(33 days)
The MinXray HFP24 and HFP40 is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. These units are specifically designed for podiatric and extremity applications.
MinXray HFP24 and HFP40 are x-ray units which operate from 120 V 50-60~ AC. They utilize a newly designed high frequency inverter designed to be mounted on a stand. The usual safety precautions regarding the use of x-rays must be observed by the operator.
The provided text describes a 510(k) premarket notification for the MinXray HFP24 and HFP40 High Frequency Diagnostic X-Ray Units. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting extensive clinical studies with specific acceptance criteria that would typically be associated with new efficacy claims or significant changes in intended use.
Therefore, the requested information elements related to robust clinical studies, such as specific performance metrics, sample sizes, expert ground truth establishment, MRMC studies, or standalone algorithm performance, are not applicable in this context.
Here's an analysis based on the provided document:
Acceptance Criteria and Device Performance
The core "acceptance criteria" for a 510(k) submission are met by demonstrating substantial equivalence to existing predicate devices. This involves showing that the new device has the same intended use and either the same technological characteristics or, if technological characteristics are different, that these differences do not raise new questions of safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic / Criteria | Predicate Device (MinXray HF100H+ K052721) Baseline | Study Device (MinXray HFP24/40) Performance | Acceptance/Equivalence Rationale |
|---|---|---|---|
| Intended Use | For diagnostic x-rays on adult/pediatric subjects, specifically podiatric and extremity applications. | SAME | The new device shares the identical intended use as the predicate device. |
| Safety & Effectiveness | Safe and effective (as previously cleared in K052721). | As safe and effective as predicate device. | "The results of bench and user testing indicates that the new device is as safe and effective as the predicate device." This is the general acceptance criteria for a 510(k), demonstrated by comparing technological characteristics and functionality. Specific clinical efficacy metrics are not detailed because no new claims are made. |
| Technological Characteristics (Comparison to Predicate) | The most detailed "performance" is a direct comparison of specifications. Differences identified (e.g., size/weight, energy source, exposure times, kV range, mA, focal spot size, X-ray tube) are presented with the implicit claim that these differences do not alter the fundamental safety or effectiveness for the stated intended use. The acceptance is that these differences are not significant enough to warrant a new clinical review for safety and efficacy beyond the substantial equivalence framework. For example: |
- Size/weight: Modified device is generally smaller/lighter, presented as an improvement without new safety concerns.
- Energy Source: Different kVA, but still within typical medical device operation and tested for safety.
- kV steps, mA: Modified kV range (50-70kV) and mA (10 mA) are specific to the "podiatric and extremity applications" noted in the intended use, and are therefore considered appropriate subsets of the predicate's capabilities.
- Focal Spot Size: 0.8 mm (Modified Device) vs. 1.2 mm (Predicate). A smaller focal spot generally improves image resolution. This is considered a technological improvement that does not raise new safety concerns.
- Exposure Times: Adjusted range (e.g., 1.0-2.0 sec vs. 1.0-4.0 sec) within acceptable limits for the intended use.
- X-ray tube: Different model (SNMIF XDT-S70 vs. Toshiba D-124S), but deemed suitable through bench testing and compliance with performance standards. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated as a separate "test set" in the context of clinical images or patients. The evaluation appears to be based on bench testing and "user testing" of the physical device, comparing its specifications and functional performance to the predicate devices. This typically involves engineering verification and validation (V&V) activities.
- Data Provenance: The data provenance is from bench testing and "user testing" conducted by the manufacturer, Mikasa X-Ray Co., LTD. (Japan) and their distributor MinXray, Inc (USA). The nature of "user testing" in this context likely refers to usability and functional validation, not a formal clinical trial with patient data. It is retrospective in the sense of comparing against established predicate device performance and existing standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This is not applicable for a 510(k) submission based on substantial equivalence of an X-ray unit. There is no mention of a clinical "test set" requiring expert radiographic interpretation to establish ground truth for diagnostic accuracy, as the device is not an AI diagnostic tool or making new diagnostic claims. The "experts" involved would be the engineers and quality assurance personnel performing the bench and user testing, verifying the technical specifications and safety.
4. Adjudication Method for the Test Set
- Not applicable. As there is no clinical "test set" with diagnostic findings requiring ground truth, there is no need for an adjudication method.
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, an MRMC study was not done. This device is an X-ray generator, not an AI-powered diagnostic software. Therefore, questions regarding AI assistance or improvements in human reader performance are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, a standalone algorithm performance study was not done. This device is hardware (an X-ray unit), not a software algorithm.
7. The Type of Ground Truth Used
- For the purpose of this 510(k), the "ground truth" is primarily based on technical specifications, functional performance, and safety standards as verified through engineering tests and comparison to the predicate devices. Compliance with these technical ground truths (e.g., accurate kV output, appropriate filtration, physical dimensions, safety interlocks) constitutes the basis for demonstrating safety and effectiveness.
8. The Sample Size for the Training Set
- Not applicable. This device does not involve machine learning or AI models, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set.
§ 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.