(185 days)
The Optical Tracking System (OTS) is a graphical planning tool that allows for preoperative and operative planning of surgical procedures. The OTS is indicated for use in surgical procedures in which anatomical landmarks are not clearly visible or where a desired target is close to critical structures.
The Optical Tracking System (OTS), addressed in this premarket notification, has the same intended use and similar technological characteristics as the commercially available Radionics Operating Arm System and the StealthStation Stereotactic System. The OTS is a modification of the Operating Arm System but substitutes a camera array for the operating arm to track the position of probes and various tools. This is the same camera array utilized by StealthStation. The OTS provides an interactive, image-guided means of localizing targets in surgical procedures. In addition to the camera array, the OTS consists of a computer workstation, application software, and probes. Upon calibration of the system in the surgical environment, the surgeon selects points on the patient using a probe which are interpreted by the computer and related to corresponding points on the image.
Here's a breakdown of the acceptance criteria and study information for the Optical Tracking System (OTS), based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy: The system is correctly encoded for stereotactic CT and MR localizer transformation equations, and all target coordinate input and displays are accurate. | The camera array is accurate to a mean value of 0.3 mm. |
| Stability: Accuracy is maintained over a period of extended operation. | This accuracy is maintained over a period of extended operation. |
2. Sample Size Used for the Test Set and Data Provenance
The text explicitly states: "The results from the OTS are compared to a phantom with targets of known position."
- Sample Size for Test Set: The text does not specify a numerical sample size for the targets on the phantom. It only mentions "targets of known position."
- Data Provenance: The data is generated through testing with a phantom (a physical model with known properties), not clinical patient data. Therefore, it is a simulated/laboratory setting, not retrospective or prospective clinical data from a specific country.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable.
- Qualifications of Experts: Not applicable.
The ground truth for this device's performance test is established by the known, pre-defined positions of targets on a phantom. Human experts are not involved in establishing this ground truth.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable.
Since the ground truth is established by the known positions on a phantom, there is no need for human adjudication of the test results. The device's measurements are directly compared to these known values.
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
- MRMC Comparative Effectiveness Study: No, an MRMC comparative effectiveness study was not done.
This submission is for an image-guided surgical planning tool, not an AI diagnostic tool. The performance evaluation focuses on the system's accuracy in tracking and localization, not on changes in human reader performance with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Yes, a standalone performance evaluation was done.
The reported accuracy of "0.3 mm" for the camera array appears to be a standalone measurement of the system's ability to track positions against a known phantom. While the system is intended for use with a surgeon ("human-in-the-loop"), the verification of its core accuracy is performed independently of a surgeon's interpretation or action, by comparing its output to predefined phantom targets. The statement "RSA Optical Tracking System (OTS) systems testing verifies that the stereotactic CT and MR localizer transformation equations are correctly encoded into the application software. Further, it verifies that all target coordinate input and displays are accurate. The results from the OTS are compared to a phantom with targets of known position. The camera array is accurate to a mean value of 0.3 mm. This accuracy is maintained over a period of extended operation" describes a standalone evaluation of the device's technical specifications.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The ground truth used is based on known, pre-defined positions of targets on a phantom. This is a form of physical/engineering ground truth.
8. The Sample Size for the Training Set
- Sample Size for Training Set: The document does not provide information about a training set. This device is described as an "Optical Tracking System," not a machine learning or AI algorithm that would typically require a training set in the modern sense. Its functionality is based on established principles of optical tracking and geometry.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as no training set is mentioned or implied for this type of device in the provided text.
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PAGE of
Optical Tracking System 510(k) Submission
K96480
Appendix 1
JUN - 3 1997
Summary of Safety and Effectiveness
General Information
| Classification: | Class II |
|---|---|
| Common Name: | Surgical Planning and Guidance System |
| Device Trade Name: | Optical Tracking System (OTS) |
| Intended Uses: | The Optical Tracking System (OTS) is a graphicalplanning tool that allows for pre-operative andoperative planning of surgical procedures. TheOTS is indicated for use in surgical procedures inwhich anatomical landmarks are not clearly visibleor where a desired target is close to criticalstructures. |
| Predicate Devices: | Radionics Operating Arm System, K951262 andK961844; |
| StealthStation Stereotactic System, manufactured bySurgical Navigation Technologies, Inc., K954276. | |
| Establishment Name and Address: | Radionics Software Applications, Inc.22 Terry AvenueBurlington, MA 01803 |
| Contact Name and Phone: | Amy J. LaForte, PhD,(617) 272-1233 |
| Establishment registration number: | 1222895 |
| Performance Standard: | None established under Section 514. |
Substantial Equivalence Determination
A summary of the information contained in this premarket notification that addresses safety and effectiveness follows.
Description of the Device and Basis for Substantial Equivalence
The Optical Tracking System (OTS), addressed in this premarket notification, has the same intended use and similar technological characteristics as the commercially available Radionics Operating Arm System and the StealthStation Stereotactic System. The OTS is a modification of the Operating Arm System but substitutes a camera array for the operating arm to track the position of probes and various tools. This is the same camera
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array utilized by StealthStation. The OTS provides an interactive, image-guided means of localizing targets in surgical procedures. In addition to the camera array, the OTS consists of a computer workstation, application software, and probes. Upon calibration of the system in the surgical environment, the surgeon selects points on the patient using a probe which are interpreted by the computer and related to corresponding points on the image.
Safety Summary
RSA Optical Tracking System (OTS) systems testing verifies that the stereotactic CT and MR localizer transformation equations are correctly encoded into the application software. Further, it verifies that all target coordinate input and displays are accurate. The results from the OTS are compared to a phantom with targets of known position. The camera array is accurate to a mean value of 0.3 mm. This accuracy is maintained over a period of extended operation.
General Safety and Effectiveness Concerns
The device labeling contains instructions for use. It includes indications for use, cautions, warnings and user quality assurance procedures. The training and installation sessions ensure that the user understands all aspects of the Optical Tracking System: hardware, computer, and software and its intended functionality. This information promotes safe and effective use of the device.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 3 1997
Amy J. LaForte, Ph.D. Senior Regulatory Engineer Radionics Software Applications, Inc. P.O. Box 358 22 Terry Avenue Burlington, Massachusetts 01803-0658
K964801 Re : Trade Name: Optical Tracking System Requlatory Class: II Product Code: 84HAW Dated: March 3, 1997 Received: March 4, 1997
Dear Dr. LaForte:
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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 requlatory 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 - Amy J. LaForte, Ph.D.
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) 594-4648. 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 regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other qeneral 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,
Thomas J. Callahon
Thomas J. Callahan, Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): _ 196 48 0 /
Optical Tracking System 510(k) Submission Device Name:
Indications for Use
The following is the indications for use of the OTS :
The Optical Tracking System (OTS) is a graphical planning tool that allows for preoperative and operative planning of surgical procedures. The OTS is indicated for use in surgical procedures in which anatomical landmarks are not clearly visible or where a desired target is close to critical structures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Thomas J. Callahan
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number K964801
Prescription Use
(Per 21 CFR 801.109) ✓
OR
Over-The-Counter Use
§ 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).