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

The HERMES HDAQ Acquisition Station is a system designed to acquire nuclear medicine image data using a compatible gamma camera system. The HERMES Workstation is a system designed to process, display, analyze, and manage nuclear medicine and other medical imaging data transferred from other workstations or HDAQ acquisition stations.

The HERMES system consists of two components, a data acquisition station and a computer workstation. The HERMES HDAQ acquisition station and workstation are designed for use with commercially available gamma cameras. Software applications control acquisition, processing, display, analysis, and management of data and can be connected via network to other vendors' medical imaging workstations.

The provided 510(k) summary for the HERMES HDAQ Acquisition Station and HERMES Workstation, Ver. 3.4 does not include information about specific acceptance criteria or an explicit study proving performance against such criteria.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (HERMES HDAQ Acquisition Station and HERMES Workstation, K002782) based on the following:

• Same intended use: The modified device (Ver. 3.4) has the same intended use as the original device.
• Same technological characteristics: The document states, "The technological characteristics of the modified device are the same as the original device." The modification is explicitly stated as "the addition of six additional software applications."
• Device testing: The summary mentions, "Testing of the modified device followed Nuclear Djagnostic AB's normal procedures. A test plan was developed containing a description of relevant test procedures. Test results were documented, including what was tested, expected results, who performed the test, and which resources were used (i.e., automated test tools)." However, it does not provide details about what was tested, what the expected results were, or the actual results that would constitute acceptance criteria.

Therefore, I cannot provide the requested table of acceptance criteria and reported device performance from this document, nor can I answer questions about sample size, ground truth, expert opinions, or comparative effectiveness studies, as these types of detailed performance studies were not a part of this 510(k) submission for substantial equivalence.

This submission is based on the premise that since the modified device's core technological characteristics and intended use are the same as the predicate, and new software applications operate independently, a detailed performance study like those for entirely new devices or those with significant changes impacting clinical performance were not required for this type of 510(k) clearance.

Ask a specific question about this device