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The surgical instruments are specifically designed for use with the Pulse System, which enables computer-assisted navigation for spinal surgical procedures in which the use of stereotactic surgery may be appropriate.

When used with a Pulse Navigation system, the patient reference hardware is intended to provide a reference to a rigid anatomical structure that can be identified relative to the acquired image of the anatomy.

The subject NuVasive Rod Registration Frame is introducing modifications based on the design of existing patient reference hardware, the Spinous Process Clamp (Pulse System K210574). The Rod Registration Frame was designed to offer surgeons more flexibility during the registration process of Pulse Navigation by providing an additional patient reference hardware design option for attaching the existing Patient Reference Array to the patient. Despite the changes introduced to predicate Spinous Process Clamp (K210574), the subject device Rod Registration Frame is substantially equivalent to the predicate as demonstrated by verification and validation testing performed using well established and previously cleared test methods.

The NuVasive Rod Registration Frame is a surgical instrument designed for use with the Pulse System, enabling computer-assisted navigation for spinal surgical procedures. The device provides a reference to a rigid anatomical structure that can be identified relative to an acquired image of the anatomy when used with a Pulse Navigation system. The device is a modification of an existing patient reference hardware (Spinous Process Clamp, K210574), with updated distal and proximal connection features and removal of radiographic markers (as it is used only for non-fiducial registration).

Here's an analysis of the acceptance criteria and the study proving the device meets these criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document describes non-clinical testing to demonstrate substantial equivalence, rather than a direct table of specific numerical acceptance criteria and performance for a new, independent claim of efficacy. The core acceptance criterion is that the Rod Registration Frame performs equivalently to its predicate device (Spinous Process Clamp K210574).

2. Sample size used for the test set and the data provenance:

• The document states that "non-clinical testing was performed." However, it does not specify the sample size for the test sets used in System Level Accuracy Testing, Cadaver Verification, Design Validation, Tolerance Analysis, or Usability Validation.
• The data provenance (e.g., country of origin, retrospective or prospective) is not explicitly stated in this summary. Given that it's non-clinical testing for a U.S. FDA submission, it's highly probable the testing was conducted in a controlled lab environment and likely within the U.S. or by a recognized testing facility.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not provided in the summary. For non-clinical performance testing of a medical device, ground truth is typically established through engineering measurements, biomechanical modeling, and cadaveric studies where anatomical landmarks might serve as a reference. The "design validation" and "cadaver verification" sections imply that expert evaluation (e.g., of surgical applicability) would have been involved, but details on their number or qualifications are not given.

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

• This information is not provided as the testing described is non-clinical performance and validation testing, not a clinical study involving human reader assessments requiring adjudication.

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 MRMC study was done. The device (Rod Registration Frame) is a physical surgical instrument used for navigation, not an AI or imaging diagnostic tool. Therefore, a study on human reader improvement with AI assistance is not applicable. The document explicitly states: "No clinical studies were conducted."

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

• This question is not applicable as the device is a physical surgical instrument, not an algorithm or AI system.

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

• For the performance data mentioned (System Level Accuracy, Design Validation, Tolerance Analysis), the ground truth would be based on engineering specifications, physical measurements, and established performance criteria for navigation devices.
• For Cadaver Verification, the ground truth would involve anatomical landmarks and verified instrument placement/registration accuracy against known anatomical points. This would likely involve precise measurement tools and potentially expert anatomical assessment.

8. The sample size for the training set:

• This question is not applicable as the device is a physical surgical instrument and does not involve a "training set" in the context of machine learning or AI algorithms.

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

• This question is not applicable for the same reason as point 8.

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