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510(k) Data Aggregation
(101 days)
TruDi Probe
The TruDi™ Probe is intended for use with the TruDi™ Navigation System to locate anatomical structures during surgical procedures in ENT and ENT skull base surgery.
The subject device, TruDi™ Probe, is a single-use and sterile electromagnetically (EM) navigated instrument, which is intended for use with the TruDi™ Navigation System (K192397) to locate anatomical structures during surgical procedures in ENT and ENT skull base surgery.
The TruDi™ Probe consists of two configurations, straight (0°) and frontal (70°). The TruDi™ Probe comprises of a fixed proximal connector, cable, handle, stainless steel shaft, and a distal tip that houses a magnetic sensor. The device is sold in sterile packaging. Each package includes one TruDi™ Probe (either straight or frontal) in conjunction with a disposable bending tool. The bending tool is provided to allow the user to customize the shape of distal tip as needed.
The TruDi™ Probe incorporates a sensor at the distal tip, which is tracked by the TruDi™ Navigation System. The location of the distal tip of the device is identified by the navigation system and displayed in real-time view over the patient's pre-operative CT scan to confirm access and locate anatomical structures during ENT surgery.
The document describes the Acclarent TruDi™ Probe, a single-use electromagnetically (EM) navigated instrument for locating anatomical structures during ENT and ENT skull base surgery. The device is intended for use with the TruDi™ Navigation System.
Here's an analysis of the acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance:
The document outlines performance data from various non-clinical tests. Since specific quantified acceptance criteria are not presented in a direct table format alongside the reported performance values, I will infer them from the descriptions.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Mechanical Performance: | |
| - Dimensional specifications met | Bench testing performed and met all acceptance criteria |
| - Connector joint separation force met | Bench testing performed and met all acceptance criteria |
| - Tip flexure within limits | Bench testing performed and met all acceptance criteria |
| - Distal tube to handle separation force met | Bench testing performed and met all acceptance criteria |
| - Cable strain relief separation force met | Bench testing performed and met all acceptance criteria |
| - Bending tool functionality | Bench testing performed and met all acceptance criteria |
| Navigational Location Accuracy: | A mean bench accuracy of 0.43 mm (Standard deviation 0.15 mm) was measured for the device. With 95% confidence measured devices have location accuracy of ≤ 2 mm RMS over the entire navigation volume. |
| Electrical Safety and EMC: | Met requirements of IEC 60601-1 (3rd Edition) and IEC60601-1-2 (4th Edition). |
| Sterilization: | Sterility assurance level of 10-6 per ISO 11135:2014 (overkill/half-cycle approach). Ethylene oxide residuals meet ISO 10993-7:2008 requirements. |
| Biocompatibility: | Successfully completed per ISO 10993-1. |
| Packaging Shelf Life: | Confirmed to meet a shelf life of three months through accelerated aging per ASTM F1980-07, ASTM F88/F88M-09, and ASTM F2096-11. |
| Simulated Use Performance: | Successfully conducted on cadavers to verify function, intended use, and design specifications. Packaging and IFU also assessed. |
2. Sample Size for Test Set and Data Provenance:
The document mentions "bench testing" and "simulated use testing on cadavers." However, specific sample sizes for these tests are not provided. The provenance of the data is implied to be from the manufacturer's internal testing as part of their 510(k) submission, and it is retrospective (performed before the submission). There is no mention of country of origin for the data; it is assumed to be part of the manufacturer's internal development and testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document describes "simulated use testing on cadavers" where "packaging and instructions for use were also successfully assessed by evaluators." However, the number of experts and their qualifications used to establish ground truth for these tests are not mentioned.
4. Adjudication Method:
The document does not specify an adjudication method for the "simulated use testing" or any other performance evaluation involving human assessment.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A MRMC comparative effectiveness study was not conducted or reported. The submission explicitly states "Clinical data was not necessary for the TruDi™ Probe. The performance data demonstrated that the device performs as intended." This indicates no study was done to assess human reader improvement with or without AI assistance.
6. Standalone Performance Study (Algorithm Only):
The document describes the standalone performance of the device concerning its navigational accuracy:
- A mean bench accuracy of 0.43 mm (Standard deviation 0.15 mm) was measured for the device.
- With 95% confidence, measured devices have a location accuracy of ≤ 2 mm RMS over the entire navigation volume.
This indicates algorithm-only performance testing for its core functionality (localization).
7. Type of Ground Truth Used (for standalone performance):
For the navigational accuracy, the ground truth would have been established by a highly precise engineering and metrology setup (e.g., using a known reference system or precision measurement tools) to determine the true position, against which the device's reported position was compared. This is typical for such electromagnetic navigation systems.
8. Sample Size for the Training Set:
The TruDi™ Probe is an electromagnetic navigation instrument, not an AI or machine learning algorithm in the typical sense that would require a "training set" of data to learn from. Its performance is based on physical principles and sensor technology. Therefore, a training set size is not applicable in this context.
9. How the Ground Truth for the Training Set Was Established:
As mentioned above, the concept of a "training set" and associated ground truth is not applicable to this device, which relies on direct physical measurement and not a learning algorithm.
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