(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. The StealthStation™ System with the ENT option is also indicated for intranasal or sinus use.
This submission describes changes made to the StealthStation™ System to include the use of a camera array utilizing two 2-dimensional cameras as an alternative to the originally cleared camera array utilizing three 3-dimensional cameras.
The provided text is a 510(k) summary for a digitizer change to the StealthStation® System, indicating substantial equivalence to a previously cleared device. It does not contain primary study data or explicit acceptance criteria with specific performance metrics as would be found in a detailed clinical or technical study report.
Therefore, many of the requested elements about acceptance criteria, detailed study design, and performance metrics cannot be found in this document.
Here's an analysis based on the available information:
Acceptance Criteria and Device Performance
Based on the provided document, the primary "acceptance criterion" is a demonstration of substantial equivalence to the original StealthStation® System (cleared in K954276) despite a change in the digitizer.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Substantial Equivalence to the original StealthStation™ System (K954276) | The StealthStation™ System - Digitizer Change was shown to be substantially equivalent to the original StealthStation™ System. Performance data was provided to support this claim. |
Important Note: The specific performance metrics (e.g., accuracy, precision measurements) that were used to demonstrate substantial equivalence are not detailed in this summary. The summary only states that "Performance data was provided to support the claim of substantial equivalence."
Study Information (Based on available text)
-
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not provided. The document states "Performance data was provided," but does not specify any sample sizes, data provenance (e.g., country of origin), or whether the data was retrospective or prospective.
-
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):
- Not provided. This type of information is not typically found in a 510(k) summary focused on hardware changes for an existing device.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not provided.
-
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/Not done (based on the device type and context). The device is a surgical navigation system, not an AI-assisted diagnostic tool for human readers. The change described is a digitizer hardware change.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable in the typical sense of "algorithm only." The "device" is a physical system involving hardware (digitizers) and software for surgical navigation. While its performance would be evaluated as a system, the concept of a "standalone algorithm" in the context of AI without human-in-the-loop doesn't directly apply here. The "performance data" mentioned would likely pertain to the accuracy and reliability of the navigation system's output.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated in relation to specific "ground truth" establishment. For a surgical navigation system, "ground truth" would typically relate to known physical measurements, phantom studies, or potentially cadaveric studies with precise fiducial markers. The document does not specify the method used for the "performance data."
-
The sample size for the training set:
- Not applicable/Not provided. This device is a hardware/software system for surgical navigation, not a machine learning model that undergoes a "training set" in the common sense.
-
How the ground truth for the training set was established:
- Not applicable/Not provided. (See point 7)
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AUG - 7 1998
Summary of Safety and Effectiveness
StealthStation® System - Digitizer Change
K981686
- Surgical Navigation Technologies I. Company: 530 Compton St. Broomfield, CO 80020 (303) 439-9709
- Product Name: StealthStation™ System Digitizer Change II.
- III. This submission describes changes made to the StealthStation™ System to include the use of a camera array utilizing two 2-dimensional cameras as an alternative to the originally cleared camera array utilizing three 3-dimensional cameras.
- 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 perculaneous 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.
- V. The StealthStation™ System - Digitizer Change was shown to be substantially equivalent to the original StealthStation™ System cleared in K954276. Performance data was provided to support the claim of substantial equivalence.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 7 1998
Mr. Roger White Group Director, Quality Systems and Regulatory Affairs Surgical Navigation Technologies, Inc. 530 Compton Street Broomfield, Colorado 80020
Re: K981686 Trade Name: StealthStation® System Digitizer Change Regulatory Class: II Product Code: HAW Dated: June 25, 1997 Received: May 13, 1998
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, good 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 current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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 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 regulations.
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Page 2 - Mr. Roger White
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) 594-4595. 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 regulation 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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative 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): K981686 --------------------------------------------------------------------------------------------------------------------------------------------
Device Name: StealthStation® System Digitizer Change
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 General Restorative Devices |
| K981686 |
5100k) Number .
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).