(131 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 a revised indications statement for the StealthStation System to provide specifically for the ENT application of intranasal or sinus use.
I'm sorry, but based on the provided text, I cannot extract the detailed information required to fill out the table and answer all the questions about acceptance criteria and a study proving device performance. The document is a 510(k) summary for a revised indication (ENT application) of an existing device, the StealthStation System. It primarily focuses on demonstrating substantial equivalence to the original device.
Here's what I can and cannot infer:
Information I can provide (partially):
- 1. A table of acceptance criteria and the reported device performance: The document states, "The StealthStation System ENT Application was shown to be substantially equivalent to the original StealthStation System. Clinical data was provided to support the claim of substantial equivalence." This is the core "acceptance criteria" (substantial equivalence to a predicate device) and the "reported device performance" (it met this criteria). However, it does not provide specific quantitative performance metrics (like accuracy, precision, sensitivity, specificity, etc.) that would typically be found in an acceptance criteria table alongside numerical results.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is described as "an aid for precisely locating anatomical locations in either open or percutaneous procedures." This strongly implies it's a tool used by a human surgeon. The concept of "standalone" performance without human interaction doesn't directly apply here as it's a surgical navigation system, not an autonomous diagnostic algorithm.
- 7. The type of ground truth used: The system identifies anatomical structures relative to a "CT or MR based model of the anatomy." This strongly suggests the ground truth for positioning would be based on these imaging modalities.
Information I cannot provide from the given text:
- 2. Sample sized used for the test set and the data provenance: The document mentions "clinical data was provided" but does not specify the sample size, number of cases, or the origin (country, retrospective/prospective nature) of this data.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is completely absent.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: No details on adjudication are provided.
- 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: This type of study is not mentioned, and the device is a navigation system, not a diagnostic AI intended to assist "readers."
- 8. The sample size for the training set: This information is not provided.
- 9. How the ground truth for the training set was established: This information is not provided.
Summary of available information:
| Acceptance Criteria & Performance | Details |
|---|---|
| Acceptance Criteria | Substantial equivalence to the original StealthStation System for its intended use as an aid for precisely locating anatomical locations, specifically for intranasal or sinus use. |
| Reported Device Performance | The StealthStation System ENT Application was shown to be substantially equivalent to the original StealthStation System. "Clinical data was provided to support the claim of substantial equivalence." (Specific quantitative performance metrics are not provided in this summary.) |
Study Details:
- Sample size for the test set & data provenance: Not specified. "Clinical data was provided."
- Number of experts for ground truth & qualifications: Not specified.
- Adjudication method for the test set: Not specified.
- MRMC comparative effectiveness study: Not applicable/not mentioned. This is a surgical navigation aid, not a diagnostic AI for human reader improvement studies.
- Standalone algorithm performance: Not applicable. The device is an aid for human surgeons.
- Type of ground truth used: Likely based on CT or MR imaging models of the anatomy, given the description "reference to a rigid anatomical structure... identified relative to a CT or MR based model of the anatomy."
- Sample size for the training set: Not specified.
- How ground truth for training set was established: Not specified.
§ 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).