(28 days)
The Micro C Medical Imaging System, M01 is a handheld and portable general purpose X-ray system that is indicated for use by qualified/trained clinicians on adult patients for taking diagnostic static and serial radiographic exposures of extremities. The device is not intended to replace a radiographic system that has both variable tube current and voltages (kVp) in the range that may be required for full optimization of image quality and radiation exposure for different exam types.
The Micro C Medical Imaging System, M01 (subject device) is a handheld X-ray system designed to aid clinicians with point of care visualization through diagnostic X-rays of distal extremities. The device allows a clinician to select desired technique factors best suited for their patient anatomy. The Micro C Medical Imaging System, M01 consists of three major subsystems: The Emitter, Cassette, and Control Unit. The System is interface an external Monitor (touchscreen or non-touchscreen display), keyboard and a mouse, and can provide a remote operator interface over the network to a laptop. The Micro C Medical Imaging System, M01 utilizes a computer vision positioning system to allow the emitter to be positioned above the patient anatomy and aligned to the cassette by the operator. The device is used in a clinical environment.
This looks like a 510(k) summary for a medical device called "Micro C Medical Imaging System, M01". The summary primarily focuses on establishing substantial equivalence to a predicate device and discussing technical characteristics and compliance with various standards.
There is no information provided regarding acceptance criteria nor a typical clinical study with patient data that would involve the following:
- A table of acceptance criteria and the reported device performance: This document does not specify quantitative acceptance criteria for image quality or diagnostic performance, nor does it report device performance against such metrics.
- Sample size used for the test set and the data provenance: There is no mention of a test set with patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: As there's no clinical test set, there's no mention of experts or ground truth establishment.
- Adjudication method for the test set: Not applicable as there's no patient test set.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable as there's no patient test set or reader study mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document describes an X-ray imaging system, not an AI algorithm. Therefore, this is not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable as there's no clinical test set.
- The sample size for the training set: Not applicable as there's no AI algorithm with a training set discussed.
- How the ground truth for the training set was established: Not applicable as there's no AI algorithm with a training set discussed.
What the document does provide:
The document focuses on demonstrating substantial equivalence to predicate devices based on:
- Technological Characteristics Comparison (Table 5-2 and 5-3): This table compares the subject device (Micro C Medical Imaging System, M01) with a predicate mobile X-ray system (Nomad MD 75kV Handheld X-Ray System, K140723) and reference devices (KDR™ AU-DDR System, K193225 and Faxitron VisionCT, K173309). It details various technical specifications like product code, regulation, classification, indication for use, age of device use, principle of operation, image type, detector characteristics (for the detector incorporated), collimator, weight, dimensions, triggering mechanism, SSD, SID, light field, energy source, exposure time, mA, kVp, ingress protection, image processing, connectivity options, DICOM compliance, and device package contents.
- Non-Clinical Performance Data: The document states that testing was performed successfully according to a list of international standards (e.g., ISO, IEC) and FDA regulations. These standards cover aspects like risk management, diagnostic X-ray system requirements, electrical safety, electromagnetic compatibility, usability, X-ray tube assemblies, software product lifecycle, biocompatibility, labeling, and laser safety.
- Additional Non-Clinical Performance Testing: This includes Functional Testing, an Image Quality Study, Usability Testing, and a Cleaning Study. However, no specific details, criteria, or results from these studies are provided in this summary.
Conclusion from the document:
The summary concludes that the Micro C Medical Imaging System, M01 is similar to the legally marketed predicate device (Nomad MD 75kV Handheld X-Ray System) in intended use, similar technologies, and performance data, and therefore does not raise different questions of safety and effectiveness, thus supporting its 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.