FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

Intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremittes, and other body parts. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. Not for mammography.

Device Description

The MobileDiagnost wDR 2.2 is a motorized mobile radiographic system consisting of a mobile base unit, a user interface consisting of Eleva Workspot combined with flat solid state X-ray detectors used to operate, generate, process and handle digital X- ray images. The MobileDiagnost wDR 2.2 integrates a new wireless portable detector (SkyPlate E). The family of SkyPlate detectors (Large and Small) have already been integrated into the MobileDiagnost wDR 2.0 based on the K141736 pre-market submission.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the MobileDiagnost wDR 2.2, a mobile X-ray system. The focus of the submission is to demonstrate substantial equivalence to a predicate device, the MobileDiagnost wDR 2.0 (K141895), with several modifications. The document does not contain a clinical study to prove the device meets acceptance criteria in terms of diagnostic effectiveness or a "performance study" in the typical sense of evaluating a new diagnostic algorithm's accuracy. Instead, the submission relies on demonstrating substantial equivalence through non-clinical verification and validation tests against established standards.

Therefore, the requested information needs to be framed within this context of demonstrating substantial equivalence, rather than a traditional diagnostic performance study.

Here's the breakdown of the information based on the provided text:

Acceptance Criteria and Device Performance (within the context of Substantial Equivalence)

The acceptance criteria are implicitly defined by the compliance with recognized international and FDA consensus standards and the outcome of the comparison to the predicate device, showing that modifications do not raise new questions of safety or effectiveness. The device performance is assessed against these standards and through direct comparison of technical characteristics to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission relying on technical changes and compliance with standards, the "acceptance criteria" are compliance with these standards and the "reported device performance" is the verification that these standards are met, and that the technical characteristics of the modified device are acceptably equivalent to the predicate.

Feature Area / Acceptance Criteria	Reported Device Performance (MobileDiagnost wDR 2.2)	Conclusion (vs. Predicate)
I. Compliance with International and FDA-recognized Consensus Standards & FDA Guidance Documents	Non-clinical verification and validation tests demonstrate compliance with:

IEC 60601-1 (Edition 3.1)
IEC 60601-1-2 (Edition 4.0)
IEC 60601-1-3 (Edition 2.1)
IEC 60601-1-6 (Edition 3.1)
IEC 60601-2-54 (Edition 1.1)
IEC 62304 (Edition 1.0:2006)
IEC 62366 (Edition 1.0 2015)
ISO 14971 (Edition 2.0, 2007)
ISO 10993-1 (Edition 4.0 2009)
IEC 60601-2-28 (Edition 2.0 2010-03)
IEC 62220-1 (Edition 1.0 2015-03)
NEMA PS 3.1 - 3.20 (DICOM)
"Guidance for the Submission of 510(k)s for Solid State X-Ray Imaging Devices" (Sept 1, 2016)
"Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005)
"Pediatric Information for X-ray Imaging Device Premarket Notifications" (Nov 28, 2017) | Meets acceptance criteria and is adequate for its intended use, demonstrating substantial equivalence. Non-clinical information deemed sufficient to support substantial equivalence. |
| II. Technical Characteristics Equivalence (MobileDiagnost wDR 2.2 vs. MobileDiagnost wDR 2.0) | | |
| Base Unit Type, X-ray Tube rotational capabilities, Mains Supply, Mode of Exposure, Available Exposure Methods, X-ray Absorber, Installation type, Readout Mechanism, Maximum X-ray Dose for Linear Response, Maximum Usable Dose, Maximum Lifetime Dose, Image Processing (Eleva Workstation), ADC Digitisation, Signal to Electronic Noise Ratio (SENR), Data Interface to Workstation, X-ray Tube type, material, maximum voltage, nominal focal spot, anode type, nominal anode input power, Generator configurations, Collimator operation mode, beam shape, External Connectivity (DICOM), Software Platform (Eleva WorkSpot with SkyFlow). | Same/Identical to predicate. | Identical; thus, demonstrating Substantial Equivalence (SE). |
| Dimensions (overall, transport, source-floor distance) | Minor differences in mm measurements. | Differences do not impact safety or effectiveness. Thus, demonstrating SE. |
| Detector Models | Addition of SkyPlate E Large (Trixell 3543DR). Previously cleared SkyPlate Large/Small retained. | Addition of SkyPlate E detector does not impact safety or effectiveness. Thus, demonstrating SE. All technical detector characteristics influencing image quality assessed per FDA guidance. |
| Detector Weight | Max 3.1 kg (vs. Max 3 kg for predicate). | Difference has no impact on clinical workflow, safety, or effectiveness. Thus, demonstrating SE. |
| Image Size (X-ray field) | 345.0 mm x 426.0 mm (vs. 344.8 mm x 421.2 mm for predicate). | Difference does not impact clinical Image Quality, safety, or effectiveness. Thus, demonstrating SE. |
| Pixel Size | 160 µm (vs. 148 µm for predicate). | Difference of 12 µm pixel size does not impact image resolution "to an extent that can impact the clinical image quality," safety or effectiveness. Thus, demonstrating SE. |
| Image matrix size (Number of pixels) | 2156 x 2662 pixels (vs. 2330 x 2846 pixels for predicate). | "Infinitesimal change" and reduction in number of pixels due to 160 µm pixel size does not impact clinical Image Quality, safety, or effectiveness. Thus, demonstrating SE. |
| Nyquist Frequency | 3.125 lp/mm (vs. 3.38 lp/mm for predicate). | Difference does not impact clinical Image Quality, safety, or effectiveness. Thus, demonstrating SE. |
| Modulation Transfer Function (MTF) & Detective Quantum Efficiency (DQE) | Slightly different typical values reported (e.g., MTF at 1 lp/mm: 62% vs. 61%; DQE at 3 lp/mm: 22% vs. 29%). | Differences do not impact clinical Image Quality, safety, or effectiveness. Thus, demonstrating SE. |
| Grids | Addition of new large grids for SkyPlate E. Previously cleared grids retained. | Addition of new grids has no impact on clinical workflow, safety, or effectiveness. Thus, demonstrating SE. |
| Column Configuration | Sliding Column (vs. Standard/Short Column for predicate). | Sliding Column provides better viewing; its introduction does not impact safety or effectiveness. Thus, demonstrating SE. |
| System Power ON/OFF | Keyless user access (vs. Physical Key for predicate). | Keyless user access provides authenticated access; its introduction does not impact safety or effectiveness. Thus, demonstrating SE. |
| Exposure @ zero degree column position | Exposures allowed (vs. No Exposure allowed for predicate). | Allows examinations in space-constrained situations; difference does not impact safety or effectiveness. Thus, demonstrating SE. |
| Exposure during Charging | Exposures allowed (vs. Not allowed for predicate). | Allows charging during exam preparation; exposure energy still drawn from generator batteries, not mains. Does not impact safety or effectiveness. Thus, demonstrating SE. |
| Handles on Collimator | Handles can be used to move both Tube head and Collimator (vs. only Tube head for predicate). | Provides ease of use; difference does not impact safety or effectiveness. Thus, demonstrating SE. |
| Image Processing Algorithm | UNIQUE 2 (vs. UNIQUE for predicate). | UNIQUE 2 provides improved image processing (reduced noise, improved contrast) and was already cleared under K182973. Upgrading does not alter clinical workflow, safety, or effectiveness. Thus, demonstrating SE. |

Study Details (as applicable for a Substantial Equivalence submission based on non-clinical data)

The provided text clearly states: "The MobileDiagnost wDR 2.2 does not require clinical study since substantial equivalence to the primary currently marketed and predicate device MobileDiagnost wDR 2.0 (K141895- September 18, 2014) was demonstrated with the following attributes: Indication for use; Technological characteristics; Non-clinical performance testing; and Safety and effectiveness."

This means there was no "study" in the sense of a clinical trial or a diagnostic performance study to evaluate accuracy, sensitivity, specificity, etc., with human or AI readers. The "study" here refers to the comprehensive non-clinical verification and validation process against relevant standards.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not applicable. No clinical test set of patient data was used for a diagnostic performance evaluation. The "tests" were non-clinical verification and validation tests on the device itself (e.g., electrical safety, electromagnetic compatibility, radiation protection, software validation, usability, risk management).
Data Provenance: Not applicable. No patient data (retrospective or prospective, from any country) was used for evaluating the device's diagnostic performance for the purpose of this 510(k) submission.

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. There was no diagnostic test set requiring ground truth established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There was no diagnostic test set requiring adjudication.

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 comparative effectiveness study was done. This device is not an AI-assisted diagnostic product but rather an X-ray imaging system with updated components and software functionalities.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is an X-ray system, not a standalone diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. There was no diagnostic performance study requiring ground truth. Ground truth for the non-clinical tests would be the established scientific/engineering principles, specifications, and regulatory standards.

8. The sample size for the training set

Not applicable. This device is an X-ray system, not a machine learning model that requires a "training set" in the context of AI. The software (UNIQUE 2) was previously cleared (K182973), indicating its own development and validation, but details of its training are not provided here.

9. How the ground truth for the training set was established

Not applicable, as there was no training set for the device itself. For the incorporated UNIQUE 2 image processing algorithm, its ground truth establishment (if it involved machine learning) would have been part of its original 510(k) (K182973), but those details are not in this document.

Summary

Regulation Number and Section

§ 892.1720 Mobile x-ray system.

(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.