(82 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 describes updates made to the StealthStation® System to provide for optical tracking of instruments via the use of reflection of infrared light off of reflective spheres on the instruments.
The provided text does not contain detailed information about the acceptance criteria or a specific study that proves the device meets those criteria. It states that "Performance data was provided to support the claim of substantial equivalence" but does not elaborate on what that data entails, what the specific acceptance criteria were, or the methodology of the study.
Therefore, many of the requested fields cannot be populated from the given text.
Here's a breakdown of what can and cannot be extracted:
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A table of acceptance criteria and the reported device performance: This information is not explicitly provided. The summary states that the passive instrument option was shown to be "substantially equivalent" to the original StealthStation® System with active probes and the BrainLAB VectorVision System. However, it does not list specific performance metrics or acceptance thresholds.
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Sample size used for the test set and the data provenance: Not mentioned.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
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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: Not applicable as this is a medical device for surgical navigation, not an AI for human reader assistance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a "StealthStation® System - Passive Instrument Option," which is a surgical navigation system, implying human-in-the-loop operation. No information is provided about a standalone algorithm performance.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned. For a surgical navigation system, ground truth would likely relate to the accuracy of instrument positioning relative to anatomical structures.
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The sample size for the training set: Not mentioned.
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How the ground truth for the training set was established: Not mentioned.
Summary of available information:
| Category | Information from Text |
|---|---|
| Acceptance Criteria & Performance | The device was shown to be "substantially equivalent" to the original StealthStation® System with active probes and the BrainLAB VectorVision System. No specific performance metrics or acceptance criteria are detailed. |
| Test Set Sample Size | Not mentioned. |
| Test Set Data Provenance | Not mentioned. |
| Experts for Ground Truth | Not mentioned. |
| Expert Qualifications | Not mentioned. |
| Adjudication Method | Not mentioned. |
| MRMC Comparative Study | Not applicable (device is a surgical navigation system, not AI for human reader assistance). |
| Standalone Performance | Not applicable (device is a surgical navigation system, implying human interaction). No data on algorithm-only performance. |
| Type of Ground Truth | Not mentioned. (Likely related to positional accuracy for surgical navigation, but not specified). |
| Training Set Sample Size | Not mentioned. (Given the nature of the device as a passive instrument option for an existing system, the "training" may have been more about calibration and validation against existing benchmarks rather than a typical AI model training set). |
| Training Set Ground Truth Method | Not mentioned. (Again, likely related to established accuracy standards for surgical navigation systems and calibration methods rather than a data labeling process common in AI). |
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SEP 1 6 1997
Summary of Safety and Effectiveness
StealthStation® System - Passive Instrument Option
| I. | Company: Surgical Navigation Technologies530 Compton St.Broomfield, CO 80020(303) 439-9709 |
|---|---|
| ---- | -------------------------------------------------------------------------------------------------------- |
- StealthStation® System Passive Instrument Option Product Name: II.
- III. This submission describes updates made to the StealthStation® System to provide for optical tracking of instruments via the use of reflection of infrared light off of reflective spheres on the instruments.
- IV. The indications for use for the StealthStation® System have not changed and are as follows:
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.
- v. The StealthStation® System - Passive Instrument Option was shown to be substantially equivalent to the original StealthStation® System with active probes. Performance data was provided to support the claim of substantial equivalence. In addition, the StealthStation System with the Passive Instrument Option was shown to be substantially equivalent to the BrainLAB VectorVision System.
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, with flowing lines beneath them, possibly representing water or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 6 1997
Mr. Roger N. White Surgical Navigation Technologies, Inc. 530 Compton Street Broomfield, Colorado 80020
Re: K972398 StealthStation® Treatment Guidance Platform Trade Name: Requlatory Class: II Product Code: 84HAW Dated: June 25, 1997 Received: June 26, 1997
Dear Mr. White:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, qood manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any
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Page 2 - Mr. Roger N. White
obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled,
"Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597.
Sincerely yours,
Thomas J. Callahan
Thomas J. Callawan, Ph.D Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page ___ 1__ of__1
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: StealthStation® System - Passive Instrument Option ______________________________________________________________________________________________________________
Indications For Use:
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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office Of Device Evaluation (ODE) | |
|---|---|
| -------------------------------------------------------- | -- |
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular, Respiratory,and Neurological Devices | |
| 510(k) Number | K972398 |
| Prescription Use(Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| (Optional Format 1-2-96) |
§ 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).