(26 days)
The WBR Xact.cardiac & Xpress.cardiac is indicated for the acquisition, formatting and storage of scintigraphy camera output data. They are capable of processing and displaying the acquired information in traditional formats, as well as in pseudo three dimensional renderings, and in various forms of animated sequences, showing kinetic attributes of the image organs.
The Xact.cardiac & Xpress.cardiac are image processing systems, which are interfaced to gamma cameras. Gamma camera cardiac data is reconstructed by the Xact.cardiac. . Gamma camera cardiac, fast acquired, data is reconstructed by the Xpress.cardiac. The Xact.cardiac & Xpress.cardiac utilize parallel and non parallel beams and produce high resolution images. The images can be transferred to any other PACS device, which is DICOM or Interfile compatible.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Xact.cardiac & Xpress.cardiac device:
Based on the provided 510(k) summary and FDA clearance letter, specific acceptance criteria and detailed study data (like sample sizes for test and training sets, exact ground truth establishment, or MRMC studies) are not explicitly provided. The document is a regulatory submission summary rather than a detailed scientific publication of a study.
The submission focuses on declaring substantial equivalence to a predicate device, and the "Safety & Effectiveness" section primarily states that the device was designed, verified, and validated according to 21 CFR 820.30 regulations. It generally claims that "Bench and clinical data demonstrate that reconstructed images are equivalent or of better resolution comparing to images that are reconstructed by filter back-projection. No adverse affects have been detected."
Given the limitations of the provided text, I will address each point based on what can be inferred or is directly stated, and explicitly state when information is not available in the document.
Acceptance Criteria and Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Image Resolution Equivalent or Better than Filter Back-Projection | Reconstructed images are equivalent or of better resolution comparing to images that are reconstructed by filter back-projection. |
| No Adverse Effects | No adverse affects have been detected. |
| Compliance with 21 CFR 820.30 | Device has been designed, verified and validated complying to 21CFR 820.30 regulations. |
| Substantial Equivalence to Predicate Devices (Mirage Workstation K972886, WBR - fHR and WBR -fWB K040370) | UltraSPECT opinion that the Xact.cardiac & Xpress.cardiac are substantially equivalent in terms of safety and effectiveness to the above predicate device. |
Study Details:
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated. The document mentions "bench and clinical data" but does not quantify the sample size of the clinical data used for validation.
- Data Provenance: Not explicitly stated. Given UltraSPECT Ltd. is based in Haifa, Israel, it's possible some data originated there, but this is not confirmed. It's also not stated if the data was retrospective or prospective.
-
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)
- Not explicitly stated. The document does not provide details on ground truth establishment or the involvement of experts in the validation process.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not explicitly stated. There is no information provided about any adjudication methods used for the test set.
-
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
- Not explicitly stated. The document does not mention a multi-reader, multi-case study nor does it discuss human reader improvement with or without AI assistance. The device is an image processing system for reconstruction, not explicitly an AI-assisted diagnostic tool in the sense of a standalone AI system for interpretation.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Implied: The device is an "image processing system" that "reconstructs" images. The claim is about the quality of the reconstructed images being equivalent or better. This suggests the primary "study" (clinical data) would assess the output images themselves, likely in a standalone manner comparing them to images generated by the predicate or traditional methods. However, a formal "standalone performance" study with specific metrics (e.g., sensitivity, specificity for a diagnostic task) is not detailed. The focus is on image quality.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not explicitly stated. Given the claim is about "resolution," the "ground truth" for image quality assessment would likely involve objective measures of resolution (e.g., phantom studies, edge sharpness, contrast-to-noise ratio) and/or subjective assessments by experts comparing images, rather than a diagnostic ground truth like pathology for identifying disease. The document states "reconstructed images are equivalent or of better resolution comparing to images that are reconstructed by filter back-projection," suggesting a comparison of image characteristics.
-
The sample size for the training set
- Not explicitly stated. The document does not provide details about a training set. As an image reconstruction algorithm, it might involve algorithm development and tuning without a distinct "training set" in the machine learning sense, or if it did, the size is not disclosed.
-
How the ground truth for the training set was established
- Not explicitly stated. Since information on a training set itself is absent, the method for establishing its ground truth is also not 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.