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510(k) Data Aggregation
(12 days)
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.
| Acceptance Criteria (What the device aims to achieve) | Reported Device Performance |
|---|---|
| Radiation Leakage: | |
| Exposure from surface of housing, shutter closed | < 0.2 mR/hr @ 100cm |
| Exposure during scan, at 30 cm, shutter opened | < 10 mR/hr @ 30cm |
| (Implicit) Attenuation Correction Functionality | The device performs attenuation correction and scatter correction by measuring gamma ray attenuation to compensate emission images. It is technologically similar to its predicate devices, CardioMD-AC (K040616) and e.cam-AC (K963983) (for the radioactive source). |
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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(7 days)
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
| Acceptance Criteria (Specification) | Reported Device Performance (Test Result) |
|---|---|
| Intrinsic Spatial Resolution, FWHM, UFOV: $\leq \pm 3.7mm$ | "All calculations have all been performed according to the NEMA Standard NU 1-1994." (Implies meeting the criteria given no deviation is stated) |
| Spatial Resolution, FWHM, LEGP collimator @ 10cm, Tc-99m: $< 9.2 mm$ | "All calculations have all been performed according to the NEMA Standard NU 1-1994." (Implies meeting the criteria given no deviation is stated) |
| Energy Resolution, @Tc-99m: $\leq9.4%$ | "All calculations have all been performed according to the NEMA Standard NU 1-1994." (Implies meeting the criteria given no deviation is stated) |
| Spatial Linearity, UFOV: $<\pm 0.5$ mm absolute. | "All calculations have all been performed according to the NEMA Standard NU 1-1994." (Implies meeting the criteria given no deviation is stated) |
| Intrinsic Flood Field Uniformity, UFOV Integral: $< \pm 2.5 %$ | "All calculations have all been performed according to the NEMA Standard NU 1-1994." (Implies meeting the criteria given no deviation is stated) |
| Maximum Count rate: $> 180k$ cps with scatter, $> 290k$ cps w/o scatter | "All calculations have all been performed according to the NEMA Standard NU 1-1994." (Implies meeting the criteria given no deviation is stated) |
| Count rate @ 20 % loss: $> 225k$ cps | "All calculations have all been performed according to the NEMA Standard NU 1-1994." (Implies meeting the criteria given no deviation is stated) |
| Detector Background Sensitivity, @180 °, 140 keV: $< 2.0 %$ | "The maximum % was calculated according to [missing details, but implies compliance given it's listed as a verified specification]." |
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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