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The Preview Shoulder software is intended to be used as a tool for orthopedic surgeons to develop pre-operative shoulder plans based on a patient CT imaging study.

The import process allows the user to select a DICOM CT scan series from any location that the user's computer sees as an available file source.

3D digital representations of various implant models are available in the planning software. Preview Shoulder allows the user to digitally perform the surgical planning by showing a representation of the patient's shoulder anatomy as a 3D model and allows the surgeon to place the implant in the patient's anatomy.

The software allows the surgeon to generate a report, detailing the output of the planning activity.

Experience in usage and a clinical assessment are necessary for a proper use of the software. It is to be used for adult patients only and should not be used for diagnostic purposes.

The Preview Shoulder, a 3D total shoulder arthroplasty (TSA) surgical planning software, is a standalone software application which assists the surgeon in planning reverse and anatomic shoulder arthroplasty. Preview Shoulder includes 3D digital representations of implants for placement in images used for surgical planning. Preview Shoulder is a secure software application used by qualified or trained surgeons and is accessed by authorized users.

The primary function of Preview Shoulder is to receive and process DICOM CT image(s) of patients. Preview Shoulder can be used to place an implant in the original CT image and place an implant in the 3D model of reconstructed bone. The Preview Shoulder allow the user to perform surgical planning and generate an output surgical report. Preview Shoulder does not provide a diagnosis or surgical recommendation. The surgeon is responsible for selecting and placing the implant model for pre-surgical planning purposes.

Here's an analysis of the acceptance criteria and the study information for the "Preview Shoulder" device, based on the provided text:

1. Table of Acceptance Criteria & Reported Device Performance

The provided text does not explicitly state acceptance criteria in a quantitative format (e.g., minimum accuracy percentages, specific error margins). Instead, the bench testing section describes the goals of validation as:

• "assess the safety and effectiveness of the device"
• "demonstrate the processing of patient images to produce accurate and repeatable 3D reconstructed bones and surgical coordinates provided to the surgeon"
• "demonstrate the safety and efficacy of the device to meet its intended use and specifications"
• "measurement capabilities of the Preview Shoulder were validated to be significantly equivalent to a benchmark tool with CT rendering measurement capabilities, Osirix MD (K101342)"
• "All validation testing was performed on a fully configured system using anonymized patient shoulder CT images to emulate intended use. All user features have been validated by surgeons."

Given this, the table for reported performance will focus on the qualitative outcomes described:

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not explicitly stated. The text only mentions "anonymized patient shoulder CT images" were used.
• Data Provenance: "anonymized patient shoulder CT images". The country of origin is not specified, nor is whether the data was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Number of Experts: Not explicitly stated for ground truth establishment. However, the document notes that "All user features have been validated by surgeons." This implies at least some surgeons were involved in testing, but doesn't specify if they established the ground truth for measurements or just validated features.
• Qualifications of Experts: The experts who validated user features are identified as "surgeons." No further qualifications (e.g., years of experience, subspecialty) are provided in this document.

4. Adjudication Method for the Test Set

• The document does not describe a formal adjudication method (e.g., 2+1, 3+1, none) for establishing ground truth or resolving discrepancies in the test set.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

• No, a MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence of the Preview Shoulder to the predicate device." The validation focused on equivalence to a benchmark tool (Osirix MD) rather than human readers, or comparing human readers with and without AI assistance.
• Effect Size: Not applicable as no such study was performed or reported.

6. Standalone Performance

• Yes, a standalone performance evaluation was done. The device itself is described as a "standalone software application." The "Bench Testing" section details verification and validation tests indicating the algorithm's performance in reconstructing 3D bone models and its measurement capabilities. The validation comparing its measurement capabilities to Osirix MD (K101342) is a form of standalone performance evaluation.

7. Type of Ground Truth Used

• The ground truth for validating "measurement capabilities" was established by comparison to a "benchmark tool with CT rendering measurement capabilities, Osirix MD (K101342)." For "3D reconstructed bones and surgical coordinates," the ground truth implicitly refers to the accuracy and repeatability against accepted standards or the output of the benchmark tool. Implicitly, the accuracy and repeatability would be compared to a derived ground truth based on the CT images themselves or measurements obtained from the benchmark. It is not explicitly pathology or outcomes data.

8. Sample Size for the Training Set

• Not stated. The document mentions the use of an "AI algorithm" for 3D model reconstruction but does not provide any information about the training set size, composition, or how it was used to train the AI.

9. How the Ground Truth for the Training Set Was Established

• Not stated. As the training set size and details are not provided, the method for establishing its ground truth is also not mentioned in this document.

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