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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.

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.

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

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.

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