(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.
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NOV 2 1 1997
Summary of Safety and Effectiveness
K954276 Addendum - August 14, 1997 StealthStation™ Drill Attachment
Surgical Navigation Technologies, Inc. I. Company: 530 Compton Street Broomfield, CO 80020
- Product Name: StealthStation™ Drill Attachment II.
- This submission is an addendum to K954276 which allows the III. StealthStation™ to track a powered surgical drill.
- The StealthStation™ Drill Attachment's ability to track a drill bit of known IV. length was shown to be substantially equivalent to the method used to track other optical probes specified in 510(k) No. K954276.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 symbol, which is a stylized representation of a human figure. The symbol is composed of three curved lines that form the shape of a person's head and shoulders. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
NOV 21 1997
Mr. David A. Mire Clinical and Regulatory Affairs Associate Surgical Navigation Technologies, Incorporated 530 Compton Street Broomfield, Colorado 80020
Re : K974161 StealthStation™ System Trade Name: Requlatory Class: II Product Code: HAW Dated: August 26, 1997 Received: August 27, 1997
Dear Mr. Mire:
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, Druq, 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, labelinq, and prohibitions aqainst 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 Requlations, 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 Requlation (QS) for Medical Devices: General requlation (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 In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does
. . *
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Page 2 - Mr. Mire
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 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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, MD Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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510(k) Number (if known): K 9741 C /
Device Name: _________________________________________________________________________________________________________________________________________________________________
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)
Coneurrence of CDRH, Office Of Device Evaluation (ODE)
(Division Sign-Off)
on Control Division of Dental, Into and General Hospita 510(k) 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).