatomical models	Met (results showed substantial equivalence)
Specific quantitative metrics for accuracy, precision, or other performance characteristics were not provided in this summary.	Performed equivalently to the predicate device K111811 and K033621.

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

Sample Size for Test Set: Not specified in the document. The testing involved "anatomical models" but the number or details of these models are not provided.
Data Provenance: Not explicitly stated, but typically nonclinical testing in such submissions is conducted internally by the manufacturer (NuVasive, Inc. in San Diego, California) or a contract research organization. The data is retrospective in the sense that it's gathered from completed tests, but not "retrospective patient data" as it was nonclinical testing.

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

This information is not provided. Given that the testing involved "verification of software algorithms using anatomical models" and "system accuracy during data acquisition," ground truth likely would have been established through controlled physical measurements (e.g., using metrology equipment or highly precise fiducial markers on the anatomical models). Expert opinion on "ground truth" is less common in this type of mechanical/software system accuracy testing compared to, for example, image-based diagnostic AI.

4. Adjudication Method for the Test Set

Not applicable as the ground truth establishment method typically involves direct measurement against known values or engineering specifications, rather than expert adjudication in this context.

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

No, an MRMC comparative effectiveness study was not explicitly mentioned or performed. The document describes nonclinical testing for device performance and substantial equivalence, not a study assessing human reader improvement with or without AI assistance. The device is a tool to assist surgeons in rod bending, not an AI for interpretation or diagnosis.

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

Yes, implicitly, standalone performance was assessed. The "nonclinical testing" and "verification of software algorithms" and "system accuracy during data acquisition" using anatomical models would constitute standalone algorithmic performance assessment. The device generates bend instructions, and the accuracy of these instructions and the system's ability to locate implants were tested. While a surgeon uses the instructions, the core accuracy of the system in determining relative locations and generating instructions is a standalone function.

7. The Type of Ground Truth Used

Ground Truth Type: Likely established through highly precise physical measurements on "anatomical models" or test fixtures, using known geometric parameters or fiducial markers. This would be analogous to engineering specifications or a gold standard measurement technique rather than pathology or patient outcomes data.

8. The Sample Size for the Training Set

Training Set Sample Size: Not specified. This 510(k) summary focuses on device verification and validation for substantial equivalence, not on the development or training of AI models. While "proprietary set of algorithms" are mentioned, details about their training or any data used for internal algorithm development are not typically included in these summaries.

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

Ground Truth for Training Set Establishment: Not specified. As with question 8, details about the development and training of the algorithms, including how their ground truth was established, are not provided in this regulatory summary.

Summary

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DEC 0 7 2012

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Special 510(k) Premarket Notification Bendini® Spinal Rod Bending System

510(k) Summary

K122742

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) 909-1800 Fax: (858) 320-4615 Date Prepared: November 6, 2012

B. Device Name

Trade or Proprietary Name: Common or Usual Name: Classification Name: Device Class: Classification: Product Code:

NuVasive® Bendini® Spinal Rod Bending System Stereotaxic Instrument Instrument, Stereotaxic Class II 8882.4560 -OLO

C. Predicate Devices

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

· K111811 Bendini Spinal Rod Bending System
· K033621 Northern Digital Inc. (NDI) Passive Spheres

D. Device Description

The Bendini System consists of three main components:

I } IR Stylus composed of a sterile handle with integrated IR markers, and non-sterile shaft options (solid or offset), that helps obtain the location of the implants,
1. Software provided on a Bendini System control unit, converts the implant locations to a series of bend instructions, and
1. Mechanical Rod Bender tool used by the surgeon to execute the bend instructions.

E. Intended Use

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rod using the Bendini Bender, a mechanical rod bender.

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.

The Bendini Spinal Rod Bending System shares the following components with the predicate device: a computer with touch screen display, a six (6) DOF optical localizer system, and localized pointers or stylus 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.

The main technological differences between the subject Bendini Spinal Rod Bending System and the predicate device, K111811, are the following:

. Bendini IR Stylus Handle - modification to incorporate integrated reflective IR markers in a preassembled, sterile, single-use configuration for ease of use. The IR markers used in the predicate Bendini Stylus referenced in 510(k) K111811 were off-the-shelf components.
Bendini IR Stylus Shaft modification to a detachable design that attaches to the IR . Stylus Handle, and can extend by 2mm increments to add an offset distance to a desired acquisition point.

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, and verification of software algorithms using anatomical models.

The results of the studies performed show 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.

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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 the legally marketed predicate devices.

. . .

・.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

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

December 7, 2012

Re: K122742

Trade/Device Name: NuVasive® Bendini® Spinal Rod Bending System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: November 06, 2012 Received: November 07, 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Peter D. Rumm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: _ NuVasive Bendini Spinal Rod Bending System

Indications For Use:

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 instrumentation (Screws, no spinal rod. A surgeon is able to use those genciate bond "motract a rod using the Bendini Bender, a mechanical rod bender.

Over-The-Counter Use AND/OR Prescription Use × (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dwight Yen 2012.12.05 10:12:57 -05'00'

(Division Sign-off) Division of Surgical 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).