(74 days)
The MinXray HF100H will be initially marketed for portable and mobile general purpose diagnostic medical radiography. Because of its compact size and high output to weight ratio, we anticipate that the initial uses will be in field, home care, and nursing home diagnostic radiographic applicatons. These uses are typical of the predicate device, the MinXray HF80H. We believe that the safety and effectiveness of the two models are substantially equivalent.
Experience in the market with the HF100H may make us aware of other possible applications. This unit may be eventually married with stands for permanent or semi-permanent installation for intra-operative use, hand and/or foot radiography, or other medical diagnostic applications.
The MinXray HF100H is a compact, self-contained high frequency X-ray unit consisting of the control, X-ray generator, and beam limiting device. Tube voltage (KV) and exposure time are variable and selected by the operator. Tube current is fixed at 20 mA.
The provided document is a 510(k) Summary of Safety and Effectiveness for the MinXray HF100H High Frequency Diagnostic X-ray Unit, submitted in 1997. This document focuses on demonstrating substantial equivalence to a predicate device (MinXray HF80H), rather than establishing new performance criteria or conducting a comprehensive study with acceptance criteria for a novel device. Therefore, much of the requested information regarding acceptance criteria, study design, and sample sizes for performance evaluation (as would be typical for AI/software-controlled devices) is not applicable to this submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The concept of "acceptance criteria" as applied to novel device performance is not explicitly stated in this document. Instead, the submission aims to demonstrate substantial equivalence to a predicate device. The performance is reported by comparing features and stating that "radiographs of the same patient produced on either device were essentially identical."
| Feature | Acceptance Criteria (Implied by Predicate Device) | Reported Device Performance (MinXray HF100H) |
|---|---|---|
| X-ray output | Similar to MinXray HF80H (10mA @ 50-80kV) | 20 mA @ 40-100 kV in 2 kV steps (Improved/Higher) |
| Timer | Similar to MinXray HF80H (0.08-3.98 sec) | 0.08-2.00 sec (Within range or adjusted) |
| X-ray generator | Constant potential, 45 kHz, Full-wave rectified | Constant potential, 60 kHz, Full-wave rectified (Improved/Higher frequency) |
| Line voltage adjustment | Automatic, dynamic | Automatic, dynamic (Equivalent) |
| X-ray tube | Toshiba D-102 or equiv. | Toshiba D-124K or equiv. (Similar but newer model) |
| Focal spot size | 1.0 mm | 1.2 mm (Slight difference, but considered equivalent for general radiography) |
| Total filtration | 3.2 mm Al equivalent | 3.2 mm Al equivalent (Equivalent) |
| Collimator | Advantech R-70ET or equiv. | Advantech R-70ET or equiv. (Equivalent) |
| Exposure cord | 8 feet (2.44 meters) | 8 feet (2.44 meters) (Equivalent) |
| Exposure switch | Two-stage, deadman type | Two-stage, deadman type (Equivalent) |
| Power cord | 10 feet (3.05 meters) | 10 feet (3.05 meters) (Equivalent) |
| Overload protection | Thermal, built-in | Thermal, built-in (Equivalent) |
| Size (tubehead/control) | 6.5" W, 7.5" H, 14.5" L | 9.5" W, 8.75" H, 15.35" L (Different, but still compact and portable) |
| Weight | 27.5 lbs (12.5 kgs) | 40.9 lbs (18.6 kgs) (Heavier, but still portable) |
| Control display | Digital | Digital (Equivalent) |
| Image Quality | Radiographs essentially identical to predicate (HF80H) | Radiographs essentially identical to predicate (HF80H) |
Note: The "acceptance criteria" here are implicitly defined by the performance characteristics of the legally marketed predicate device (MinXray HF80H). The new device is considered acceptable if its performance is "substantially equivalent" in terms of safety and effectiveness for the intended use. In some cases, performance is improved (e.g., higher output, higher generator frequency), which is generally viewed positively.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document states "Preproduction testing showed that radiographs of the same patient produced on either device were essentially identical." This implies a comparison was made, but the number of patients or images is not provided.
- Data Provenance: Not specified, but given the context of medical device preproduction testing, it would generally involve internal testing data. The country of origin is not mentioned. The study would be prospective in the sense that radiographs were specifically produced for comparison during preproduction.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. It can be inferred that qualified personnel (e.g., radiologic technologists, possibly radiologists) would have evaluated the image quality, but no details are given.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified. The statement "radiographs... were essentially identical" suggests a subjective comparison, but no formal adjudication process is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
- MRMC Study: No, an MRMC comparative effectiveness study was not conducted. This type of study focuses on evaluating diagnostic accuracy and reader performance, commonly used for AI-based diagnostic aids. This 1997 submission for a conventional X-ray unit does not involve an AI component or complex diagnostic performance evaluation in this manner.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: Not applicable. The MinXray HF100H is a physical X-ray generating device, not an algorithm or software. The document explicitly states: "The subject device is not software controlled."
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" here is the visual quality and diagnostic utility of the radiographs produced by both the new device and the predicate device. The claim is that they are "essentially identical," implying that they provide comparable diagnostic information. This is a subjective assessment of image quality by human observers, rather than an objective "ground truth" derived from pathology or clinical outcomes for specific diagnoses.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is a hardware X-ray generator, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set was Established
- How Ground Truth for Training Set was Established: Not applicable, as there is no training set for this hardware device.
In summary: This 510(k) submission is a traditional medical device submission focused on demonstrating substantial equivalence to a predicate device based on technical specifications and a general assertion of comparable image quality. It does not employ the structured study designs, performance metrics, and "ground truth" definitions that are typical for AI/software-controlled devices.
§ 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.