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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 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.

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.

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