(105 days)
The PROMO is intended for use in obtaining human anatomical images of patients who cannot be moved to the radiology department for medical diagnosis.
The PROMO is based on predicate device TOPAZ and the x-ray detectors are the same as the predicate system. The PROMO is moved smoothly with manual by user. The core part of x-ray source adopts high quality tube assembly, x-ray collimator, HV cable assembly and High Voltage x-ray Generator with excellent performance, lifetime and stability. Digital flat panel detector with CsI screen provides excellent spatial resolution, MTF, DQE and stability based on fine pixel pitch. The core part of x-ray source adopts high quality tube assembly, x-ray collimator, HV cable assembly and High Voltage x-ray Generator which have worldwide reputation on excellent performance, lifetime and stability. Touch screen LCD based x-ray control console provides user-friendly interface and easy technique selection. Collimator supports high accuracy for selected x-ray field size over any SID. The PROMO include imaging software that is the RADMAX. The RADMAX software can perform processing the radiological image acquired from solid state x-ray imaging device. The RADMAX software is based on predicate device TOPAZ. The CTR function is a manual quantitative imaging feature that allows users to measure the cardiothoracic ratio by manually selecting points using a mouse. The software function has been verified and validated as safe and effective.
The provided FDA 510(k) clearance letter and summary for the PROMO Mobile X-ray System do not contain information about specific acceptance criteria, reported device performance metrics in relation to those criteria, or details of a clinical study that proves the device meets acceptance criteria.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (TOPAZ) through non-clinical performance testing and compliance with various recognized standards and guidance documents. It confirms that the device's image performance was evaluated through bench testing.
Therefore, for the specific questions asked, most of the information is not available in the provided text.
Here's an breakdown of what can and cannot be answered based on the provided document:
Information that CANNOT be provided from the document:
- 1. A table of acceptance criteria and the reported device performance: The document mentions "bench testing was conducted to evaluate the image performance of the detector" and that "PROMO meets or exceeds TOPAZ in key image quality metrics such as uniformity, SNR, linearity, spatial resolution, and low contrast resolution." However, it does not provide specific numerical acceptance criteria for these metrics nor the quantitative reported performance of the device against them.
- 2. Sample size used for the test set and the data provenance: Since no clinical study or specific test set with patient data is described, this information is not available. The "test set" mentioned refers to non-clinical bench testing.
- 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 study involving expert interpretation is detailed.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as no clinical study involving expert interpretation is detailed.
- 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. The PROMO is a mobile X-ray system, not an AI diagnostic tool, and the document does not describe any MRMC studies. The "CTR function" mentioned is a manual measurement tool, not an AI feature for diagnostic assistance.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this device itself is the imaging hardware, not an AI algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the non-clinical bench testing mentioned, the "ground truth" would be objective physical measurements of image quality parameters (e.g., standard phantoms for linearity, resolution, etc.). The document does not describe clinical ground truths.
- 8. The sample size for the training set: The document does not describe any machine learning or AI models with a "training set."
- 9. How the ground truth for the training set was established: Not applicable, as no training set is mentioned.
Information that CAN be inferred or directly stated from the document (regarding non-clinical testing and general acceptance):
The document implicitly defines "acceptance criteria" by stating compliance with recognized national and international standards for medical electrical equipment, radiation protection, usability, software life cycle, risk management, and cybersecurity. The "study" that proves the device meets these (non-clinical) acceptance criteria is the bench testing and verification/validation processes conducted according to these standards.
1. A table of acceptance criteria and the reported device performance:
| Aspect | Acceptance Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Image Quality Metrics | Meeting or exceeding predicate device (TOPAZ) performance in key image quality metrics. Implicitly, compliance with industry standards for image quality. | "PROMO meets or exceeds TOPAZ in key image quality metrics such as uniformity, SNR, linearity, spatial resolution, and low contrast resolution." (supported by objective bench testing data) |
| Safety | Compliance with IEC 60601-1 (General requirements for basic safety and essential performance), IEC 60601-2-28 (X-ray tube assemblies), IEC 60601-2-54 (X-ray equipment for radiography and radioscopy). | Verified through testing to international safety standards. Differences from predicate do not negatively impact safety. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 (Electromagnetic disturbances). | Verified through testing to international EMC standards. |
| Radiation Protection | Compliance with IEC 60601-1-3 (Radiation protection in diagnostic X-ray equipment) and IEC 61910-1 (Radiation dose documentation). | Testing confirmed compliance. |
| Usability | Compliance with IEC 60601-1-6 and IEC 62366-1 (Usability engineering). | Testing confirmed compliance. |
| Risk Management | Compliance with ISO 14971 (Application of risk management to medical devices). | Potential vulnerabilities identified via cybersecurity risk analysis; design integrates security controls. |
| Software Life Cycle | Compliance with IEC 62304 (Medical device software). Software development process for RADMAX. | RADMAX software is "Basic Documentation Level," "verified and validated as safe and effective." |
| Cybersecurity | Compliance with FDA Guidances on Cybersecurity. Ensuring confidentiality, integrity, and availability of data and systems. | Device "complies with cybersecurity requirements," identified vulnerabilities through risk analysis, design integrates security controls (authentication, encryption, etc.). Verification and tests conducted. |
| DICOM Conformance | Compliance with NEMA PS 3.1 - 3.20 (DICOM Set). | Testing confirmed compliance. |
| Pediatric Information | Compliance with FDA Guidance on Pediatric X-ray Imaging Devices. | Testing confirmed compliance. |
| Detector Performance | Maintenance of performance characteristics (uniformity, SNR, linearity, spatial resolution, low contrast resolution) despite system changes. | "The results showed that PROMO meets or exceeds TOPAZ in key image quality metrics such as uniformity, SNR, linearity, spatial resolution, and low contrast resolution." |
Summary regarding the device performance study:
The PROMO Mobile X-ray System's substantial equivalence to its predicate (TOPAZ) and its safety and effectiveness are established through non-clinical performance testing (bench testing). This testing focused on comparing technical specifications and image quality metrics against the predicate and ensuring compliance with a comprehensive set of international and FDA-recognized standards and guidance documents. The document explicitly states: "Bench testing was conducted to evaluate the image performance of the detector. The results showed that PROMO meets or exceeds TOPAZ in key image quality metrics such as uniformity, SNR, linearity, spatial resolution, and low contrast resolution. Therefore, the substantial equivalence in image quality performance is supported by objective bench testing data."
Type of ground truth used (for bench testing):
For the non-clinical bench testing, the ground truth would be established by objective physical measurements using standardized phantoms and test objects to assess imaging characteristics (e.g., bar patterns for spatial resolution, step wedges for linearity, uniform fields for uniformity).
§ 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.