(84 days)
The GC70 Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
The GU60A & GU60A-65 Digital X-ray Imaging Systems are intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
GF50 Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
The GF50A Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
The GR40CW Digital X-ray Imaging System is intended for use in general projection radiographic applications wherever conventional screen-film systems or CR systems may be used. This device is not intended for mammographic applications.
The GM85 Digital Mobile X-ray imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
GC70, GU60&GU60A-65, GF50, GF50A, GR40CW and GM85 are used to capture images by transmitting X-ray to a patient's body. The X-ray passing through a patient's body is sent to the detector and then converted into electrical signals. These signals go through the process of amplification and digital data conversion in the signal process on the S-station, which is the Operation Software (OS) of Samsung Digital Diagnostic X-ray System, and save in DICOM file, a standard for medical imaging. The captured images are tuned up by an Image Post-processing Engine (IPE) which is exclusively installed in S-station, and sent to the Picture Archiving & Communication System (PACS) sever for reading images.
An IPE operates, from the input image, the roles of a region-of-interest extraction, tonescale mapping, noise reduction and texture restoration. The IPE employing an advanced noise reduction algorithm is shown that the image quality of PA radiograph for average adult chest, exposed at the condition of 50% lower dose at Entrance Skin Exposure (ESE) in comparison with the condition of the conventional noise reduction algorithm, is substantially equivalent. It was cleared with K172229 that using the IPE is able to reduce dose of 50% for chest PA of average adult in GC85A.
This submission is purposed to get 510(k) clearance for expanding the scope of the claim, cleared with K172229, from GC85A to the proposed devices, Samsung x-ray systems.
The IPE, a software which has no relation with imaging chain, is applied to the proposed devices and it is evaluated that images acquired by a various imaging chain are substantially equivalent to GC85A in a non-clinical evaluation.
The proposed devices with the IPE employing an advanced noise reduction algorithm are able to reduce dose of 50% for chest PA of average adult for marketing purpose.
This claim is based on a limited study of an anthropomorphic phantom that simulates the x-ray properties of an average size adult, and on a small clinical study at one facility. Only routine PA chest radiography was studied, and results for larger-size adults (body mass index) greater than 30 was not studied to statistical significance. The pediatric patients was not studied and the clinical site is responsible for determining whether the particular radiographic imaging needs are not impacted by such x-ray dose reduction.
The provided text is a 510(k) Premarket Notification summary for several Samsung Digital X-ray Imaging Systems (GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85). The core of the submission is to expand the scope of a previously cleared Image Post-processing Engine (IPE) with an advanced noise reduction algorithm (from K172229 for GC85A) to these additional devices, claiming that the IPE can achieve a 50% dose reduction for chest PA of average adults while maintaining image quality.
However, the document explicitly states: "This submission does not required clinical data." This means that a clinical study proving the device meets specific acceptance criteria based on human reader performance with or without AI (MRMC study) was not conducted or submitted as part of this premarket notification. The evaluation relies heavily on non-clinical data and the substantial equivalence to a predicate device that previously demonstrated the dose reduction claim for a specific device (GC85A).
Given this, I cannot provide a table of acceptance criteria based on a clinical study or details about a MRMC study, as none were required or performed for this specific submission's scope expansion.
Here's what can be extracted and inferred from the document regarding the device and its testing, tailored to the questions where information is available:
Acceptance Criteria and Device Performance (Based on Non-Clinical Data)
Since no clinical study was required for this submission, the "acceptance criteria" and "reported device performance" are based on non-clinical evaluations comparing the image quality of the proposed devices with the IPE to the predicate device (GC85A) and to images produced with conventional settings. The primary claim revolves around the ability to maintain image quality at a 50% reduced dose.
Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)
| Acceptance Criterion (Non-Clinical) | Reported Device Performance (Non-Clinical) |
|---|---|
| Image Quality Equivalence at Same Dose: Image quality produced by the subject devices (with IPE) at the same dose level must be substantially equivalent to the predicate device (GC85A) at the same dose level. | "As a result of comparison [of MTF, CNR, and visibility], the image quality produced at the same dose level by different Samsung was same. This testing shows that the image quality produced by the subject devices and predicate GC85A are substantially equivalent when used at the same dose levels." |
| Dose Reduction Claim: The IPE (Image Post-processing Engine) should enable a 50% dose reduction for chest PA of average adult while maintaining image quality. (This claim was previously cleared for the predicate GC85A). | "The IPE employing an advanced noise reduction algorithm is shown that the image quality of PA radiograph for average adult chest, exposed at the condition of 50% lower dose at Entrance Skin Exposure (ESE) in comparison with the condition of the conventional noise reduction algorithm, is substantially equivalent. It was cleared with K172229 that using the IPE is able to reduce dose of 50% for chest PA of average adult in GC85A." |
"Therefore, the IPE is capable of providing the same dose reduction in AP adult chest radiographs for the proposed devices as it does for the predicate GC85A." |
| Safety and EMC Standards Compliance: Electrical, mechanical, environmental safety, and EMC testing according to relevant standards. | "Electrical, mechanical, environmental safety and performance testing according to standard ES 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-28, IEC 60601-2-54, ISO14971, 21CFR1020.30 and 21CFR1020.31 were performed, and EMC testing was conducted in accordance with standard IEC 60601-1-2. Wireless function was tested and verified followed by guidance, Radio frequency Wireless Technology in Medical Devices. All test results were satisfying the standards." |
Study Details (Based on Available Information)
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Sample sized used for the test set and the data provenance:
- Test Set (Non-clinical): The document mentions "a limited study of an anthropomorphic phantom that simulates the x-ray properties of an average size adult" and "a small clinical study at one facility." However, the quantitative assessment for this specific submission's purpose (expanding IPE scope) was non-clinical: "The quantitative assessment of image quality was conducted with the images of TOR CDR radiography phantom and TO20 contrast detail phantom taken at a various exposure condition with different Samsung X-ray imaging systems." No specific sample size (number of phantom images) is provided.
- Data Provenance: The anthropomorphic phantom study and "small clinical study" mentioned for the initial GC85A clearance (K172229) are noted as having limitations: "Only routine PA chest radiography was studied, and results for larger-size adults (body mass index) greater than 30 was not studied to statistical significance. The pediatric patients was not studied..." The origin country of the data is not explicitly stated for these studies, but Samsung is a Republic of Korea company. The non-clinical test set for this submission involved "various Samsung X-ray imaging systems" which would likely be internally generated. The studies mentioned (phantom and small clinical) for the original IPE clearance (K172229) were likely a mix of retrospective/prospective, but this detail is not provided for those underlying studies, nor are they claimed as part of this current submission's direct evidence, only referenced as a basis.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For the non-clinical quantitative assessment in this submission (MTF, CNR, visibility of phantom images), human experts were not used to establish quantitative ground truth. These are objective measures.
- For the original clearance of the IPE (K172229) where the "small clinical study" and "substantially equivalent" image quality claim was made with 50% dose reduction based on human perception, no details about expert readers, their number, or qualifications are provided in this summary.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for the non-clinical quantitative assessment of phantom images.
- Not provided for the underlying "small clinical study" that was part of the original IPE clearance.
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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. The document explicitly states: "This submission does not required clinical data." Therefore, no MRMC comparative effectiveness study was performed or submitted for this specific 510(k) notification. The evaluation relies on substantial equivalence to the predicate and non-clinical data.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The IPE is a software component (algorithm) that processes images. The "quantitative assessment of image quality was conducted with the images of TOR CDR radiography phantom and TO20 contrast detail phantom," which constitutes a standalone (algorithm only) performance evaluation based on objective image quality metrics (MTF, CNR, visibility). This confirms the algorithm's ability to process images in a way that, quantitatively, maintains image quality.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical quantitative assessment (of image quality parameters like MTF, CNR, visibility), the "ground truth" is derived from physical phantoms with known properties and objective measurements. It is not based on expert consensus, pathology, or outcomes data.
- The claim of "substantially equivalent" image quality at 50% dose reduction (from K172229) implicitly relies on human perception from a "small clinical study," but the ground truth establishment method for that is not detailed here.
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The sample size for the training set:
- Not mentioned in the document. The document describes the "proposed devices" (SAMSUNG X-ray systems) and the "IPE" (Image Post-processing Engine) as software. It asserts that the IPE "operates, from the input image, the roles of a region-of-interest extraction, tonescale mapping, noise reduction and texture restoration." It also notes the IPE "employing an advanced noise reduction algorithm." While algorithms require training data, the submission does not delve into the development or training of the IPE.
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How the ground truth for the training set was established:
- Not mentioned in the document, as details about the IPE's development and training process are outside the scope of this 510(k) summary, which focuses on demonstrating substantial equivalence for the application of an already cleared IPE to new devices.
§ 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.