Orthoview™ intended use is to enable a suitably licensed and qualified healthcare professional access to medical images with the intention of using such images, in conjunction with templates for prosthetic and fixation devices, for the purposes of choosing the nature and characteristics of the prosthetic/fixation device to be used when planning a potential surgical procedure. In addition, Trauma and Osteotomy modules and Trauma Templates are included to extend the range of functionality available to the healthcare professional.
Device Story
Orthoview™ is a software-based PACS-integrated tool for orthopedic surgical planning. It receives digital X-ray images from third-party PACS or digitizers; processes images via scaling and overlaying manufacturer-specific prosthetic/fixation templates; and provides modules for trauma and osteotomy planning. Operated by qualified healthcare professionals on a PC/workstation, the device enables selection of device sizes and characteristics, generates reports, and archives session data. It facilitates surgical decision-making by allowing clinicians to visualize and plan implant placement pre-operatively. Benefits include improved surgical preparation and traceability of planning decisions. No patient contact occurs; processing is performed post-image acquisition.
Clinical Evidence
Bench testing only. Verification and validation confirmed functionality for patient/procedure selection, image scaling, procedure planning, templating, trauma reduction, osteotomy, and report compilation. No clinical data required due to similarity to predicate.
Technological Characteristics
Software-based PACS-integrated planning tool; runs on standard PC/workstation; processes digital X-ray images; features include image scaling, template overlay, and trauma/osteotomy modules; password-protected access; no patient contact; non-invasive.
Indications for Use
Indicated for use by licensed healthcare professionals to access medical images for surgical planning, specifically for selecting prosthetic and fixation devices using digital templates, including trauma and osteotomy applications.
Regulatory Classification
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.
Special Controls
*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).
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KO63327
## 510k Summary of Safety and Effectiveness
| Date of Submission | 1st June 2006. |
|-------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Submitter Name and Address | Meridian Technique Ltd<br>2 Venture Road<br>Chilworth Science Park<br>Southampton<br>Hampshire<br>SO16 7NP<br>Great Britain |
| Telephone | 011 44 2380 762 500 |
| Fax | 011 44 2380 762 550 |
| Official Correspondent Name and Address | Mr Anthony Thorne<br>Omsbar Ltd<br>Unit 7 Building T2<br>Area 200<br>Milton Park<br>Abingdon<br>OX14 4TA<br>Great Britain |
| Telephone | 011 44 1235 820 401 |
| Fax | 011 44 1235 820 401 |
| Classification and Name | Class II - Picture Archiving and Communications (PACS) System |
| Common Name | PACS System |
| Proprietary Name | Orthoview™ |
| Predicate Device | 510k references K042816 and K032401 |
| Substantial equivalence is claimed between Orthoview™ and : | |
| Manufacturer | Orthocrat Ltd |
| Tradename | TraumaCAD |
Meridian Technique Ltd
Orthoview™ Manufacturer Tradename
,
{1}------------------------------------------------
#### Device Description -
Orthoview™ is intended to provide the following for the Operator (a suitably qualified and trained healthcare professional):
- To be downloaded from the Internet and to be unlocked using a Meridian . Technique Ltd provided key.
- . Grant access rights only to authorized users (via PC password system).
- . Receive X-Ray images in a digital format from third party X-Ray machines/ X-Ray digitisers or PACS systems.
- Process such images securely with respect to patient confidentiality, patient . identification and image integrity.
- . Allow the image to be retrieved for processing as follows:
- Scaling of the image. o
- Selection of appropriate prosthetic and fixing device manufacturer and ୍ size range templates.
- O Overlaying the template on the image and permitting selection of appropriate size of prosthetic/fixing.
- o Provide additional functionality in the form of Trauma and Osteotomy modules
- Print and archive appropriate reports. ୍
- Receive and store templates for prostheses and fixations supplied by ் Meridian Technique Ltd for particular manufacturer's range of products.
- o Provide traceability of operator, date and decisions made.
#### Intended Use -
Orthoview™ intended use is to enable a suitably licensed and qualified healthcare professional access to medical images with the intention of using such images, in conjunction with templates for prosthetic and fixation devices, for the purposes of choosing the nature and characteristics of the prosthetic/fixation device to be used when planning a potential surgical procedure. In addition, Trauma and Osteotomy modules and Trauma Templates are included to extend the range of functionality available to the healthcare professional.
{2}------------------------------------------------
### Assessment of Clinical and Non-clinical Performance Data
Risk analysis indicates that Orthoview™ is identical to the predicate device in the patient environment. Orthoview™ uses similar materials and constructional principles to the predicate device. Due to this similarity, clinical testing of Orthoview ™ is considered unnecessary.
Orthoview ™ processes data in the form of Images collected in the patient environment after the event of actual collection. This non-patient contact processing is described exactly in terms of its software functions and associated Wizards and Templates. It is therefore feasible to verify and validate the functionality of Orthoview ™ outside of the clinical environment. This is the method which has been adopted.
#### Conclusions of the Non-clinical Tests
Verification and Validation of Orthoview ™ indicates that the requirements for intended use and associated performance characteristics are satisfied. In particular, the following functions have been tested and confirmed as operating according to specified requirements.
- . Patient and Procedure Selection
- . Image Scaling
- . Procedure Planning
- . Templating and Trauma (Fracture) reduction
- Osteotomy and alleviation of congenital deformity .
- Committing and Saving operating session Data .
- . Compilation and Printing of associated Reports
{3}------------------------------------------------
| | Comparison of Technological Characteristics | | |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|------------------|--|
| Characteristic | Orthoview™ | Predicate Device | |
| Computer | Personal Computer or<br>Workstation/Server | Same | |
| Availability of<br>Device | Is used for planning<br>orthopedic procedures using<br>templates and wizards in the<br>areas of Prosthetic<br>placement, Trauma and<br>Osteotomy | Same | |
| Means of<br>collecting data | Obtained from pre-obtained<br>digital images via PACS<br>system | Same | |
| Processing of<br>data | The software processes data<br>to provide prosthetic and<br>fixing template, trauma and<br>osteotomy overlay and<br>placement | Same | |
| Patient Contact | No intentional patient<br>contact | Same | |
| Control of Life<br>Sustaining<br>Devices | None | Same. | |
| Human<br>intervention for | Requires physician<br>intervention. | Same. | |
and the comments of the comments of the comments of the comments of the contraction of the contribution of the contribution of the contribution of the contribution of the con
{4}------------------------------------------------
Image /page/4/Picture/1 description: The image shows a logo for the Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" written around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Merdian Technique, Ltd. % Mr. Neil E. Devine, Jr. Responsible Third Party Official Intertek Testing Services NA, Inc. 2307 East Aurora Rd., Unit B7 TWINSBURG OH 44087
NOV 2 2 2006
Re: K063327
Trade/Device Name: Orthoview™ Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 2, 2006 Received: November 3, 2006
Dear Mr. Devine:
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 (Premarket Approval), 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.
Image /page/4/Picture/10 description: The image is a black and white circular logo. The logo contains the text "1906-2006" at the top, "PA" in the center, and "Centennial" at the bottom. There are three dots below the word "Centennial". The logo appears to be a commemorative emblem for a centennial celebration of the organization "PA" from 1906 to 2006.
diana Public .
{5}------------------------------------------------
Page 2 -
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 one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |
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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{6}------------------------------------------------
# Indications for Use
510(k) Number (if known):
Device Name:
# Orthoview™
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 and fixation devices, for the purposes of choosing the nature and characteristics of the prosthetic/fixation device to be used when planning a potential surgical procedure. In addition, Trauma and Osteotomy modules and Trauma Templates are provided to extend the range of functionality available to the healthcare professional.
1063327
AND/OR Over-The-Counter Use Prescription Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of of 1
Nancy C. Brogdon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
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Learn the FDA Browser
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
