(21 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 cranial and spinal surgical procedures in which anatomical structures are not clearly visible or where a desired target is close to critical regions. Examples of such procedures using OTS with the Non-Invasive DRF include, but are not limited to: Catheter shunt placement Craniotomies Tumor resections Skull lesioning Vascular malformations Various ENT procedures
The above device consists of a headband that secures a light array to the patient. When coupled with the OTS workstation, the device allows for preoperative and operative planning of surgical procedures through workstation images. The device allows a light array to be secured to a patient non-invasively. Like its Cranial DRF and Spinal DRF predicates it is intended to maintain registration of the system during surgical procedures.
The provided text describes a 510(k) summary for the Radionics Non-Invasive Dynamic Reference Frame (DRF) for use with Radionics Optical Tracking System (OTS), but it does not contain the specific details required to answer all parts of your request.
The document primarily focuses on establishing substantial equivalence to a predicate device and obtaining marketing clearance. It does not include a detailed study report with acceptance criteria, reported performance, sample sizes, ground truth establishment, or expert qualifications for the new device.
Here's what can be extracted and what cannot:
1. Table of acceptance criteria and the reported device performance:
- Cannot be provided based on this document. The text states that the "technological characteristics are the same or similar to those found with the predicate device," implying that performance is expected to be similar, but no specific acceptance criteria or performance metrics for the new device are reported.
2. Sample size used for the test set and the data provenance:
- Cannot be provided based on this document. No test set or study details are mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Cannot be provided based on this document. No ground truth establishment related to a test set is discussed.
4. Adjudication method for the test set:
- Cannot be provided based on this document. No test set or adjudication process is described.
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:
- Cannot be provided based on this document. This device is a hardware component (a headband securing a light array) for an intraoperative guidance system, not an AI-powered diagnostic or interpretive tool that would typically involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Cannot be provided based on this document. Again, this is a hardware device. The "algorithm" or "software" would be part of the Optical Tracking System (OTS), and its standalone performance is not detailed here. The focus is on the Non-Invasive DRF itself.
7. The type of ground truth used:
- Cannot be provided based on this document. No specific ground truth type is mentioned for any performance evaluation of this device.
8. The sample size for the training set:
- Cannot be provided based on this document. There is no mention of a "training set" as this is a hardware accessory, not a machine learning model.
9. How the ground truth for the training set was established:
- Cannot be provided based on this document. Not applicable for this type of device and information provided.
In summary: The provided 510(k) document is a regulatory submission focused on demonstrating substantial equivalence. It does not include the detailed scientific study results, performance data, or ground truth establishment information that would typically be found in a study report addressing acceptance criteria.
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6.0 510(k) Summary:
510(k) Summary
This summary of the 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 C.F.R. 807.92.
- The submitter of this premarket notification is: 1
Kevin J. O'Connell Regulatory Engineer Radionics Software Applications, Inc, 22 Terry Avenue Burlington, MA 01803 Tel .: (781) 272-1233 Fax: (781) 272-2428
This summary was prepared on November 25, 1998.
- The name of the device is the Radionics Non-Invasive Dynamic Reference Frame 2 (DRF) for use with Radionics Optical Tracking System (OTS). The common name is an Intraoperative Guidance Device, and its classification name is a stereotaxic instrument (accessory).
- 3 The above device is substantially equivalent to the Radionics Cranial and Spinal DRFs for OTS.
- The above device consists of a headband that secures a light array to the patient. 4 When coupled with the OTS workstation, the device allows for preoperative and operative planning of surgical procedures through workstation images.
- The device allows a light array to be secured to a patient non-invasively. Like its 5 Cranial DRF and Spinal DRF predicates it is intended to maintain registration of the system during surgical procedures.
- The technological characteristics are the same or similar to those found with the 6 predicate device.
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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is an abstract image of three human profiles facing right, with a stylized design above them that could represent wings or flowing hair.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 18 1998
Mr. Kevin J. O'Connell Regulatory Engineer Radionics Software Applications, Inc. 22 Terry Avenue Burlington, Massachusetts 01803-2516
K984245 Re:
Trade Name: Radionics Non-Invasive Dynamic Reference Frame Regulatory Class: II Product Code: HAW Dated: November 25, 1998 Received: November 27, 1998
Dear Mr. O'Connell:
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. Kevin J. O'Connell
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,
fo coles
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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510(k) Number (if known):
Device Name: Optical Tracking System (OTS) Non-Inyasive Dynamic Reference Frame
Indications for use:
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 cranial and spinal surgical procedures in which anatomical structures are not clearly visible or where a desired target is close to critical regions. Examples of such procedures using OTS with the Non-Invasive DRF include, but are not limited to:
Catheter shunt placement Craniotomies Tumor resections Skull lesioning Vascular malformations Various ENT procedures
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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Division Sian-Off كما Division of General Restorative Devices كمك 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).