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510(k) Data Aggregation
(45 days)
MobileDiagnost M50
The MobileDiagnost M50 is a mobile radiographic system used for general X-ray imaging. This system can be used for taking x-ray images of patients who can't be moved to a fixed system. Applications include examinations of chest, upper and lower extremities, spinal column, skull radiography and abdominal cavities. MobileDiagnost M50 is not suitable for Mammography.
The MobileDiagnost M50 is a digital mobile X-ray system, used to perform X-ray examinations in different locations of a hospital, particularly for the patient who cannot be transferred to a fixed X-ray room. The MobileDiagnost M50 allows the user to take X-rays on a digital wireless detector and the image can then be viewed on the Eleva Workspot. The MobileDiagnost M50 consists of a mobile base unit and a user interface combined with a flat solid state X-ray detector. It is used by the operator to generate, process and handle digital X-ray images.
The provided text is a 510(k) summary for the Philips MobileDiagnost M50. It does not describe a study involving an AI/Machine Learning device, but rather a mobile x-ray system. The basis of the submission is demonstrating substantial equivalence to a predicate device through non-clinical performance testing and technical comparisons, rather than a clinical effectiveness study of an AI algorithm improving human performance.
Therefore, many of the requested criteria related to AI/ML device studies (such as MRMC studies, ground truth establishment, sample sizes for training/test sets for AI, expert consensus, etc.) are not applicable to this document.
However, I can extract information regarding the device's technical specifications and the non-clinical tests performed to demonstrate safety and effectiveness, which serve as its "acceptance criteria" and "proof" in the context of this 510(k) submission for substantial equivalence.
Here's a breakdown of the requested information based on the provided document, with explanations for what is not applicable:
Device: MobileDiagnost M50 (Mobile X-ray System)
1. Table of Acceptance Criteria and Reported Device Performance
In the context of this 510(k), acceptance criteria are primarily compliance with recognized standards and demonstration of comparable performance to the predicate device through technical specifications and non-clinical testing. The "reported device performance" is the MobileDiagnost M50's specifications and its compliance with the standards.
| Acceptance Criteria (General) | Reported Device Performance (MobileDiagnost M50) | Discussion (from document) |
|---|---|---|
| Compliance with International & FDA Standards | Complies with: ISO 14971, IEC 60601-1, -1-2, -1-3, -1-6, IEC 60601-2-54, IEC 62304, IEC 62366, ISO 10993-1, ISO 13485, CFR 1020.30, CFR 1020.31, FDA Guidance Documents. | Non-clinical verification and validation test results demonstrate that the MobileDiagnost M50 complies with these standards and meets the acceptance criteria for its intended use. This is the primary "proof" of meeting safety and effectiveness for a device of this type seeking 510(k) clearance via substantial equivalence. |
| Technical Equivalence to Predicate (MobileDiagnost wDR 2.0 - K141895) | Demonstrated through direct comparison of specifications. Examples: | The document provides a detailed table comparing features. For minor differences (e.g., dimensions, mono bloc rotation, mains supply, max kVp, nominal anode input power, mAs range), the justification provided is that "The minor differences... do not impact the safety or effectiveness of the device. Thus, demonstrating SE." For cases where the MobileDiagnost M50 uses a different component (e.g., detector scintillator, X-ray tube type, image matrix size, pixel size, image resolution), the justification leans on the fact that these components are either functionally equivalent OR are identical to those in other referenced/cleared devices (e.g., Varian PaxScan 4336Wv4 detector from K161459), thereby inheriting their demonstrated safety and effectiveness and not impacting that of the MobileDiagnost M50 differently. |
| - Base Unit Type | Mobile X-ray unit with wireless detector | Same as predicate. No difference. |
| - Dimensions | LxWxH: Operations 1836x618x2293mm; Transport 1371x618x1500mm | Minor differences from predicate, deemed not to impact safety/effectiveness. |
| - Detector Type | Digital wireless flat detector | Same as predicate. |
| - Scintillator | Gadox | Different from predicate (Cesium Iodide) but uses same wireless detector (PaxScan 4336Wv4) as a cleared reference device (K161459), thus no impact on safety/effectiveness. |
| - Detector Size (Large) | 14" x 17" | Same as predicate. |
| - Image Matrix Size (Large) | 2476 x 3072 pixels | Different from predicate (2330x2846 pixels) but uses same wireless detector as cleared reference device (K161459), thus no impact on safety/effectiveness. |
| - Pixel Size | 139 µm | Different from predicate (148 µm) but uses same wireless detector as cleared reference device (K161459), thus no impact on safety/effectiveness. |
| - Image Resolution | 3.6 lp/mm | Different from predicate (3.38 lp/mm) but uses same wireless detector as cleared reference device (K161459), thus no impact on safety/effectiveness. |
| - X-Ray Tube Type | X22 (Predicate: TOSHIBA E7886X) | Operates in the same manner as predicate's tube; no impact to safety/effectiveness. |
| - Maximum Tube Voltage | 130 kVp (Predicate: 150 kVp) | Minor difference, deemed not to impact safety/effectiveness. |
| - mAs Range | 0.1 mAs - 110 mAs (Predicate: 0.1 mAs - 500 mAs) | Difference noted, but justified as "required detector dose can be achieved for all clinical examinations for the MobileDiagnost M50. Therefore, there is no impact on the safety and effectiveness of the device." |
| - Software Platform | Philips Eleva Workspot | Same as predicate; therefore no impact on safety/effectiveness. |
| Adequacy for Intended Use | Demonstrated via non-clinical verification and validation tests. | "Non-clinical verification and validation test results demonstrate that the MobileDiagnost M50… Meets the acceptance criteria and is adequate for its intended use." |
2. Sample size used for the test set and the data provenance
- Not Applicable: This is a submission for an X-ray system, not an AI/ML device that requires a "test set" of images for AI performance evaluation. The "testing" referred to is non-clinical verification and validation against engineering specifications and regulatory standards. The documentation does not detail specific sample sizes of patients/images for performance testing, as it's not a clinical efficacy study.
- Data Provenance: Not applicable in the context of image data for an AI model.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable: No "ground truth" establishment by experts on a test set of images is mentioned as this is not an AI/ML device. The "ground truth" for this device's performance is compliance with established engineering and safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: No clinical 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
- Not Applicable: This is a mobile X-ray hardware system, not an AI assistance tool. No MRMC study was performed or required. The document explicitly states: "The MobileDiagnost M50 did not require a clinical study since substantial equivalence to the currently marketed and predicate MobileDiagnost wDR 2.0 was demonstrated with the following attributes: Design features; Indication for use; Fundamental scientific technology; Non-clinical performance testing including validation; and Safety and effectiveness."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is not an algorithm/AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable: No clinical ground truth was established from patient data. The "ground truth" for clearance is the device's adherence to technical performance specifications and safety standards as demonstrated through non-clinical testing.
8. The sample size for the training set
- Not Applicable: This is not an AI/ML device. No training set for an algorithm.
9. How the ground truth for the training set was established
- Not Applicable: This is not an AI/ML device. No training set or ground truth for it.
Summary of Acceptance/Proof for this Device:
The "acceptance criteria" for the Philips MobileDiagnost M50, as presented in this 510(k) summary, revolve around:
- Compliance with recognized electrical, radiation safety, usability, and quality management standards. This is demonstrated through non-clinical verification and validation tests.
- Demonstration of "substantial equivalence" to a legally marketed predicate device (MobileDiagnost wDR 2.0 - K141895). This is proven by showing that any differences in design features or fundamental scientific technology do not impact the safety or effectiveness of the device. Where components differ (e.g., the detector's scintillator), justification is provided by referencing other predicate/cleared devices that use the same component and have already demonstrated safety and effectiveness (e.g., Varian PaxScan 4336Wv4 detector, K161459).
The "study that proves the device meets the acceptance criteria" is the comprehensive set of non-clinical verification and validation tests performed to ensure compliance with the listed international and FDA-recognized consensus standards and internal design requirements. The results of these tests are stated to have demonstrated that the device "met the acceptance criteria and is adequate for its intended use."
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