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.

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.

AI/ML Overview

The provided text describes the Orthoview™ device, a Picture Archiving and Communications (PACS) System. However, it explicitly states that clinical testing was considered unnecessary, and instead, non-clinical verification and validation were performed. Therefore, there is no information in the provided text regarding acceptance criteria based on clinical performance or a study demonstrating the device meets such criteria in a clinical setting.

The information below is derived from the non-clinical assessment as described in the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Functionality)	Reported Device Performance
Patient and Procedure Selection	Confirmed as operating according to specified requirements.
Image Scaling	Confirmed as operating according to specified requirements.
Procedure Planning	Confirmed as operating according to specified requirements.
Templating and Trauma (Fracture) reduction	Confirmed as operating according to specified requirements.
Osteotomy and alleviation of congenital deformity	Confirmed as operating according to specified requirements.
Committing and Saving operating session Data	Confirmed as operating according to specified requirements.
Compilation and Printing of associated Reports	Confirmed as operating according to specified requirements.

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" in terms of patient data or images. The testing was non-clinical verification and validation of software functions. It does not mention the number of images or cases used for this internal testing, nor their provenance. The device "Receives X-Ray images in a digital format from third party X-Ray machines/ X-Ray digitisers or PACS systems," but the testing described does not detail specific datasets used.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The ground truth for the non-clinical functional testing appears to be the "specified requirements" of the software itself. There is no mention of experts establishing ground truth for a clinical test set because no clinical testing was performed.

4. Adjudication method for the test set

Not applicable. There was no clinical test set requiring adjudication. The non-clinical verification and validation involved confirming software functions operated according to specified requirements.

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

No MRMC study was performed. The device is a PACS system with templating tools, and the submission explicitly states clinical testing was unnecessary.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The context describes "non-clinical tests" where "Verification and Validation of Orthoview™ indicates that the requirements for intended use and associated performance characteristics are satisfied." This would inherently involve testing the algorithm's functions (e.g., image scaling, templating overlay, data saving) without a human-in-the-loop for clinical decision-making evaluation. The device's intended use, however, always involves a "suitably licensed and qualified healthcare professional" for interpretation and planning.

7. The type of ground truth used

For the non-clinical testing, the "ground truth" was the pre-defined software requirements and specifications. The tests aimed to confirm that the software functions (e.g., patient selection, image scaling, templating, data saving/printing) operated precisely as designed and expected by the developers.

8. The sample size for the training set

Not applicable. The document does not describe the use of machine learning or AI models requiring a training set in the contemporary sense. The device is described as a PACS system with templating and processing capabilities, not a diagnostic AI algorithm.

9. How the ground truth for the training set was established

Not applicable, as there was no described training set.

Summary

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KO63327

510k Summary of Safety and Effectiveness

Date of Submission	1st June 2006.
Submitter Name and Address	Meridian Technique Ltd2 Venture RoadChilworth Science ParkSouthamptonHampshireSO16 7NPGreat Britain
Telephone	011 44 2380 762 500
Fax	011 44 2380 762 550
Official Correspondent Name and Address	Mr Anthony ThorneOmsbar LtdUnit 7 Building T2Area 200Milton ParkAbingdonOX14 4TAGreat 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

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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.

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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

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	Comparison of Technological Characteristics
Characteristic	Orthoview™	Predicate Device
Computer	Personal Computer orWorkstation/Server	Same
Availability ofDevice	Is used for planningorthopedic procedures usingtemplates and wizards in theareas of Prostheticplacement, Trauma andOsteotomy	Same
Means ofcollecting data	Obtained from pre-obtaineddigital images via PACSsystem	Same
Processing ofdata	The software processes datato provide prosthetic andfixing template, trauma andosteotomy overlay andplacement	Same
Patient Contact	No intentional patientcontact	Same
Control of LifeSustainingDevices	None	Same.
Humanintervention for	Requires physicianintervention.	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

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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 .

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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

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Indications for Use

510(k) Number (if known):

Device Name:

Orthoview™

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 ________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 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).