(29 days)
The intended use of the Philips EasyDIAGNOST is the same as for the Philips DIAGNOST 76 plus.
The Philips EasyDIAGNOST is a multi-functional R/F system consisting of a floormounted tilting patient support table and a spotfilm device holding an image intensifier and the TV camera. The tabletop can be moved by motor in longitudinal and lateral directions. The spot film device tilts with the table, and can be moved in three directions, relative to the table and to the patient. As a fully integrated system, it can be configured with generators from the Philips Medio, Super CP, and OPTIMUS families, with digital spot film cameras from the Philips DSI family, and with a Philips EASY VISION workstation. The system comes with a trimode Image Intensifier, XTV imaging system, Philips glass or metal X-ray tube(s), and TV monitor(s). An optional dedicated ultrasound system (Scanner 200X) can also be added.
The system can also be extended with an overtable tube which operates on a bucky tray inside the table and/or on a bucky wallstand (so-called second plane). This second plane option is identical to a Philips bucky DIAGNOST system, except for the table itself.
Philips Grid Controlled Fluoroscopy (GCF) can be provided using an SRM (metal) gridswitched X-ray tube. GCF improves overall image quality and provides dose reduction through precise control of fluoroscopic pulse shapes, eliminating excess radiation associated with pulse ramping and trailing effects of conventional pulsed fluoroscopy.
The provided text is a 510(k) Summary for the Philips EasyDIAGNOST, an R/F (Radiography/Fluoroscopy) system. It focuses on demonstrating substantial equivalence to a predicate device and compliance with established safety and performance standards for X-ray equipment. It does not include information about specific acceptance criteria related to a device's diagnostic performance, nor does it describe a study to prove the device meets such criteria in the context of diagnostic accuracy, which is what your request implies.
Therefore, I cannot populate the table or answer most of your questions based on the provided text. The document is about regulatory clearance of an imaging hardware system, not the diagnostic performance of an AI or image analysis algorithm.
Here's what I can extract and address from your request based on the provided text, and what I cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|
| Compliance with federal X-Ray performance standards (CFR 1020.30, .31, .32) | "This device complies with the federal X-Ray performance standards" |
| Compliance with relevant national and international standards for Electrical and Mechanical Safety (UL 187, IEC 601-1, IEC 601-2-7) | "as well as with the relevant national and international standards for Electrical and Mechanical Safety" |
| Software equivalence to predicate device software | "The software used in the EasyDIAGNOST is equivalent to the software used in the predicate device." |
| Minor level of concern per "Reviewers Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review" (August 29, 1991) | "The results of the hazard analysis, combined with the appropriate preventive measures taken indicate the device is of minor level of concern" |
| Substantial equivalence to predicate device (Philips DIAGNOST 76 plus) | "The Philips EasyDIAGNOST is a modification of, and substantially equivalent to, the Philips DIAGNOST 76 plus" |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. The document describes a hardware system and its compliance with engineering standards. It does not refer to a test set of data for evaluating diagnostic performance.
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 provided. No test set or ground truth establishment relevant to diagnostic accuracy is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. No test set or adjudication process relevant to diagnostic accuracy is mentioned.
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 provided. This device is an R/F system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not provided. This device is an R/F system, not a standalone algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable / Not provided. No ground truth for diagnostic purposes is mentioned. The "ground truth" for the claims made in this document relates to engineering specifications and regulatory compliance.
8. The sample size for the training set
- Not applicable / Not provided. No training set for an algorithm is mentioned.
9. How the ground truth for the training set was established
- Not applicable / Not provided. No training set or ground truth establishment for an algorithm is mentioned.
In summary, the provided document is a regulatory submission for a medical imaging hardware system, demonstrating its safety and equivalence to existing technology, not an AI or diagnostic software study. Therefore, the information you're requesting regarding diagnostic performance, test sets, ground truth, and reader studies is not present.
§ 892.1980 Radiologic table.
(a)
Identification. A radiologic table is a device intended for medical purposes to support a patient during radiologic procedures. The table may be fixed or tilting and may be electrically powered.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.