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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.

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:

1. 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,
2. Software provided on a Bendini System control unit, converts the implant locations to a series of bend instructions, and
3. Mechanical Rod Bender tool used by the surgeon to execute the bend instructions.

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

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.

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