(133 days)
The Optical Tracking System (OTS) is a graphical planning tool that allows for pre-operative and operative planning of cranial and spinal 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) provides an interactive, image-guided means of localizing targets in surgical procedures. A camera array tracks the position of probes and various tools. In addition to the camera array, the OTS consists of a computer workstation, application software, and probes. Upon registration 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.
The provided text does not contain the detailed information required to answer all parts of your request. This document is a 510(k) summary for a medical device (Optical Tracking System) and focuses on establishing substantial equivalence to predicate devices, rather than presenting a detailed study report with specific performance metrics and validation methodologies.
However, I can extract what is available and indicate where information is missing.
Description of Acceptance Criteria and Study to Prove Device Meets Criteria
The provided document, a 510(k) summary for the Optical Tracking System (OTS), does not explicitly define quantitative acceptance criteria for device performance. Instead, it focuses on demonstrating substantial equivalence to predicate devices and describes the safety testing performed. The "study" described is primarily internal system and unit testing rather than a formal clinical or controlled comparative performance study to prove specific acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Explicitly Stated in Document) | Reported Device Performance (as per Safety Summary) |
|---|---|
| Not explicitly defined (e.g., target accuracy, precision thresholds). | Functionality Testing: Rigorously tests the functionality of application software. Verifies capabilities to match and map markers on patient scan and patient. Verifies stereotactic CT and MR localizer transformation equations are correctly encoded. Verifies spatial accuracy of the digitizer. Verifies accuracy of transformations from image space to screen space and screen space to image space. |
Missing Information: Specific quantitative acceptance thresholds (e.g., "accuracy must be within X mm").
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document refers to "system and unit testing" but does not give details on the number of cases, images, or tests performed.
- Data Provenance: Not specified. Given it's internal "system and unit testing," it's likely internal simulated or lab data, but no details are provided. It does not mention retrospective or prospective studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
Missing Information: The document does not describe the involvement of external experts or the process of establishing ground truth for any test sets beyond internal software verification.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified.
Missing Information: There is no mention of an adjudication process, implying that ground truth was likely established through internal validation/verification methods as part of the software testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- MRMC Study: No, an MRMC comparative effectiveness study is not mentioned in the provided text. The document focuses on the device's technical functionality and substantial equivalence.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was done
- Standalone Study: Yes, the described "system and unit testing" appears to be a form of standalone performance evaluation. The testing verifies the software's functionality, accuracy of transformations, and spatial accuracy of the digitizer independently. It's essentially an assessment of the algorithm and hardware's technical capabilities.
7. The Type of Ground Truth Used
- Type of Ground Truth: The document implies that ground truth was established through engineered or calculated accuracy standards for software and hardware components. For example, "spatial accuracy of the digitizer" and "accuracy of the transformations" suggest that known inputs were used to verify calculated outputs, rather than clinical ground truth like pathology or expert consensus on patient data.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable/Not specified. The document does not describe a machine learning algorithm that requires a training set in the modern sense. It refers to a "graphical planning tool" and "application software" which are likely rule-based or algorithm-driven rather than learned models.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable/Not specified, as no training set for a machine learning model is mentioned.
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Appendix 1
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 Optical Tracking System (K964801)Surgical Navigation Technologies StealthStationStereotactic System (K954276). |
| Establishment Name and Address: | Radionics Software Applications, Inc.22 Terry AvenueBurlington, MA 01803Phone (781) 272-1233FAX (781) 272-2428 |
| Contact Name and Phone: | Lisa Misterka Benati(781) 272-1233 |
| Date Summary was Prepared | December 8, 1997 |
| 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.
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Description of the Device and Basis for Substantial Equivalence
The Optical Tracking System (OTS) provides an interactive, image-guided means of localizing targets in surgical procedures. A camera array tracks the position of probes and various tools. In addition to the camera array, the OTS consists of a computer workstation, application software, and probes. Upon registration 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.
The OTS with cranial and spinal applications, addressed in this premarket notification, has the same intended use and similar technological characteristics as the commercially available Radionics OTS and the Surgical Navigation Technologies StealthStation Stereotactic System. The OTS with cranial and spinal applications retains the complete functionality of the commercially available OTS while incorporating the following modifications: a new version of OAS/OTS base application software written in a new software architecture, and a new add-on software module and spinal Dynamic Reference Frame to support spinal applications. Like the OTS with cranial and spinal applications, the SteathStation Stereotactic System supports both cranial and spinal applications.
Safety Summary
RSA Optical Tracking System (OTS) system and unit testing rigorously tests the functionality of the application software. The testing verifies the capabilities of the software to match and map markers on both the patient scan and the patient. The testing also verifies that the stereotactic CT and MR localizer transformation equations are correctly encoded into the application software. Further, the testing verifies the spatial accuracy of the digitizer, as well as the accuracy of the transformations which translate points from image space to screen space and screen space to image space.
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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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a stylized caduceus symbol. The caduceus is composed of three intertwined strands and a cross at the top. 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 20850
APR 21 1998
Ms. Lisa Misterka Benati Senior Requlatory Engineer Radionics Software Applications, Inc. 22 Terry Avenue 01803-2516 Burlington, Massachusetts
K974602 Re: Optical Tracking System Trade Name: Regulatory Class: II Product Code: HAW Dated: March 10, 1998 Received: March 12, 1998
Dear Ms. Benati:
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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ದ 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 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. Please note: concerning your device in the Federal Register. 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 - Ms. Benati
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.
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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Indications for Use
The following are the indications for use of the OTS:
The Optical Tracking System (OTS) is a graphical planning tool that allows for pre-The Operative and operative planning of cranial and spinal surgical procedures. The OTS is operative and operative planing of certifical procedures in which anatomical landmarks are not clearly visible or where a desired target is close to critical structures.
Prescription Use
(Per 21 CFR 801.109)
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(Division Sign-Off Division of General Restorative D 510(k) Number
§ 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).