Search Results

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, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.

The AMX4-50 is an AMX portable that has been upgraded to accommodate the Canon 50G digital imaging system. The AMX4 will operate in the same manner as before except that, instead of using film cassettes, it will be making digital images with the Canon sensor. The original AMX system is disassembled and reconstructed with new batteries, a DC to AC power supply for the Canon digital imaging system, and enclosure sheet metal to accommodate the modifications. An added control coordinates x-ray exposure and digital image acquisition. The AMX4-50 asses the Canon CXDI-50G and the AMX4-31 uses the Canon CXDI-31 portable detector.

The provided document K063262 describes the AMX4-50 and AMX4-31 Mobile Digital Diagnostic Radiographic Systems. This device is an upgrade of the GE AMX-4 Plus Mobile X-ray System incorporating Canon digital imaging systems (CXDI-50G or CXDI-31).

The core of the submission is to demonstrate substantial equivalence to predicate devices, namely the GE AMX-4 Plus Mobile X-ray System (K021016) and the Sedecal Mobile X-Ray Units with Digital Detector (K043002).

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria provided are through comparison to predicate devices, focusing on functional aspects and compliance with existing standards rather than quantifiable performance metrics typical for AI/CADe devices.

2. Sample Size Used for the Test Set and Data Provenance

The document states, "The results of bench and user testing indicates that the new device is as safe and effective as the predicate devices." However, it does not provide specific details on:

• The sample size of the test set for user testing.
• The data provenance (e.g., country of origin, retrospective or prospective nature of the user testing data).
• Any details about the "bench testing" other than its conclusion.

Given the nature of the device as a new iteration of an existing mobile x-ray system incorporating a new digital detector, the "user testing" likely refers to validating the functionality and usability of the integrated system in a clinical-like setting, rather than a diagnostic performance study on a large patient dataset.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not provide information on the number or qualifications of experts used to establish a ground truth for any diagnostic performance test set. This type of information would typically be expected for devices that provide diagnostic interpretations or aid in diagnosis. Since this device is a digital radiographic system, the "ground truth" would implicitly be the image quality and diagnostic utility as perceived by a qualified radiologist or clinician during the "user testing", but no explicit details are given about this evaluation.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method for a test set. This is consistent with the nature of the device, which is a hardware system for image acquisition, not a software algorithm that provides diagnostic output requiring adjudication of its findings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned or described in the provided document. The device is a radiographic system, not an AI/CADe tool intended to assist human readers in interpretation. Therefore, an MRMC study to measure the effect size of human readers' improvement with AI assistance is not applicable to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone performance study (algorithm-only) was not done. This device is a digital radiographic system, which is hardware for image acquisition. It does not contain a standalone algorithm for diagnostic interpretation that would require such a study.

7. The Type of Ground Truth Used

The document does not explicitly define a "ground truth" in the context of diagnostic accuracy, as it would for a diagnostic AI device. The testing conducted was for safety and effectiveness, likely focusing on:

• Technical performance: Image quality (resolution, contrast, etc.), dose output, system functionality, and integration.
• Compliance with standards: Electrical safety, radiation emission, and mechanical integrity.
• User feedback: Usability and operational equivalence to existing systems.

The "ground truth" for showing substantial equivalence appears to be that the integrated system functions as intended by acquiring diagnostic quality images and that its performance (e.g., digital resolution) is equivalent to or better than the predicate digital detector system.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable to this device. This is a hardware device (a mobile digital x-ray system) and not an AI or machine learning algorithm that requires training data.

9. How the Ground Truth for the Training Set Was Established

As above, the concept of a "training set" and establishing "ground truth for a training set" is not applicable to this device, as it is a hardware system.

Ask a specific question about this device