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The Mobile Millennium MG Imaging System is intended for use as a diagnostic imaging system which, when used with appropriate radiopharmaceuticals, produces images representative of the internal distribution of radioactivity in the head or body. It is designed to acquire, display, process, archive, and communicate data for whole body, planar, tomographic (SPECT), multislice, and attenuation corrected images. The system allows for the acquisition of data for high resolution three dimensional, static, gated, or dynamic images of biochemical and metabolic processes. It can be operated in a mobile as well as a fixed site environment.

The GE Millennium Mobile MG System is composed of a gantry, patient table, image acquisition hardware and software, an operator console, a processing and review workstation, and associated accessories. Materials and construction are equivalent to the Millennium MG System and eNTEGRA Workstation and are compliant with CISPR 11, IEC 801, UL2601-1, IEC 60601-1 and associated collateral standards, and applicable sections of 21 CFR Subchapter J.

The provided text does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria. The document is a 510(k) summary for a medical device (Millennium Mobile MG Imaging System and eNTEGRA Workstation) and primarily focuses on demonstrating substantial equivalence to a predicate device.

The "Summary of Studies" section states: "The device has been evaluated for electrical, mechanical, and radiation safety, and conforms to applicable medical device safety and performance standards." However, it does not provide:

• A table of specific acceptance criteria and reported device performance.
• Details about sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods for any performance studies.
• Information on MRMC comparative effectiveness studies or standalone algorithm performance.

Therefore, I cannot fulfill your request for the detailed information regarding acceptance criteria and a study proving the device meets them based on the provided text.

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MG ATC is indicated to improve the quality of emission SPECT images obtained on the Millennium MG dual head camera by attenuation correction.

The MG ATC attenuation correction system is an optional addition to the Millennium MG gamma camera (K962738). It comprises additional hardware and software to generate a correction map and corrected NM images for non-uniform attenuation.

The provided text describes the MG ATC: Attenuation Correction System for Dual-Head Variable-Angle Gamma Camera. Here's an analysis of the acceptance criteria and study information:

1. Acceptance Criteria and Reported Device Performance

Study Details:

The document provides a high-level summary of the studies but lacks specific quantitative details for many of the requested points.

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

• Sample Size for Test Set: Not specified. The document only mentions "Bench data and Clinical data."
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

• Not specified.

4. Adjudication Method for the Test Set:

• Not specified.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Not explicitly mentioned. The statement "Comparison to V TransACT images shows no significant difference" suggests a comparison, but it doesn't specify if human readers were part of an MRMC study or if it was an assessment based on objective metrics. Therefore, the effect size of human readers improving with AI vs. without AI assistance is not provided.

6. Standalone (Algorithm Only) Performance Study:

• The nature of the "Bench data" suggests some form of standalone evaluation of the algorithm's output (images). However, the document doesn't explicitly state a separate standalone performance study or provide specific metrics for it. The primary comparison is implied to be visual image quality and equivalence to the predicate.

7. Type of Ground Truth Used:

• The document mentions "better uniformed images" and "no significant difference" in comparison, suggesting that the ground truth was likely based on subjective image quality assessment or comparison to an established reference standard for image uniformity and accuracy in SPECT imaging. It does not mention pathology, outcomes data, or expert consensus in a structured way for ground truth creation.

8. Sample Size for the Training Set:

• Not specified. The document focuses on demonstrating equivalence to a predicate device rather than detailing model training.

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

• Not specified. As it's a device for attenuation correction, the "training" (if any, as this predates modern deep learning) would likely involve calibration data and possibly phantom studies to accurately model photon attenuation. However, no specifics are provided.

Overall Conclusion from the Provided Text:

The submission focuses heavily on demonstrating substantial equivalence to a legally marketed predicate device (V TransACT) based on the stated intended use and general performance improvements (better uniformed images compared to uncorrected SPECT). While "Bench data and Clinical data" are cited, specific details regarding sample sizes, expert involvement, and ground truth methodologies are not included in this summary document. The information is high-level for a 510(k) summary, aiming to establish equivalence rather than a detailed performance report for a novel AI algorithm.

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