Search Results

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

The Hermes Medical Imaging Suite 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 provided text describes a 510(k) submission for the Hermes Medical Imaging Suite v5.3. It focuses on the substantial equivalence of the new version to previously marketed predicate devices, primarily due to a change in the software's operating environment from Oracle® Solaris to Microsoft® Windows.

Although the document mentions "acceptance criteria" and "testing results supports that all the software specifications have met the acceptance criteria," it does not provide specific details on what these acceptance criteria were, what the reported device performance against those criteria was, or any clinical study details.

Therefore, many of the requested items cannot be extracted from this document.

Here's a breakdown of what can be inferred and what is explicitly missing:

1. A table of acceptance criteria and the reported device performance

Explanation: The document states, "The testing results supports that all the software specifications have met the acceptance criteria." However, it does not define what those specifications or acceptance criteria were, nor does it provide any quantitative performance metrics. The testing was primarily focused on demonstrating that the transfer of NM-processing applications to a new operating environment maintained the same technological characteristics and intended use as the predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size (Test Set): Not specified.
• Data Provenance: Not specified.

Explanation: The document focuses on technical verification and validation of software functionality after an operating environment change. It does not describe a clinical study involving a test set of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Number of Experts: Not applicable, as no clinical test set for ground truth establishment is described.
• Qualifications of Experts: Not applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication Method: Not applicable.

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

• MRMC Study: No. This document describes a software update for an image processing system, not an AI-assisted diagnostic tool or a comparative effectiveness study involving human readers.
• Effect Size: Not applicable.

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

• Standalone Study: The document does not describe a standalone performance study in the context of an algorithm's diagnostic accuracy. The "testing" mentioned refers to verification and validation of software specifications, ensuring the functionality remained consistent after the platform migration.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Type of Ground Truth: Not applicable, as the document does not describe a clinical study requiring ground truth for diagnostic accuracy. The testing was against design specifications and predicate device performance, not clinical ground truth.

8. The sample size for the training set

• Sample Size (Training Set): Not applicable. This device is not described as an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

• Ground Truth Establishment (Training Set): Not applicable.

Summary of the Study described:

The study described in the 510(k) summary is a technical verification and validation study to demonstrate that the Hermes Medical Imaging Suite v5.3, with its NM-processing applications transferred from Oracle® Solaris to Microsoft® Windows, maintains the same technological characteristics and intended use as its predicate devices. The "testing" ensured that "all the software specifications have met the acceptance criteria," and "comparisons were made between HERMES Medical Imaging Suite v5.3 and HERMES Medical Imaging Workstation (K121278), HERMES HDAQ Acquisition Station and Hermes Workstation (K021656), HERMES HDAQ Acquisition Station and Hermes Workstation (K002782) and Xeleris 2 processing and review workstation (K051673). The results showed a good compliance."

This is a regulatory submission focused on demonstrating substantial equivalence for a software update rather than a clinical performance study with specific diagnostic accuracy metrics.

Ask a specific question about this device

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 Hermes Medical Imaging Suite 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 provided text describes the 510(k) summary for the HERMES Medical Imaging Suite v5.2, but it does not contain the specific details required to complete all sections of your request regarding acceptance criteria and the study proving the device meets them.

The document states that "The testing results supports that all the software specifications have met the acceptance criteria," and "Comparisons were made between Hybrid Display and e.cam computer / e.soft workstation (K023190), and between Hybrid Recon™ and Xeleris 2 processing and review workstation (K051673). The results showed a good compliance." However, it does not provide the quantitative acceptance criteria, reported device performance, or detailed information about the studies.

Therefore, I will fill in the table and other sections with what can be inferred from the text, and clearly state where information is Not Provided (NP).

Description of the Acceptance Criteria and the Study

The HERMES Medical Imaging Suite v5.2 underwent verification and validation testing following Hermes Medical Solutions AB design controlled procedures. The testing aimed to demonstrate that all software specifications met the defined acceptance criteria and that the device was substantially equivalent to its predicate devices. The primary focus of the comparison appears to be on the equivalence in processing, display, analysis, and management of nuclear medicine and other medical imaging data. Specific comparisons were made for the "Hybrid Display" and "Hybrid Recon™" features against existing, legally marketed workstations to show "good compliance," implying that their performance matched or was equivalent to the predicate devices.

1. Table of Acceptance Criteria and the Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not Provided (NP). The document mentions "testing" and "comparisons" but does not specify the number of cases, images, or data points used in these assessments.
• Data Provenance: Not Provided (NP). The document does not specify the country of origin of the data or whether the data was retrospective or prospective.

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

• Number of Experts: Not Provided (NP).
• Qualifications of Experts: Not Provided (NP).

4. Adjudication method for the test set

• Adjudication Method: Not Provided (NP).

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

• MRMC Study Done: No. The provided text refers to comparisons between software applications, not studies involving human readers or AI assistance.
• Effect Size of Human Readers Improvement with AI: Not Applicable (NA), as no MRMC study with AI assistance for human readers was mentioned.

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

• Standalone Performance Study: Yes, implied. The "good compliance" results for "Hybrid Display" and "Hybrid Recon™" against predicate devices suggest an evaluation of the device's processing and display capabilities independent of human interpretation or intervention, focusing on its functional equivalence to existing validated software.

7. The type of ground truth used

• Type of Ground Truth: Implied to be comparison against the performance and output of previously cleared, legally marketed predicate devices (e.g., e.cam computer / e.soft workstation, Xeleris 2 processing and review workstation). This is a form of predicate device equivalence, where the "ground truth" is established by the accepted performance of the predicate.

8. The sample size for the training set

• Sample Size for Training Set: Not Provided (NP). The document does not mention any machine learning or AI components that would require a distinct "training set."

9. How the ground truth for the training set was established

• Ground Truth Establishment for Training Set: Not Applicable (NA), as no training set for machine learning was mentioned.

Ask a specific question about this device

Centricity PACS IW ™ by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

Centricity PACS IW ™ PACS System is an Internet bases software picture archiving and communications system that provides users with capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images (including digital mammograms). Centricity PACS System includes features to access and manage medical imaging studies from cat-scan (CT), magnetic radiography (MR), ultrasound (US), nuclear medicine (NM), computerized radiography (CR), digital radiography (DR), digital mammography (DM), digital x-ray (DX), x-ray angiography (XA), PET scan (PT), and other imaging modalities. Centricity PACS IW ™ PACS System is designed to be deployed over conventional TCP/IP networking infrastructure available in most healthcare organizations and utilizes commercially available computer platforms (Intel Pentium-based) and operating systems (Microsoft Windows 2000, Windows NT, and Windows 98). The system does not produce any original medical images. All images located on Centricity PACS IW ™ PACS System have been received from DICOM compliant modalities and/or systems.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the Centricity PACS IW™ PACS System meets those criteria:

Device Name: Centricity PACS IW™ PACS System

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not contain explicit, quantitative acceptance criteria with specific performance metrics (e.g., sensitivity, specificity, or objective measurements for image display quality). Instead, the validation appears to be qualitative, focusing on "substantial equivalence" and user experience.

• Acceptance, transfer, display, storage, and digital processing of medical images (including digital mammograms).
• Access and manage studies from various modalities (CT, MR, US, NM, CR, DR, DM, DX, XA, PET).
• Deployment over TCP/IP networks.
• Use of commercial computer platforms (Intel Pentium-based) and operating systems (Microsoft Windows 2000, NT, 98). | "Testing performed has shown that the Centricity PACS IW™ PACS System incorporating enhanced PET-CT user preferences is substantially equivalent to the above referenced predicate devices." |
  | II. Safe and Effective Use:
• No contact with the patient.
• Does not control life-sustaining devices.
• Provides ample opportunity for competent human intervention in image interpretation.
• Proper handling of mammographic images (no lossy compression for primary interpretation, requires FDA-approved 5 Mpixel monitor). | "Thorough system verification and validation testing was performed to ensure the safe and effective use of the Centricity PACS IW™ PACS System with enhanced PET-CT user preferences."
  "The information provided... has shown that the Centricity PACS IN™ PACS System with enhanced PET-CT user preferences is substantially equivalent to the predicate device and is safe and effective for its intended use." |
  | III. Enhanced PET-CT User Preferences:
• Improvement or equivalence in user experience with PET-CT specific functionalities compared to the predicate. | "A reader evaluation, consisting of 11 board certified Radiologist was conducted where they evaluated the new enhanced PET-CT user preferences to the predicate device on actual clinical cases." (Implicitly, the evaluation found them equivalent or improved enough for substantial equivalence). |

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

• Sample Size: The text states "actual clinical cases" were used, but the specific number of cases or images in the test set is not provided.
• Data Provenance: The origin of the data (e.g., country) is not specified. It refers to "actual clinical cases," implying retrospective data.

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

• Number of Experts: 11 board-certified Radiologists.
• Qualifications: "board certified Radiologist" (no specific number of years of experience mentioned).

4. Adjudication Method for the Test Set

The text describes a "reader evaluation" where 11 radiologists "evaluated the new enhanced PET-CT user preferences to the predicate device." It does not explicitly state an adjudication method (like 2+1 or 3+1 consensus). It implies that their collective evaluation or individual feedback contributed to the substantial equivalence conclusion rather than a formal ground truth adjudication process for specific diagnostic decisions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.

• Was it done? Yes, a form of reader comparison was performed. The "reader evaluation, consisting of 11 board certified Radiologist was conducted where they evaluated the new enhanced PET-CT user preferences to the predicate device on actual clinical cases." This compares the experience with the new system's features against a predicate.
• Effect Size of human readers' improvement with AI vs. without AI assistance: This study does not measure improvement with AI assistance. The device is a PACS system, a tool for displaying and managing images, not an AI diagnostic algorithm. The study compared user preferences and the experience of using the PACS features (specifically "enhanced PET-CT user preferences") between the new device and a predicate device. Therefore, there's no "AI vs. without AI assistance" effect size to report here.

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

• Was it done? No, a standalone algorithm performance study was not conducted. The Centricity PACS IW™ PACS System is a Picture Archiving Communications System (PACS), which is a display and management system for medical images, not a diagnostic algorithm that provides standalone interpretations. The system "does not produce any original medical images" and "does not contact the patient, nor does it control any life sustaining devices." Human interpretation is explicitly part of the intended use.

7. The type of ground truth used.

The "ground truth" for this study was based on the evaluation and feedback of 11 board-certified radiologists regarding the "enhanced PET-CT user preferences" on "actual clinical cases." This is more akin to a usability or comparative user experience evaluation rather than a ground truth for diagnostic accuracy (e.g., pathology, clinical outcomes, or expert consensus on disease presence). The study aims to show that the new system's features are at least equivalent in utility and user experience to those of the predicate device.

8. The sample size for the training set.

The document refers to "Thorough system verification and validation testing" and a "reader evaluation." It does not mention a training set in the context of an algorithm. This device is a PACS system, not a machine learning model, so the concept of a "training set" for an algorithm doesn't apply.

9. How the ground truth for the training set was established.

As there is no mention of a training set for an algorithm, the method for establishing its ground truth is not applicable and not provided.

Ask a specific question about this device