Search Results

The QuantumCam is a gamma camera system designed to acquire data for whole body static, gated or dynamic and multislice images. The system is intended for use as diagnostic imaging device. When used with appropriate radio pharmaceuticals, images are produced representing the internal distribution of radioactivity in head or 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, TI-201, I-123, I-131, In-111, Ga-67, Co-57.

The QuantumCam is a general purpose dual detector gamma camera system comprised of a mechanical gantry allowing the Detectors to be positioned and moved in close proximity to the patient for scanning. The Gantry provides for positioning of the detectors in location(s) suitable for patient to be brought in position for tomographic, whole body scanning as well as planar scanning in sitting or standing position.

The Detectors are standard Nal (Sodium Iodide) / Photomultiplier based scintillation detectors designed following the Anger Camera principles first described by Hal Oscar Anger. This detector technology has been used effectively in Nuclear Medicine for decades. The Detectors are equipped with standard Collimators following the principles known to the industry and this submission is specific about the HEGP collimator. The image data from the detectors are collected by hardware in the detector and the data acquisition is controlled by software running on a standard personal computer with a suitable operating system. The data may subsequently be transferred to a Nuclear Medicine Workstation for processing and interpretation. This Workstation is not part of the QuantumCam system.

Here's a breakdown of the acceptance criteria and study information for the QuantumCam 9SYS2070-B02, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily based on NEMA (National Electrical Manufacturers Association) tests for gamma camera systems. The performance reported is for the new High Energy General Purpose (HEGP) collimator, which is the main addition that expands the device's energy range.

Important Note: The document focuses on demonstrating substantial equivalence to a predicate device. The "acceptance criteria" presented are primarily the physical specifications of the HEGP collimator and results from standard NEMA tests. However, for "Spatial Resolution @ 10cm" and "Septal Penetration", the actual test result that directly compares to the specified criteria is not explicitly provided in the table. The statements indicate that these were NEMA tested, but not the explicit numerical outcome for direct comparison to the "less than 16.5 mm" or the 39.8% calculated value (which seems to be the expected performance rather than an acceptance threshold).

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

• Sample Size: Not explicitly stated. The document mentions "NEMA test on a QuantumCam system" and measurements of collimator hole properties. This suggests a single or very small number of physical devices/collimators were tested.
• Data Provenance: The tests were conducted internally by DDD-Diagnostic A/S as part of their quality system procedures. The country of origin for the data is implicitly Denmark, where DDD-Diagnostic A/S is located. The study is retrospective in the sense that it's a verification of a product design feature rather than a clinical trial with patients over time.

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

• Number of Experts: Not explicitly stated. The document mentions "conducted and reported by qualified experts." No specific number or qualifications are provided beyond "qualified experts."
• Qualifications: "Qualified experts" is the only description given. No specific details like "radiologist with 10 years of experience" are provided.

4. Adjudication Method for the Test Set

• The document does not describe any adjudication method. The testing appears to be objective, physical measurements and NEMA standard tests, rather than subjective interpretation requiring adjudication among multiple readers.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No, an MRMC comparative effectiveness study was not done. The submission is for a device modification (expanded energy range with a new collimator) based on substantial equivalence, not a clinical effectiveness study to compare diagnostic accuracy or reader performance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Yes, the tests described are standalone performance tests of the gamma camera system itself (e.g., sensitivity, spatial resolution, septal penetration), without human involvement in interpreting images or making diagnoses. This is an objective measurement of the device's physical imaging capabilities.

7. The Type of Ground Truth Used

• The ground truth for the device performance tests (sensitivity, spatial resolution, septal penetration) is based on NEMA standards and physical measurements. For the collimator specifications (shape, size, septa, length), the ground truth is the Unicorn drawings (presumably engineering or design drawings) that define the intended specifications, against which the manufactured collimator was measured.

8. The Sample Size for the Training Set

• Not applicable. This device is hardware (gamma camera system), not a machine learning or AI algorithm that requires a training set of data.

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

• Not applicable, as there is no training set for this hardware device.

Ask a specific question about this device