(153 days)
Portable X-ray Equipment REMEX Xcam6 is intended to be used in a hospital or clinic setting under the supervision of a qualified and trained clinician. This product is used as an x-ray source to produce diagnostic x-ray images of patient's extremities using an X-ray detector. It may be used in handheld or stand-mounted configurations for acquiring diagnostic radiographic images of extremities.
The device is not intended for mammography.
The REMEX Xcam6 is not intended to replace a stationary radiographic system, which may be required for full optimization of image quality and radiation exposure for different exam types.
The REMEX Xcam6 is a handheld and portable general-purpose X-ray system intended for use by qualified and trained clinicians to obtain diagnostic radiographic images of patient's extremities.
The REMEX Xcam6 serves as an X-ray source and is designed to be used in conjunction with a Flat Panel Detector (FPD), which is not included as part of the system. The FPD is connected to a computer equipped with imaging software that enables image acquisition, display, manipulation, storage, and transmission.
The X-ray source is securely enclosed within the housing of the handheld unit, and the device does not come into direct contact with the patient during use.
During imaging procedures, the patient is positioned appropriately—either sitting or lying down—and the X-ray receptor is aligned accordingly. The patient is instructed to remain still while the operator sets the exposure parameters and initiates the radiographic exposure.
The operator has control over the following exposure parameters:
- Tube Voltage (kVp): Adjustable from 40 to 90 kVp, in 1 kV increments.
- Tube Current (mA): Adjustable from 2 to 6 mA, in 1 mA increments.
- Exposure Time: Adjustable from 0.06 to 2.00 seconds, in 0.01-second increments.
The provided document outlines the FDA 510(k) clearance for the REMEX Xcam6, a portable X-ray equipment. While it confirms the device meets safety and performance standards for substantial equivalence to a predicate device, it does not provide explicit acceptance criteria in the form of specific performance metrics (e.g., sensitivity, specificity, accuracy) or detailed clinical study results typical for an AI/CADe device.
The document primarily focuses on technical characteristics, electrical safety, image quality (bench testing), and software validation. The "Clinical Performance Testing" section is very limited and only states that a board-certified radiologist verified the images were suitable for diagnostic interpretation, without quantifiable results.
Therefore, many of the requested details, especially those pertaining to a comparative effectiveness study involving AI assistance, multi-reader multi-case studies, or detailed AI performance metrics, are not available in the provided text as this is a traditional X-ray device clearance, not an AI/CADe device clearance.
Below is an attempt to address the questions based only on the information available in the provided FDA 510(k) clearance letter. Missing information will be explicitly stated as "Not provided."
Acceptance Criteria and Device Performance Study for REMEX Xcam6
The REMEX Xcam6 is a mobile X-ray system, not an AI or CADe (Computer-Aided Detection/Diagnosis) device, as indicated by the product code "IZL" (Mobile x-ray system) and the lack of AI-specific claims. Therefore, the acceptance criteria and study detailed in the document focus on demonstrating substantial equivalence to a predicate conventional X-ray system through technical specifications, safety, and image quality for diagnostic interpretation by a human clinician, rather than on AI-driven performance metrics like sensitivity, specificity, or reader improvement.
1. Table of Acceptance Criteria and Reported Device Performance
The document describes several non-clinical tests (electrical safety, EMC, image quality, dosimetry, software V&V) and a limited clinical test. The "acceptance criteria" for these tests are implicitly that the device performs "as intended" and is "as safe and effective as the predicate device," and that "all predefined acceptance criteria established in the test protocol" were met for bench testing. Specific, quantitative acceptance criteria for image quality beyond "suitable for diagnostic interpretation" are not explicitly stated for the clinical review.
| Acceptance Criteria Category/Metric | Reported Device Performance |
|---|---|
| Electrical Safety | Complies with IEC 60601-1, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-28, IEC 60601-2-54 standards. |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2 standard. |
| Image Quality (Bench Testing) | Met all predefined acceptance criteria established in the test protocol; image quality characteristics are substantially equivalent to the predicate device. |
| Dosimetry (Bench Testing) | Met all predefined acceptance criteria established in the test protocol; radiation dose characteristics are substantially equivalent to the predicate device. |
| Software Verification & Validation | Performed in accordance with IEC 62304:2006/A1:2015 for Class B software; Cybersecurity addressed per FDA guidance. |
| Clinical Image Quality | Acquired images were reviewed and assessed by a board-certified radiologist, who verified that the image quality was suitable for diagnostic interpretation. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly provided. The documentation states "A limited clinical test was conducted." It does not specify the number of images or patients included in this test.
- Data Provenance: Not provided (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: "A board-certified radiologist" (singular) was stated to have reviewed and assessed the images.
- Qualifications of Experts: "Board-certified radiologist." No specific experience level (e.g., years of experience) is mentioned.
4. Adjudication Method for the Test Set
- Adjudication Method: Not provided. Given only one radiologist was mentioned for clinical review, a formal multi-reader adjudication method (e.g., 2+1, 3+1) is unlikely to have been performed for this specific clinical assessment. The radiologist's assessment served as the verification.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- MRMC Study: No. The provided information is for a traditional X-ray system, not an AI-assisted device. The clinical performance testing focused on verifying the image suitability for diagnostic interpretation by a single radiologist, not on human reader performance improvement with AI assistance.
- Effect Size of Human Readers Improvement: Not applicable, as no AI assistance is mentioned or evaluated.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) was Done
- Standalone Study: Not applicable. This device is a hardware X-ray system; it does not feature an AI algorithm that would have standalone performance. Its software controls the X-ray system's operation, not image interpretation.
7. The Type of Ground Truth Used
- Ground Truth Type: For the "limited clinical test," the "ground truth" for verifying image quality appears to be the subjective assessment and verification by a single "board-certified radiologist" that the images were "suitable for diagnostic interpretation."
- For bench testing, phantoms were used, with "predefined acceptance criteria" as the ground truth.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This product is a physical X-ray machine. It does not utilize an AI model that requires a training set in the conventional sense. The software mentioned (IEC 62304 Class B) relates to the operational control of the device, not image analysis or AI interpretation.
9. How the Ground Truth for the Training Set was Established
- Ground Truth Establishment for Training Set: Not applicable, as there is no AI model or training set specified for this device.
§ 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.