(82 days)
The XR-910 folds into a compact unit (20" W 54.5" L 21" H). The XR-910 is then easily transported by a van or similar vehicle, to a private residence, nursing home, medical clinic, and other such facilities. With the large 15" pneumatic wheels, and 20" wheelbase and a weight of only 78 lbs., the XR-910 can be easily maneuvered through doorways, hallways, and up and down flights of stairs. This can be accomplished by an average person. Due to the large vertical movement of the tubehead and boom arm, and rotational positions of the tubehead, radiographs may be taken with the patient standing, sitting or supine. Radiographs may be taken of the chest and extremities. The XR-910 is a 60 to 90 kVp, 10 mA unit. Using 800 speed film and screens, exposure times for most radiographs are less than 100 milliseconds.
The XR-910 Mobile X-Ray unit is a light weight (78 pounds), compact (20" W 54.5" L 21" H), X-Ray System. The system can be easily loaded into a van or similar vehicle for transporting to the site where the unit will be used.
Here's an analysis of the provided text regarding acceptance criteria and the supporting study:
The provided document is a 510(k) Summary for the Imaging Sciences International Inc. XR-910 Mobile X-Ray unit, submitted in 1998. This document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than defining and proving unique acceptance criteria through a formal, quantitative study as might be expected in a modern AI/software device submission.
As such, many of the typical acceptance criteria and study details for an AI-powered device (e.g., sample size for test sets, expert ground truth, MRMC studies, standalone performance) are not present or applicable. The device described is a physical X-ray unit, not an AI algorithm.
However, I can extract the closest equivalent information based on the text provided:
1. Table of Acceptance Criteria (or rather, Performance Claims) and Reported Device Performance
For this device, the "acceptance criteria" are implied by the claims of substantial equivalence and suitability for its intended use, particularly in mobility and image quality comparable to a predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mobility & Maneuverability | The unit was "maneuvered through doorways, across concrete floors, carpeted floors and up and down stairways with relative ease" during evaluation. It is lightweight (78 lbs), has large 15" pneumatic wheels, and a 20" wheelbase, enabling an "average person" to maneuver it. |
| Image Quality (Radiographic Performance) | "radiographs of a step wedge and a phantom that were comparable with the DynaRad unit, and adequate for their intended use." |
| kVp Range | 50 to 90 kVp (adjustable in 1 kVp increments). |
| mA Current | 10 mA. |
| Exposure Times | Less than 100 milliseconds for most radiographs (using 800 speed film and screens). |
| Size (Compactness) | Folds into a compact unit (20" W x 54.5" L x 21" H). |
| Portability (Transport) | "easily transported by a van or similar vehicle." |
| Positional Flexibility | Radiographs may be taken with the patient standing, sitting, or supine (due to large vertical movement of tubehead/boom arm and rotational positions). |
| Power Supply | Operates on either 120 VAC or 220 VAC, 50-60 Hz. |
| mA Accuracy | Monitored to within a 10% accuracy. |
| Exposure Timer Range | 0.01 to 4.0 seconds (in increments of 0.01 seconds). |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated. The "test" involved evaluating the physical unit's mobility and taking radiographs of a "step wedge and a phantom." This implies a very small, controlled set of test cases, not a large patient data set.
- Data Provenance: The "evaluation process" appears to have been conducted internally by Imaging Sciences International Inc. at their facility ("throughout various parts of our building"). This is a manufacturer-conducted, non-clinical, prospective evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified. Given the nature of the tests (mobility, phantom image quality), it's highly unlikely that multiple human experts in the sense of clinical reviewers were involved to establish ground truth for a diagnostic outcome. The assessment of "comparable" image quality would likely have been made by the engineers or technical staff conducting the test.
- Qualifications of Experts: Not specified.
4. Adjudication method for the test set
- Adjudication Method: Not applicable/specified. No formal adjudication process as understood in clinical studies (e.g., 2+1 reading) is mentioned or implied for this type of non-clinical, technical evaluation.
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
- MRMC Study: No, an MRMC study was not done.
- Effect Size of AI Improvement: Not applicable, as this device is a traditional X-ray unit, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable, as this is a physical X-ray device, not an algorithm.
7. The type of ground truth used
- Ground Truth: For the mobility assessment, the "ground truth" was the direct observation of the unit's ability to be maneuvered through various environments by an "average person." For radiographic performance, the "ground truth" was a comparison of images from a "step wedge and a phantom" to those produced by the predicate DynaRad unit, and a qualitative assessment of whether they were "adequate for their intended use." This is essentially expert judgment based on internal technical evaluation using standard test objects.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This is a hardware device, not an AI algorithm that undergoes "training." Its design and engineering are based on established X-ray technology (specifically, the Keystone X-Ray Intrex VSK, K931486) and general engineering principles.
9. How the ground truth for the training set was established
- Training Set Ground Truth: Not applicable for a hardware device. Its performance is validated through physical testing and comparison to established medical device standards and predicate device performance.
Summary for this specific document:
The provided document describes a traditional mobile X-ray unit and its 510(k) submission from 1998. The "studies" conducted were non-clinical performance assessments focusing on mechanical, electrical, and radiographic equivalence to a predicate device ("DynaRad Corporation Phantom Portable X-Ray system"). The assessment criteria were suitability for its intended use, mobility, and image quality on phantoms/step wedges, not AI performance metrics. Therefore, most of the requested information pertaining to AI algorithm evaluation (sample sizes for training/test sets, expert adjudication, MRMC studies, standalone performance, etc.) is not present and not applicable to 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.