(86 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.
This submission is an addendum to K954276 which allows the StealthStation™ to track a powered surgical drill. The StealthStation™ Drill Attachment's ability to track a drill bit of known length was shown to be substantially equivalent to the method used to track other optical probes specified in 510(k) No. K954276.
The provided text describes an addendum to an existing 510(k) submission (K954276) for the StealthStation™ Drill Attachment (K974161). This addendum aims to allow the StealthStation™ to track a powered surgical drill.
However, the provided text does not contain enough information to answer many of the specific questions regarding acceptance criteria and a study proving device performance in detail. The document is primarily a regulatory approval letter and a summary of safety and effectiveness for a device addendum, not a detailed study report.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Ability to track a drill bit of known length substantially equivalent to tracking other optical probes. | The StealthStation™ Drill Attachment's ability to track a drill bit of known length was shown to be substantially equivalent to the method used to track other optical probes specified in 510(k) No. K954276. |
Missing Information:
- The specific quantitative metrics for "substantially equivalent" are not provided (e.g., accuracy, precision tolerances). The document only states that it was shown to be substantially equivalent.
- The actual performance values (e.g., "device achieved tracking accuracy of X mm") are not reported.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Missing Information: This information is not present in the provided text. The document refers to "the method used to track other optical probes specified in 510(k) No. K954276," suggesting a comparison, but details of that study or any new study for the drill attachment's tracking ability are absent.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Missing Information: This information is not present in the provided text. No mention is made of human experts establishing ground truth for any test.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Missing Information: This information is not present in the provided text. No adjudication method is mentioned, as the nature of the "study" is unclear and focused on technical tracking rather than diagnostic or interpretative tasks.
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
Missing Information: This information is not present in the provided text. The device is a surgical navigation system component, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this device's function as described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Likely Applicable Based on Context: Yes, the essence of the "study" mentioned for the StealthStation™ Drill Attachment is a standalone evaluation of its tracking capabilities. The text states: "The StealthStation™ Drill Attachment's ability to track a drill bit of known length was shown to be substantially equivalent to the method used to track other optical probes specified in 510(k) No. K954276." This implies a technical performance evaluation of the device itself, independent of a human-in-the-loop scenario.
Missing Information: Specific details of how this standalone performance was measured (e.g., the test setup, measurement equipment, environmental conditions) are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Inferred Ground Truth: For tracking a drill bit of known length, the ground truth would likely be the known physical length of the drill bit and its true spatial position/orientation as measured by a highly accurate external reference system (e.g., a precision optical tracker, coordinate measuring machine) during the test.
Missing Information: Specifics on how this ground truth was established or measured are not provided.
8. The sample size for the training set
Not Applicable/Missing Information: This device involves a tracking system, not a machine learning or AI model in the modern sense that typically requires a separate training set. Even if there were internal calibration/configuration processes, they wouldn't be referred to as a "training set" in the context of an AI/ML device.
9. How the ground truth for the training set was established
Not Applicable/Missing Information: As above, a "training set" as understood for AI/ML is not applicable here.
§ 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).