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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 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.

The provided text focuses on the 510(k) summary for the Preview Shoulder software, outlining its substantial equivalence to a predicate device and general non-clinical testing. However, it does not include detailed information about specific acceptance criteria for performance metrics, nor does it describe a study that explicitly proves the device meets such criteria with reported performance values.

The document states:

• "Software Verification and Validation testing was performed on the Preview Shoulder, and documentation is provided as recommended by FDA's Guidance for Industry and FDA Staff, 'Content of Premarket Submissions for Device Software Functions'."
• "Testing verified that the system performs as intended."
• "The 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."
• "Clinical testing was not necessary to demonstrate substantial equivalence of the Preview Shoulder to the predicate device."

Given this, I cannot provide the requested information in full detail. Here's what can be inferred and what is missing:

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

This information is not provided in the document. While it mentions "Testing verified that the system performs as intended" and "measurement capabilities... were validated to be significantly equivalent to a benchmark tool," it does not specify what those performance metrics, acceptance criteria, or reported performance values are.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not explicitly stated. The document mentions "anonymized patient shoulder CT images" were used for validation testing, but the number of such images (sample size) is not given.
• Data Provenance: "Anonymized patient shoulder CT images" were used. The country of origin and whether the data was retrospective or prospective is not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• The document states, "All user features have been validated by surgeons." It does not specify the number of surgeons or their qualifications or how they established "ground truth" for quantitative assessments.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• The document mentions "All user features have been validated by surgeons" but does not detail any adjudication method.

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 document explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence of the Preview Shoulder to the predicate device." The software is not an AI for diagnosis or interpretation but a surgical planning tool.

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

• Not explicitly detailed as a standalone performance study in the context of typical AI performance evaluation. The document states that "The measurement capabilities of the Preview Shoulder were validated to be significantly equivalent to a benchmark tool with CT rendering measurement capabilities, Osirix MD (K101342)." This suggests a comparison of the software's output with a benchmark, which could be considered a form of standalone validation for its measurement capabilities. However, specific metrics and results are not provided. The device itself is described as a "tool for orthopedic surgeons," implying human-in-the-loop operation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• The document implies that "benchmark tool with CT rendering measurement capabilities, Osirix MD (K101342)" served as a reference for validating measurement capabilities. For user features, "validation by surgeons" might have implicitly used their clinical judgment as a form of ground truth for usability and functionality, but this is not explicitly defined in terms of a formal ground truth process.

8. The sample size for the training set

• This device is described as a "software application" for surgical planning and emphasizes its validation through comparison of measurement capabilities against a benchmark tool and user feature validation by surgeons. It does not explicitly state that it uses machine learning/AI models that require a "training set" in the conventional sense. If there are AI algorithms as implied by "Post-processing algorithm is added to further refine the 3D mesh quality" and "Algorithm is added to calculate humerus-side features," the training set size is not provided.

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

• As the existence of a "training set" is not confirmed or described, the method for establishing its ground truth is also not provided.

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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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