(55 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 capacitor assisted 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 a battery to supply the internal PC up to 3 hours without mains connection. This system has been made lighter and more maneuverable, such that battery assisted motorized movement is no longer necessary. The removal of the movement motorization and the required rechargeable batteries resulted in a much lighter system. The generator is also smaller resulting in further weight reduction. The indication for use remains the same as the predicate. The system uses a different xray generator than the one used by the predicate but both are monoblock x-ray generators (same type of generator). The collimator has been changed from the Ralco R108F to the Varex Optica 10. They are functionally identical, having just two manual controls. Although the available generator options have lower peak outputs, the full range of examinations can still be made.
The provided text describes a 510(k) submission for a mobile x-ray system (SM-V) and its substantial equivalence to a predicate device (PHOENIX). It does not include information about clinical studies with acceptance criteria for device performance in the context of diagnostic accuracy, sensitivity, specificity, or reader studies typical for AI/CAD devices.
The "study" referenced in the document is a comparison of the characteristics of the new device (SM-V) against a predicate device (PHOENIX) and compliance with international standards, along with non-clinical testing. This comparison is to establish "substantial equivalence," not to prove diagnostic performance against specific acceptance criteria in a clinical setting.
Therefore, many of the requested sections about clinical study details, such as sample sizes, ground truth establishment, expert adjudication, and MRMC studies, are not applicable or cannot be extracted from this document, as clinical testing was explicitly not required.
Here's an attempt to answer the questions based only on the provided text, indicating when information is not present:
1. Table of acceptance criteria and the reported device performance
Based on the provided text, the acceptance criteria are related to the technical specifications and adherence to international standards, comparing the new device (SM-V) against a predicate device (PHOENIX). There are no "performance" metrics in terms of diagnostic accuracy (e.g., sensitivity, specificity) for a clinical study in this document.
| Acceptance Criteria (Implied) | Reported Device Performance (SM-V) |
|---|---|
| Indications for Use: Same as predicate. | "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 radiographic 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." (Same as Predicate) |
| Configuration: Similar to predicate. | Mobile System. "SAME but no image acquisition software is supplied." |
| X-ray Generator(s): Capable of full range of examinations. | 16, 20, 32 kW Monoblock generator. kV range: from 40 kV to 150 kV. mAs range: from 0.32 mAs to 200 mAs. "Although the peak power is lower, the full range of examinations from hand to chest can be effectively imaged." |
| Collimator: Functionally identical to predicate. | Varex Optica 10. "Controls are the same." (Predicate used Ralco R108F) |
| Touch screen control: Same as predicate. | Yes, 19". (SAME) |
| Motorized movement: Not included (a difference). | Not included. (Predicate included it) |
| Meets US Performance Standard: Compliance with 21 CFR 1020.30. | YES 21 CFR 1020.30. (SAME) |
| Power Source: Same as predicate. | Universal power supply, from 100 V~ to 240 V~. 1 phase. (SAME) |
| Imaging Software: Not included (a difference). | Not included. (Predicate included Konica-Minolta control software) |
| Panel Interface: Not applicable (a difference). | Not applicable. (Predicate had Ethernet or Wi-Fi wireless) |
| Size & Weight: Improved/reduced. | Size: 123 x 59 x 191 cm (including column) / 123 x 59 x 126 cm. "Smaller, more compact." (Predicate: 122 x 54 x 223 cm). Weights: 275kg. "Much lighter. Weight reduction due to elimination of motion motors and their heavy rechargeable batteries as well as using a smaller generator." (Predicate: 520 kg). |
| Digital Detectors: Not included (a difference). | Not included. (Predicate had AeroDR Series) |
| Compliance with International Standards: | IEC 60601-1:2005+A1:2012 (Edition 3.1), IEC 60601-1-2:2020 + A1:2020 (Edition 4.1), IEC 60601-1-3:2008+A1:2013 (Edition 2.1), IEC 60601-2-54:2009+A1:2015 + A2:2018 (Edition 1.2), IEC 60601-2-28:2017 (Edition 3.0), IEC 60601-1-6:2010 + A1:2013 (Edition 3.1), IEC 62304:2006 + A1:2015 (Edition 1.1). |
| Cybersecurity: Observed recommendations. | "Because the system has an Ethernet interface, we observed the recommendations contained in the FDA Guidance Document: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. The document explicitly states, "Clinical testing was not required to establish substantial equivalence." The testing performed was non-clinical (bench testing and compliance with standards).
- Data Provenance: Not applicable, as no clinical test set was used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication method: Not applicable.
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
- MRMC study: No, an MRMC study was not done. The device (SM-V) is a mobile diagnostic x-ray system, not an AI/CAD diagnostic aid. It explicitly states, "There is no imaging hardware or software supplied with the unit. That is the responsibility of the purchaser."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance: No, this is not an algorithm, but a hardware x-ray system. The document states, "There is no imaging hardware or software supplied with the unit."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not applicable, as no clinical study with a diagnostic ground truth was conducted. The "truth" in this context is adherence to technical specifications and safety standards.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This document describes an x-ray hardware system, not a machine learning algorithm.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable.
In summary: The provided 510(k) submission focuses on demonstrating substantial equivalence for a mobile x-ray hardware system by comparing its technical specifications and compliance with standards to a predicate device. It explicitly states that no clinical testing was required to establish this equivalence. Therefore, inquiries related to diagnostic performance studies, AI algorithms, human reader improvement, and associated methodologies for clinical data are not addressed in this document.
§ 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.