(76 days)
Bone Track software provides pre-operative digital implant templating to facilitate the selection and ordering of orthopedic implants. The software allows for a semi-automatic ordering process, by printing a pick list, which can be used by the physician to order orthopedic components directly from the manufacturer. The software also tracks those components and provide post-operative patient follow-up all in a digital environment. The software will be provided on a stand-alone or hospital network workstation.
The VIDAR Bone Track System is comprised of three modules: The Pre-Operative Module, the Tracking Module and the Post-Operative Module
In the Pre-Operative Module, the patient's digital x-ray is then loaded into the software, either from the hospital network, via a disk or from a digital scanner. The x-ray image is located in the system using standard digital measuring tools. The physician chooses which orthopedic device to template. The user then utilizes the software tools to overlay pre-loaded digital templates onto the x-ray image to allow for proper prosthetic selection. Once the physician has selected all of the appropriate prosthetic components, the software generates a pick list to allow for easy ordering of parts. This list can be printed out.
The VIDAR Bone Track System allows for tracking of orthopedic devices used during patient surgery. Using a PDA and a bar code reader, the devices' bar codes are scanned. Device manufacturer. device part number, lot number, and serial number are captured.
The VIDAR Bone Track System's Post-Operative Module allows the physician to track migration or other changes to the implant in the bones' structures for a specific patient over time using industry-accepted algorithms. The physician can use measurements include stem dislocation, wear circle cup and wear elliptic cup. Bone Track is not a diagnostic tool. It is to be used by the physician as an assistance tool.
The Vidar Bone Track System Software, a device designed for pre-operative digital implant templating and post-operative tracking of orthopedic implants, underwent "bench testing" to ensure it met its intended performance.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Device performs as intended for: | All testing demonstrated satisfactory performance of the device. |
| - Pre-operative digital implant templating (selection and ordering of orthopedic implants) | Satisfactory performance |
| - Semi-automatic ordering process (printing a pick list) | Satisfactory performance |
| - Tracking of orthopedic components | Satisfactory performance |
| - Post-operative patient follow-up (tracking migration or changes to implant using industry-accepted algorithms) | Satisfactory performance |
2. Sample Size Used for the Test Set and Data Provenance:
The document broadly states "Bench testing was performed." It does not specify a distinct "test set" in terms of patient data or images. The testing appears to be focused on the software's functional capabilities rather than its performance on a dataset of patient cases. Therefore, information regarding sample size, country of origin, or retrospective/prospective nature of a patient dataset is not provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
As no specific test set based on patient cases or outcomes is described, there is no mention of experts establishing ground truth or their qualifications. The "bench testing" likely involved internal software validation and verification by the company's development team or independent testers against functional specifications.
4. Adjudication Method for the Test Set:
Given the nature of "bench testing" without a specific patient-based test set, an adjudication method for reconciling expert opinions is not applicable and therefore not described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not performed. The document focuses on the device's functional performance and its substantial equivalence to a predicate device, not on its comparative effectiveness with human readers or the effect size of AI-assisted improvements.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The description implies that the software's functionality was tested in a standalone manner as part of the "bench testing." However, the device is explicitly intended to be an "assistance tool" for physicians, meaning human-in-the-loop interaction is inherent to its intended use. The performance data provided does not differentiate between standalone algorithmic performance and human-in-the-loop performance.
7. The Type of Ground Truth Used:
For the "bench testing," the "ground truth" would have been the functional specifications and design requirements of the software. Each feature, from digital templating to pick list generation and tracking capabilities, would have been tested against its intended design and expected output. There is no mention of ground truth derived from expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set:
The document does not provide information about a training set. The Vidar Bone Track System Software appears to be a rule-based or template-driven system rather than a machine learning model that would require a distinct training set for algorithm development.
9. How the Ground Truth for the Training Set was Established:
As no training set is mentioned or implied for this device, information on how its ground truth was established is not provided.
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Company:
Vidar Systems Corporation 460 Springpark Place Herndon, VA 20170
Contact:
MEDIcept 200 Homer Ave Ashland, MA 01721 F. David Rothkopf
Date Prepared:
December 4, 2002
Name of Device:
VIDAR Bone Track System Software
Predicate Device:
Agfa IMPAX OT3000 Orthopedic Display Station
Intended Use:
Bone Track software provides pre-operative digital implant templating to facilitate the selection and ordering of orthopedic implants. The software allows for a semi-automatic ordering process, by printing a pick list, which can be used by the physician to order orthopedic components directly from the manufacturer. The software also tracks those components and provide post-operative patient follow-up all in a digital environment. The software will be provided on a stand-alone or hospital network workstation.
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Device Description:
The VIDAR Bone Track System is comprised of three modules: The Pre-Operative Module, the Tracking Module and the Post-Operative Module
In the Pre-Operative Module, the patient's digital x-ray is then loaded into the software, either from the hospital network, via a disk or from a digital scanner. The x-ray image is located in the system using standard digital measuring tools. The physician chooses which orthopedic device to template. The user then utilizes the software tools to overlay pre-loaded digital templates onto the x-ray image to allow for proper prosthetic selection. Once the physician has selected all of the appropriate prosthetic components, the software generates a pick list to allow for easy ordering of parts. This list can be printed out.
The VIDAR Bone Track System allows for tracking of orthopedic devices used during patient surgery. Using a PDA and a bar code reader, the devices' bar codes are scanned. Device manufacturer. device part number, lot number, and serial number are captured.
The VIDAR Bone Track System's Post-Operative Module allows the physician to track migration or other changes to the implant in the bones' structures for a specific patient over time using industry-accepted algorithms. The physician can use measurements include stem dislocation, wear circle cup and wear elliptic cup. Bone Track is not a diagnostic tool. It is to be used by the physician as an assistance tool.
Technological Characteristics:
The technological characteristics of the new device are the same as those of the predicate device.
Performance Data:
Bench testing was performed to ensure that the device performs as intended. All testing demonstrated satisfactory performance of the device.
This information is provided pursuant to the requirements of the Safe Medical Devices Act of 1990 (SMDA).
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Image /page/2/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 an eagle with three lines representing the wings and head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 0 4 2003
Mr. F. David Rothkopf MEDIcept for Vidar System Corporation 200 Homer Avenue Ashland, Massachusetts 01721
Re: K024171
Trade Name: Vidar Bone Track System Software Regulation Number: 21 CFR 892.1750, 21 CFR 888.4800 Regulation Name: Computed Tomography/X-Ray System, Template for Clinical Use Regulatory Class: II Product Code: JAK, HWT Dated: December 16, 2002 Received: December 18, 2002
Dear Mr. Rothkopf:
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.
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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. 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- _ . 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,
Mark A. Millman
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: K024171
Device Name: Vidar Bone Track System Software
Indications For Use:
Bone Track software provides pre-operative digital implant templating to facilitate the selection and ordering of orthopedic implants. The software allows for a semiautomatic ordering process, by printing a pick list, which can be used by the physician to order orthopedic components directly from the manufacturer. The software also tracks those components and provide post-operative patient follow-up all in a digital environment. The software will be provided on a stand-alone or hospital network workstation.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
to Mark N Milken
" estorative
510(k) Number
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.