(63 days)
Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
The MX40 is comprised of a High Voltage Generator with a maximum power output of 50 kW, the MX40 can meet different exposure needs for varying positions and body mass. With the MX40's state-of-the-art design and powerful 50 kW generator coupled with the Varex PaxScan digital flat panel image receptor and E-COM Digital Radiography Operator Console (used on previously cleared devices K130883 and K143232), users can obtain clearer images quickly and easily. Our latest mobile X-ray system is based on the revolutionary MX family.
The provided text describes the MX40 Mobile Digital X-ray System and its substantial equivalence to a predicate device, the RadPRO Mobile 40KW. However, it does not contain information about acceptance criteria for device performance in terms of diagnostic accuracy or a clinical study proving the device meets specific acceptance criteria related to its diagnostic output.
Instead, the document focuses on:
- Regulatory Clearance: A 510(k) premarket notification for demonstrating substantial equivalence to a legally marketed predicate device.
- Device Description: Details about the MX40's components and features.
- Comparison to Predicate Device: A table detailing the technological and functional characteristics of the MX40 compared to the RadPRO Mobile 40KW.
- Non-Clinical Performance Testing: A list of international and FDA standards with which the device complies.
- Conclusion: The device is considered substantially equivalent to the predicate based on non-clinical tests and the use of previously cleared digital image panels and acquisition software.
Therefore, many of the requested details about acceptance criteria for diagnostic performance and a clinical study are not available in the provided text.
Here's a summary of what can be extracted:
Acceptance Criteria and Device Performance (based on regulatory substantial equivalence)
The acceptance criteria are implied by demonstrating substantial equivalence to the predicate device, the RadPRO Mobile 40KW (K161345). The device is deemed to meet these criteria by complying with relevant medical device standards and having comparable technical specifications.
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance (MX40) |
|---|---|
| Intended Use: Diagnostic radiographic exposures of skull, spinal column, chest, abdomen, extremities, and other body parts for adult and pediatric subjects, performed with patient sitting, standing, or lying prone/supine. Not for mammography. | Matches predicate device's intended use exactly. |
| Modes of Operation: Manual | Manual |
| Classification Name: Mobile X-Ray System | Mobile X-Ray System |
| Classification Panel: Radiology | Radiology |
| Classification Regulation: 21 CFR 892.1720 | 21 CFR 892.1720 |
| Product Code: IZL | IZL |
| Subsequent Product Code: MQB | MQB |
| Medical Device Class: Class II | Class II |
| Performance Standard: 21CFR1020.30 | 21CFR1020.30 |
| Configuration: Mobile Battery or Line Operated | Mobile Battery or Line Operated |
| Power Source: Single Phase Line Regulation from 100 - 240 Vac (+/-10%) | Single Phase Line Regulation from 100 - 240 Vac (+/-10%) |
| Electrical Safety and EMC Standards: IEC 60601-1 and IEC 60601-1-2 | IEC 60601-1 and IEC 60601-1-2 |
| Other Standards: Wi-Fi 802.11b/g and FCC Rules and Regulations | Wi-Fi 802.11b/g and FCC Rules and Regulations |
| kV Range: 40 - 150kV | 40 - 150KV |
| Nominal Focal Spot: 0.6/1.2 | 0.6/1.2 |
| Anode type: Rotating | Rotating |
| System Software: Previously cleared image acquisition and control software (K130883, K143232) | ECOM Digital Radiography Operator Console (Acquisition Software and Graphical Interface-previously cleared as part of K130883 and K143232) |
| Operating System: Windows OS | Windows OS |
| Environment of Use: Medical Facilities and/or Universities | Medical Facilities and/or Universities |
| Collimator Operation: Manual, square/rectangular field, field indicator lamp | Manual, square/rectangular field, field indicator lamp |
| Anatomical Programs: 500+ Anatomical settings | 500+ Anatomical settings |
| External Connectivity: Wi-Fi and Ethernet Cable | Wi-Fi and Ethernet Cable |
| DICOM: YES | YES |
| Wi-Fi Communication with detectors: Wireless | Wireless |
Deviations/Improvements over Predicate:
- Generator Power Level: MX40: 50KW vs. Predicate: 40 KW
- mA Range: MX40: 10 - 630 mA vs. Predicate: 10 - 500 mA
- Exposure Time Range: MX40: 0.001 – 6.3 sec vs. Predicate: 0.001 - 10 sec
- mAs Range: MX40: 0.1 – 320 mAs vs. Predicate: 0.1 - 500 mAs
- X-Ray Tube: MX40: Toshiba E7843X vs. Predicate: (not specified, but implies a difference)
- Nominal Anode Input Power: MX40: Large Focus 50kW @ 6Hz, Small focus 22kW @ 60Hz vs. Predicate: (not specified)
- Imaging Panel: MX40 uses Varian 4336R, PAXSCAN 4336W (previously cleared K161459) vs. Predicate using Canon CXDI series (K133693, K131106). Both are previously cleared digital panels.
- Generator Type: MX40: Shenzhen Browiner vs. Predicate: Sedecal
- Collimator Model: MX40: Shenzhen Browiner Tech Co., Ltd Or Huestis 150MC vs. Predicate: Ralco R221 DHHS Manual Collimator
Regarding a study to prove the device meets acceptance criteria:
- Sample size used for the test set and the data provenance: Not applicable. The submission is a 510(k) for substantial equivalence based on non-clinical performance and a comparison of technical specifications, not a clinical study on diagnostic performance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth was established from expert readings for a diagnostic performance study.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set requiring adjudication was used for diagnostic performance.
- 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. This device is an X-ray system, not an AI-powered diagnostic tool.
- 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 an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this 510(k) clearance is the demonstrated compliance with engineering standards and performance characteristics of the device itself and its components, and its substantial equivalence to a predicate device.
- The sample size for the training set: Not applicable. This device is an X-ray system, not a machine learning algorithm that requires a training set.
- How the ground truth for the training set was established: Not applicable.
Summary of Non-Clinical Performance Testing:
The device undergone non-clinical performance testing for compliance with various international and FDA standards, including:
- ISO14971 (Risk Management)
- IEC60601-1 (Basic Safety and Essential Performance)
- IEC60601-1-2 (Electromagnetic Compatibility)
- EN 55032, EN 55024 (Electromagnetic Compatibility)
- IEC60601-1-3 (Radiation Protection)
- EN60601-1-6 (Usability)
- IEC60601-2-54 (X-Ray Equipment Specific Requirements)
- IEC62304 (Software Life-cycle Processes)
- ISO13485 (Quality Management)
- 21CFR 1020.30 (Diagnostic X-Ray systems and their major components)
- 21CFR 1020.31 (Radiographic equipment)
The submission leverages previous clearances for the digital image panel (K161459) and the image acquisition software (K130883 and K143232) to support the substantial equivalence claim.
§ 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.