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510(k) Data Aggregation
(279 days)
XELIS 3D
Xelis 3D™ is a software device intended for viewing of images acquired from various imaging modalities: CT. MR. CR. DR. US. PET and other DICOM compliant medical imaging systems when installed on suitable commercial standard hardware. Images and data can be captured, stored, communicated, processed, and displayed within the system and or across computer networks at distributed locations.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretation. For primary diagnosis, post process DICOM "for presentation" images must be used. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images. It is the User's responsibility to ensure monitor quality, ambient light conditions, and image compression ratios are consistent with the clinical application.
XELIS 3D is a software package intended for viewing and manipulating DICOMcompliant medical images from CT (computerized tomography), PET (positron emission tomography) or MRI (magnetic resonance imaging) scanners and other imaging modalities. XELIS 3D can be used for real-time viewing, 3D volume rendering, segmentation, registration, and reporting.
XELIS 3D application conforms to the DICOM 3.0 standard to allow interoperability with other DICOM compliant systems and is based upon the predicate device software used in Infinitt Xelis K082990.
XELIS 3D does not include any automated or semi-automated process for the detection of nodules or other shapes.
XELIS 3D is supplied to end users in both Windows 32 bit and 64 bit operating systems. The device software can connect to other workstations, PACS server/software, and modalities, through DICOM communication standard.
The provided text describes the XELIS 3D software, a picture archiving and communications system, and its substantial equivalence to predicate devices. However, it does not contain specific details regarding acceptance criteria and a structured study with quantifiable performance metrics. Instead, it focuses on demonstrating that XELIS 3D performs as intended and is as safe and effective as its predicate devices.
Here's an analysis based on the provided text, highlighting what is present and what is missing:
Acceptance Criteria and Device Performance Study for XELIS 3D
The XELIS 3D is a software package intended for viewing and manipulating DICOM-compliant medical images. The submission for its 510(k) clearance emphasizes its substantial equivalence to predicate devices rather than presenting a comparative effectiveness study with specific quantified acceptance criteria and performance metrics against a defined ground truth.
1. Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of specific, quantifiable acceptance criteria with corresponding performance metrics like sensitivity, specificity, accuracy, or any task-specific performance measures. Instead, the acceptance criteria are described in more general terms related to system functionality and safety.
| Acceptance Criteria Category | Reported Device Performance Summary |
|---|---|
| Functional Verification | The complete system configuration has been assessed and tested at the factory and has passed all in-house testing criteria. The Validation Test Plan was designed to evaluate all input functions, output functions, and actions performed by the XELIS 3D software in each operational mode. Validation testing indicated that all verification and validation activities were performed by designated individuals, and the results demonstrated that the predetermined acceptance criteria were met. |
| Integration & Installation | When installed by INFINITT CO., LTD, integration and installation verification tests are conducted against acceptance criteria prior to release to the client. The results are provided in the 510(k) submission. |
| Safety and Effectiveness | The device is described as "as safe, as effective, and performs as well as the predicate devices." It does not contact the patient, nor does it control any life-sustaining devices. Diagnosis is performed by Radiologists, Clinicians, and referring Physicians, with ample opportunity for competent human intervention. It is deemed not to raise any new potential safety risks and is equivalent in performance to existing legally marketed devices. |
| DICOM Conformance | The XELIS 3D application conforms to the DICOM 3.0 standard. (Ensures interoperability with other DICOM compliant systems). |
| Operating Systems | Supplied to end users in both Windows 32-bit and 64-bit operating systems. |
| Clinical Limitations | Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis. For primary diagnosis, post-process DICOM "for presentation" images must be used. Mammographic images should only be viewed with an FDA-approved monitor for mammographic images. It is the User's responsibility to ensure monitor quality, ambient light conditions, and image compression ratios are consistent with the clinical application. (These are conditions of use rather than performance metrics, but they define acceptable clinical performance boundaries). |
2. Sample Size and Data Provenance (Test Set)
The document does not provide specific details on the sample size used for any test set or the provenance (e.g., country of origin, retrospective/prospective) of the data. The testing described is "in-house testing criteria" and "validation testing" which seem to refer to internal software quality assurance rather than a clinical performance study with a distinct test set of patient cases.
3. Number and Qualifications of Experts for Ground Truth (Test Set)
This information is not provided in the document. The text indicates that "Diagnosis is not performed by the software but by Radiologists, Clinicians and referring Physicians," implying that human experts are responsible for interpretation, but it does not specify how ground truth was established for any performance evaluation in the context of the device's 510(k) submission.
4. Adjudication Method (Test Set)
An adjudication method (e.g., 2+1, 3+1) for establishing ground truth on a test set is not mentioned in the provided text, as a specific clinical test set for performance evaluation is not detailed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. There is no information regarding the effect size of how much human readers might improve with or without AI assistance, as the device primarily functions as a viewing and processing tool, not an AI-assisted diagnostic aid for detection. The text explicitly states: "XELIS 3D does not include any automated or semi-automated process for the detection of nodules or other shapes."
6. Standalone Performance Study (Algorithm Only)
A standalone performance study of the algorithm without human-in-the-loop performance is not described. Given the device's function as an imaging workstation and its statement that "Diagnosis is not performed by the software," a standalone study for diagnostic performance would not be applicable or expected. The testing described focuses on functional verification of the software.
7. Type of Ground Truth Used
The type of ground truth used (e.g., expert consensus, pathology, outcomes data) for any performance evaluation is not specified. The regulatory submission focuses on demonstrating functional equivalence and safety rather than a diagnostic performance study against a clinical ground truth.
8. Sample Size for the Training Set
The document does not provide information on a training set size. As the XELIS 3D does not perform automated detection or analysis (i.e., it doesn't describe AI/ML functionality requiring a training set), this information would not be relevant in this particular submission.
9. How Ground Truth for Training Set Was Established
Similarly, since there's no mention of a training set for an AI/ML algorithm, the method for establishing ground truth for a training set is not discussed.
In summary, the 510(k) submission for XELIS 3D demonstrates substantial equivalence primarily through functional verification, safety assessments, and conformance to standards (like DICOM 3.0), rather than through a clinical performance study with defined quantifiable acceptance criteria against a clinical ground truth. The device is presented as an image viewing and manipulation tool, not an automated diagnostic system, hence many of the requested elements pertaining to AI/ML performance studies are not present or applicable in this context.
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