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510(k) Data Aggregation
(28 days)
The TruDi® Navigation system is intended for use during surgical procedures in ENT and ENT skull base surgery to support navigation of instruments to targeted anatomy, where reference to a rigid anatomical structure can be identified relative to a CT or MR based model.
The TruDi® Navigation System V3 is intended to be used during surgical procedures in ENT and ENT skull base surgery to support navigation of instruments to the targeted anatomy, where reference to a rigid anatomical structure can be identified relative to a CT or MR based model. The TruDi® Navigation System V3 enables ENT physicians to access sphenoid, frontal, and maxillary sinuses, as well as the skull base, by using the systems magnetic tracking technology, which is the same technology used by the predicate device. The system incorporates a Navigation Console, Emitter Pad, Instrument Hub, Patient Tracker, Registration Probe, Workstation and peripherals. A magnetic field generated by the Emitter Pad induces a current in the magnetic sensor embedded in the tip of the navigated tool, which helps to accurately calculate the tool tip position. A CT or MR image is imported and registered to the patient coordinates and the navigated tool tip icon is displayed on top of the registered image, indicating the position of the tool tip in reference to the patient anatomy. A Patient Tracker is fixed to the patient forehead to compensate for the head movement during the surgical procedure.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Specification) | Reported Device Performance (Subject Device V3) |
|---|---|
| Accuracy specification: 2mm RMS | Bench Location Accuracy: 0.55mm (STD 0.2) |
| Simulated Use Location Accuracy: 1.2mm (STD 0.2mm) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of human data or patient cases. The performance data is derived from non-clinical bench testing and simulated use.
- Bench Location Accuracy: This test compared the TruDi® Navigation System's electromagnetic locations to those provided by a highly accurate robot system over its entire navigation volume. While a sample size of "locations" would have been involved in this measurement, the specific number is not provided.
- Simulated Use Location Accuracy: This involved performing a complete CT image registration and instrument navigation workflow. The specific sample size for "simulated uses" is not provided.
The data provenance is not from human patients; it's from laboratory (bench) and simulated environments. Therefore, country of origin is not applicable in the typical sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not applicable as the 'test set' for accuracy was based on objective measurements (robot system, simulated workflow) and not on expert interpretation of medical images or patient outcomes.
4. Adjudication Method for the Test Set
This information is not applicable as the ground truth was established through objective measurement tools and processes (robot system, simulated workflow) rather than human adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical data was not necessary to determine that the subject TruDi® Navigation System V3 performs as intended." This indicates that the evaluation was purely technical and non-clinical.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, a standalone (algorithm only without human-in-the-loop performance) evaluation of the device's core accuracy functions was done. The "Location Accuracy tests... where the TruDi® Navigation System electromagnetic locations were compared to the locations provided by a highly accurate robot system" directly assesses the system's inherent accuracy in a controlled, non-human environment. The "Simulated use accuracy test" also falls under this, evaluating the system's accuracy within a simulated workflow.
7. The Type of Ground Truth Used
The ground truth used for accuracy assessments was based on:
- Highly accurate robot system measurements for Location Accuracy tests.
- Known/defined parameters within a simulated use workflow for Simulated Use Location Accuracy tests.
8. The Sample Size for the Training Set
The document does not provide any information regarding a training set size. This device is a navigation system primarily relying on electromagnetic tracking technology, not a machine learning model that typically requires a separate training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no mention of a training set or its ground truth establishment within the provided document.
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(101 days)
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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