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TruDi® Shaver Blades are intended for use with the Bien-Air S120 Shaver Handpiece and the TruDi® Navigation System to aid in the incision and removal of soft and hard tissue or bone in ENT, Maxillofacial surgery, Head and Neck and ENT skull base surgery. Their use is indicated for any medical condition in which the use of navigated surgery may be appropriate, and where reference to a rigid anatomical structure can be identified relative to a CT or MR based model.

TruDi® Shaver Blades may be used in, but is not limited to, the following procedures:

• · Endoscopic sinus surgery (such as ethmoidectomy, polypectomy, septoplasty)
• · Drainage of mucoceles or abscesses that have extended from the paranasal sinuses and up to the dura mater
• · Orbital decompression
• · Any other of a number of tumors involving the lateral nasal wall, paranasal sinuses and orbit
• · Access to the sphenoid sinus

The subject device, TruDi® Shaver Blade, is a single-use and sterile electromagnetically (EM) navigated instrument, which is intended to be used with the Bien-Air S120 Shaver Handpiece (reference device, K083720) and the TruDi® Navigation System (K192397) to aid in the incision and removal of soft and hard tissue or bone in ENT, Maxillofacial surgery, Head and Neck and ENT skull base surgery. The device is tracked by the navigation system within the low energy magnetic field volume generated by the TruDi® Navigation System. The TruDi® Navigation System software displays the position of the shaver blade distal tip on preoperative scans (e.g. CT, MRI). The TruDi® Shaver Blade consists of several configurations ranging from straight to curved blades of different diameters.

The TruDi® Shaver Blade underwent various performance tests to demonstrate its substantial equivalence to its predicate device. This device is an electromagnetically (EM) navigated instrument intended for use with the Bien-Air S120 Shaver Handpiece and the TruDi® Navigation System to aid in incision and removal of soft and hard tissue or bone in various ENT and maxillofacial surgeries.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test set sample size: Not explicitly stated for each bench test, but the design validation testing involved "cadavars." The number of cadavers used is not specified.
• Data provenance: The testing was non-clinical (bench testing and simulated use on cadavers). The country of origin for the data is not specified, but the submission is for the US FDA, implying testing was conducted to meet US regulatory requirements. The testing is considered prospective as it was conducted to demonstrate the performance of the specified device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• The document mentions "evaluators" for assessing packaging, labeling, and instructions for use during the simulated use study. However, the number and qualifications of these evaluators or other experts establishing ground truth for the bench tests or cadaver study are not specified.

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

• No specific adjudication method is mentioned for the test set. The data appears to be derived from direct measurements and objective assessments against predefined technical specifications.

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 comparative effectiveness study was mentioned. This device is a surgical instrument with navigation capabilities, not an AI-assisted diagnostic device typically evaluated with MRMC studies.

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

• A "standalone" performance for the navigation accuracy component was assessed as part of the system accuracy requirement, stating "The accuracy of TruDi® Shaver Blade used in conjunction with the navigation views of the TruDi® Navigation System is < 2mm RMS over the entire navigation volume." This refers to the accuracy of the system's tracking and display. However, the overall device performance in terms of surgical outcome inherently involves human-in-the-loop (the surgeon). The simulated use on cadavers assesses both the device's technical function and its usability for a surgeon.

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

• For bench testing, the ground truth was based on engineering specifications and established test standards (e.g., dimensional tolerances, electrical safety standards, sterilization standards, biocompatibility standards).
• For navigational accuracy, the ground truth would be established by precision measurement systems (e.g., optical tracking systems) used to verify the reported position of the instrument within the navigation volume.
• For the simulated use on cadavers, the "ground truth" for functional performance would be assessed against the intended surgical actions and design specifications for incision and removal of tissue/bone, likely through expert observation and potentially post-procedure assessment of the cadaver.

8. The sample size for the training set:

• The document does not provide information about a separate "training set" as it would for a machine learning or AI-based device. The development and validation of medical devices typically involve design verification and validation testing, which are distinct from the training/test set paradigm of AI.

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

• Not applicable, as no external "training set" in the context of machine learning was described. The device's design and engineering would be based on established medical and engineering principles rather than learn from a labeled dataset.

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