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510(k) Data Aggregation
(101 days)
The intended use of the QuantumCam gamma camera system is to perform general nuclear medicine imaging procedures. This is intended to be accomplished by imaging the distribution of a radiopharmaceutical within the human body. Gamma rays emitted from the radiopharmaceutical are detected by the gamma camera system and formed into images characterizing and showing the state of organs or structures in the form of functional images. When QuantumCam is connected to a nuclear medicine workstation, these images can be used in concert with other clinical data to assist in making clinical diagnoses by authorized medical personnel.
Indications for use.
The QuantumCam is a gamma camera system designed to acquire data for whole body static, gated or dynamic and multi-slice 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, 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.
Functional description:
The Detectors are standard Nal (Sodium lodide) / 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. 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 summary of the acceptance criteria and the study details for the QuantumCam device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Specification | Acceptance Criteria (NEMA Standard NU 1:2007) | Reported Device Performance (from NEMA testing) |
|---|---|---|
| Intrinsic Spatial Resolution, FWHM, UFOV @ surface | ≤ ± 3.9 mm | Not explicitly stated as a single value, but compliance with NEMA standard implies meeting this. |
| Spatial Resolution, FWHM, LEGP collimator @ 10cm, Tc-99m | < 9.1 mm | Not explicitly stated as a single value, but compliance with NEMA standard implies meeting this. |
| Energy Resolution, @ Tc-99m | ≤ 9.6 % | Not explicitly stated as a single value, but compliance with NEMA standard implies meeting this. |
| Spatial Linearity, UFOV, Diff. | < ± 0.2 mm | Not explicitly stated as a single value, but compliance with NEMA standard implies meeting this. |
| Flood Field Uniformity, UFOV Intrinsic, Diff. | < ± 2.55 % | Not explicitly stated as a single value, but compliance with NEMA standard implies meeting this. |
| Maximum Count rate with scatter | > 320 kcps | Not explicitly stated as a single value, but compliance with NEMA standard implies meeting this. |
| Count rate Sensitivity, @ 20% loss | > 225 kcps | Not explicitly stated as a single value, but compliance with NEMA standard implies meeting this. |
| Detector shielding Sensitivity, @ 184 keV | < 2.0 % | Not explicitly stated as a single value, but compliance with NEMA standard implies meeting this. |
Important Note: The document states that the "test equipment used, test setup and all calculations have all been performed according to the NEMA Standard NU 1:2007 in a 20% energy." This implies that the device met the specifications outlined in the NEMA standard, even if explicit performance values are not listed next to each criterion. For the detector shielding sensitivity, it is specifically mentioned that the test was performed according to NEMA Standard NU 1:2007.
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes non-clinical testing conducted according to NEMA Standard NU 1:2007. This standard outlines procedures for measuring the performance of gamma cameras.
- Sample Size: The document does not specify a "sample size" in terms of patient data or clinical cases. Instead, it refers to testing of the physical device components (detectors, collimators) using standard phantoms and calibrated sources as per NEMA guidelines. Therefore, there isn't a "test set" in the traditional sense of patient data.
- Data Provenance: The testing was "performed according to DDD quality system procedures as investigations performed according to standards... conducted and reported by qualified experts." This indicates the testing was done by the manufacturer (DDD-Diagnostic A/S) in Denmark. It is a prospective test in the sense that the device was actively tested against the NEMA standard.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since this was a non-clinical, performance-based test against a technical standard (NEMA NU 1:2007), there was no "ground truth" established by human experts in a diagnostic sense (e.g., radiologists interpreting images). The "ground truth" was the objective measurement values obtained by following the NEMA standard, which are then compared to the specified acceptance criteria of the standard itself.
The document mentions "qualified experts" conducted and reported the investigations, but their specific number or qualifications (e.g., "radiologist with 10 years of experience") are not provided. These "experts" would likely be engineers or physicists specializing in nuclear medicine imaging system performance.
4. Adjudication Method for the Test Set
Not applicable. As described above, this was a non-clinical, objective performance test against a standard, not a subjective interpretation task requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating the device's technical performance and substantial equivalence to a predicate device, not on how human readers perform with or without AI assistance. The QuantumCam is a gamma camera system, not an AI-assisted interpretation tool.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The QuantumCam is a physical gamma camera system (hardware) that acquires data. It is not an algorithm that provides standalone diagnostic interpretations. While it uses software for acquisition and control, the "performance" described is about the quality of the raw data acquisition, not an automated diagnostic output from an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this study was the objective measurements obtained by following the specific protocols outlined in the NEMA Standard NU 1:2007. This standard provides a framework for quantitatively assessing the physical performance characteristics of gamma cameras. The device's performance was compared directly to the numerical acceptance criteria defined by this standard.
8. The Sample Size for the Training Set
Not applicable. This is a medical device (gamma camera) performance study, not an AI algorithm development study. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set mentioned or implied by the document.
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