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510(k) Data Aggregation
(267 days)
Stereotaxic Guiding Surgical Devices, NaoTrac S is intended for the spatial positioning and orientation of instrument holder or instrument tool to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode). The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may be appropriate.
Stereotaxic Guiding Surgical Devices, NaoTrac S is a robotized platform for the guidance of neurosurgical instruments compatible with the diameter of instrument adaptor provided by Brain Navi Biotechnology Co., Ltd.
Stereotaxic Guiding Surgical Devices, NaoTrac S is composed of a compact robotic arm and display screen mounted on a wheeled trolley. Different types of instruments may be attached to the end of the arm and changed according to the requirements of the procedure to be completed.
The display screen permits to ensure the communication between NaoTrac S and its user by indicating the realizable actions as well as by proposing various commands. NaoTrac S is an aid for locating anatomical structures in either open or percutaneous procedures.
The provided FDA 510(k) Clearance Letter for the Stereotaxic Guiding Surgical Devices, NaoTrac S (K242575) includes details on acceptance criteria and supporting studies.
Here's an analysis of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (NaoTrac S) |
|---|---|
| Positional Error (Euclidean distance) < 2 mm | Mean: 1.13 mm |
| Standard Deviation: 0.38 mm | |
| 99% Confidence Interval: 1.31 mm | |
| Trajectory Angle Error < 2 degrees | Mean: 0.64 degrees |
| Standard Deviation: 0.37 degrees | |
| 99% Confidence Interval: 0.82 degrees | |
| Electrical Safety | Complies with IEC 60601-1 and ANSI AAMI ES 60601-1 |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2 |
| Software Verification & Validation | Complies with FDA guidance for Software in Medical Devices and IEC 62304 Standard |
| Cleaning Validation (re-use accessories) | Complies with FDA Guidance, AAMI TIR30, and AAMI TIR12 |
| Sterilization Validation (re-use accessories) | Complies with ISO 17665-1, ISO 17664, ISO 11737-1, ISO 11737-2, and AAMI TIR12 (two cycles) |
| Sterilization Validation (single-use accessories) | Complies with ISO 11137-1 |
| Shelf-life & Packaging (single-use accessories) | Complies with ASTM F1980 and ISO 11607-1 |
2. Sample Size Used for the Test Set and Data Provenance
The document describes "Accuracy Testing" which includes "systematic accuracy," but it does not specify the sample size for this test set (e.g., number of measurements, number of trajectories).
The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective. Given the nature of a medical device accuracy test, it is typically conducted in a controlled environment (e.g., lab setting) rather than with patient data.
3. Number of Experts Used and Qualifications for Ground Truth
The document does not mention the use of experts to establish ground truth for the "Accuracy Testing." This type of accuracy evaluation for a stereotaxic device typically relies on metrology (precise measurement instruments and setups) to define the true position and angle, not human expert interpretation.
4. Adjudication Method for the Test Set
Since the ground truth for accuracy testing is established through metrological measurements rather than human interpretation, an adjudication method like 2+1 or 3+1 is not applicable and not mentioned in the document.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
The document does not indicate that a Multi Reader Multi Case (MRMC) comparative effectiveness study was done. The NaoTrac S is a robotic guiding surgical device, not an imaging diagnostic tool that typically involves human reader interpretation for comparative effectiveness studies. The primary evaluation focuses on the device's accuracy in guidance.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop)
The "Accuracy Testing" results (Positional Error and Trajectory Angle Error) represent the standalone performance of the NaoTrac S device. These metrics evaluate how accurately the robotic arm positions and orientates instruments without direct human intervention in the final positioning step that is being measured. The device's function is to guide the neurosurgeon, but its intrinsic accuracy is a standalone measure.
7. Type of Ground Truth Used
For the accuracy testing, the ground truth was metrological measurements. The document states that the tests were conducted "according to internally defined methods" for "systematic accuracy," comprising "position accuracy and angular accuracy." This implies the use of highly precise measurement tools and techniques to determine the true position and angle against which the device's performance was compared.
8. Sample Size for the Training Set
The document does not specify a sample size for a training set. The NaoTrac S is a robotic guidance system, and its accuracy is primarily determined by its mechanical design, control algorithms, and calibration, rather than a machine learning model trained on a dataset in the way a diagnostic AI would be. While there are software components, the "Software Verification and Validation" section refers to standard software development lifecycle processes, not specifically to training a machine learning model.
9. How the Ground Truth for the Training Set Was Established
Since a machine learning training set is not explicitly mentioned or implied for the core function of the NaoTrac S in its accuracy evaluation, the method for establishing its ground truth is not applicable and not discussed in the document.
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