(60 days)
These radiographic systems are 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, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
Proteus Radiographic System, Models XR/f ST and XR/f ET; MULTIRAD and MULTIRAD NET. These radiographic systems are designed for general radiography in hospitals, clinics, radiology imaging centers and medical practices. It is 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. Patients may be physically abled, disabled, immobilized or in state of a shock. The Radiographic Systems are not intended for mammography applications. If children are to be examined, they should always be accompanied by an adult.
Radiographic System Proteus XR/f has been interfaced with the Digital Imaging System of Konica Minolta Inc consisting of the image receptor and application for image acquisition (control console & image processing controller).
Here's an analysis of the provided text regarding the acceptance criteria and study information for the Proteus XR/f, Models ST and ET, Multirad, and Multirad NET Radiographic Systems:
Acceptance Criteria and Device Performance:
The document describes the device as being "substantially equivalent" to a legally marketed predicate device (K090279: Sedecal "Millennium Plus Digital Diagnostic X-Ray System") and references a reference device (K182688: Konica Minolta Wireless Detector SKR3000) without modification. The performance comparison is primarily qualitative, focusing on similar specifications and compliance with standards rather than explicit quantitative acceptance criteria with reported numerical performance.
Here's a table summarizing the implicit acceptance criteria based on the comparison to the predicate devices and the reported device characteristics:
| Acceptance Criteria (Implied from Predicate/Reference Device Comparison & Standards) | Reported Device Performance (Proteus XR/f) |
|---|---|
| Indications for Use: Same as predicate device (diagnostic radiographic exposures of skull, spinal column, chest, abdomen, extremities, and other body parts, for adult and pediatric subjects, sitting, standing, prone, or supine positions). | Same (Wording allows for both digital and traditional versions, essentially equivalent to the predicate) |
| Digital Receptor Panel/Panel Sizes: Performance comparable to predicate's Canon models. | Konica Minolta Wireless Detector SKR3000, K182688 (Reference device, without modification). Specific models: AeroDR 2 1417S, AeroDR 3 1417HD, AeroDR 3 1012HQ, AeroDR 3 1717HD. |
| Panel Properties: Comparable to predicate's $160 \mu m$, 2208 × 2688, 14 x 17 panel size, 12 bit. | $100 \mu m / 200 \mu m$, 1,994 x 2,430, 14 x 17 and 17 x 17 panel sizes, 16 bit. (Higher resolution/bit depth reported, indicating equivalent or better.) |
| Typical MTF/DQE: Performance comparable to predicate's 0.70 @ 1 lp/mm (MTF) and 0.30 @ 1 lp/mm (DQE). | MTF: 0.53 at 1 cycle/mm, DQE: 0.51 at 1 cycle/mm. Similar performance (explicitly stated). |
| Tube Mount: Same as predicate (Wall/Floor Suspension). | SAME |
| Image Acquisition Software: Comparable to Canon control software CXDI-NE. | Konica Minolta CS-7 provided with panel (provided with the reference panel). |
| Panel Interface: Ethernet or Wi-Fi wireless. | SAME or Wi-Fi wireless (Supports both, similar to predicate's Ethernet and extended with Wi-Fi). |
| Compliance with US Performance Standards: 21 CFR 1020.30 and 21 CFR 1020.31. | SAME (Explicitly stated to meet these standards). |
| X-ray Generator Output Power: Comparable to predicate's SHF Family: 32, 40 kW, 64 kW, 80 kW. | SHFR Family: 50 KW, 65 KW, 80 KW. SIMILAR RANGE OF OUTPUT POWER (explicitly stated). |
| kVp Range & Accuracy: Comparable to predicate's 40-125/150 kV, ±(3% + 1 kVp). | 40-150 kV, ±(3% + 1 kVp). (Similar range and accuracy, extended to 150 kV). |
| mA Range & Accuracy: Comparable to predicate's 10-800 mA, ±(4% + 1 mA). | 10-800 mA, ±(4% + 1 mA). (Similar range and accuracy). |
| mAs Range & Accuracy: Comparable to predicate's 0.1-500/640 mAs, ±(10% + 0.2 mAs). | 0.1-650 mAs, ±(10% + 0.2 mAs). (Similar range and accuracy, extended to 650 mAs). |
| Collimator: Functionally similar to Ralco R 302/A DHHS. | Ralco R 225 DHHS (Manual Collimator) (updated version of collimator). |
| Power Source: Mains operated. | SAME |
| Safety and Effectiveness: As safe and effective as predicate devices. | Confirmed through bench testing and compliance with various international standards (IEC 60601 series). |
| Firmware Validation: Complies with FDA guidance. | Validated according to FDA Guidance: "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document issued on: May 11, 2005." |
| Cybersecurity: Complies with FDA guidance. | Observed recommendations in FDA Guidance: "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff Document Issued on: October 2, 2014." Covered by the digital panel (K182688). |
| Pediatric Information: Labeling includes pediatric information. | Labeling developed and information provided in accordance with FDA Guidance: "Pediatric Information for X-ray Imaging Device Premarket Notifications, November 2017" and reference to Image Gently website. |
| Wireless Technology: Complies with FDA guidance (if applicable). | Consulted FDA Guidance: "Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and FDA Staff, AUGUST 2013" and incorporated recommendations into labeling (pertaining to K182688). |
Study Information:
-
Sample size used for the test set and the data provenance:
- The document states: "Clinical testing was not required to establish substantial equivalence because all digital x-ray receptor panels have had previous FDA clearance."
- Therefore, there is no explicit test set of patient images or data described for the Proteus XR/f system itself. The substantial equivalence relies on non-clinical (bench) testing and the prior clearance of its components (particularly the digital x-ray detector panel).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable, as no clinical test set requiring expert ground truth establishment for the Proteus XR/f was conducted. The clearance is based on substantial equivalence to predicate devices and component (digital x-ray receptor panel) clearances.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable, as no clinical test set was conducted.
-
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 MRMC comparative effectiveness study was mentioned or performed. This device is an X-ray system, not an AI-powered diagnostic tool, so such a study would not be relevant for its primary clearance.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is an X-ray imaging system, not an AI algorithm. Its performance is related to image quality and system functionality, not diagnostic algorithmic output.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the X-ray system itself, the "ground truth" for its performance is assessed through bench testing against established engineering and safety standards (e.g., IEC 60601 series, 21 CFR 1020.30, 1020.31) and comparison of technical specifications (kVp, mA, mAs accuracy, MTF/DQE values) to the predicate devices. The image quality, for instance, is implicitly compared to "diagnostic quality images as good as our predicate generator/panel combination."
- For the digital X-ray receptor panels used within the system (Konica Minolta Wireless Detector SKR3000), their prior FDA clearances would have involved their own ground truth evaluations, but those details are not provided in this document.
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The sample size for the training set:
- Not applicable, as this is an X-ray imaging system, not an AI algorithm that requires a training set.
-
How the ground truth for the training set was established:
- Not applicable, as this device does not utilize a training set.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.