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The CapIMAGE Gamma Camera System is intended to produce planar images depicting the anatomical distributions of single photon emitting radioisotopes in the human body within the energy range of 59kev to 167kev. The system provides software applications for processing, analyzing, and displaying medical images for interpretation by medical personnel.

The CapIMAGE Gamma Camera System is intended for examination (and diagnosis) of disorders and diseases in the thyroid gland, the heart and other small organs. The device is not interpretative. Data from the device are interpreted by medical personnel who, based on these, make the clinical diagnosis.

The CapIMAGE is a mobile Small Field of View (SFOV) gamma camera system utilizing a scintillation detector to detect gamma rays. The CapIMAGE is designed to be manually transported and deployed for scanning of patients in laying, sitting or standing positions. The system can operate powered from mains or from the internal battery source for at least 60 min.

Here's a summary of the acceptance criteria and study information for the CapIMAGE Gamma Camera System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the CapIMAGE device are based on compliance with industry standards, specifically NEMA NU 1-2001 for performance specifications. The reported device performance metrics are presented as meeting or being within the specified limits of these standards. The document doesn't provide specific quantitative acceptance thresholds for each performance characteristic but implies compliance.

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

The document explicitly states "None." for "Clinical Performance Data." This indicates that no clinical test set with patient data was used to demonstrate the device's performance in a clinical setting. The device's performance was evaluated through non-clinical testing against established physical and safety standards.

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

Not applicable, as no clinical test set was used.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set was used.

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

Not applicable. The document describes a gamma camera system and does not mention any AI components or MRMC studies.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable, as the device is a gamma camera system, not an algorithm. Its performance is physical and independent of human interpretation for these specifications.

7. The Type of Ground Truth Used

For the non-clinical performance data, the ground truth was based on the standards and methodologies prescribed by NEMA NU 1-2001 and other relevant electrical safety standards (UL 60601-1, IEC601-1, IEC601-1-1, IEC601-1-2). These standards define the procedures and expected outcomes for measuring the physical performance characteristics of gamma cameras.

8. The Sample Size for the Training Set

Not applicable. This device is a medical imaging hardware system, not a software algorithm that requires a training set.

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

Not applicable.

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