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HERMES Medical Imaging suite that provides software applications used to process, display, analyze and manage nuclear medicine and other medical imaging data transferred from other workstation or acquisition stations.

The base product design of Hermes Medical Imaging Suite v5.7 is the same as for the Hermes Medical Imaging Suite v5.6 (K153056). The following modules have been added in this applicatio to Hybrid Viewer NM Processing: Colonic Transit, Remnant Liver, Parathyroid, Dosimetry, Classic DMSA, Oesophageal Transit/Reflux, HIDA, Salivary Gland, Bone3Phase Analysis and Uniformity.

Here's an analysis of the provided text regarding the acceptance criteria and study details for the Hermes Medical Imaging Suite v5.7:

Understanding the Device:

The device, HERMES Medical Imaging Suite v5.7, is a software application suite for processing, displaying, analyzing, and managing nuclear medicine and other medical imaging data. It has added several new modules compared to its predecessor (v5.6).

Challenges in Extracting Information:

The provided text is a 510(k) summary, which is a regulatory document focused on demonstrating substantial equivalence to a predicate device. It doesn't present a traditional "acceptance criteria" table or a single, comprehensive study report with detailed methodologies. Instead, it describes a series of comparative tests against predicate devices and manual calculations. Therefore, the "acceptance criteria" are implied by the comparisons and the statement that "the testing results supports that all the software specifications have met the acceptance criteria." The reported performance is the outcome of these comparisons.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Hybrid Recon (Myocardial SPECT):

  • Sample Size: 10 subjects.
  • Data Provenance: Not explicitly stated, but implicitly retrospective as they were "compared" to a previous version and involved "stress&rest myocardial SPECT scan with Tc99m tetrofosmin." No country of origin is mentioned.

• Hybrid Recon (Phantom Studies):

  • Sample Size: Jaszczak phantom and IEC Phantom (physical phantoms, not patient data).
  • Data Provenance: Not applicable in the same way as patient data. These are controlled experimental setups.

• Classic DMSA, Colonic Transit, Oesophageal Transit/Reflux, 3Phase Bone Analysis, HIDA, Salivary Gland Analysis:

  • Sample Size: Not explicitly stated for these modules. The phrasing "compared to manual calculations" or "compared to Xeleris 3.1" does not provide the number of cases used in these comparisons.
  • Data Provenance: Not explicitly stated. Assumed to be retrospective if patient data was used, or simulated/phantom data for manual calculations.

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

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: Not explicitly stated.
  • For the modules compared against "manual calculations (from first principles)," the "expert" is implied to be a human capable of performing these calculations, but specific qualifications are not provided.
  • For comparisons against predicate devices, the predicate devices themselves are the "truth" or reference, not human experts establishing ground truth for the test set.

4. Adjudication Method for the Test Set

• The document describes direct comparisons of results generated by the device (v5.7) against predicate devices (v5.6, v5.3, GE Xeleris 3.1) or against "manual calculations."
• There is no mention of an adjudication method (like 2+1 or 3+1 consensus) involving multiple human experts for determining a ground truth label for the test cases used. The reference is either an older software version or predefined manual calculation methods.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was not done. The studies described are comparisons of one software version against another, or against manual calculations, focusing on the output consistency and accuracy of the software itself, not on how human readers perform with or without AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

• Yes, the described studies are standalone algorithm-only performance tests. The comparisons are between algorithm versions or between an algorithm and manually calculated results. There is no mention of a human interacting with the AI outputs as part of the performance evaluation.

7. The Type of Ground Truth Used

The ground truth used varies by the type of comparison:

• Hybrid Recon (Myocardial SPECT): The outputs from the predicate device (Hermes Medical Imaging Suite v5.6) were used as the reference for comparison.
• Hybrid Recon (Phantom Studies): The known true activity concentrations within the Jaszczak and IEC phantoms were used as the ground truth.
• Classic DMSA: The outputs from the predicate device (Classic DMSA application in Medical Imaging Suite v5.3) were used as the reference.
• Colonic Transit: The outputs from the predicate device (GE Xeleris 3.1 review and workstation) were used as the reference.
• Oesophageal Transit/Reflux, 3Phase Bone Analysis, HIDA, Salivary Gland Analysis: Manual calculations (from first principles) were used as the ground truth. This implies an established, understood method of calculation is the reference.

8. The Sample Size for the Training Set

• Not provided. The document focuses entirely on verification and validation testing, and the 510(k) summary typically does not include details about the training set for the software, especially for traditional medical imaging software (not AI/ML in the modern sense) where "training" might refer to software development and bug fixing rather than data-driven model training.

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

• Not applicable / Not provided. As no information on a training set (in the context of machine learning) is given, how its ground truth was established is also not mentioned. The software modules appear to be based on established algorithms and calculations for nuclear medicine image processing, rather than being "trained" on a dataset with external ground truth labels.

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Hybrid3D that provides software applications used to process, display, and manage nuclear medicine and other medical imaging data transferred from other workstation or acquisition stations.

HERMES Hybrid3D is a reading and processing module for the advanced needs in medical imaging. It offers multi-modal (PET/CT/MR/SPECT) coregistration and interactive fusion of multiple datasets. HybridViewer 3D handles viewing and fusion of multi-sequence MRI studies with oblique orientation and allows switching between original and standard TCS view orientation as well as defining own slice directions. 3D segmentation, cropping and interpolation techniques allow complex tasks in VOI definition and can cover cases like cavities, splitting structures into subsections or logic operations (compute intersections, merge, grow). Results can be imported and exported as DICOM and are therefore available for research in 3rd party tools. Additionally, it provides tools for advanced 3D fusion rendering of studies and VOIs.

The Lung Lobe Quantification module in Hybrid 3D, introduces an efficient and automated workflow solution to accurately compute 3D lobar anatomy from CT (with or without contrast). The workflow supports the addition of functional images (SPECT V/Q, SUV SPECT, CT iodine maps, hyperpolarized xenon MRI, etc.) to accurately relate lobar anatomy to function.

Here's a breakdown of the acceptance criteria and study information for the Hybrid3D device, extracted from the provided text:

Acceptance Criteria and Device Performance

The provided document describes comparisons between the new device (Hybrid3D v2.0) and its predicate devices (HERMES Medical Imaging Suite v5.6 and Hybrid3D v1.0). The acceptance criteria are implicitly defined by the "good results" or numerical thresholds reported in the comparative testing.

Study Information

The document describes verification and validation testing, focusing on comparisons with predicate devices.

1. Sample sizes used for the test set and the data provenance:

   • Phantom studies: Used for linear measurements and Hounsfield unit estimations. The number of phantom studies is not specified, but it states "phantom studies acquired with cameras from two different vendors."
   • Patient studies: Used for quantitative parameters (SUV max, mean, peak) and automatic registration. The number of patient studies is not specified, but it mentions "patient studies acquired with cameras from two different vendors" for SUV calculations and "serial PT/CT patient studies, a PT study and external MR study, and a SPECT study and external CT study" for automatic registration testing.
   • Data Provenance: Not explicitly stated, but the company is based in Stockholm, Sweden, and the description of "cameras from two different vendors" and various types of patient studies suggests a diverse dataset. It is implied to be retrospective as it's for verification against existing data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This information is not provided in the document. The comparisons are made against results generated by the predicate devices, not interpreted by independent human experts. The document does mention "operator variation" as a possible reason for differences in SUV peak and mean values, implying human involvement in drawing VOIs on both the new and predicate applications. However, these operators are not explicitly designated as "experts" for ground truth establishment.

3. Adjudication method for the test set:

   • This information is not provided. The testing appears to be quantitative comparison against predicate device outputs rather than an adjudication process involving human reviewers for discrepancies.

4. 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 was not done or reported in this document. The device, Hybrid3D, is a software application for processing, displaying, and managing medical imaging data, including automated workflows like lung lobe quantification, but the testing focuses on its performance relative to predicate devices, not on human reader improvement with or without AI assistance.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • The testing described is essentially standalone in the sense that the device's calculations and outputs (linear measurements, Hounsfield units, SUV values, registration, image labeling, RT structure sets) are compared directly with those of the predicate device. While human operators are involved in setting up the comparisons (e.g., drawing VOIs), the evaluation is of the software's output itself. The "Lung Lobe Quantification module" mentioned in the description implies an automated (standalone) workflow component, but dedicated standalone performance of this specific module isn't detailed in the testing summary beyond its general functionality.

6. The type of ground truth used:

   • The ground truth is based on comparison with predicate devices' performance and outputs. For quantitative measures (linear, HU, SUV), the "ground truth" is implied to be the values generated by the predicate device (HERMES Medical Imaging Suite v5.6 and Hybrid3D v1.0). For automatic registration and image labeling, the "ground truth" is equivalence to the predicate's behavior.

7. The sample size for the training set:

   • This information is not provided. The document describes the device and its validation but does not mention any machine learning components that would require a distinct training set. The "Lung Lobe Quantification module" uses an "efficient and automated workflow solution to accurately compute 3D lobar anatomy from CT," which might involve machine learning, but there is no specific mention of a training set or its size.

8. How the ground truth for the training set was established:

   • This information is not provided, as no training set is explicitly mentioned or detailed in the document.

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Hybrid3D that provides software applications used to process, display, and manage nuclear medicine and other medical imaging data transferred from other workstation or acquisition stations.

The Lung Lobe Quantification module in Hybrid 3D, introduces an efficient and automated workflow solution to accurately compute 3D lobar anatomy from CT (with or without contrast). The workflow supports the addition of functional images (SPECT V/Q, SUV SPECT, CT iodine maps, hyperpolarized xenon MRI, etc.) to accurately relate lobar anatomy to function.

The provided text is a 510(k) summary for the Hybrid3D device, specifically focusing on its Lung Lobe Quantification module. However, it does not contain the detailed study information required to answer your specific questions about acceptance criteria and how they were met.

The document broadly states:

• "The testing results supports that all the software specifications have met the acceptance criteria." (Page 4, Section H)
• "Comparisons were made between the module Lung Lobe Quantification in Hybrid3D v1.0 and Hermes Medical Imaging Suite v5.6 (K153056), Hybrid3D v1.0 and PMOD. The results showed a good compliance." (Page 4, Section I)

This general statement indicates that testing was performed and acceptance criteria were met, but it does not provide the specifics of those criteria, the reported device performance, sample sizes, expert qualifications, or adjudication methods.

Therefore, I cannot extract the information required for your request from the provided text. To answer your questions, I would need a more detailed scientific or clinical study report, which is typically found in the full 510(k) submission, but not in this summary document.

Ask a specific question about this device