(111 days)
The NaviPro™ Knee Software Module is an extension of the NaviPro™ Navigation System whose purpose is to measure the spatial orientation of the resection guides and limb alignment during total knee replacement surgery, and for assessing soft tissue balance and changes in the limb mechanical axis as a result of the knee replacement. General spatial measurements may be made and recorded as deemed necessary by the surgeon user.
The NaviPro™ Knee Software Module is an extension of the previously cleared The Navil Navigation System. It uses an optical localizing camera and infra-red Navil 10 - Navigation 173.60m. 'It ucces an valial position of bones and medical instruments during knee replacements obtained from the system allow for intra-operative assessments of implant position, orientation, and soft-tissue balance.
This 510(k) submission for the NaviPro™ Knee Software Module does not include a study describing acceptance criteria and device performance as typically expected for imaging or diagnostic AI/ML devices. Instead, it focuses on demonstrating substantial equivalence to predicate devices for a surgical navigation system.
Therefore, many of the requested sections regarding acceptance criteria, study design, and ground truth cannot be directly extracted from the provided text.
However, I can provide information based on what is available:
1. A table of acceptance criteria and the reported device performance
The provided document does not contain an explicit table of acceptance criteria or reported device performance metrics in the way one would typically see for an AI/ML diagnostic device (e.g., sensitivity, specificity, AUC). The submission is for a surgical navigation software module, and its "performance" is more about its ability to accurately measure spatial orientation and alignment during knee replacement surgery, rather than a diagnostic output.
The summary of technological characteristics implies performance in terms of:
- Generating the position of tibial and femur resection guides.
- Measuring changes in the mechanical axis of the limb.
- Utilizing infra-red trackers for patient and instrument localization.
- Determining spatial information using trackers and palpated landmarks.
However, no quantitative acceptance criteria or specific performance data (e.g., accuracy in degrees or millimeters) are reported in this document.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a "test set" in the context of validating an algorithm's diagnostic or predictive performance. As a surgical navigation system, its validation would likely involve precision and accuracy testing on models or cadavers, and potentially clinical use observational studies, but details of such studies (including sample sizes or data provenance) are not present here.
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 there's no mention of a "test set" requiring expert ground truth in the provided text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as there's no mention of a "test set" requiring adjudication in the provided text.
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
Not applicable. The NaviPro™ Knee Software Module is a navigation tool for surgeons, not an AI-assisted diagnostic tool that would typically be evaluated with an MRMC study comparing human reader performance with and without AI. It assists the surgeon directly in guiding resections and assessing alignment.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is inherently "human-in-the-loop" as it is a navigation system used by a surgeon during an operation. Its purpose is to provide real-time spatial information to the surgeon, rather than operate autonomously.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The document focuses on the capabilities of the system to provide spatial measurements and guidance, rather than a diagnostic output that would have a "ground truth" established by pathology or expert consensus. The "ground truth" for a navigation system would relate to the physical accuracy of its measurements and guidance relative to a known reference standard (e.g., a highly accurate measuring device), but these details are not provided.
8. The sample size for the training set
The document does not describe a "training set" as it would for an AI/ML algorithm. The device is based on optical tracking and geometric calculations, not on a machine learning model trained on a dataset.
9. How the ground truth for the training set was established
Not applicable, as there's no "training set" in the AI/ML sense described.
Summary of the Device and Submission Context:
The NaviPro™ Knee Software Module is an extension of an existing surgical navigation system. Its function is to provide real-time spatial orientation measurements of resection guides and limb alignment during total knee replacement surgery. It also assists in assessing soft tissue balance and changes in the mechanical axis. The submission focuses on demonstrating substantial equivalence to predicate navigation devices, rather than presenting a performance study with acceptance criteria and ground truth typical for AI/ML diagnostic tools. The technology described relies on optical tracking of infra-red markers and palpated landmarks to determine spatial relationships.
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MAR 1 1 2004
510(k) Summary
| Submitter: | Kinamed, Inc. |
|---|---|
| Address: | 820 Flynn Road |
| Camarillo, CA 93012 | |
| Phone number: | (805) 384-2748 |
| Fax number: | (805) 384-2792 |
| Contact person: | Vineet K. Sarin Ph.D. |
| Date prepared: | November 21, 2003 |
| Trade name: | NaviPro™ Knee Software Module |
Substantial equivalence claimed to: 1. OrtholYilot® (K003347) filed by Kinaned Inc. 2. NaviPro™ (K020764) filed by Kinamed, Inc.
Description:
The NaviPro™ Knee Software Module is an extension of the previously cleared The Navil Navigation System. It uses an optical localizing camera and infra-red Navil 10 - Navigation 173.60m. 'It ucces an valial position of bones and medical instruments during knee replacements obtained from the system allow for intra-operative assessments of implant position, orientation, and soft-tissue balance.
Intended use:
The NaviPro" Knee Software Module is an extension of the NaviPro" Navigation The Navil 10 - Rife® Ourpose is to measure the spatial orientation of the resection guides and System whose parpose is to tinee replacement surgery, and for assessing soft tissue mino angininent daming toan mechanical axis as a result of the knee replacement. General spatial measurements may be made and recorded as deemed necessary by the surgeon user.
Summary of technological characteristics:
Sunlinary of recument generts the position of the tibial and femur resection guides during knee replacement surgery, and measures changes in the mechanical axis of the limb as a result of prosthetic implantation. Pre-operative CT or fluoroscopic imaging the min as a reader of problement patient and computer is established by infra-red 15 untiecessary. The this betrocely attached to the patient and surgical instruments. An felfective trackers that are books is linked to the computer calculates the position and orientation of the trackers.
A calibrated measurement probe is also outfitted with infra-red trackers and can be A canorated measurement prove is allent. NaviPro™ Knee requires only the information provided by the trackers and palpated landmarks to determine the spatial mionnations of the resection guides. joint centers, and mechanical axis.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle with three wavy lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 1 2004
Mr. Vineet K. Sarin, Ph.D. Director of Research and Development Kinamed. Inc. 820 Flynn Road Camarillo, California 93012
Re: K033668
Trade/Device Name: NaviPro™ Knee Software Module Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: January 23, 2004 Received: January 23, 2004
Dear Dr. Sarin:
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 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as sct 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. Vineet K. Sarin, Ph.D.
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,
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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(2) Indications for Use
510(k) Number (if known): K033668
Device Name:
NaviPro™ Knee Software Module
Indications For Use:
The NaviPro™ Knee Software Module is an extension of the NaviPro™ Navigation System whose purpose is to measure the spatial orientation of the resection guides and limb alignment during total knee replacement surgery, and for assessing soft tissue balance and changes in the limb mechanical axis as a result of the knee replacement. General spatial measurements may be made and recorded as deemed necessary by the surgeon user.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of
510(k) Number K033668
§ 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).