(77 days)
The Navitrack® System – OS Knee Universal is indicated for use as a stereotaxic instrument to assist in the positioning of Total Knee Replacement components intraoperatively. It is a computer controlled image-guidance system equipped with a three-dimensional tracking sub-system. It is intended to assist the surgeon in determining reference alignment axes in relation to anatomical landmarks, and in precisely positioning the alignment instruments relative to these axes by displaying their locations.
Identically as in the predicates, the Navitrack System - OS Knee Universal device consists of software, a computer workstation, an optical tracking system, surgical instruments, and tracking accessories, designed to assist the surgeon in the placement of Total Knee Replacement (TKR) components. Tracking devices are incorporated with given surgical instruments, as well as on to fixation bases that attach to each of the femur and tibia, such to allow the ability to track and display to the user their respective positions intra-operatively. The femur and tibia are displayed to the user in the form of their main alignment axes. The alignment axes are determined and recorded intraoperatively by identifying the key anatomical references that are used clinically to align and position the TKR components. The instruments are schematically represented. The main modifications to the predicates are to incorporate a new set of instruments with universal implant instrument interface features along with corresponding software changes such that the application can be compatible to track a variety of TKR implant lines.
The provided text describes the Navitrack® System - OS Knee Universal and its substantial equivalence to predicate devices, but it does not contain explicit acceptance criteria or a detailed study proving the device meets specific performance criteria.
The document states: "Non-clinical tests were performed to assess that no new safety and efficacy issues were raised in the device. These included tests and analyses to verify that the accuracy and performance of the system was adequate for its intended use and not reduced in comparison to the predicates." However, it does not provide the results of these tests, the specific metrics used, or the thresholds for "adequate" performance.
Therefore, many of the requested sections cannot be filled from the provided text.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | "accuracy and performance of the system was adequate for its intended use and not reduced in comparison to the predicates." (No specific metrics or numbers provided.) |
2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample size for test set: Not specified.
- Data provenance: Not specified.
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 applicable as the document does not describe a clinical study with expert ground truth establishment. The "non-clinical tests" likely refer to bench testing or simulation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable.
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
- No MRMC study was described. The device is a navigation system, not an AI diagnostic tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The document mentions "non-clinical tests" to verify accuracy and performance "adequate for its intended use and not reduced in comparison to the predicates." This implies standalone testing of the system's accuracy, but no details of the test or results are provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not specified. For non-clinical tests of a navigation system, ground truth would likely involve highly precise measurement instruments (e.g., coordinate measuring machines, optical tracking systems with known accuracy) to establish the true position/orientation of anatomical landmarks or instruments.
8. The sample size for the training set
- The document does not describe a machine learning model that would require a "training set" in the typical sense. This device is a computer-assisted surgical navigation system based on established principles of optical tracking and anatomical landmark registration, not a deep learning model requiring vast training data.
9. How the ground truth for the training set was established
- Not applicable.
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APS " 0 " " "
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS Navitrack® System - OS Knee Universal
Applicant: ORTHOsoft Inc. 75 Queen Street, suite 3300 Montreal, Quebec Canada, H3C 2N6 Tel .: 514 861 4074 Fax: 514 866 2197
Contact Person: Christopher McLean
Date Summary Prepared: February 8, 2006
Device Trade Name: Navitrack® System - OS Knee Universal
Device Classification Name: Stereotaxic Instrument (84 HAW); 21 CFR § 882.4560
Predicate Devices:
- Navitrack System -- Optical TKR CT-Less; from Orthosoft Inc; 510(k) # K021760 2) Navitrack® System – S&N Image Free Knee; from Orthosoft Inc; 510(k) # K043536
Device Description:
Identically as in the predicates, the Navitrack System - OS Knee Universal device consists of software, a computer workstation, an optical tracking system, surgical instruments, and tracking accessories, designed to assist the surgeon in the placement of Total Knee Replacement (TKR) components. Tracking devices are incorporated with given surgical instruments, as well as on to fixation bases that attach to each of the femur and tibia, such to allow the ability to track and display to the user their respective positions intra-operatively. The femur and tibia are displayed to the user in the form of their main alignment axes. The alignment axes are determined and recorded intraoperatively by identifying the key anatomical references that are used clinically to align and position the TKR components. The instruments are schematically represented.
The main modifications to the predicates are to incorporate a new set of instruments with universal implant instrument interface features along with corresponding software changes such that the application can be compatible to track a variety of TKR implant lines.
Indications for Use / Intended Use:
The Navitrack® System – OS Knee Universal is indicated for use as a stereotaxic instrument to assist in the positioning of Total Knee Replacement components intraoperatively.
It is a computer controlled image-guidance system equipped with a three-dimensional tracking sub-system. It is intended to assist the surgeon in determining reference
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alignment axes in relation to anatomical landmarks, and in precisely positioning the alignment instruments relative to these axes by displaying their locations.
This is identical to the predicates.
Technological Comparisons to the Predicate:
The fundamental scientific technology of the predicates is unchanged. The intended use, the indications, along with the main operating principle and control mechanism, are maintained in the proposed device to perform the same surgery to provide the same image guidance assistance in the placement of TKR orthopedic implants. The main changes from the predicates generally included secondary engineering and software modifications in relation to including instrumentation with universal interface features such that they can attach to, and track, the cutting guides of the implant systems. This is opposed to instruments which were specific to given implants in the predicates. In addition, software modifications were involved with respect to improving the user interface, to improving the joint laxity information for ligament balance assistance, and, in combination with instrument changes, to allowing for instruments with multifaced trackers, and to allowing for calibration and measurement functions being combined into a single instrument.
Performance Data:
Non-clinical tests were performed to assess that no new safety and efficacy issues were raised in the device. These included tests and analyses to verify that the accuracy and performance of the system was adequate for its intended use and not reduced in comparison to the predicates.
Conclusion:
The information and data provided in this 510(k) Premarket Notification established that the Navitrack System - OS Knee Universal Knee device is substantially equivalent to the predicates.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular fashion around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 8 2006
ORTHOsoft Inc. c/o Mr. Christopher McLean, Eng. Regulatory Affairs & Quality Management Director 75 Queen Street, - Suite 3300 Montreal, Quebec Canada H3C 2N6
Re: K060336
Trade/Device Name: Navitrack® System - OS Knee Universal Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: March 28, 2006 Received: March 29, 2006
Dear Mr. McLean
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above 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 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) 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 or any Federal 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
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Page 2 - Mr. Christopher McLean, Eng.
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. 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,
e.mall
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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8060336 510(k) Number:
Device Name: Navitrack® System - OS Knee Universal
Indications for Use.
The Navitrack® System - OS Knee Universal is indicated for use as a stereotaxic instrument to assist in the positioning of Total Knee Replacement components intraoperatively.
It is a computer controlled image-guidance system equipped with a threedimensional tracking sub-system. It is intended to assist the surgeon in determining reference alignment axes in relation to anatomical landmarks, and in precisely positioning the alignment instruments relative to these axes by displaying their locations.
Prescription Use V (per 21CFR 801.109) OR
Over-the-Counter Use
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) 200 -Off) 29 Division of General, Restorative. and Neurological Devices
KO60336 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).