(25 days)
Cardius 1 XPO, Cardius 2 XPO, Cardius 3 XPO Imaging Systems:
The Cardius product models are intended for use in the generation of cardiac studies, including planar and Single Photon Emission Computed Tomography (SPECT) studies. in nuclear medicine applications.
2020tc SPECT Imaging System:
The Digirad 2020tc SPECT Imaging system is intended for use in the generation of both planar and Single Photon Emission Computed Tomography (SPECT) clinical images in nuclear medicine applications. The Digirad SPECT Rotating Chair is used in conjunction with the Digirad 2020tc Imager™ to obtain SPECT images in patients who are seated in an upright position.
Specifically, the 2020tc Imager™ is intended to image the distribution of radionuclides in the body by means of a photon radiation detector. In so doing, the system produces images depicting the anatomical distribution of radioisotopes within the human body for interpretation by authorized medical personnel.
Mirage XP is an automated processing and interpretation software package. This software will be available as standard software on the Digirad imaging systems and/or as a standalone software package on a workstation or a laptop. The enhancements to previous versions of software include automated processing, preference based selections, improved EF algorithm and segment scoring for quantification and interpretation.
The provided text is a 510(k) summary for a medical device (SPECT Imaging System with new software). It describes the changes to the device (software update), its intended use, and the conclusion from testing. However, it does not include specific acceptance criteria, detailed study results, or information about ground truth establishment, expert adjudication, or training/test set sample sizes as requested in the prompt.
The core conclusion from the provided text is that the new software functions as intended and produces images equivalent to previous versions, without impacting safety or effectiveness. This is a general statement rather than a detailed performance report against specific criteria.
Therefore, I cannot populate the table and answer all questions based on the provided text alone. I will indicate where information is Not Available (N/A) from the text.
Acceptance Criteria and Device Performance Study Summary
The provided 510(k) summary focuses on a software update (Mirage XP, equivalent to Segami's Mirage 5.6) for existing Digirad SPECT imaging systems. The study detailed in the summary is primarily a functional verification and equivalence assessment rather than a detailed performance study against numerical acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (as implied or stated) | Reported Device Performance |
|---|---|---|
| Functional Equivalence | The new Mirage XP software can be installed and functions as intended on Digirad imaging systems. | Confirmed. Software installs and functions as intended. |
| Safety | Use of Mirage XP software (with existing acquisition/reconstruction) does not result in known anomalies impacting safety. | No known anomalies impacting safety. |
| Effectiveness | Use of Mirage XP software (with existing acquisition/reconstruction) does not result in known anomalies impacting effectiveness, including operator usage and human factors. | No known anomalies impacting effectiveness, including operator usage and human factors. |
| Image Quality | Quality of images produced with Mirage XP software is equivalent to those seen in previous versions of Mirage software used on Digirad imaging systems. | Image quality is equivalent to previous versions of Mirage software. |
| Automated Processing | Specific performance criteria for enhancements (e.g., speed, accuracy of segmentation, EF algorithm improvements) are not specified. | Enhancements include automated processing, preference-based selections, improved EF algorithm, and segment scoring for quantification and interpretation. No specific performance metrics or acceptance criteria for these improvements are provided in this summary. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not Available (N/A). The document states "Testing was done," but does not specify the number of cases, scans, or an exact test set size.
- Data Provenance: Not Available (N/A). The document does not mention the country of origin of the data or whether the data was retrospective or prospective. It only implies that the testing was likely conducted internally by Digirad Corporation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not Available (N/A).
- Qualifications of Experts: Not Available (N/A).
- The comparison for image quality ("equivalent to those seen in previous versions") suggests an internal subjective assessment, but no details on expert involvement are provided.
4. Adjudication method for the test set
- Adjudication Method: Not Available (N/A). No information on adjudication methods for the test set (e.g., 2+1, 3+1, none) is provided.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No, an MRMC comparative effectiveness study was not done or reported in this summary. The device in question is software for SPECT imaging system processing and interpretation, which includes "automated processing, preference based selections, improved EF algorithm and segment scoring for quantification and interpretation," but it's not explicitly described as an "AI assistance" device in the context of improving human reader performance.
- Effect Size: Not Available (N/A). Since an MRMC study was not reported, there's no information on the effect size of human reader improvement with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, implicitly. The software "Mirage XP is an automated processing and interpretation software package." The statement that "Mirage XP software can be installed and functions as intended" and produces "equivalent" images suggests that the algorithm's standalone functional and image output capabilities were assessed. However, no specific standalone performance metrics (e.g., detection sensitivity/specificity for particular conditions) were provided, as the focus was on functional equivalence to previous versions.
7. The type of ground truth used
- Type of Ground Truth: Not explicitly stated. The comparison is primarily against the performance of previous versions of the software and images, implying a "referent standard" of previously accepted image quality and processing outputs. It does not mention an independent ground truth like pathology, outcomes data, or a consensus of multiple expert interpretations for clinical findings.
8. The sample size for the training set
- Sample Size for Training Set: Not Available (N/A). This document is about a new release of pre-existing software. Information on the training set used during the development of Mirage 5.6 (or Mirage XP) is not included in this 510(k) summary.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not Available (N/A). As the training set size and details are not provided, neither is information on how its ground truth was established.
§ 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.