(151 days)
The NOMAD MD is a handheld and portable general purpose X-ray system. The device uses a fixed tube current and voltage (kVp) and, therefore, is limited to taking diagnostic X-rays of extremities.
It is intended to be used by a qualified and trained clinician on both adult and pediatric patients. It is not intended to replace a radiographic system with variable tube current and voltage (kVp) which may be required for full optimization of image quality and radiation exposure for different exam types.
The NOMAD MD is a handheld, general purpose X-ray system that operates on 14.4 V DC supplied by a rechargeable NiCd battery pack. The X-ray tubehead, X-ray controls, and power source are assembled into a single hand-held enclosure. The package includes a spare battery, a Charging Cradle, and an AC-to-DC Power Supply.
The provided text describes the safety and effectiveness testing for the NOMAD MD Handheld X-ray System, as part of its 510(k) premarket notification. Here's a breakdown of the requested information:
1. Table of acceptance criteria and the reported device performance:
The document doesn't explicitly state "acceptance criteria" for diagnostic image quality in a quantitative, pass/fail table format. Instead, it states the objective was to demonstrate substantial equivalence to the predicate device (MinXray HF 100H+) for diagnostic image quality.
| Feature / Criterion | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Image Quality | Diagnostic quality images of adult and pediatric extremities, equivalent to predicate device. | "NOMAD MD can produce diagnostic images of adult and pediatric extremities and they are of equivalent diagnostic quality as the MinXray device." |
| Operator Exposure | Below the requirements of 21 CFR 1020.30(k) leakage radiation limits. | "Test results indicate that the level of exposure is well below the requirements of 21 CFR 1020.30(k)." |
| Extremity Imaging | Ability to capture diagnostic quality images of extremities from fingers (1.5cm) to thighs (21cm). | "NOMAD MD has been validated... to capture diagnostic quality images of body part extremities, such as fingers (from 1.5cm) and thighs (up to 21cm)." |
| Compliance with Standards | Meet requirements of relevant IEC and CFR standards (e.g., IEC 60601-1, 21 CFR 1020.30/31). | "EMC and Electrical Safety testing... found to meet all the requirements in standards IEC 60601-1: 2005, IEC 60601-1-3:2008, IEC 60601-1-6:2010, IEC 60601-2-28:2010, IEC 60601-2-54:2009, IEC 60825:2007, IEC 62366:2007, and IEC 60601-1-2:2007." (Also 21 CFR 1020.30, 1020.31). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: The document mentions "radiographic images of foot, knee, elbow, and hand phantoms" were used. It does not specify the exact number of phantoms or the number of images taken.
- Data Provenance: Not specified, but likely obtained in a controlled laboratory or testing environment by the manufacturer (Aribex, Inc., located in Orem, UT, USA). The study appears to be prospective as it involved taking new images for comparison.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: "A board-certified radiologist" (singular) was used.
- Qualifications of Experts: "Board-certified radiologist." No further details on years of experience are provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Based on the description "reviewed by a board-certified radiologist who determined that images from both devices were of diagnostic quality and, therefore, substantially equivalent," there was no formal adjudication method described involving multiple readers. It was a single-reader assessment.
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:
- No MRMC study was done. The described study was a comparison of image quality between two X-ray devices, not an assessment of human reader performance with or without AI assistance.
- No AI component is mentioned in this device or its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The NOMAD MD is an X-ray imaging device, not an AI algorithm. Its performance was evaluated based on the diagnostic quality of the images it produced, assessed by a human expert.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for image quality was expert assessment/consensus by a single board-certified radiologist. The images were of phantoms, simplifying the "ground truth" to the radiologist's determination of "diagnostic quality."
8. The sample size for the training set:
- Not applicable. This device is an X-ray emitter, not an AI or imaging processing algorithm that typically requires a training set. The descriptions relate to hardware performance, radiation safety, and image generation capabilities.
9. How the ground truth for the training set was established:
- Not applicable, as there was no training set for an AI algorithm.
§ 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.