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510(k) Data Aggregation
(28 days)
MINXRAY, MODEL HF100H+
The MinXray HF100H+™ - is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays.
MinXray HF100H+1M is a portable unit which operates from 120 V 50-60~ AC. The unit utilizes a newly designed high frequency inverter and can be mounted to a tripod or support arm. The usual safety precautions regarding the use of xrays must be observed by the operator.
Here's an analysis of the provided text regarding the MinXray HF100H+™ High Frequency Diagnostic X-Ray Unit, structured to address your specific questions about acceptance criteria and study details:
The provided documentation details a 510(k) premarket notification for an X-ray unit, which is a hardware device. The "acceptance criteria" and "study" described are focused on demonstrating substantial equivalence to existing predicate devices, rather than establishing clinical performance metrics in the way AI/software devices typically would for diagnostic accuracy. Therefore, many of your requested points regarding AI device studies (like expert consensus, MRMC studies, training sets, etc.) are not applicable to this submission.
I will answer the questions based on the information available in the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
The "acceptance criteria" for this submission are primarily focused on demonstrating that the new device, MinXray HF100H+™, performs as safely and effectively as its predicate devices and meets relevant technical standards. The "reported device performance" is a comparison of its technical specifications to those predicates.
| Characteristic / Acceptance Criteria | MinXray HF100H+™ (Modified device) Performance | Assessment |
|---|---|---|
| Intended Use: "Intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays." (Same as Predicates) | SAME as HF100H (Predicate K973712) | Meets - Consistent with predicate device. |
| Size/weight: (Compared to HF100H) | SAME as HF100H | Meets - Consistent with predicate device. |
| Energy Source: (Compared to HF100H) | SAME as HF100H | Meets - Consistent with predicate device. |
| Mounting method: (Compared to HF100H) | SAME as HF100H | Meets - Consistent with predicate device. |
| User Interface: (Compared to HF120/60H) | SAME as HF120/60H (Predicate K040046) | Meets - Consistent with predicate device. |
| Exposure switch: (Compared to HF100H) | SAME as HF100H | Meets - Consistent with predicate device. |
| Controls: (Compared to HF120/60H) | SAME as HF120/60H | Meets - Consistent with predicate device (software-based, 2 CPUs). |
| Construction: (Compared to HF100H) | SAME as HF100H | Meets - Consistent with predicate device. |
| High Voltage Energy Source: (Compared to HF100H) | SAME as HF100H (High frequency (60kHz) inverter) | Meets - Consistent with predicate device. |
| Line Voltage adjustment: (Compared to HF100H) | SAME as HF100H | Meets - Consistent with predicate device. |
| Exposure times: (Specific ranges/steps) | 0.03-0.2 sec (in 0.01 sec. Steps) | |
| 0.2-0.4 sec (in 0.02 sec. Steps) | ||
| 0.4-1.0 sec (in 0.05 sec. Steps) | ||
| 1.0-4.0 sec (in 0.1 sec. Steps) | Different from HF100H (0.08 - 4.00 sec), but similar in range and steps to HF120/60H (0.01-5.0 sec range) with some specific changes (e.g., max 4.0 sec vs 5.0 sec). The document implies this is acceptable relative to the predicates. | |
| Tube potential (kV): (Compared to HF100H) | SAME as HF100H (40 - 100kV 2kVstep) | Meets - Consistent with predicate device. |
| kV steps: (Compared to HF100H) | 31 (2kV-step) | Meets - Consistent with HF100H, different from HF120/60H (41 steps), but within an acceptable performance range for a diagnostic X-ray. |
| Tube current (mA): (Specific ranges) | 30mA (40-60kV) | |
| 25mA (62-80kV) | ||
| 20mA (82-100kV) | Different from both HF100H (20mA constant) and HF120/60H (variable mA). This is a technical difference, but accepted as safe and effective. | |
| mA steps: (Compared to HF100H) | SAME as HF100H (Constant) | Meets - Consistent with predicate device. |
| X-ray tube: (Compared to HF100H) | SAME as HF100H (Toshiba D-124S) | Meets - Consistent with predicate device. |
| Anode heat Storage: (Compared to HF100H) | SAME as HF100H (20,000HU) | Meets - Consistent with predicate device. |
| Focal Spot Size: (Compared to HF100H) | SAME as HF100H (1.2 mm) | Meets - Consistent with predicate device. |
| mAs: (Specific ranges) | 0.6-120mAs | Different from HF100H (1.6-80mAs) and HF120/60H (0.6-202mAs). This is a technical difference, but accepted as safe and effective. |
| Total filtration: (Compared to HF120/60H) | SAME as HF120/60H (3.2mm AL equivalent) | Meets - Consistent with predicate device. |
| Collimator: (Compared to HF100H) | SAME as HF100H | Meets - Consistent with predicate device. |
| Source to Skin Distance (SSD): (Compared to HF100H) | SAME as HF100H (300 mm) | Meets - Consistent with predicate device. |
| Performance Standard: (21CFR 1020.30) | SAME as HF100H | Meets - Complies with required standard. |
| Electrical safety: (UL2601, IEC60601-1) | SAME as HF100/60H (and UL listed) | Meets - Complies with required safety standards. |
Study Description:
The study proving the device meets the acceptance criteria is a "bench and user testing" comparison to predicate devices, focusing on demonstrating substantial equivalence in safety and effectiveness. The conclusion states "the results of bench and user testing indicates that the new device is as safe and effective as the predicate device."
2. Sample size used for the test set and the data provenance
- Sample size for the test set: Not explicitly stated in the document. "Bench and user testing" is mentioned, implying internal testing and perhaps observation of performance. There is no information regarding a specific dataset of X-ray images or clinical cases used for testing.
- Data provenance: Not applicable in the context of an X-ray hardware device. The "testing" refers to the device itself, not patient data. "Bench testing" implies laboratory conditions, and "user testing" would likely involve qualified personnel operating the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This question is not applicable to this submission. This is a hardware device focusing on general X-ray production, not a diagnostic AI algorithm that interprets images or requires expert ground truth for image interpretation. The "testing" here assesses technical performance and adherence to safety and function standards.
4. Adjudication method for the test set
- This question is not applicable to this submission. Adjudication methods are typically used for assessing disagreements in image interpretation or clinical outcomes, which is not the subject of this hardware device submission.
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
- This question is not applicable to this submission. An MRMC study is relevant for AI-powered diagnostic tools designed to assist human readers. This device is a general-purpose diagnostic X-ray unit.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable to this submission. This is a standalone hardware X-ray machine. There is no algorithm for image interpretation described or evaluated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- This question is not applicable to this submission in the context of diagnostic accuracy. "Ground truth" for this device would refer to its technical specifications matching design parameters and fulfilling performance standards (e.g., producing X-rays at specified kV and mA settings, meeting safety requirements). The "bench testing" would verify these physical and electrical performance points.
8. The sample size for the training set
- This question is not applicable to this submission. This device is an X-ray hardware unit, not an AI model that requires a training set.
9. How the ground truth for the training set was established
- This question is not applicable to this submission, as there is no training set for an AI model.
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