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The CryoVizion is indicated as a tool to quantify angles on digital photograph depictions such as body angles related to postural asymmetries. It is intended for use in professional health specialists such as podiatrists, orthopedist, physiotherapists, chiropractors, osteopaths, and kinesiotherapists

The CryoVizion System is a non-invasive and radiation-free system. Patients, suitably undressed, are placed in an observation booth. Two digital colour cameras mounted on a column are placed facing the patient booth. Patients are illuminated by two LED lighting units-one on each side of the imaging column. Using the CryoVizion System, the health specialist can then take images of the patient at various heights and in different positions. These images are then saved in the patient's file. The health specialists can then visually review anatomical and morphological features related to the patient's posture. To do this, the CryoVizion System provides an image analysis toolbox including a palette of six graphic filters. Surface markers corresponding to the anatomical body landmarks placed using palpation by healthcare professionals, prior to taking the photographs, may also be used to help identify and reference anatomical landmarks in the photographs. The CryoVizion System is composed of two sections: hardware and software. The data and the images collected with the CryoVizion System are available immediately for clinical use and may be downloaded to a computer for storage or further analysis or comparison. The hardware section comprises the above noted two digital colour cameras and two LED lighting units, mounted on a column and a positioning booth. The two cameras are mounted in the central tube of the imaging column. The LED lighting systems are vertically disposed to each side of the column. The column also houses the control centre which, linked to a computer, controls the two digital cameras and the intensity of the lighting. The software comprises image manipulation functions, including the user selectable filters noted above and controls to operate each of the cameras.

The CryoVizion System is intended to quantify angles on digital photographs of body angles related to postural asymmetries for use by healthcare specialists.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document implicitly defines acceptance criteria through the performance tests conducted, specifically for "Angle Measurement Accuracy and Single Tester's Measurement Repeatability." However, explicit numerical acceptance thresholds for accuracy and repeatability are not provided in the summary.

2. Sample Size for Test Set and Data Provenance:

The document mentions "a clinical study specific to the CryoVizion System" complementing information from literature. However, the exact sample size for the test set used to determine angle measurement accuracy and repeatability is not explicitly stated. The data provenance (country of origin, retrospective/prospective) for this clinical study is also not specified.

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set):

The document mentions that the system's output was compared to a "manual goniometer which is a 'gold standard' method currently used for body segment angle measurements." This implies that measurements using goniometers, presumably performed by trained professionals, served as a surrogate for ground truth. However, the number of experts used to establish this goniometer-based ground truth for the test set and their specific qualifications are not detailed.

4. Adjudication Method:

The document does not describe an adjudication method for establishing ground truth for the test set. It relies on comparison to "gold standard" manual goniometer measurements.

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

A MRMC comparative effectiveness study was not performed that compares human readers with and without AI assistance. The study focuses on the device's performance against a manual "gold standard" and within-device (intra- and inter-user) variability.

6. Standalone Performance:

Yes, a standalone performance study was done for the algorithm's angle measurement functionality. The study verified the system's output for accuracy and assessed repeatability, comparing it to manual goniometer measurements. This evaluates the algorithm's ability to quantify angles independently.

7. Type of Ground Truth Used:

The primary type of ground truth used for the angle measurement accuracy study was expert consensus / reference standard based on manual goniometer measurements. The goniometer is referred to as a "gold standard" for body segment angle measurements.

8. Sample Size for the Training Set:

The document does not provide any information regarding the sample size for a training set. As the device is primarily described as a measurement tool with image filters for analysis rather than an AI-driven diagnostic system requiring extensive machine learning training data, a traditional "training set" might not be applicable in the same way. However, if any internal algorithms were trained, this information is not disclosed.

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

Since no training set information is provided, how ground truth for a training set was established is not detailed.

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