(10 days)
Orthoview™ is indicated for use when a suitably licensed and qualified healthcare professional requires access to medical images with the intention of using such images, in conjunction with templates for prosthetic devices, for the purposes of choosing the nature and characteristics of the prosthetic device to be used when planning a potential surgical procedure.
Orthoview™ is a software device that permits the orthopedic surgeon to pre-plan surgical procedures by permitting image viewing and manipulation and prosthetic template overlay within a PACS workstation or standalone environment.
The Orthoview™ device, a software for pre-operative surgical planning using digital prosthetic template overlay, was evaluated for its performance.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for Orthoview™ were established implicitly through a comparison to traditional hand-scoring templating methods. The device was deemed acceptable if it demonstrated "similar accuracy" to these traditional methods.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Similar accuracy to traditional templating methods. | The comparison concluded that "Orthoview™ provides an accurate alternative to traditional templating methods" and offers "similar accuracy" to these methods for determining prosthetic size. |
| Provide an alternative to traditional templating. | The study confirms that Orthoview™ "provides an accurate alternative to traditional templating methods." |
2. Sample Size and Data Provenance for the Test Set
- Sample Size: Not explicitly stated. The document mentions "a retrospective technique of comparing the performance of 'templating' using a hand-scoring method versus the scoring achieved by Orthoview™," implying a test set of some size was used but the specific number of cases or images is not provided.
- Data Provenance: Retrospective. The study utilized a "retrospective technique." The country of origin for the data is not specified.
3. Number of Experts and Qualifications for Ground Truth of Test Set
- Number of Experts: Not explicitly stated, but the assessment was "carried out by experienced healthcare professionals."
- Qualifications of Experts: Described as "experienced healthcare professionals." More specific qualifications (e.g., number of years of experience, specific specialty like orthopedic surgeon) are not provided.
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly stated. The document describes a comparison between "hand-scoring method versus the scoring achieved by Orthoview™," implying a direct comparison without detailing a specific adjudication process for discrepancies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- A MRMC comparative effectiveness study was not explicitly reported. The document focuses on the performance of the device itself compared to traditional methods, rather than
human readers using AI vs. without AI assistance.
6. Standalone (Algorithm Only) Performance
- A standalone performance study was implicitly done. The study compared the "scoring achieved by Orthoview™" against a hand-scoring method, suggesting an evaluation of the algorithm's output independently, even if human interaction is required for its use. The device is a "software device" that permits "image viewing and manipulation and prosthetic template overlay," implying the algorithm generates the templating suggestion.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth was established by "the actual assessment and determination of prosthetic size using traditional templating methods using X-Ray film and template overlay" (referred to as "hand-scoring"). This can be categorized as expert consensus based on traditional methods.
8. Sample Size for the Training Set
- Sample Size: Not applicable/not provided. As a templating and overlay software, and given the release date (2003), it's highly probable that Orthoview™ relied on predefined algorithms and templates rather than a machine learning model requiring a distinct training set. The descriptions focus on its functionality and comparison to traditional methods. If an internal development set was used, it is not mentioned.
9. How Ground Truth for the Training Set Was Established
- How Ground Truth Was Established: Not applicable/not provided, as no training set is mentioned or implied for an AI/ML model for this device. The software likely implements rules and calculations for scaling and overlay, with templating designs provided by prosthetic manufacturers.
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K03 2401
AUG 1 4 2003
510k Summary of Safety and Effectiveness
| Date of Submission | 9th June 2003 |
|---|---|
| Submitter Name and Address | Meridian Technique Ltd |
| Pinewood | |
| Chineham Business Park | |
| Basingstoke | |
| Hampshire | |
| RG24 8AL | |
| Great Britain | |
| Telephone | 011 44 1256 698007 |
| Fax | 011 44 1256 698233 |
| Official CorrespondentName and Address | Mr Anthony ThorneOmsbar LtdUnit 10 Harrier ParkHawksworthSouthmead Industrial EstateDidcotOxfordshireOX11 7PLGreat Britain |
| Telephone | 011 44 1235 817758 |
| Fax | 011 44 1235 815183 |
| Classification Name | Image Processing System |
| Common Name | Picture Archiving and Communication (PACS)System |
| Proprietary Name | Orthoview™ |
| Predicate Device | 510k reference K020995 |
Substantial equivalence is claimed between Orthoview™ and the templating, overlaying and image viewing elements only of:
eFilm Workstation with Modules eFilm Medical inc 500 University Avenue Suite 300 Toronto Ontario - Canada M5G 1V7
| Meridian Technique LtdOrthoview™ 510k Notification | Section Number5 | Total Pages inSection3 | Page Number inSection1 |
|---|---|---|---|
| -------------------------------------------------------- | --------------------- | -------------------------------- | -------------------------------- |
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Device Description - Orthoview™ is a software device that permits the orthopedic surgeon to pre-plan surgical procedures by permitting image viewing and manipulation and prosthetic template overlay within a PACS workstation or standalone environment.
Intended Use - The Orthoview™ system is designed with the intention that licensed medical professionals can access digitised medical X-Ray images in DICOM or other formats obtained from a variety of modalities such as PACS systems, X-Ray digitisers etc.
This permits the review of such images and allows the overlay of digitised images of templates for prosthetic devices thereby providing an altemative to traditional means of optically viewing processed X-Ray films overlaid with the acetate templates of such prostheses supplied by the prosthetic manufacturer.
Orthoview™ provides the means of recording, storing and retrieving the templating process steps performed by the licensed medical professional when assessing the optimum prosthetic device for a particular patient.
The Orthoview™ system does not have any function such as image acquisition, image storage etc, this is the responsibility of the systems alongside which Orthoview™ operates. The Orthoview™ system does not specify the requirements for the prosthetic template - this is the responsibility of the prosthetic manufacturer.
Assessment of Non-clinical Performance Data
The comparison of intended performance versus actual performance was carried out by experienced healthcare professionals using a retrospective technique of comparing the performance of 'templating' using a hand-scoring method versus the scoring achieved by Orthoview™
The hand-scoring carried out was the actual assessment and determination of prosthetic size using traditional templating methods using X-Ray film and template overlay versus the template size suggested by Orthoview™. The outcome of the comparison was that Orthoview™ provides an accurate alternative to traditional templating methods.
Conclusions of the non-clinical tests
Using a digital templating system such as Orthoview™™ avoids unnecessary hard copying and also provides other benefits such as the ability to save the templating outcome in the patients electronic record, the templates are never lost or damaged and are readily available anywhere on the PACS network.
Using Orthoview™ provides an alternative to traditional templating methods with similar accuracy and can be used to augment standard PACS functionality to provide the required orthopaedic preoperative planning functionality.
Meridian Technique Ltd
Orthoview™ 510k Notification
| Section Number | 5 |
|---|---|
| Total Pages in Section | 3 |
| Page Number in Section | 2 |
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| Comparison of Technological Characteristics | ||
|---|---|---|
| Characteristic | Predicate Device | Orthoview™ |
| Computer | PC Workstation. | PC compatible computer. |
| Availability of Device | Launched from within theeFilm Workstation™ | Can be configured to belaunched from within aworkstation environmentor as a standalone PCapplication. |
| Source of images | Receive digital images fromvarious sources. | Same. |
| Processing of Image | Scaling of image facility. | Same. |
| Superimposing digitalProsthetic Templates | Permits Overlay of template. | Same. |
| Permits automatic scaling. | Same. | |
| Interactive positioning ofTemplate. | Same. | |
| Interactive sizing oftemplate. | Same. | |
| Permits Template rotation. | Same. | |
| Permits mechanical linkingof prosthetic components. | Same. | |
| Provides templating supportfrom prostheticmanufacturers. | Same. | |
| Preoperative Planning | Permitted. | Same. |
| Patient Contact &Control of LifeSustaining Devices | None. | Same. |
| Human interventionfor interpretation ofimages | Permits physicianintervention. | Requires physicianintervention. |
| Meridian Technique LtdOrthoview™ 510k Notification | Section Number | Total Pages inSection | Page NumberSection |
|---|---|---|---|
| 5 | 3 | 3 |
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the edge. Inside the circle is an abstract image of an eagle's head and three lines representing the eagle's wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 4 2003
Omsbar Ltd. % Ms. Pamela Gwynn Principal Engineer Underwriters Laboratories, Inc. 12 Laboratory Drive P.O. Box 13995 Research Triangle Park, NC 27709
Re: K032401
Trade/Device Name: Orthoview™ Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communication system Regulatory Class: II Product Code: 90 LLZ Dated: July 16, 2003 Received: August 4, 2003
Dear Ms. Gwynn:
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 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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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 one of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Ko 3 2401
Indications for Use
Orthoview™ is indicated for use when a suitably licensed and qualified healthcare professional requires access to medical images with the intention of using such images, in conjunction with templates for prosthetic devices, for the purposes of choosing the nature and characteristics of the prosthetic device to be used when planning a potential surgical procedure.
Prescription Use
David A. Sezman
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
| Meridian Technique LtdOrthoview™ 510k Notification | Section Number | Total Pages inSection | Page Number inSection |
|---|---|---|---|
| 1 | 6 | 6 |
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).