(232 days)
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
| Acceptance Criteria Category | Specific Acceptance Criteria (Quantitative if available) | Reported Device Performance |
|---|---|---|
| Overall Software Specification Compliance | All software specifications are met. | All software specifications were met. |
| Risk Mitigation | Identified hazards are mitigated through risk controls. | Risk control implemented to mitigate identified hazards. |
| Hybrid Display Feature | Performance equivalent to e.cam computer / e.soft workstation (K023190). | Showed "good compliance" with predicate device. |
| Hybrid Recon™ Feature | Performance equivalent to Xeleris 2 processing and review workstation (K051673). | Showed "good compliance" with predicate device. |
| Intended Use Compliance | Device can process, display, analyze, and manage nuclear medical imaging data. | Device fulfills intended use as described. |
| Technological Characteristics Equivalence | Same technological characteristics and indication for use as original device (K021656, K002782) with specified modifications. | Similar technology, fundamental concepts, and operation as predicate devices. |
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.
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.