(103 days)
TruDi™ Curette is intended for use with the TruDi™ Navigation System to manipulate, dissect and/or remove tissue, cartilage and bone during surgical procedures in ENT and ENT skull base surgery.
The subject device, TruDi™ Curette (K201174), is a single-use and sterile electromagnetically (EM) navigated instrument, which is intended for use with the TruDi™ Navigation System (K192397) to manipulate, dissect and/or remove tissue, cartilage and bone during surgical procedures in ENT and ENT skull base surgery. The TruDi™ Curette consists of one configuration (straight 0°). The TruDi™ shaft, and a curette cup, which is located at the distal tip and houses a magnetic sensor. The device is sold in sterile packaging. Each package includes one TruDi™ Curette in conjunction with a disposable bending tool. The bending tool is provided to allow the user to customize the shape of the distal shaft as needed.
The TruDi™ Curette 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/MRI scan to confirm access, and to locate anatomical structures during ENT and ENT skull base surgery.
The provided document is a 510(k) summary for the TruDi™ Curette, which seeks to demonstrate substantial equivalence to a predicate device. While it includes a lot of information about bench testing and design validation, it does not detail a study involving AI performance or human readers. Therefore, several requested sections, particularly those related to AI and human reader studies, cannot be extracted from this document.
Here's a summary of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Non-Clinical Performance Data: | |
| Dimensional specifications | Met all acceptance criteria |
| Connector joint separation force | Met all acceptance criteria |
| Distal shaft deflection/flexure | Met all acceptance criteria |
| End to end joint strength | Met all acceptance criteria |
| Cable strain relief separation force | Met all acceptance criteria |
| Tip sharpness | Met all acceptance criteria |
| Bending tool functionality | Met all acceptance criteria |
| Navigational location accuracy | Met all acceptance criteria; Accuracy of TruDi™ Curette in conjunction with TruDi™ Navigation System is ≤ 2mm RMS over the entire navigation volume. |
| Electrical safety and EMC | Compliance with IEC 60601-1 (3rd Edition) and IEC60601-1-2 (4th Edition) |
| Sterilization process | Validated per ISO 11135:2014, demonstrated a sterility assurance level of 10^-6 |
| Ethylene oxide residuals | Met ISO 10993-7:2008 requirements |
| Biocompatibility | Successfully completed per ISO 10993-1 |
| Packaging shelf life | Established for three months via accelerated aging (ASTM F1980-07, ASTM F88/F88M-09, ASTM F2096-11) |
| Design Validation (Simulated Use Testing): | |
| Functionality in simulated clinical setting | Successfully conducted and verified that the TruDi™ Curette functions in accordance with its intended use and design specifications |
| Packaging and instructions for use assessment | Successfully assessed by evaluators |
| Overall Product Performance | Passed all intended criteria in accordance with appropriate test criteria and standards |
2. Sample size used for the test set and the data provenance
The document mentions "Design validation testing (simulated use testing) on cadavers" but does not specify the sample size (number of cadavers or test cases) used for this test set nor the detailed provenance beyond "cadavers". It is a prospective study in a simulated clinical setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not specified in the provided document. The document mentions "evaluators" for assessing packaging and instructions for use, but not for establishing ground truth regarding clinical performance.
4. Adjudication method for the test set
Not specified in the provided document.
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
Not applicable. The TruDi™ Curette is a physical surgical instrument, not an AI or imaging diagnostic device that would involve human readers or AI assistance in the way typically assessed by MRMC studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The TruDi™ Curette is a physical surgical instrument, not an algorithm. Its navigation capability is part of the TruDi™ Navigation System, which has a stated accuracy of ≤ 2mm RMS. This accuracy is a standalone measurement of the system's ability to track the instrument's tip.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the navigational location accuracy, the ground truth would typically be established through precise metrological measurements using a known standard or reference system. For the simulated use testing on cadavers, the "ground truth" or successful performance would be based on the device functioning as intended in manipulating, dissecting, and/or removing tissue, cartilage, and bone, as verified by the evaluators. Specific methods for establishing this ground truth (e.g., expert observation, quantitative assessment of tissue removal) are not detailed.
8. The sample size for the training set
Not applicable. The TruDi™ Curette is a physical device, and the document describes performance testing and design validation, not the development or training of an AI algorithm.
9. How the ground truth for the training set was established
Not applicable. There is no mention of a training set or AI model in the context of this device.
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).