(158 days)
The XperCT Rel. 3 reconstructs 3D volumes from rotational fluoroscopic acquisitions, and provides CT-like images that assist the physician with diagnosis, surgical planning, interventional procedures, and treatment follow-up. XperCT Rel. 3 helps to manually estimate the dimension of the lesion.
The XperCT Rel. 3 is a software medical device intended to provide high-speed and high resolution 3D cross-sectional imaging in the angiography lab. The XperCT Rel. 3 generates a 3D image that visualizes soft tissue, which helps in identifying anatomy, for example cerebral, abdominal, and peripheral, etc., from a single rotational scan. The XperCT Rel. 3 includes filters to improve the image quality of the reconstruction by reducing the noise caused by metal objects or other objects that absorb high levels of x-ray radiation.
The provided text discusses the XperCT Rel. 3 device, but it does not contain specific acceptance criteria, study details (like sample sizes for test or training sets, data provenance), or performance metrics. The document states that "Non-clinical verification and validation tests were performed... The test results demonstrate that the XperCT Rel. 3 software medical device complies with international recognized standards as detailed in this premarket submission and met the acceptance criteria." However, it does not explicitly list these criteria or their fulfillment.
Therefore, the following table and information can only reflect what is explicitly stated or can be inferred from the provided text, and will highlight where information is missing.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance with international recognized standards (as detailed in the premarket submission). | The test results demonstrate that the XperCT Rel. 3 software medical device complies with international recognized standards as detailed in this premarket submission. |
| Meeting specific requirement specifications and risk management results for software verification, validation, and conformance testing. | The test results demonstrate that the XperCT Rel. 3 software medical device met the acceptance criteria for requirement specifications and risk management results. |
| (Specific numerical or functional performance criteria - e.g., accuracy, precision, image quality metrics) | Not reported in the provided text. The document states it "provides CT-like images that assist the physician with diagnosis, surgical planning, interventional procedures, and treatment follow-up" and "helps to manually estimate the dimension of the lesion." |
Study Details
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Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not specified in the provided text.
- Data Provenance: Not specified in the provided text. The document refers to "Non-clinical verification and validation tests" but does not indicate the source or nature of the data used in these tests (e.g., country of origin, retrospective or prospective).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified in the provided text.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified in the provided text.
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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:
- No MRMC comparative effectiveness study is mentioned in the provided text. The device is a software medical device for imaging, which assists physicians, but there is no study described that compares human reader performance with and without its assistance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The "Non-clinical verification and validation tests" could imply standalone testing for the software's functionality and image reconstruction capabilities. However, specific details of such a standalone performance study (e.g., metrics, dataset) are not provided. The device is described as assisting the physician, implying it is not intended for fully autonomous use.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not specified in the provided text. For image reconstruction, ground truth could refer to ideal reconstructed images or phantom data used for validation.
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The sample size for the training set:
- Not specified in the provided text. Information about a training set is not explicitly mentioned as the document focuses on the validation of the device rather than its development or initial training.
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How the ground truth for the training set was established:
- Not specified, as information about a training set or its ground truth is not provided.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.