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The Surgical Microscope Navigator (SMN) and the Surgical Tool Navigator (STN) System are a modular product group intended to provide the surgeon with navigational support during surgery They permit the surgical team to load radiological imaging studies onto a workstation equipped with image processing and visualization software. After correlation of the patient position with the images, (the registration procedure) the system displays the position, trajectory and other localization information of the current "tool" interactively throughout the surgical procedure.

The Surgical Microscope Navigator (SMN) and the Surgical Tool Navigator (STN) System are a modular product group intended to provide the surgeon with navigational support during surgery. The SMN's primary "tool" is a surgical microscope. The STN uses a variety of "Pointers" and instruments as tools. Both systems localize the tools in space via an industry standard infra-red LED based camera system. The LED's coordinates are then transferred to the workstation which in turn converts them to the coordinate system of the imaging data and interactively displays them.

The provided 510(k) summary for K965739 does not contain the information required to answer your questions regarding acceptance criteria and the study that proves the device meets the acceptance criteria.

This 510(k) summary focuses primarily on:

• Device Description and Intended Use: Explaining what the SMN and STN systems are and how they function.
• Substantial Equivalence Claims: Comparing the new devices to previously cleared devices (MKM system and StealthStation) based on their intended use, technology, and operating principles.
• Legal Basis for Submission: Referencing an exemption for surgical microscopes or substantial equivalence to existing devices.

Missing Information:

To answer your questions, the following information would typically be found in a more detailed technical report or study summary submitted as part of the 510(k) application, which is not present in this publicly available summary:

1. Acceptance Criteria and Reported Device Performance Table: This would require specific performance metrics (e.g., accuracy, precision) and defined thresholds for "acceptable" performance, along with the measured results from a validation study.
2. Sample Sizes and Data Provenance for Test Set: Details about the number of cases/patients used to evaluate the device's performance, where the data came from (e.g., specific hospitals, geographic regions), and whether it was collected retrospectively or prospectively.
3. Number and Qualifications of Experts for Ground Truth: Information about the professionals (e.g., surgeons, radiologists) who reviewed the test cases to establish the reference standard, including their number and years of experience.
4. Adjudication Method: How disagreements among experts were resolved (e.g., 2+1, 3+1, consensus).
5. MRMC Comparative Effectiveness Study: Whether a study comparing human performance with and without the device's assistance was conducted, and the quantitative effect size.
6. Standalone Performance Study: Data on the algorithm's performance without human interaction.
7. Type of Ground Truth Used: The specific method used to establish the truth for the test cases (e.g., histopathology, clinical outcome, expert consensus).
8. Sample Size for Training Set: The amount of data used to develop and train the device's algorithms (if applicable, though this device appears hardware-focused with localization algorithms).
9. Ground Truth Establishment for Training Set: How the reference standard was created for the training data.

Conclusion:

Based solely on the provided 510(k) summary, it is not possible to provide the requested details regarding acceptance criteria, study design, and performance metrics. The summary focuses on establishing substantial equivalence rather than detailing the specifics of a performance validation study against defined acceptance criteria.

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