(136 days)
The RADspeed fit is intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine radiography examinations. The RADspeed fit enables radiographic exposure of the whole body of all ages including pediatric patients. Exposures may be taken with the patient sitting, standing, or lying in the prone or supine position. The RADspeed fit uses portable or integrated flat panel detectors to generate diagnostic images by converting x-rays into electronic signals. The device is also designed to be used with conventional film/screen or computed radiography (CR) cassettes. The device is not intended for mammographic techniques. The indications for use remain the same as those for the predicate, except for the removal of tomographic technique.
The RADspeed fit is an X-ray radiography system that is mainly used for the radiography of various regions of the patient's body in a standing or recumbent position. The RADspeed fit can be used in a wide range of applications from general radiography using X-ray film or Computed Radiography (CR) cassettes, to digital radiography. The RADspeed fit consists of an X-ray high voltage generator, X-ray tube unit, X-ray tube support and collimator. The system can be configured with radiographic table, radiographic stand and digital radiography system as well. The X-ray generator of RADspeed fit has the capability to communicate with the digital radiography system to synchronize exposure timing, receive a code to select an anatomical program and to send X-ray technique factors and dose information after exposure.
The provided document describes a 510(k) premarket notification for the "RADspeed fit" device, which is a stationary X-ray system. The core of the submission is to demonstrate substantial equivalence to a legally marketed predicate device (K152244 RADspeed Pro) and a digital radiography system (K170332 Digital Radiography CXDI-710C Wireless / CXDI-810C Wireless).
The document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria through a clinical or non-clinical evaluation comparing the device's output to ground truth, as typically seen for AI/ML-based medical devices or devices where image quality itself is the primary novelty.
Instead, the submission focuses on demonstrating substantial equivalence through:
- Comparison of Technological Characteristics: Showing that the new device shares fundamental technology with the predicate devices and that modifications (removed functions, added features like FPD rotation tray and calculated dose-area product display) do not affect safety or essential effectiveness.
- Compliance with Standards: Stating that the new device conforms to relevant IEC standards (IEC60601-1, IEC60601-1-2, IEC60601-1-3) and CFR, which are general safety and performance standards for medical electrical equipment and X-ray systems.
- Software Verification and Validation: Showing that these processes were conducted according to FDA guidance, assuring safety and effectiveness for the software modifications related to interface adaptation.
- Claim of Substantial Equivalence for Image Quality: Since the digital radiography system (detectors) used in the new device is "exactly the same as the predicate device (K170332)," the submission argues that "the output image is substantially equivalent to the predicate device as long as the quality and profile of input X-ray are similar." The compliance of X-ray generators with IEC60601-1 is cited to ensure similar X-ray quality.
Therefore, many of the requested details regarding acceptance criteria, test set characteristics, expert involvement, and specific performance metrics (like sensitivity, specificity, or MRMC results) are not applicable or not present in this type of 510(k) submission, which relies on demonstrating equivalence through design similarity, functional comparison, and adherence to general safety standards rather than a de novo performance study against a specified ground truth for a novel function.
However, I can extract the information that is present and explain why other points are not detailed.
Summary of Device Acceptance Criteria and Performance Data (Based on provided document):
The acceptance criteria are not presented in a quantitative table with specific metrics (e.g., sensitivity, specificity, accuracy). Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices by ensuring:
- Safety and Effectiveness: The device is as safe, as effective, and performs as well as the predicate device(s).
- Technological Equivalence: Key technological elements (energy emission, X-ray generation mechanism, image data acquisition/processing, hardware/software components) are the same or comparable.
- Compliance with Standards: Adherence to relevant IEC standards (IEC60601-1, 60601-1-2, 60601-1-3) and CFR for electrical, mechanical, chemical, thermal, and radiation safety, and electromagnetic compatibility.
- Software Verification and Validation: Software risks are analyzed, and V&V testing is conducted per FDA guidance to ensure its safety and effectiveness, despite modifications to adapt interfaces.
- Image Quality Equivalence: The digital radiography system (detector) is identical to a legally marketed predicate (K170332), thus ensuring "substantially equivalent" output image quality when combined with X-ray generators complying with relevant IEC standards.
- Non-introduction of New Safety/Effectiveness Concerns: Modifications (removed functions, added minor features) do not adversely impact safety or effectiveness.
The "study" proving this device meets its "acceptance criteria" is primarily the comparative analysis of its design, technology, and compliance with standards against established predicate devices, as documented in the 510(k) submission.
Breakdown of Requested Information based on the provided text:
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A table of acceptance criteria and the reported device performance
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Acceptance Criteria (Implicit - Substantial Equivalence):
- Device is as safe, as effective, and performs as well as predicate device (K152244 RADspeed Pro).
- Digital Radiography system (Canon CXDI-710C/810C) is identical to a legally marketed device (K170332).
- Compliance with IEC 60601-1, 60601-1-2, 60601-1-3, and CFR (for radiation safety).
- Software V&V conducted per FDA guidance, showing no new risks.
- No new safety or effectiveness concerns due to modifications.
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Reported Device Performance (as stated in the document):
- Electromagnetic compatibility: In conformity with IEC60601-1-2.
- Materials and Bio-compatibility: In conformity with IEC 10993-1. All materials in clinical use by other commercial products.
- Sterility: Not sterilized (same as predicate).
- Electrical, Mechanical, Chemical and Thermal safety: Substantially equivalent to predicate by conformed standards.
- Software: Risk Analysis and V&V testing conducted; identified level of concern, documentation consistent. "Difference does not affect its safety and effectiveness."
- Non-clinical Image Performance: "Substantially equivalent to the predicate device" because the Digital Radiography system is identical to K170332, and X-ray generators comply with IEC60601-1.
- Clinical Performance: "Substantially equivalent to the predicate device" for the same reasons as non-clinical performance.
- Radiation safety: Substantially equivalent by conformities of CFR and IEC60601-1-3.
(Note: This is not a quantitative performance table but a qualitative statement of equivalence and compliance.)
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Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/Not provided in this document. This submission primarily relies on design comparison, compliance with general standards, and leveraging the prior clearance of the identical digital detector system. There is no specific test set of patient images with ground truth described for "proving" the device's image quality or diagnostic performance via a clinical trial.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not provided. As there is no described test set with ground truth established, no experts for this purpose are mentioned.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided.
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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 study was done or mentioned. This device is a basic X-ray system, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not done. This device is an X-ray imaging system, not an algorithm providing a standalone diagnostic output.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not provided. No specific "ground truth" for diagnostic accuracy or image quality assessment (beyond compliance with technical standards) is detailed in this type of submission. The ground truth in this context is implicitly the "known good performance" of the predicate devices and the established performance of the identical digital detector.
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The sample size for the training set
- Not applicable/Not provided. This is a hardware device submission. While software V&V is mentioned, it's about system integration and safety, not an AI/ML algorithm that requires a "training set."
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How the ground truth for the training set was established
- Not applicable/Not provided. (See point 8).
§ 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.