(25 days)
The DigitalDiagnost is intended to acquire, process, store, display and export digital radiographic images. The DigitalDiagnost is suitable for all routine radiography examinations, including specialist areas like intensive care, trauma or pediatric work, excluding fluoroscopy, angiography and mammography.
The proposed DigitalDiagnost is a high-end digital radiography system consisting of a height adjustable patient support table and a ceiling suspension consisting of a tube including a control handle used to acquire images with a flat panel fixed RAD detector. Additionally, different vertical stands for the radiography examinations are available. The ceiling suspension can be moved in longitudinal and lateral directions and additionally the tube can be tilted and rotated as well. The system is configured with a Philips x-ray generator and a flat panel fixed RAD detector, Pixium 4343RCE. Together with the tube these components form the radiography Image Chain. The additional option of the portable wireless detector i.e. the SkyPlates family can be used for free exposures as well as in the patient support table or in the vertical stand.
The proposed DigitalDiagnost is a modification of the predicate device, DigitalDiagnost C90 (K202564). The modifications include change of colour of the table, stand and ceiling suspension; changes in ceiling suspension, service features and a software update. The changes related to the software updates and service features have been recently cleared in the reference device, CombiDiagnost R90 (K203087).
The provided text describes a 510(k) summary for the Philips Medical Systems DMC GmbH DigitalDiagnost, demonstrating its substantial equivalence to a predicate device. The information details the device, its intended use, and the non-clinical tests performed. It explicitly states that no clinical data was submitted for this 510(k) premarket notification.
Therefore, many of the requested details regarding acceptance criteria for device performance, expert ground truth, MRMC studies, or training/test set specifics cannot be directly extracted from the provided document as they pertain to clinical studies or AI/algorithm performance evaluations, which were not part of this submission. The provided text focuses on demonstrating the substantial equivalence of modifications (e.g., color changes, mechanical button changes, software updates for service features) to an existing cleared device through non-clinical testing.
Here's a breakdown based on the available information:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are implicitly met by "Pass" results for the listed non-clinical tests. The reported device performance is that it complies with the requirements for each test.
| Test Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| System Verification Testing | The system conforms to the system requirements. For service features (Monitoring of key system parameters, Remote Silent Logfile Export, Configurable Philips Remote Server Upload, Additional DICOM Information to Support Performance Bridge, and Migrate Eleva software logging platform from HSDP PF1.0 to HSDP PF2.0 APIs), the protocols are identical to the previously cleared reference device (CombiDiagnost R90 (K203087)), except for the newly introduced 'Monitoring of key system parameters'. | Pass. System verification test activities substantiate that the system conforms to the system requirements. |
| Software Verification Testing | The software conforms to the requirements. (Specific to service features where protocols are identical to the reference device, CombiDiagnost R90 (K203087), except for 'Monitoring of key system parameters'). | Pass. Software verification test activities substantiate that the software conforms to the requirements. |
| Risk Control Measure Verification Testing | The system meets the defined risk control measures. (Identical to Predicate device, DigitalDiagnost C90 (K202564)). | Pass. System meets the defined risk control measures. |
| Image Quality Testing | The tested equipment complies with the applicable Imaging Performance requirements. (Identical to Predicate device, DigitalDiagnost C90 (K202564)). | Pass. Results demonstrate that the tested equipment complies with the applicable Imaging Performance requirements. |
| Usability Engineering | The test complies with the usability requirements. (Identical to Predicate device, DigitalDiagnost C90 (K202564) and in compliance with IEC 60601-1-6 Edition 3.1 2013-10). | Pass. Results demonstrate that the test complies with the usability requirements. |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of clinical data, as it explicitly states that no clinical data was submitted. The tests conducted were non-clinical verification and validation tests, implying laboratory or engineering testing rather than a clinical study with patient samples. Therefore, information on sample size for a test set (meaning patient data) and data provenance (country of origin, retrospective/prospective) is not applicable or provided in this 510(k) summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical ground truth was established for a test set in this non-clinical submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set requiring adjudication was used.
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
No MRMC study was performed or reported, as no clinical data or AI assistance feature is mentioned in the context of this 510(k) for the DigitalDiagnost. The changes are related to physical components and underlying software infrastructure, not an AI-based interpretation aid.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as there is no mention of a standalone algorithm for diagnostic performance. The device is an X-ray system, and the software updates are described as related to service features (logging, remote export, etc.) and not image interpretation algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests, the "ground truth" would be the engineering specifications and performance standards against which the device was tested (e.g., system requirements, risk control measures, imaging performance requirements, usability requirements). These are established technical benchmarks, not clinical ground truth derived from expert consensus or pathology.
8. The sample size for the training set
Not applicable, as there is no mention of a training set, which is typically associated with machine learning or AI models. The software updates are for system functionality and service.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI/ML model.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. 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). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.