(23 days)
The DuraDiagnost is intended for use in generating radiographic images of human anatomy by qualified/trained doctor or technician. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. This device is not intended for mammographic applications.
The DuraDiagnost is a flexible digital radiography (DR) system that is designed to provide fast and smooth radiography examinations of sitting, standing or lying patients.
The DuraDiagnost consist of the following components: Tube column with X-ray assembly, wall stand with detector carrier, patient table with detector carrier and floating table top, high voltage generator, and acquisition and reviewing workstation for post-processing, storage and viewing of images. Images may be transferred via a DICOM network for printing, storage and detailed review.
The provided text describes a 510(k) premarket notification for the Philips DuraDiagnost, an X-ray system. The submission focuses on demonstrating substantial equivalence to a predicate device (DuraDiagnost K141381), rather than proving the performance of a novel AI algorithm. Therefore, many of the requested details, such as acceptance criteria for AI performance metrics, sample sizes for test sets, expert adjudication methods for AI ground truth, MRMC studies, standalone AI performance, and AI training set details, are not applicable to this submission.
The document primarily evaluates the DuraDiagnost against safety and effectiveness standards applicable to X-ray systems and its equivalence to a previous version of the device.
Here's the information that can be extracted, and an explanation of why other requested information is not present:
1. A table of acceptance criteria and the reported device performance
The document does not provide specific quantitative acceptance criteria for image quality or clinical performance metrics in a readily extractable table format for human or AI performance. Instead, it states that the device meets acceptance criteria by:
- Complying with international and FDA-recognized consensus standards.
- Demonstrating substantial equivalence to its predicate device in terms of design, technology, indications for use, safety, and effectiveness.
The "performance" is reported as compliance with the following standards and internal tests:
| Acceptance Criteria (Demonstrated via) | Reported Device Performance |
|---|---|
| Compliance with Consensus Standards | - AAMI / ANSI ES60601-1: 2005/(R)2012 and . C1:2009/(R)2012 and, A2:2010/(R)2012 (consolidated text) Medical electrical equipment -Part 1: General requirements for basic safety and essential performance. (Edition 3.1). |
| - IEC 60601-1-2 (Edition 4.0 2014): Electromagnetic Disturbances | |
| - IEC 60601-1-3 (Edition 2.1 2013): Radiation Protection in Diagnostic X-Ray Equipment | |
| - IEC 60601-2-28 (Edition 2.0 2010-03): X-ray tube assemblies for medical diagnosis | |
| - IEC 60601-2-54 (Edition 1.1 2015): X-Ray Equipment for Radiography and Radioscopy | |
| - IEC 60601-1-6 (Edition 3.1 2013): Usability | |
| - IEC 62304 (Edition 1.1 2015): Medical device software (Software life cycle processes) | |
| - IEC 62366-1 (Edition 1.0 2015): Application of usability engineering to medical devices | |
| - ISO 14971 (Edition 2.0, corrected version, 2007): Application of risk management to medical devices | |
| - CFR 1020.30: Diagnostic x-ray systems and their major components | |
| - CFR 1020.31: Radiographic equipment | |
| - FDA Guidance: "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices - September 1, 2016" | |
| - FDA Guidance: "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - May 11, 2005." | |
| - FDA Guidance: "Guidance for Industry and FDA Staff - Content of Premarket Submissions for Management of Cybersecurity in Medical Devices", issued October 2, 2014 | |
| - FDA Guidance: "Pediatric Information for X-ray Imaging Device Premarket Notifications," issued November 28, 2017 | |
| Verification/Validation Tests (Non-clinical) | - Tests performed with regards to intended use, technical claims, requirement specifications, and risk management results. |
| Substantial Equivalence to Predicate Device (K141381) | - The DuraDiagnost, including its wireless portable detector (SkyPlate E) and fixed RAD detector (Pixium 4343RCE), and the UNIQUE 2 Post Processing software, are found to be substantially equivalent to components and functionalities of legally marketed predicate devices and reference devices. Minor differences in technical characteristics (e.g., image area, image matrix, pixel size, operating system) are stated not to affect safety or effectiveness. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document as it is a 510(k) submission based on comparison to a predicate device and compliance with general safety and performance standards for X-ray systems, not specific clinical performance studies with AI. The non-clinical verification/validation tests performed would typically use test phantoms or specific equipment testing, not a "test set" of patient data in the way an AI algorithm would.
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)
This is not applicable as the submission is not for an AI algorithm requiring clinical ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable.
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
This is not applicable. The device is an X-ray system, not an AI-powered diagnostic aide. The document explicitly states: "The DuraDiagnost does not require clinical study since substantial equivalence to the primary currently marketed and predicate device was demonstrated..." (Page 15).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device includes image processing software (UNIQUE 2 and SkyFlow), listed as comparable or updated versions of software present in predicate/reference devices, but it is not presented as a standalone AI diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This is not applicable in the context of an AI study. The "ground truth" for this submission refers to the established safety standards and the performance characteristics of the predicate device, against which the new device (DuraDiagnost) is compared. Compliance with engineering standards and performance specifications (e.g., tube voltage, focal spot size, image matrix, pixel size) serves as the "ground truth" for the device's equivalent performance to what is already on the market.
8. The sample size for the training set
This is not applicable. The document does not describe the development or training of a new AI algorithm.
9. How the ground truth for the training set was established
This is not applicable.
§ 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.