(29 days)
The Navitrack™ System - Total Hip Replacement CT-Free is indicated for use as a stereotaxic instrument to assist in the positioning of hip replacement components. It is a computer controlled image-guidance system equipped with a three-dimensional tracking sub-system. It is intended to assist in precisely positioning hip replacement components intra-operatively by displaying their positions relative to the joint's alignment axes as based on user-identified anatomical landmarks.
Identically as in the predicate, the Navitrack™ System – Total Hip Replacement CT-Free device consists of a software-driven workstation, an optical tracking system, surgical instruments, and tracking accessories, designed to assist the surgeon in the placement of Total Hip Replacement (THR) components. Tracking devices are incorporated with given surgical instruments, as well as on to fixation bases that attach to the pelvis, such to allow the ability to track and display to the user their respective positions intraoperatively. The pelvis is displayed to the user in the form of its main alignment axes. The alignment axes are determined and recorded intra-operatively by identifying the kev anatomical references that are used clinically to align and position the THR components. The instruments are schematically represented. The modifications to the predicate are to additionally track the femur and femoral instrumentation similarly as is done for the pelvis, in order to also assist in the placement of the THR components for the femur.
The Navitrack™ System – Total Hip Replacement CT-Free is a surgical navigation system that assists in the placement of Total Hip Replacement (THR) components.
Here's an analysis of its performance data based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Comments |
|---|---|---|---|
| Accuracy and Performance | Adequacy of depicting the positioning of femoral THR component for intended use. | Assessed to be "adequate for its intended use." | No specific quantitative metrics (e.g., error margins, precision) are provided for this system in the available text. The assessment refers to the femoral component, which is the new addition compared to the predicate. |
| Safety and Efficacy | No new safety and efficacy issues raised with modifications. | "Non-clinical tests were performed to assess that no new safety and efficacy issues were raised in the device." | General statement; no specific testing details or results are outlined. |
| Substantial Equivalence | Equivalence to predicate device (Navitrack System™ - Total Hip Replacement CT-Free Cup, K030827). | Determined to be "substantially equivalent" by the FDA. | The device is a modification of the predicate, extending its capabilities to the femur. The fundamental technology is unchanged. |
2. Sample Size Used for the Test Set and Data Provenance:
The document explicitly states that "Non-clinical tests were performed." It does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). Given the nature of a non-clinical test for a surgical navigation system, it likely involved bench testing or cadaveric studies, rather than patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not mention the use of experts to establish a ground truth for the test set. The "non-clinical tests" likely focused on technical performance and accuracy measurements rather than expert clinical assessment of outcomes.
4. Adjudication Method for the Test Set:
Not applicable, as no expert-based ground truth establishment is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No mention of a multi-reader multi-case (MRMC) comparative effectiveness study. The document focuses on the technical performance and substantial equivalence to a predicate, not on a direct comparison of human reader performance with and without AI assistance.
6. Standalone Performance:
Yes, a standalone (algorithm only without human-in-the-loop performance) study was inferred from the "Non-clinical tests were performed to assess that no new safety and efficacy issues were raised in the device. They consisted in verifying that the accuracy and performance of the system in depicting the positioning of the femoral THR component was adequate for its intended use." This indicates the system's ability to accurately depict component positioning, which is an intrinsic function of the algorithm.
7. Type of Ground Truth Used:
The type of ground truth used for the non-clinical tests is not explicitly stated but can be inferred as technical or metrological ground truth. For a navigation system, this would typically involve:
- Precise physical measurements: Using highly accurate measurement tools (e.g., CMM, optical trackers, calibrated jigs) to determine the true position and orientation of components in a controlled environment.
- Geometric models: Comparing the system's output to known, precisely defined geometric models of the pelvic and femoral anatomy and the THR components.
It is not expert consensus, pathology, or outcomes data, as these are typically associated with clinical studies or diagnostic devices.
8. Sample Size for the Training Set:
The document does not provide any information about a training set size. This device describes a "software-driven workstation" and an "optical tracking system" that uses "user-identified anatomical landmarks" to determine alignment axes. This suggests a rule-based or model-based system, rather than a machine learning model that would typically require a distinct training set. The "software was correspondingly modified to handle the added capabilities" rather than "retrained."
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no mention of a traditional machine learning training set or associated ground truth establishment process. The "ground truth" for the system's functionality is likely embedded in the engineering design, calibration, and pre-defined algorithms for geometric calculations based on digitized landmarks.
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OCT 2 1 2003
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS Navitrack™ System - Total Hip Replacement CT-Free
ORTHOsoft Inc. Applicant: 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: September 19, 2003
Device Trade Name: Navitrack™ System - Total Hip Replacement CT-Free
Device Classification Name: Stereotaxic Instrument (84 HAW); 21 CFR § 882.4560
Predicate Device:
Navitrack System™ -- Total Hip Replacement CT-Free Cup, from Orthosoft Inc. 510(k) #K030827
Device Description:
Identically as in the predicate, the Navitrack™ System – Total Hip Replacement CT-Free device consists of a software-driven workstation, an optical tracking system, surgical instruments, and tracking accessories, designed to assist the surgeon in the placement of Total Hip Replacement (THR) components. Tracking devices are incorporated with given surgical instruments, as well as on to fixation bases that attach to the pelvis, such to allow the ability to track and display to the user their respective positions intraoperatively. The pelvis is displayed to the user in the form of its main alignment axes. The alignment axes are determined and recorded intra-operatively by identifying the kev anatomical references that are used clinically to align and position the THR components. The instruments are schematically represented.
The modifications to the predicate are to additionally track the femur and femoral instrumentation similarly as is done for the pelvis, in order to also assist in the placement of the THR components for the femur.
Indications for Use / Intended Use:
The Navitrack™ System - Total Hip Replacement CT-Free is indicated for use as a stereotaxic instrument to assist in the positioning of hip replacement components.
It is a computer controlled image-guidance system equipped with a three-dimensional tracking sub-system. It is intended to assist in precisely positioning hip replacement components intra-operatively by displaying their positions relative to the joint's alignment axes as based on user-identified anatomical landmarks.
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This is identical to the Navitrack System™ - Total Hip Replacement CT-Free Cup predicate.
Technological Comparisons to the Predicate:
The comparisons showed that the proposed device is substantially equivalent to the predicate, the Navitrack System - Total Hin Replacement CT-Free Cup. It is a modification to the predicate. The fundamental scientific technology of the Navitrack predicate is unchanged. It utilizes the same workstation and tracking technology. The modification consists in extending the capabilities of the predicate to also track the femur and its instrumentation in addition to the pelvis and its instrumentation in the predicate. Similarly as for the pelvis in the predicate, it employs the same method of having the user identify and digitize key landmarks from which the system determines femoral alignment axes relative to which the user can verify the placement of the femoral THR components. The software was correspondingly modified to handle the added capabilities, and the instrument set extended to include femoral instrumentation.
Performance Data:
Non-clinical tests were performed to assess that no new safety and efficacy issues were raised in the device. They consisted in verifying that the accuracy and performance of the system in depicting the positioning of the femoral THR component was adequate for its intended use.
Conclusion:
The information and data provided in this 510(k) Premarket Notification established that the Navitrack " System - Total Hip Replacement CT-Free device is substantially equivalent to the Navitrack System™ - Total Hip Replacement CT-Free Cup predicate.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
OCT 2 1 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Christopher McLean Regulatory Affairs and Quality Assurance Manager Orthosoft, Inc. 75 Queen Street, Suite 3300 Montreal, Quebec Canada, H3C 2N6
Re: K032917
Trade/Device Name: Navitrack™ System – Total Hip Replacement CT-Free Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: September 19, 2003 Received: September 22, 2003
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. Iisting 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 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 - Mr. Christopher McLean
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 (301) 594-4659. 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,
L. Mark A. Milburn
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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K032917 510(k) Number:
· Device Name: Navitrack™ System – Total Hip Replacement CT-Free
Indications for Use:
The Navitrack™ System – Total Hip Replacement CT-Free is indicated for use as a stereotaxic instrument to assist in the positioning of hip replacement components. It is a computer controlled image-guidance system equipped with a threedimensional tracking sub-system. It is intended to assist in precisely positioning hip replacement components intra-operatively by displaying their positions relative to the joint's alignment axes as based on user-identified anatomical landmarks.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(per 21CFR 801.109)
OR
Over-the-Counter Use
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number. K032917
12
§ 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).