(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 TM 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 key 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 provided FDA 510(k) summary for the Navitrack™ System - Total Hip Replacement CT-Free does not contain explicit acceptance criteria or a detailed study that proves the device meets those criteria in the format requested.
The document is a premarket notification for a medical device seeking substantial equivalence to a predicate device. It focuses on demonstrating that the modifications to the predicate device (adding femoral tracking capabilities) do not raise new safety or efficacy issues and that the fundamental technology remains the same.
Here's an breakdown of the information that can be extracted and the information that is not present based on your prompt:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated. The document indicates "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 is a general statement, not a quantifiable criterion.
- Reported Device Performance: Not explicitly provided with numerical values. The conclusion states the device is "substantially equivalent" and implies adequate accuracy and performance, but no specific metrics (e.g., accuracy, precision, sensitivity, specificity) are reported.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not mentioned.
- Data Provenance: Not mentioned (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not mentioned. The device's function involves a surgeon (user) identifying and digitizing key anatomical landmarks. Therefore, the "ground truth" during operation relies on the surgeon's input, but for formal testing, details about expert involvement are absent.
4. Adjudication Method for the Test Set:
- Not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC study is mentioned. The document is for a computer-assisted surgical navigation system, not an imaging diagnostic device typically requiring MRMC studies for reader performance.
6. Standalone (Algorithm Only) Performance Study:
- The document describes "non-clinical tests" to verify accuracy and performance. While this implies a standalone assessment of the system's ability to track and display positions, no specific quantitative results or details of such a study are provided.
7. Type of Ground Truth Used:
- The system itself determines alignment axes based on "user-identified anatomical landmarks." For non-clinical testing, the "ground truth" would likely involve highly precise measurements using phantoms or cadaveric models, but this is not detailed. The document does not specify the ground truth used for performance assessment.
8. Sample Size for the Training Set:
- Not mentioned. Surgical navigation systems like this typically rely on pre-programmed anatomical models and algorithms rather than a "training set" in the machine learning sense for image recognition. The "training" would be in the form of algorithm development and refinement, not typically dataset-driven.
9. How the Ground Truth for the Training Set Was Established:
- Not mentioned, as the concept of a "training set" in the machine learning context isn't directly applicable or described here.
In summary:
The provided 510(k) summary focuses on demonstrating substantial equivalence based on technological comparisons and a general statement about non-clinical testing for accuracy and performance for "intended use." It lacks the detailed quantitative performance data, specific acceptance criteria, and study methodologies typically found in submissions for AI/ML-driven diagnostic devices or those requiring extensive clinical validation with detailed ground truth establishment. The nature of this device (a surgical navigation system) means its "performance" is often evaluated differently than a diagnostic imaging device.
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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS Navitrack™ System - Total Hip Replacement CT-Free
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: September 19, 2003
Device Trade Name: Navitrack TM 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 TM 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 key 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 Hip 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 100 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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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 2 2004
Mr. Christopher McLean RA/OA Director Orthosoft, Inc. 75, Queen Street, Suite 3300 Montréal, Quebec Canada H3C 2N6
Re: K041369
K041369
Trade/Device Name: Navitrack™ System – S & N Image Free Hip Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: May 21, 2004 Received: May 24, 2004
Dear Mr. McLean:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 310(x) prematically equivalent (for the indications
referenced above and have determined the devices merketed in interstate referenced above and have determined the devices marketed in interstate for use stated in the encrosule) to regally maneves por the Medical Device Ameralments, or to
commerce prior to May 28, 1976, the enactment date of the Foderal Food. Drug commerce prior to May 28, 1970, the chacatience with the provisions of the Federal Food, Drug, devices that have been recuired in accordance with as proval approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a providions of the Act. The and Cosment Act (Act) that to not require approvate of the general controls of the Act. The You may, inerefore, market the devices, basjest to the may be supportunent in the specifically and general controls provisions of the rice 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 if your device is classifica (seculove) the existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations FDA may be subject to such adultional controls. Linbang may of the 21, Parts 800 to 898. In addition, FDA may be found in the Ood of Peachar Sincerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualted of a basedianal with other requirements of the Act
that FDA has made a determination that your device complies with other requirements that FDA has made a decemmanon that your steered by other Federal agencies. You must of any Federal Statutes and regulations adminities or registration and listing (21 l comply with an the Act 3 requirements, me; good manufacturing practice requirements as set CFR Part 807), labeling (21 CFR Part 801), good manart 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and 16 am 1960 form in the quality systems (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) I ms letter will anow you to obgin manieting your and equivalence of your device to a legally premarket nothleadon: "The FDA midning of castification 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 If you desire specific advice 101 Jour as 1) 594-4659. Also, please note the regulation entitled, Contact the Office of Companisemarket notification" (21CFR Part 807.97). You may obtain Misoranung of Tereforee to prenezionsibilities under the Act from the Division of Small other general information on your response Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Octass http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
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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510(k) Number: |<o4 | 369
Device Name: Navitrack TM System - S&N Image Free Hip
Indications for Use:
The Navitrack The System - S&N Image Free Hip 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.
Prescription Use_ √ (per 21CFR 801.109)
OR
Over-the-Counter Use
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nuriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K64/369
§ 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).