(23 days)
The APX-24 Portable X-ray is intended for use by a qualified/trained physician on both adult and pediatric subjects for taking diagnostic X-rays.
The APX-24 Portable X-ray is a portable unit that operates from120 V / 220-240V, 50 / 60 Hz. The unit utilizes a newly designed high-frequency inverter and can bemounted to a tripod or support arm. The operator must observe the usual safety precautions regarding the use of x- rays.
The provided FDA 510(k) summary for the APX-24 Portable X-ray System does not contain the specific details required to answer all aspects of your request regarding acceptance criteria and a study proving the device meets those criteria. The document primarily focuses on demonstrating substantial equivalence to a predicate device through technical specifications and adherence to general safety and performance standards.
Here's a breakdown of what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for the device's performance in terms of diagnostic accuracy or image quality compared to a clinical gold standard. Instead, it relies on demonstrating that the device meets general performance standards for X-ray systems and exhibits similar technical specifications to its predicate device.
The table below summarizes the technical characteristics, but it's not an acceptance criteria table related to diagnostic performance.
| Characteristic | Predicate Device (MinXray HF100H) | Subject Device (Aspenstate APX-24) |
|---|---|---|
| Intended Use | Diagnostic X-rays for adult/pediatric subjects | Diagnostic X-rays for adult/pediatric subjects |
| Size/Weight | 406 x 222 x 241 mm, 18.6 kgs | 414 x 230 x 215.5 mm, 12.7 kg |
| Energy Source | 100-140V 50-60 Hz AC | 120VAC/220-240VAC, 50/60Hz |
| Mounting method | Usually mounted to MinXray XGS MKIII Portable Stand | Not mounted to a Portable Stand |
| User Interface | Up-Down pushbuttons for kVp/exposure time w/ LED/mAs | Up/Down pushbuttons for kVp/exposure time w/ LED |
| Exposure switch | Dual-stage, deadman type | Dual-stage, deadman type |
| Controls | Software-based, 2 CPUs | Software-based, 2 CPUs |
| Construction | Monobloc HF generator, Medical full-bridge inverter system | Monobloc HF generator, Medical full-bridge inverter system |
| High Voltage Energy Source | High frequency (60kHz) inverter | High frequency (102kHz) inverter |
| Line Voltage Adjustment | Automatic, dynamic | Automatic, dynamic |
| Exposure times | 0.03-4.0 sec (various steps) | 0.03-4.0 sec (various steps) |
| Tube potential (kV) | 40 - 100kV (2kV step) | 40-100kV (1kV step) |
| kV steps | 31 (2kV-step) | 31 (2kV-step) |
| Tube current (mA) | 30mA (40-60 kV), 25mA (62-80 kV), 20mA (82-100 kV) | Varied (30mA-10mA depending on kV) |
| mA steps | Constant | Constant |
| X-ray tube | Canon D-124S | Canon D-125SB |
| Anode heat Storage | 20,000 HU | 50,000 HU |
| Focal Spot Size | 1.2 mm | 1.2 mm |
| mAs | 0.6-120 mAs | 0.32-100 mAs |
| Total filtration | 3.2mm AL equivalent | Min 2.8 mm AL |
| Collimator | Advantech R72, continuously adjustable light beam | Continuously adjustable light beam |
| Source to Skin Distance (SSD) | 300 mm | 300 mm |
| Performance Standard | 21CFR 1020.30 | IEC60601-1-3, IEC60601-1-6, IEC60601-2-28, IEC60601-2-54, 21CFR 1020.30, 21CFR 1020.31 |
| Electrical safety | UL2601, IEC60601-1 | IEC60601-1 |
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established
Missing Information:
The provided document describes a portable X-ray system, not an AI-powered diagnostic device or software. Therefore, the concepts of "test set," "training set," "ground truth," "experts for ground truth," "adjudication methods," "MRMC studies," "AI improvement," and "standalone algorithm performance" are not applicable to this submission.
The 510(k) summary focuses on demonstrating that the APX-24 Portable X-ray System is substantially equivalent to a predicate device (MinXray HF100H+) based on its intended use, technological characteristics, and compliance with recognized safety and performance standards for X-ray equipment. It does not involve a clinical study to assess its diagnostic accuracy or the performance of an AI algorithm.
Nonclinical Testing:
The document lists several nonclinical performance standards that the device successfully met (Section VII). These standards cover aspects like:
- IEC 60601-1-3:2008+A1:2013: General requirements for basic safety and essential performance — Collateral Standard: Radiation protection in diagnostic X-ray equipment.
- IEC 60601-2-65:2012 / EN 60601-2-65:2013: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment (though this seems somewhat misplaced if the device is general-purpose X-ray).
- EN 60601-1-2:2015: General requirements for basic safety and essential performance — Collateral Standard: Electromagnetic disturbances — Requirements and tests.
- EN 61000-3-2:2014, EN 61000-3-3:2013: Electromagnetic compatibility (EMC) standards.
- IEC 62133:2012 / EN 62133:2013: Secondary cells and batteries containing alkaline or other non-acid electrolytes – Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications. (Suggests internal battery component).
- EN 60601-1:2006/A1:2013: General requirements for basic safety and essential performance.
- IEC 60601-2-54:2009+A1:2014: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy. (This is a more direct standard for such a device).
- 21CFR 1020.30 & 1020.31: Federal regulations for ionizing radiation emitting products, specifically related to diagnostic X-ray systems and their components.
These nonclinical tests are the "study" demonstrating the device meets the "acceptance criteria" inherent in these international and national standards. The acceptance criteria for these tests are the pass/fail limits defined within each standard, and the report states that "Testing was performed successfully" and "Performance evaluation (test) reports and the device inspection report confirmed that the APX-24 Portable X-ray System is suitable for the device's intended use."
§ 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.