(85 days)
The StealthStation™ System is intended as an aid for precisely locating anatomical locations in either open or percutaneous procedures. The StealthStation™ System is indicated for any medical condition in which the use of stereotactic surgery may be considered to be safe and effective, and where a reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT or MR based model of the anatomy. The StealthStation™ System with the ENT option is also indicated for intranasal or sinus use.
This submission describes updates made to the StealthStation™ System to provide the option for providing pre-sterilized passive markers for the StealthStation™ instruments.
This 510(k) submission (K981684) is for "Sterile Passive Markers for the StealthStation™ System" and primarily describes updates to provide pre-sterilized passive markers for the StealthStation™ instruments. It states that the indications for use for the StealthStation™ System have not changed. The submission declares substantial equivalence to the "Passive Marker Option for the StealthStation™ System" cleared in K972398.
Based on the provided text, the document focuses on the regulatory aspects of introducing pre-sterilized markers and does not contain detailed information about a study proving device performance against specific acceptance criteria for the navigation system's overall accuracy or clinical effectiveness.
Therefore, most of the requested information cannot be extracted directly from this document. However, I can still address the relevant points based on the available text:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the given 510(k) summary. The document does not specify performance acceptance criteria for the sterile passive markers or the StealthStation™ System concerning, for example, accuracy specifications. It focuses on the substantial equivalence of the new pre-sterilized markers to previously cleared markers.
2. Sample size used for the test set and the data provenance
This information is not provided in the given 510(k) summary. The document does not describe a performance study with a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the given 510(k) summary. No test set or ground truth establishment process is described.
4. Adjudication method for the test set
This information is not provided in the given 510(k) summary. No test set or adjudication method is described.
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
A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the provided 510(k) summary. This document is related to an image-guided surgery system's markers, not an AI-assisted diagnostic or interpretative system that would typically involve human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
A standalone performance study for an algorithm is not mentioned in the provided 510(k) summary. The device is a surgical navigation system, which inherently involves human interaction, and the submission is about passive markers for this system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not provided in the given 510(k) summary. No ground truth is described as the document does not detail a performance study.
8. The sample size for the training set
This information is not provided in the given 510(k) summary. The document does not describe an algorithm development process that would involve a training set.
9. How the ground truth for the training set was established
This information is not provided in the given 510(k) summary. No training set or ground truth establishment is described.
Summary of what the document does provide:
- Device: Sterile Passive Markers for the StealthStation™ System.
- Purpose: To offer pre-sterilized passive markers for the StealthStation™ instruments.
- Indications for Use: The StealthStation™ System is intended as an aid for precisely locating anatomical locations in either open or percutaneous procedures, where a reference to a rigid anatomical structure can be identified relative to a CT or MR based model of the anatomy. The ENT option is also indicated for intranasal or sinus use. These indications are unchanged from the predicate device.
- Predicate Device: Passive Marker Option for the StealthStation™ System (cleared in K972398).
- Basis for Clearance: Substantial equivalence to the predicate device. The 510(k) process for this device relies on demonstrating that the new sterile markers are as safe and effective as the previously cleared non-sterile markers, typically through material biocompatibility, sterility validation, and ensuring unchanged functionality in tracking performance. The document implies that these updated markers maintain the established performance of the StealthStation™ System.
§ 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).