(15 days)
XperCT is a software option on the Allura Xper product family intended for imaging bone, soft tissue and other body structures. It reconstructs 3D volumes from rotational fluoroscopy acquisitions, and provides CT-like images to assist the physician in diagnosis, surgical planning, interventional procedures and treatment follow-up.
XperCT is a software option on the Allura Xper product family. It reconstructs 3D volumes from rotational fluoroscopy acquisitions, and provides CT-like images.
The provided 510(k) summary for Philips Medical Systems Nederland B.V.'s XperCT software option (K060749) does not contain information about specific acceptance criteria, a detailed study proving the device meets those criteria, or most of the requested study design parameters.
The submission is a summary of substantial equivalence to a predicate device (DynaCT by Siemens, K042646) rather than a detailed report of a performance study with defined acceptance criteria. The basis for substantial equivalence is stated as:
- XperCT does not introduce new indications for use.
- XperCT has the same technological characteristics as the predicate device.
- XperCT does not introduce new potential hazards or safety risks.
Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics cannot be extracted from the provided text.
Here's a breakdown of what can and cannot be answered based on the provided document:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document does not specify any quantitative acceptance criteria or report performance metrics from a specific study (e.g., sensitivity, specificity, accuracy). Its clearance is based on substantial equivalence to a predicate device with similar technological characteristics and intended use.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Cannot be provided. The document does not describe a performance study with a distinct test set.
3. 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)
- Cannot be provided. No information on ground truth establishment for a test set is available.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Cannot be provided. No information on adjudication methods for a test set is available.
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
- Cannot be provided. The document does not mention any MRMC study or evaluate the improvement of human readers with AI assistance. XperCT is described as a software option that reconstructs 3D volumes and provides CT-like images, not necessarily an AI-assisted diagnostic tool in the sense of improving human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. The document describes the device's function (reconstructing 3D volumes) but does not detail a standalone performance evaluation in terms of diagnostic effectiveness. Its clearance is based on similarity to a predicate device, implying its performance is expected to be comparable without needing an explicit standalone clinical study description in this summary.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Cannot be provided. No performance study details are available to infer the type of ground truth used.
8. The sample size for the training set
- Cannot be provided. The document does not describe the development or training of an AI algorithm in a way that would involve a training set. The device is a reconstruction software.
9. How the ground truth for the training set was established
- Cannot be provided. As above, no training set or ground truth establishment for training is discussed.
§ 892.1600 Angiographic x-ray system.
(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.