(130 days)
The Stryker Navigation System is intended as a planning and intraoperative guidance system to enable open or percutaneous image guided surgery. The system is indicated for any medical condition in which the use of image guided surgery may be appropriate, and where a reference to a rigid anatomical structure such as the skull, or vertebra, can be identified relative to medical images.
The Stryker Navigation System- Spine & Fluoroscopy Module supports, but is not limited to the following surgical procedures:
- Pedicle Screw Placement
- Navigation
- Precisely positioning instruments such as internal and external fixation devices during orthopedic surgery, to include operations performed with spinal structure, hip and bones in the upper and lower extremities and long bones.
- This submission is not intended for total joint replacement procedures.
Not Found
This FDA 510(k) clearance letter (K012380) for the Stryker Navigation System - Spine & Fluoroscopy Module is a clearance of substantial equivalence, not a detailed study report. Therefore, it does not contain the specific information requested about acceptance criteria, detailed study design, or performance metrics typically found in a clinical study report.
The letter states that the device is substantially equivalent to a legally marketed predicate device, implying that its safety and effectiveness have been deemed comparable based on the provided information, which often includes performance data in the submission. However, these specific details are not present in the provided document.
To answer your questions accurately, I would need access to the full 510(k) submission (K012380) including the sections detailing performance data and clinical studies, which is not provided here.
Based only on the provided document, I can infer the following about what is missing:
- 1. A table of acceptance criteria and the reported device performance: Not present in the provided document. The 510(k) letter states substantial equivalence, but not the specific performance data against acceptance criteria.
- 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not present in the provided document.
- 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): Not present in the provided document.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not present in the provided document.
- 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: Not present in the provided document. The device is a "Navigation System," implying it's a guidance tool, not an AI interpretation tool for readers. An MRMC study is therefore unlikely to be directly applicable in the terms you describe.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present in the provided document. The device is described as "planning and intraoperative guidance system," inherently implying human-in-the-loop operation.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not present in the provided document.
- 8. The sample size for the training set: Not present in the provided document.
- 9. How the ground truth for the training set was established: Not present in the provided document.
In summary, the provided FDA clearance letter indicates the device's intended use and regulatory classification but does not contain the detailed study information required to answer your specific questions about acceptance criteria, study design, and performance metrics.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is positioned within a circle that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 3 2001
Ms. Robin L. Rowe Regulatory Affairs Representative Stryker Leibinger 4100 East Milham Avenue Kalamazoo, Michigan 49001
Re: K012380
Trade/Device Name: Stryker Navigation System - Spine & Fluoroscopy Module Regulation Number: 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: July 24, 2001 Received: July 26, 2001
Dear Ms. Rowe:
We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave roved your and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for association 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act that + Diederal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Robin L. Rowe
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Walker, MD
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 510(k) Number: | K012380 |
|---|---|
| Device Name: | Stryker Navigation System -Spine & Fluoroscopy Module |
| Intended Use: | The Stryker Navigation System is intended as a planning and intraoperative guidance system to enable open or percutaneous image guided surgery. The system is indicated for any medical condition in which the use of image guided surgery may be appropriate, and where a reference to a rigid anatomical structure such as the skull, or vertebra, can be identified relative to medical images. |
| Indications for Use: | The Stryker Navigation System- Spine & Fluoroscopy Module supports, but is not limited to the following surgical procedures: Pedicle Screw PlacementNavigationPrecisely positioning instruments such as internal and external fixation devices during orthopedic surgery, to include operations performed with spinal structure, hip and bones in the upper and lower extremities and long bones.This submission is not intended for total joint replacement procedures. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
,
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | OR | Over-The- Counter Use |
|---|---|---|
| (Per 21 CFR 801.109) |
Susan Walker, MD
| (Division Sign-Off)Division of General, Restorativeand Neurological Devices | (Optional Format 1-2-96) |
|---|---|
| ------------------------------------------------------------------------------------- | -------------------------- |
| 510(k) Number | K012380 |
|---|---|
| --------------- | --------- |
§ 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).