(22 days)
The Philips MX 16-slice CT system can be used as a Head and Whole Body Computed Tomography X-ray System featuring a continuously rotating xray tube and detector array with multislice capability up to 16 slices simultaneously. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body from the same axial plane taken at different angles. The system is suitable for all patients.
The "Philips MX 16 slice" is a Whole Body Computed Tomography X-Ray System featuring a continuously rotating X-ray tube and detectors gantry and multi-slice capability. The acquired x-ray transmission data is reconstructed by computer into crosssectional images of the body taken at different angles and planes. This device also includes signal analysis and display equipment, patient and equipment supports, components and accessories.
This looks like a 510(k) summary for a CT scanner, a device with specific regulatory pathways that often rely on substantial equivalence to predicate devices rather than novel performance studies. As such, the document does not contain detailed acceptance criteria and a study proving those criteria are met in the same way a new medical algorithm might. Instead, it focuses on demonstrating equivalence to an already approved device.
Therefore, many of the requested fields cannot be directly extracted from this document, as the standard regulatory approach for this type of medical device at the time of this 510(k) summary did not require such detailed performance study reporting in the summary itself.
Here's an analysis based on the provided text, highlighting what is and is not present:
1. A table of acceptance criteria and the reported device performance
- Not present in this document. This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Brilliance CT 16-slice, K012009). The "acceptance criteria" for this submission are fundamentally about showing that the new device has "similar technological characteristics and sub-assemblies" and adheres to relevant safety standards (GMP, ISO 13485, IEC 60601-1, 21 CFR, Subchapter J). Specific performance metrics like sensitivity, specificity, or AUC, as would be expected for an AI algorithm, are not detailed here because that was not the regulatory requirement for this type of device at this time.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/Not present. Since a specific performance study with a test set (in the context of an AI algorithm) is not detailed, this information is not provided. The substantial equivalence argument relies on comparing the device's design, intended use, and safety features to a predicate, not on a clinical performance study with patient data in the typical sense.
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)
- Not applicable/Not present. As no specific performance study on a test set (with ground truth) is described, this information is not available.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not present. No test set adjudication method is described.
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
- Not applicable/Not present. This device is a CT scanner, not an AI-assisted interpretation tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable/Not present. This device is a hardware CT scanner, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not present. No specific performance study with ground truth data is described for this submission. The "ground truth" for this 510(k) is the established safety and effectiveness of the predicate device and adherence to recognized standards.
8. The sample size for the training set
- Not applicable/Not present. As this is a CT scanner and not an AI algorithm, there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Not applicable/Not present. This question is not relevant for the type of device and submission described.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.