(28 days)
This is a mobile diagnostic x-ray system intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
This is a battery powered mobile diagnostic x-ray system which is provided without the digital x-ray acquisition systems used on our predicate model. The unit is provided with Lithium batteries to supply both X-ray generator for X-ray exposures and motors for movements instead of the Sealed Lead Acid batteries of the predicate model. This system has been made lighter and therefore more maneuverable. Lithium batteries provide a much lower charging time and more autonomy in standby. The indication for use remains the same as the predicate. The x-ray generator has been adapted to the new power supply based on Lithium batteries. The same. The main features of this equipment are:
a) A solid and ergonomic design. Easy operation, safety and precision of all positioning movements relative to the position of the patient.
b) Standard electrical outlet operation with single-phase lines at 100 -- 240 V*. Automatic line voltage compensation.
c) Head-Assembly rotation in relation to its transversal axis (±180°) and horizontal axis (120°). Collimator rotation in relation to its vertical axis (±90°).
d) Controls for lock release of Rotating Column and Telescopic Arm.
e) Column rotation in relation to its vertical axis (±317°), telescopic and vertical motion of the Arm.
f) X-ray Handswitch for X-ray exposures and Collimator Light.
Infrared Remote X-ray Handswitch (optional) for X-ray exposures and Collimator Light. g)
h) Dosimetry (optional):
i) DAP reading with an Ion Chamber. i)
ii) Calculated DAP (eDAP).
i) Manual Collimation.
Tube protection circuitry prolongs Tube life and increases system performance. i)
Equipped with closed loop control of X-ray Tube current, kVp and filaments, which minimize k) potential errors and the need for readjustments.
There is no imaging hardware or software supplied with the unit. That is the responsibility of the purchaser. The x-ray flat panel detectors (an integral part of a complete diagnostic system) are not part of the SM-IV device and must me provided separately by the user.
The provided text describes a 510(k) premarket notification for a mobile x-ray system (SM-IV) and focuses on demonstrating its substantial equivalence to a predicate device (PHOENIX, K212291). The assessment is primarily based on non-clinical testing and technical comparisons, and does not involve a study proving the device meets specific acceptance criteria related to diagnostic performance with human readers or AI.
Therefore, many of the requested details, such as those related to AI effectiveness, human reader studies, ground truth establishment for a test set, and sample sizes for diagnostic performance studies, are not applicable to this submission as it primarily concerns the safety and performance of the hardware itself, not its diagnostic accuracy in clinical use.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present a formal table of "acceptance criteria" in the sense of predefined thresholds for diagnostic accuracy (e.g., sensitivity, specificity, AUC) for an AI or human-in-the-loop system. Instead, it focuses on demonstrating substantial equivalence to a predicate device based on technical specifications and compliance with safety standards.
The "performance" is largely described in terms of functional specifications and safety compliance, not diagnostic accuracy.
| Characteristic | Predicate: K212291 PHOENIX (Reported Device Performance) | SM-IV (Reported Device Performance) | Acceptance Criteria (Implicit for Substantial Equivalence) |
|---|---|---|---|
| Indications for Use | Mobile diagnostic x-ray system for various body parts, adult/pediatric, not for mammography. | Same | Must be the same or very similar to the predicate. |
| Configuration | Mobile System with digital x-ray panel and image acquisition computer | Same, but no image acquisition software or hardware supplied. | Functionally equivalent as a mobile x-ray unit, with acceptable modifications. |
| X-ray Generator(s) | 20, 32, 40 kW and 50 kW Monoblock generator; kV range: 40-150 kV; mA range: 10-630mA; mAs range: 0.1-500 mAs | Same | Equivalent X-ray generation capabilities. |
| Collimator | Ralco R108F | Same | Equivalent collimation and radiation control. |
| Touch screen control | Yes, 19" | 19" or 21.5" | Acceptable range within control interface. |
| Motorized movement | Included | Same | Retention of mobility features. |
| Meets US Performance Standard | YES 21 CFR 1020.30 | SAME | Compliance with regulatory performance standards. |
| Power Source | Universal power supply, from 100 V~ to 240 V~. 1 phase | SAME | Equivalent power delivery. |
| Type of Batteries | Sealed Lead batteries | Lithium batteries | Acceptable battery technology change if equivalent/improved safety and performance. |
| Standby autonomy | ~11 hours | ~17 hours | Improved or equivalent standby time. |
| Charging time | ~8 hours | ~4 hours | Improved or equivalent charging time. |
| Imaging Software | Konica-Minolta control software CS-7 (K151465 or K172793) OR Konica-Minolta control software Ultra. | Not Included | Acceptable change of responsibility to purchaser. |
| Digital detector Interface | Ethernet or Wi-Fi wireless | Not Applicable | Not applicable as detectors are not included. |
| Size | 122 x 540 x 223 cm | 122 x 540 x 222 cm | Substantially equivalent size. |
| Weight | 520 kg | 450 kg | Acceptable or improved weight. |
| Digital Detectors | AeroDR Series | Not Included | Not applicable as detectors are not included. |
Study that Proves the Device Meets Acceptance Criteria:
The study described is a non-clinical bench testing and technical comparison to demonstrate substantial equivalence, rather than a clinical study of diagnostic performance.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not applicable in the context of diagnostic performance. The "test set" here refers to the physical SM-IV unit which underwent bench testing. The document states, "A system was assembled and found to be operating properly." This implies testing of a single or a few manufactured units for functional and safety compliance.
- Data Provenance: Not applicable for diagnostic performance data. The device itself is manufactured by Sedecal SA in Madrid, Spain.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. This submission does not involve establishing ground truth for diagnostic images or AI performance. The assessment is based on engineering and manufacturing standards.
4. Adjudication Method for the Test Set:
- Not applicable. No diagnostic image interpretation requiring adjudication was performed.
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 conducted because the device is a mobile x-ray system (hardware), not an AI-powered diagnostic software or a system intended to assist human readers in image interpretation. The device itself does not include imaging software or digital detectors.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This device is not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. Ground truth for diagnostic accuracy is not relevant to this submission. The "ground truth" for the device's performance is adherence to established engineering specifications and safety standards (e.g., IEC 60601 series).
8. The Sample Size for the Training Set:
- Not applicable. This device is a hardware system, not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set was Established:
- Not applicable.
In summary: The provided 510(k) summary focuses on demonstrating that the SM-IV mobile x-ray system is substantially equivalent to a legally marketed predicate device (PHOENIX) primarily through technical comparison and non-clinical bench testing to ensure safety and effectiveness of the hardware. It does not involve any studies on diagnostic performance, AI capabilities, or human reader accuracy, as these components (imaging software and digital detectors) are explicitly stated as not included with the SM-IV 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.