(117 days)
IMIX PanoRad and SomaRad X-Ray Systems are indicated for use in generating radiographic images of human anatomy. It has a Solid State X-ray Imaging system intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. (Not for mammography.)
The PanoRad consists of: A high resolution CCD detector with 14" x 17" or 17" x 17" image area. An X-Ray Tube & Collimator. A fully motorized positioned. A 65 kW high frequency generator. A 4 way floating table. An Image Acquisition workstation with DICOM 3 compliance.
The SomaRad consists of: A high resolution CCD detector with 14" x 17" or 17" x 17" image area. An X-Ray Tube & Collimator. A fully motorized positioned. A 50 kW high frequency generator. A table. An Image Acquisition workstation with DICOM 3 compliance.
The provided text describes a 510(k) summary for the IMIX PanoRad and SomaRad X-Ray Systems (K101435). This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria through a clinical study.
Therefore, many of the requested elements for a study proving acceptance criteria (like sample size for test set, number of experts for ground truth, adjudication method, MRMC study, sample size for training set, how training set ground truth was established, and specific quantifiable acceptance criteria) are not applicable in this context. The document's purpose is to show that the new device is as safe and effective as previously cleared devices by comparing technical specifications and intended use.
Here's a breakdown of the available information:
Acceptance Criteria and Reported Device Performance
The concept of "acceptance criteria" in this 510(k) is primarily based on substantial equivalence to predicate devices. The device "meets acceptance criteria" if it is determined to be as safe and effective as the predicate devices, with no new indications for use or significant technological differences that would raise new questions of safety or effectiveness.
| Characteristic | Acceptance Criteria (Based on Predicate Devices) | Reported Device Performance (IMIX PanoRad and SomaRad X-Ray Systems) |
|---|---|---|
| Intended Use | General purpose diagnostic X-ray unit. Acquisition of x-ray images when incorporated into an x-ray system, a film substitute. | SAME (General purpose diagnostic X-ray unit. Solid State X-ray Imaging system intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. Not for mammography.) |
| User Interface | Software Driven Touch Panel LCD or Windows computer | Software Driven Touch Panel LCD |
| Generator | Stadler or equivalent | CPI or Stadler (Ranges from 50 and 65 kW) |
| Maximum Output | 40, 50, and 65 kW or equivalent | 50 and 65 kW |
| Stand | Supplied by Sedecal or equivalent | Supplied by Shinyoung For M Co Ltd |
| Image Acquisition | Digital: IMIX Digital Radiographic Detector K974863, Varian detectors, 9 or 16 mp. | IMIX or Varian Digital Radiographic Detectors, 9 or 16 mp. |
| Digital Panel Size | Active image size: 16 x 16 inches (40cm x 40cm), 17" x 17", 14" x 17", 12" x 16" and 8" x 10" panel | 14" x 17" (4336R) OR 17" x 17" (4343R) |
| Digital Panel Supplier | IMIX, Varian 4336 and others | Original IMIX panels (same as K073114) OR: Varian 4343R OR 4336R |
| Digital Resolution | 160 Micron. 3056 x 3056 (9 megapixels) or 120 Micron. 4096 x 4096 (16 megapixels). 7.9 megapixel or 9.4 megapixel. 139 micron. | Same as original 510(k), 16 megapixels OR 7.9 megapixel or 9.4 megapixel. 139 micron. |
| DICOM | Yes or Optional | Yes, via O&R software cleared in K091364 |
| Method of Control | Touch Panel LCD or Windows computer | Touch Panel LCD |
| Collimator | Ralco R302L/A DHHS or equivalent | Ralco R302L/A DHHS |
| Safety | UL listed | UL listed |
Study Information (Based on the provided text)
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Sample size used for the test set and the data provenance:
- The document mentions "user (clinical image pairs)" as part of the testing data. However, it does not specify the sample size (number of images or patients) used for this "user" testing.
- The data provenance (country of origin, retrospective/prospective) is not explicitly stated.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The "user (clinical image pairs)" testing implies some form of review, but the details of who performed this review, their number, or qualifications are absent. Given it's a 510(k) for an X-ray system rather than an AI diagnostic device, formal ground truth establishment by multiple experts is less common.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is 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 document is for an X-ray imaging system, not an AI-assisted diagnostic tool. Its purpose is to demonstrate the safety and effectiveness of the hardware and software for image acquisition, primarily through comparison with predicate devices' technical specifications.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is an X-ray system, not a standalone algorithm for diagnosis. The "standalone" performance here refers to the system's ability to produce diagnostic quality images, which is addressed by a combination of bench testing, user testing, and adherence to standards.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The term "ground truth" in the context of an X-ray system's performance is typically less about definitive diagnostic labels (like pathology) and more about the diagnostic quality of the images produced and their ability to aid in general diagnostic procedures. The "user (clinical image pairs)" testing likely involved qualitative assessment of image quality for diagnostic purposes, relative to the predicate devices. However, the specific type of ground truth (e.g., clinical interpretation, comparison to established standards for image quality) is not detailed.
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The sample size for the training set:
- Not applicable. This is not an AI algorithm trained on a dataset in the way a diagnostic AI would be. The device's software is "identical to K070618" (a DICOM Pacs device), indicating it's a pre-existing software component rather than one developed through machine learning.
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How the ground truth for the training set was established:
- Not applicable for the same reasons as above.
Summary of the Study and Conclusion:
The "study" or evaluation performed for the IMIX PanoRad and SomaRad X-Ray Systems was a substantial equivalence comparison. This involved:
- Bench testing: Evaluating the technical specifications and performance of the components.
- User testing (clinical image pairs): Likely qualitative assessment of image quality in a clinical setting by users. The details of this testing (sample size, expert involvement, ground truth, adjudication) are not provided.
- Standards testing: Ensuring compliance with relevant industry and safety standards (e.g., UL listed).
The conclusion was that the device is "as safe and effective as the predicate devices, have few technological differences, and have no new indications for use," thereby establishing substantial equivalence. This is a regulatory pathway, not a clinical trial designed to quantify performance against a specific clinical acceptance criterion.
§ 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.