(30 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 GC70 digital X-ray imaging system is 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 device before being sent to the S-Station (Operation Software) and saved in DICOM file, a standard for medical imaging. The captured images are sent to the Picture Archiving & Communication System (PACS) server, and can be used for reading images.
The provided text describes a 510(k) premarket notification for the SAMSUNG GC70 Digital X-ray Imaging System. This document asserts the substantial equivalence of the GC70 to a predicate device (GC85A) and primarily discusses safety, EMC, and performance data based on standard compliance and phantom image evaluations. It does not contain information about acceptance criteria and a study proving the device meets specific clinical performance acceptance criteria in terms of diagnostic accuracy, sensitivity, or specificity for a particular clinical application. Instead, it focuses on demonstrating that the device is safe and performs comparably to its predicate regarding image quality and technical specifications.
Therefore, the following information is not present in the provided text:
- A table of acceptance criteria and the reported device performance: The document does not define specific clinical performance acceptance criteria (e.g., sensitivity, specificity, accuracy for a diagnostic task) for the GC70, beyond general safety and imaging quality.
- Sample size used for the test set and the data provenance: No details on the sample size or origin for clinical test data (if any was used beyond phantom evaluations) are provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no diagnostic accuracy study on human data is described.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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: The document does not describe an MRMC study or AI assistance.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a digital X-ray system, not an AI algorithm, so this is not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the "clinical data" section, it refers to "phantom image evaluations."
- The sample size for the training set: Not applicable as there is no mention of a training set for an AI algorithm.
- How the ground truth for the training set was established: Not applicable.
However, based on what is available, here's a summary of the stated "acceptance criteria" (which are more focused on technical equivalence and safety) and the studies mentioned:
1. A table of acceptance criteria and the reported device performance:
The document doesn't present a table of clinical acceptance criteria for diagnostic performance (like sensitivity or specificity). Instead, it focuses on demonstrating technical equivalence and safety to a predicate device (GC85A). The "acceptance" can be inferred from the comparisons made to the predicate and compliance with regulatory standards.
| Acceptance Criterion (Inferred from comparison) | Reported Device Performance (GC70 vs. GC85A) |
|---|---|
| Intended Use Equivalence | Same (GC70 and GC85A are both intended for generating radiographic images of human anatomy, not mammographic applications). |
| Imaging Performance (Detectors) | Same detectors (S4335-W, S4343-W, S3025-W) as the predicate device (GC85A). Reported MTF (Modulation Transfer Function) and DQE (Detective Quantum Efficiency) values for these detectors are identical to those of the predicate device (e.g., S4335-W: MTF 84% (0.5 lp/mm, Typical), DQE 73% (0.1 lp/mm, Typical)). |
| Image Processing Equivalence | Same image processing as the predicate device (GC85A). Specifically mentions "SimGrid" and "Bone Suppression Image" features are the same. SimGrid compensates for contrast loss due to scatter radiation, and Bone Suppression enhances visualization of chest pathology by suppressing bone anatomy in a companion image. |
| Safety, EMC, and Radiation Control Compliance (Electrical, Mechanical, Environmental) | Compliant with: ES 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-28, IEC 60601-2-54, ISO14971, 21CFR1020.30, 21CFR1020.31. EMC testing conducted in accordance with IEC 60601-1-2. Wireless function tested per "Radio frequency Wireless Technology in Medical Devices" guidance. All test results were satisfying the standards. |
| Non-clinical Imaging Performance (MTF and DQE) | Evaluated in conformance with FDA "Guidance for the Submission of 510(k)'s for Solid-State X-ray Imaging Devices" and tested by IEC 62220-1. The proposed device shows no difference in non-clinical testing data such as MTF and DQE measurements from the predicate device. |
| Software Development & Testing | Developed & tested according to IEC62304 and FDA "Guidance for Content of Premarket Submissions for Software Contained in Medical Devices." |
| Dosimetry Performance | Evaluated with IEC60601-1. Recommended exposure chart provided in the user manual. |
| Clinical Equivalence (based on images) | Phantom image evaluations performed in accordance with FDA guidance for solid-state X-ray imaging devices. Evaluated by a professional radiologist and found to be equivalent to the predicate device. |
| Impact of design differences on safety/performance/image quality (e.g., Max. Power, Tube Current, Wall Stand/Table dimensions, Patient Weight) | The document explicitly states that various differences in maximum power, tube current, vertical/lateral movement ranges, detector tilting, table dimensions, and maximum patient weight "do not contribute any adverse impacts to the device's safety and performance and image quality." This indicates acceptance based on a lack of negative impact from these differences. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The "clinical data" mentioned refers to "phantom image evaluations," not human patient data. Therefore, a sample size for a patient test set is not provided. The data provenance is not specified, but the device manufacturer is based in the Republic of Korea. The phantom studies are inherently retrospective/prospective in the sense that they are conducted in a controlled environment, not on real patients over time.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
For the "phantom image evaluations," it states they were "evaluated by a professional radiologist." The exact number (e.g., one or more) and specific qualifications (e.g., years of experience) of this radiologist are not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not specified for the phantom image evaluations. Given the mention of "a professional radiologist" (singular), it implies no adjudication method was explicitly used for multiple readers.
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:
No MRMC study was mentioned. The device is a digital X-ray system, not an AI-assisted diagnostic tool in the context described here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The GC70 is an X-ray imaging system, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the "clinical data" section, the ground truth was phantom image evaluations assessed for equivalence to the predicate by a radiologist. This is a technical assessment of image quality using a standardized object rather than diagnostic accuracy against a clinical outcome.
8. The sample size for the training set:
Not applicable. The document describes an X-ray system, not an AI algorithm that would require a training set.
9. How the ground truth for the training set was established:
Not applicable.
§ 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.