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The OrthoVis Web Portal is intended for use as a software interface and for the transfer of imaging information from a medical scanner such as a CT scanner. It is also intended as pre-operative software for simulating implant placement and surgical treatment options. The OrthoVis Web Portal is intended for use with the Glenoid Intelligent Reusable Instrument system and with the OrthoVis Preoperative Plan. It is also intended for use with the Arthrex and DePuy shoulder replacement implant systems listed below.

• · Arthrex Univers Apex
• · Arthrex Univers II
• · Arthrex Univers Revers
• · DePuy Global AP
• DePuy Global StepTech
• · DePuy Delta Xtend Reverse

The Glenoid Intelligent Reusable Instrument System ("Glenoid IRIS") is a patient specific manual instrument system intended for use to facilitate preoperative planning and intraoperative placement of the central glenoid guide pin used in the preparation of the glenoid in total shoulder systems that utilize a central guide pin for preparing the glenoid to receive the glenoid implant.

The OrthoVis Web Portal is composed of software intended for use to facilitate upload of medical images and preoperative planning and plan approval of placement and orientation of Arthrex and DePuy total shoulder replacement systems. Each surgeon user's uploaded images are grouped into cases and associated with that user's profile. Uploaded images can be downloaded from the portal by COS technicians and used to create preoperative plans (see 510(k) K13367 and K151568). The user is then able to login to the OrthoVis Web Portal to review the preoperative plan and either approve or modify the location and/or orientation of the shoulder replacement component and then approved plan is then available to download by COS technicians for further preoperative planning production (see 510(k) K123122 and K142072) and for download by the user/surgeon.

The provided document does not contain explicit acceptance criteria or a study that proves the device meets specific performance criteria. The document is a 510(k) premarket notification letter from the FDA to Custom Orthopaedics Solutions, Incorporated for their OrthoVis Web Portal.

The letter focuses on the FDA's determination of substantial equivalence to legally marketed predicate devices, rather than a clinical performance study with predefined acceptance criteria for the device itself. The device, OrthoVis Web Portal, is described as a software interface for transferring imaging information and pre-operative simulation, essentially a communication tool between surgeons and technicians.

However, the "NON-CLINICAL TESTING" section (page 6) describes the testing performed to demonstrate substantial equivalence, which can be interpreted as fulfilling the requirements for market clearance for this type of device.

Here's a breakdown based on the information provided, recognizing that it's not a typical clinical performance study:

1. A table of acceptance criteria and the reported device performance

The document does not present a table of acceptance criteria with corresponding device performance for a typical clinical study (e.g., sensitivity, specificity, accuracy). Instead, the "performance" demonstrated relates to software functionality and safety in comparison to existing methods.

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

• Software Verification and Validation:
  • Test Set Sample Size: Not explicitly stated as a number of "cases" or "patients." This testing involved numerous automated unit tests and integration tests, as well as manual tests covering various software functionalities and scenarios.
  • Data Provenance: Not applicable in the traditional sense of patient data. The "data" would be test cases and simulated inputs designed to exercise the software's capabilities and constraints.
• Dimensional Validation:
  • Test Set Sample Size: Not specified. This validation likely involved testing the software's rendering and measurement capabilities rather than a patient dataset.
  • Data Provenance: Not applicable.
• Simulated Use Comparison:
  • Test Set Sample Size: "Surgeons with experience" were asked to participate in a survey. The exact number of surgeons is not specified.
  • Data Provenance: Prospective, as surgeons were asked to compare their experiences with the old and new processes. The origin of the data is implicit as part of the manufacturer's testing in the US.

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

• For the software verification and dimensional validation, "ground truth" would be the expected correct software behavior and measurement accuracy, established by software engineers and potentially medical imaging experts involved in the development and previous clearances of OrthoVis. Specific numbers and qualifications are not provided.
• For the simulated use comparison, the "experts" were the participating surgeons. Their qualifications are stated as "Surgeons with experience in using the OrthoVis Preoperative Plan via the CD Mailer/Go-To-Meeting/Email process." No specific number is given.

4. Adjudication method for the test set

• Not applicable in the context of a clinical performance study with human reviewers.
• Software testing would involve test engineers and potentially QA personnel verifying test outcomes against expected results.
• For the surgeon survey, presumably, the survey responses were collected and analyzed directly, not adjudicated among experts to establish a "ground truth."

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, an MRMC comparative effectiveness study was not done.
• The OrthoVis Web Portal is described as a software interface for communication and pre-operative simulation, not an AI-assisted diagnostic or interpretative tool. Therefore, the concept of improving human readers with AI assistance does not apply directly to this device's intended use according to the provided text. The "Simulated Use Comparison" was about process efficiency and user experience, not diagnostic accuracy.

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

• The device is a human-in-the-loop system by design, facilitating communication and planning between surgeons and technicians. The software itself is designed to display, transfer, and allow modification of plans by human users.
• The "standalone" performance would be related to its software functionality (e.g., ability to upload, store, display data correctly), which was addressed by the software verification and validation. However, this is not a clinical "standalone" performance in the sense of making a medical decision without human input.

7. The type of ground truth used

• Software Verification and Validation: Expected software behavior, functional requirements, and logical outputs.
• Dimensional Validation: Known measurement standards and calculations, validated against established (previously cleared) software code.
• Simulated Use Comparison: User experience and feedback from surgeons, evaluated against the existing manual processes.

8. The sample size for the training set

• Not applicable. The OrthoVis Web Portal is a communication and simulation tool, not a machine learning or AI algorithm that requires a training set of data.

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

• Not applicable, as there is no training set for this device.

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