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510(k) Data Aggregation
(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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