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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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Attenuation correction is a method where the emission images acquired during SPECT acquisitions are compensated for attenuation within the patient. The purpose of attenuation correction is to compensate for varying attenuation of gamma rays in the body.

The intended use of the c.cam Attenuation Correction option is to provide the customer with means to measure the attenuation of gamma rays within the body of a patient, when using a c.cam gamma camera system for SPECT studies, and to map the measured attenuation into images that can be used to compensate emission images for the attenuation. The c.cam-AC includes additional acquisition of data for scatter correction of these images.

The c.cam-AC is an attenuation correction device, which will be marketed as an optional device for the c.cam gamma camera.

C.cam gamma camera is a dual detector system and the attenuation correction device (two units) will be mounted opposite of the two detectors, one device on each detector. The attenuation correction device is formed as two housings each containing 14 line sources in fixed positions, shutter and all shutter control.

The following described functions are performed on both detectors simultaneously.
When the scanning is initiated the emission image and the transmission images are acquired sequentially. When the emission image has been acquired, a shutter, common for all sources, located in the device housing will open for exposure from 14 line sources (max. 20 mCi each 153 Gd with a total of max. 96 mCi). A collimated beam of gamma ray photons is focused on the opposite detector field of view to create the transmission images of the patient placed in the field of view of the detector. Having acquired both emission and transmission images, the data for emission, transmission, emission scatter and transmission scatter are stored in one dataset. A scaled version of the blank transmission scan is stored in another dataset. The complete study can be export via DICOM to the OEM customer provided processing station for later processing and reviewing.

Here's a breakdown of the acceptance criteria and study information for the c.cam-AC device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text for K051460 describes a device that is essentially equivalent to existing devices and focuses on its design and radioactive source rather than specific performance metrics tied to acceptance criteria. The only performance-related data explicitly stated are for Radiation Leakage.

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

• Sample Size for Test Set: Not explicitly stated for performance evaluation that would lead to quantitative acceptance criteria beyond radiation leakage. The text mentions "acquiring Myocardial Perfusion stress studies on a Siemens e.cam system" as part of non-clinical test results collection, which implies a dataset, but the size is not specified.
• Data Provenance: The acquisition of "Myocardial Perfusion stress studies on a Siemens e.cam system" suggests clinical data. The country of origin is not specified, but the device manufacturer is Danish (3D, Danish Diagnostic Development A/S). The study appears to be retrospective in its description of collected clinical data.

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

This information is not provided in the document. The study described focuses on non-clinical tests and a comparison of technological characteristics to predicate devices. There is no mention of expert involvement in establishing ground truth for a test set in the context of diagnostic performance.

4. Adjudication Method for the Test Set

This information is not provided. As no expert-based ground truth establishment is described, an adjudication method is not applicable here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done or at least not described in the provided text. The device is an attenuation correction device, a component of a larger imaging system, and its evaluation centered on its technical performance and equivalence to predicate devices, not on direct human reader performance improvement.

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

The device itself, the c.cam-AC, is an algorithm/hardware combination designed for attenuation correction, which operates in a standalone manner as a component of the c.cam gamma camera system. The "non clinical test results have been collected by acquiring Myocardial Perfusion stress studies," suggesting the output of the attenuation correction was likely evaluated, but specific metrics of its standalone performance (e.g., accuracy of attenuation maps) are not provided beyond the radiation leakage. The focus is on its function within the entire imaging workflow.

7. The Type of Ground Truth Used

For the radiation leakage acceptance criteria, the ground truth would be established by physical measurement using appropriate radiation detectors. For the implicit functionality of attenuation correction, the "ground truth" for comparison would likely be the expected or desired attenuation map/corrected image quality, a comparison against which is implied in the "non clinical test results," but the specific methodology or precise ground truth used for that evaluation is not explicitly detailed.

8. The Sample Size for the Training Set

This information is not provided. The c.cam-AC device is described as an "attenuation correction device" and not explicitly as an AI/machine learning algorithm that would require a distinct "training set" in the modern sense. It implements a method to compensate for attenuation, which might involve pre-defined models or calculations, but not necessarily a trained AI model.

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

This information is not provided, as the document does not describe the use of a "training set" for an AI algorithm.

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Attenuation correction is a method where the emission images acquired during SPECT acquisitions are compensated for attenuation within the patient. The purpose of attenuation correction is to compensate for varying attenuation of gamma rays in the body.

The intended use of the CardioMD-AC Attenuation Correction option is to provide the costumer with means to measure the attenuation of gamma rays within the body of a patient, when using a DDD CardioMD gamma camera system type 9CSY0799 for SPECT studies, and to map the measured attenuation into images that can be used to compensate emission images for the attenuation. The CardioMD-AC includes additional acquisition of data for scatter correction of these images.

Not Found

I apologize, but the provided text from the FDA 510(k) letter for the CardioMD-AC device does not contain the detailed information necessary to answer your request regarding acceptance criteria and the study proving the device meets those criteria.

The 510(k) letter is a regulatory document confirming substantial equivalence to a predicate device, allowing the CardioMD-AC to be marketed. It does not typically include:

• A table of acceptance criteria and reported device performance: This type of data would be found within the 510(k) submission itself, not the FDA's decision letter.
• Sample sizes, data provenance, or expert qualifications for test sets.
• Details on adjudication methods.
• Information about MRMC comparative effectiveness studies.
• Results of standalone algorithm performance studies.
• Specifics on ground truth types or how ground truth was established for training and test sets.
• Training set sample sizes.

The letter primarily focuses on:

• Confirming the device name and regulation details.
• Stating the FDA's finding of substantial equivalence.
• Outlining regulatory responsibilities for the manufacturer.
• Providing the "Indications for Use" statement (on page 2 of the provided text, which states the purpose of attenuation correction and its intended use with the CardioMD gamma camera system).

To obtain the information you're looking for, you would typically need to review the full 510(k) marketing submission document, which may be publicly available through the FDA's website, though often in redacted form.

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Virgo is an emission computed tomography system intended to detect the location and distribution of gamma ray radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. The device includes display equipment, patient and equipment parts, and accessories.

Virgo is primarily intended for cardiac applications but the Virgo design also supports non-cardiac procedures of the patient's chest region and body extremities. Virgo supports radionuclides within the energy range of 60 -170 keV

The Virgo system design comprises a gantry supporting a fixed 90 degree dual head detector and a patient chair. The Virgo system is operated through interaction with a graphical user interface situated on the acquisition PC and a dedicated Virgo hand controller.

The provided text describes acceptance criteria and reported device performance for the Virgo Gamma Camera System. The study conducted to prove the device meets these criteria is a non-clinical test following documented verification plans, often adhering to the NEMA Standard NU 1-1994.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text describes non-clinical performance testing of the device's physical and technical specifications. It does not involve human subjects or a "test set" in the context of clinical trials or AI/algorithm performance. The provenance of the data is from laboratory testing conducted by the manufacturer, 3D, Danish Diagnostic Development A/S, following recognized standards like NEMA Standard NU 1-1994. No information is given about the country of origin of the data beyond the manufacturer's location (Denmark), or if it's retrospective or prospective, as these terms are not applicable to this type of testing.

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

This information is not applicable to the provided non-clinical performance data. The "ground truth" for these tests is established by physical measurement protocols defined by standards like NEMA, not by expert interpretation.

4. Adjudication Method for the Test Set

This information is not applicable as the tests are non-clinical measurements against predefined specifications. There is no individual "test set" requiring expert adjudication.

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

A multi-reader multi-case (MRMC) comparative effectiveness study or any study involving human readers and AI assistance was not done and is not described in the provided document. This document focuses on the technical specifications and performance of a medical imaging device (Gamma Camera System), not on an AI algorithm for image interpretation.

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

This information is not applicable as the device is a Gamma Camera System, not an AI algorithm. The performance described is of the hardware and integrated software for image acquisition.

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

For the non-clinical tests described, the "ground truth" is based on defined physical standards and measurement protocols (e.g., NEMA Standard NU 1-1994) using test equipment and phantoms, rather than clinical outcomes or expert consensus.

8. The Sample Size for the Training Set

This information is not applicable. The device is a Gamma Camera System, and the described testing is for its inherent physical and technical performance. There is no mention of an algorithm requiring a "training set" in the context of machine learning.

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

This information is not applicable for the same reasons as point 8.

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The Cardiocam system is a dual head system designed to acquire data for cardiat multi-slice images. The system is intended for use as diagnostic imaging device. When used with appropriate radio pharmaceuticals, intages are produced representing the internal distribution of radioactivity in the body. The system allows you to acquire data for high resolution three dimensional, static, gated or dynamic images of biochemical and metabolic processes using Tc-99m, Tl-201, Co-57.

The Cardiocam system is a dual head system designed to acquire data for cardiat multi-slice images.

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details (sample size, data provenance, expert qualifications, adjudication methods), or the results of any comparative effectiveness or standalone studies. The document is an FDA 510(k) clearance letter for the Cardiocam Model 9CSY0799, confirming its substantial equivalence to a predicate device and specifying its indications for use. It does not include the technical study details that would be required to answer your request.

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