Search Results

TruDi™ NAV Suction Instruments are intended for use with the TruDi™ Navigation System during surgical procedures in ENT medicine and skull base surgery to provide navigation of the instruments to the targeted anatomy, and evacuation of gases, liquids, and fragments.

TruDi™ NAV Suction Instruments are intended to be used by ENT surgeons or support staff.

TruDi™ NAV Suction Instruments (0°, 70°, 90°) are electromagnetically- navigated reusable devices intended to be used in conjunction with the TruDi™ Navigation System. When used with the TruDi™ Navigation System, the TruDi™ NAV Suction Instruments provide navigation of the devices to targeted anatomy and evacuate gases, liquids, and fragments. The TruDi™ Navigation System is the trade name for the ACCLARENT® ENT Navigation System cleared in K173628.

TruDi™ NAV Suction Instrument Set consists a 0° suction instrument, 70° suction instrument, 90° suction instrument, and a single-use sterile cable called the TruDi™ NAV Cable. The TruDi™ NAV Cable may be used to connect the suction instruments to the TruDi™ Navigation System.

The TruDi™ NAV Suction Instruments include an EM trackable single axis sensor, which is integrated at the distal tip of the device. The TruDi™ Navigation System acquires the position and orientation of the distal tip of the device and displays it in real-time view over the patient's pre-operative CT scan to confirm access of target anatomy. Following confirmation, the physician operates the surgical instrument at the target anatomical structure.

The provided text is a 510(k) Premarket Notification for the TruDi™ NAV Suction Instruments. It outlines the regulatory process, device description, comparison to predicate devices, and non-clinical performance data.

However, it does not contain information related to a study proving the device meets acceptance criteria regarding clinical performance or a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, or details about the training and test sets as typically found in submissions for AI/ML-based medical devices.

The document explicitly states: "Clinical data was not necessary for the TruDi™ NAV Suction Instruments." and "The performance data demonstrated that the device performs as intended." This indicates that substantial equivalence was primarily established through non-clinical testing and comparison to predicate devices, rather than a clinical trial involving human performance assessment with the device.

Therefore, many of the requested details, such as sample sizes for test and training sets, expert qualifications for ground truth, adjudication methods, MRMC study results, and specifics on AI algorithm ground truth establishment, are not present in the provided text because the device is a navigation suction instrument and not an AI/ML diagnostic tool.

I can, however, extract the acceptance criteria related to the device's physical and functional performance, along with the reported outcomes from the non-clinical tests.

Acceptance Criteria and Reported Device Performance (Non-Clinical)

Here's an analysis of the requested information based on the provided document, highlighting what is not applicable (N/A) given the nature of the device and the submission:

1. A table of acceptance criteria and the reported device performance: See table above.

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   • Test Set Sample Size: Not explicitly stated for specific non-clinical tests (e.g., number of instruments tested for accuracy, deflection, etc.). The mention of "simulated use testing with ENT surgeons and support staff" doesn't provide the number of participants or simulated cases.
   • Data Provenance: Not specified. As these are non-clinical tests, country of origin is less relevant than for clinical data. This was a premarket notification (510(k)) based on non-clinical performance and substantial equivalence.

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):

   • N/A. Ground truth in the context of AI/ML diagnostic devices (e.g., disease presence/absence) is not relevant here. For the "simulated use testing," the "experts" were "ENT surgeons and support staff," who were evaluating the device's functional and mechanical performance, not establishing a diagnostic ground truth. No specific number or qualifications beyond "ENT surgeons and support staff" are provided.

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

   • N/A. Adjudication methods are typically used to resolve discrepancies in expert labeling a dataset for AI/ML ground truth. This is not applicable to the non-clinical and simulated use testing described.

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. The document explicitly states: "Clinical data was not necessary for the TruDi™ NAV Suction Instruments." This means no MRMC study was conducted. This device is a surgical instrument, not an AI-based diagnostic tool.

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

   • N/A. There is no standalone AI algorithm discussed for this device. The device itself is an instrument that works with a navigation system. Its "performance" (accuracy) is a standalone measurement of the physical system (instrument + navigation system), but this is not an AI algorithm's standalone performance in the typical sense.

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

   • N/A. For the non-clinical tests, "ground truth" was established through engineering measurements, validated test methods (e.g., AAMI/ANSI/ISO for sterility, ASTM for packaging), and design specifications. For "clinical accuracy" in simulated use, it implies the device performed as expected by the ENT surgeons and support staff based on its design and intended function, not against a medical ground truth (like a biopsy result or patient outcome).

8. The sample size for the training set:

   • N/A. This device does not involve a training set for an AI/ML algorithm.

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

   • N/A. This device does not involve a training set for an AI/ML algorithm.

Ask a specific question about this device