(130 days)
Software used in a device that saves, enlarges, reduces, views as well as analyzes, transfers and prints medical images. (excluding fluoroscopic, angiographic, and mammographic applications.)
LG Acquisition Workstation Software ASHK100G is a diagnostic software for final postprocessed X-ray images of body parts of actual patients acquired through the integration of digital X-ray detectors (DXD+ASHK100G; refer to below list for the compatible LG DXD series) and X-ray generators. By integrating the [MWL] and the [PACS] server, this software can be used to check the information and images of the patients' body parts in real time in an HIS (Hospital Information System) based environment.
The provided text is a 510(k) Summary for the X-Clever (ASHK100G) device. Within this summary, information is given about performance testing relating to a new Wide Dynamic View (WDV) algorithm. However, the document does not provide a table of acceptance criteria, specific reported device performance metrics against those criteria, or the detailed study design (sample sizes, expert qualifications, adjudication methods, MRMC study details, ground truth specifics for test and training sets) that would typically be found in a detailed study report.
Here's a breakdown of the available information and what is not present:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states: "The performance test results indicate that the WDV algorithm enhances the performance of the proposed medical device by normalizing tissue through the creation of a regional map based on image location and distribution characteristics. This leads to more natural and consistent images compared to those that rely solely on residual and image brightness signal composition."
However, this is a qualitative statement, not a table with specific acceptance criteria (e.g., quantitative metrics like AUC, sensitivity, specificity, or specific perceptual scores with thresholds) and corresponding numerical results.
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified.
- Data provenance: Not specified. The document only mentions "clinical opinions on the images processed with WDV," implying human readers were involved in assessing image quality, but it does not detail the origin of these images (e.g., country, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document mentions "clinical opinions on the images processed with WDV." This suggests that experts evaluated the images, but:
- Number of experts: Not specified.
- Qualifications of experts: Not specified (e.g., "radiologist with 10 years of experience").
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not specified. The process of how "clinical opinions" were combined or used to establish a ground truth or a performance measure is not detailed.
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:
- MRMC study: The document does not explicitly state that a formal Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done comparing human readers with and without AI assistance. It mentions "clinical opinions on the images processed with WDV," which implies human review of images processed by the device's new algorithm, but it doesn't describe a comparison between human performance with and without the device's assistance.
- Effect size of human reader improvement: Not reported.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device (X-Clever ASHK100G) is described as "Software used in a device that saves, enlarges, reduces, views as well as analyzes, transfers and prints medical images." The "WDV algorithm" is an image processing algorithm. Its performance is assessed in terms of generating "more natural and consistent images." This evaluation implicitly refers to the standalone performance of the algorithm in processing images, but it's not a diagnostic algorithm outputting clinical findings directly. The "clinical opinions" are likely an assessment of the quality of the images produced by the algorithm, rather than its diagnostic accuracy for specific conditions.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" seems to be effectively expert opinion/consensus on image quality. The document explicitly states: "the performance test for the WDV algorithm includes clinical opinions on the images processed with WDV." It's not based on pathology, outcomes data, or a definitive diagnostic reference standard for a specific disease. Instead, it's about the perceived improvement in image characteristics.
8. The sample size for the training set:
Not specified. The document discusses a "new WDV algorithm" and "optimization process," indicating machine learning or image processing algorithm development, but it does not provide details on training data.
9. How the ground truth for the training set was established:
Not specified. As the training set size itself is not mentioned, neither is the method for establishing its ground truth.
Summary of Available Information (from the provided text):
- Device: X-Clever (ASHK100G), a medical image management and processing system.
- Key Change: Addition of a Wide Dynamic View (WDV) algorithm for image processing.
- Performance Claim for WDV: "enhances the performance of the proposed medical device by normalizing tissue through the creation of a regional map based on image location and distribution characteristics. This leads to more natural and consistent images compared to those that rely solely on residual and image brightness signal composition."
- Performance Evaluation: A "performance test for the WDV algorithm includes clinical opinions on the images processed with WDV."
- Conclusion: "the addition of the WDV feature has not had any negative impact on the performance and safety of the proposed device."
- Clinical Studies: "No clinical studies were considered necessary and performed. ... Therefore, a separate clinical study is not applicable in this case."
In essence, the document confirms that a performance test was conducted for the WDV algorithm using clinical opinions on image quality, and the results were positive (improved image naturalness and consistency). However, it lacks the detailed quantitative metrics, sample sizes, and expert qualification specifics typically requested for a comprehensive study description.
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LG Electronics Inc. Hanseul Park RA Specialist 71, Magokjungang 8-ro, Gangseo-gu Seoul. 07795 Korea, South
Re: K233599
March 18, 2024
Trade/Device Name: X-Clever (ASHK100G) Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: February 2, 2024 Received: February 2, 2024
Dear Hanseul Park:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica Lamb
Jessica Lamb Assistant Director DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
Submission Number (if known)
Device Name
X-Clever (ASHK100G)
Indications for Use (Describe)
Software used in a device that saves, enlarges, reduces, views as well as analyzes, transfers and prints medical images. (excluding fluoroscopic, and mammographic applications.)
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows the LG Electronics logo. The logo consists of a red circle with a stylized white "L" and "G" inside, followed by the text "LG Electronics" in gray. The text is in a sans-serif font and is slightly blurred.
510(K) Summary
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510(k) Summary
[As Required by 21 CFR 807.92]
1. Date Prepared [21 CFR 807.92(a)(a)]
February 01, 2024
2. Submitter's Information [21 CFR 807.92(a)(1)]
| • Name of Sponsor: | LG Electronics Inc. |
|---|---|
| - Address: | 71, Magokjungang 8-ro, Gangseo-guSeoul, 07795, Republic of Korea |
| - Contact Name: | Hanseul Park / Regulatory Affairs Specialist |
| - Telephone No.: | +82-10-9490-2109 |
| - Email Address: | hs.park@lge.com |
| • Name of Manufacturer: | LG Electronics Inc. |
|---|---|
| - Address: | 168, Suchul-daero, Gumi-si, Gyeongsangbuk-do,39368, Republic of Korea |
3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
| Product Name | LG Acquisition Workstation Software |
|---|---|
| Model Name | ASHK100G |
| Trade Name | X-Clever |
| Classification Name | Picture archiving and communicationsystem |
| Regulation Number | 21 CFR 892.2050 |
| Classification Product Code | LLZ |
| Product Code Name | System, Image Processing, Radiological |
| Device Class | II |
| 510k Review Panel | Radiology |
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Image /page/5/Picture/0 description: The image shows the LG Electronics logo. The logo consists of a red circle with the letters "L" and "G" inside, followed by the words "LG Electronics" in gray. The letters "L" and "G" are stylized to resemble a face.
4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]
The identified predicate devices within this submission are shown as follow:
Predicate Device
- 510(k) Number: K212137 ●
- Applicant: LG Electronics Inc. ●
- Trade/Device Name: ASHK100G ●
- Picture archiving and communications system ● Classification Name:
- 21 CFR 892.2050 ● Regulation Number:
- Classification Product Code: LLZ
- Device Class: II ●
- 510(k) Review Panel: Radiology ●
5. Description of the Device [21 CFR 807.92(a)(4)]
LG Acquisition Workstation Software ASHK100G is a diagnostic software for final postprocessed X-ray images of body parts of actual patients acquired through the integration of digital X-ray detectors (DXD+ASHK100G; refer to below list for the compatible LG DXD series) and X-ray generators. By integrating the [MWL] and the [PACS] server, this software can be used to check the information and images of the patients' body parts in real time in an HIS (Hospital Information System) based environment.
| Company Name | Model name | |
|---|---|---|
| LG Electronics | 17HK700G-W | 17HK700G-WP |
| 14HK701G-W | 14HK701G-WP | |
| 17HK701G-W | 17HK701G-WP | |
| 10HQ701G-B | 10HQ701G-BP | |
| 14HQ701G-B | 14HQ701G-BP | |
| 14HQ901G-B | 14HQ901G-BP | |
| 17HQ701G-B | 17HQ701G-BP | |
| 17HQ901G-B | 17HQ901G-BP | |
| 14HQ721G-B | 14HQ721G-BP |
[NOTE] All the DXD models are FDA-510(k)-cleared, and the names of DXD models integrated with ASHK100G include "P" at the end.
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Image /page/6/Picture/0 description: The image shows the LG Electronics logo. The logo consists of a red circle with the letters "L" and "G" inside, followed by the words "LG Electronics" in gray. The logo is simple and modern, and it is easily recognizable.
6. Indications for Use [21 CFR 807.92(a)(5)]
Software used in a device that saves, enlarges, reduces, views as well as analyzes, transfers and prints medical images. (excluding fluoroscopic, angiographic, and mammographic applications.)
7. Technological Characteristics (Equivalence to Predicate Device) [21 CFR 807.92(a)(6)]
ASHK100G is medical software. It digitalizes the signal sent from the detector and displays the x-ray image. Also, it can enter patient information, shot information, and other necessary references for convenience.
Compared with the predicate device, the technological characteristics of the proposed device are substantially equivalent to those of the predicate device. The proposed device is functionally similar to the predicate device. The table below presents comparisons for each device:
| Proposed Device | Predicate Device | SE Note | |
|---|---|---|---|
| K Number | K233599 | K212137 | - |
| Manufacturer | LG Electronics Inc. | LG Electronics Inc. | - |
| Model name | ASHK100G | ASHK100G | - |
| Product Code | LLZ | LLZ | Same |
| RegulationNumber | 21 CFR 892.2050 | 21 CFR 892.2050 | Same |
| 510(k) ReviewPanel | Radiology | Radiology | Same |
| Indications forUse | Software used in a devicethat saves, enlarges,reduces, views as well asanalyzes, transfers andprints medical images.(excluding fluoroscopic,angiographic, andmammographicapplications.) | Software used in a devicethat saves, enlarges,reduces, views as well asanalyzes, transfers andprints medical images.(excluding fluoroscopic,angiographic, andmammographicapplications.) | Same |
| SW Version | 3.06.XX | 3.01.XX | Different |
| Proposed Device | Predicate Device | SE Note | |
| Processor | Intel 6th gen i5 or higher | Intel 6th gen i5 | Different |
| RAM | 8GB or higher | 8GB or higher | Same |
| Hard Disk | 512 GB or greater recommended | 512 GB or greater recommended | Same |
| Network | Dual Ethernet 100/1000Mbps | Dual Ethernet 100/1000Mbps | Same |
| OperationSoftware | Microsoft Windows 10, 11 (64 bit) | Microsoft Windows 8.1(64 bit) Microsoft Windows 10(64 bit) | Different |
| Resolution | 1920 x 1080, 3840 x 2160 | 1920 x 1080, 3840 x 2160 | Same |
| GeneratorControlprotocol | Yes (can control detailed exam options, such as the level of dose on each examination) | Yes (can control detailed exam options, such as the level of dose on each examination) | Same |
| ImageProcessing | Yes (Add Wide Dynamic View (WDV) algorithm) | Yes | Different |
| Windowing | Yes (review mode has a function of control the image window level) | Yes (review mode has a function of control the image window level) | Same |
| Imageformatting | Yes (1x1,1x2,2x2,3x3) | Yes (1x1,1x2,2x2,3x3) | Same |
| Electronic zoom | Yes (Magnifying and optimizing accurate ROI(region of interest) area) | Yes (Magnifying and optimizing accurate ROI(region of interest) area) | Same |
| Image rotation | Yes (90 degree rotation and free rotation per degree) | Yes (90 degree rotation and free rotation per degree) | Same |
| Imageannotation | Yes (Review mode support applying detailed annotation immediately) | Yes (Review mode support applying detailed annotation immediately) | Same |
| Image Stitch | Yes (auto-stitch function and allow manual control options on detailed position and brightness/contrast) | Yes (auto-stitch function and allow manual control options on detailed position and brightness/contrast) | Same |
| DICOMWorklist | Yes (archive work orders automatically) | Yes (archive work orders automatically) | Same |
| DICOM Store | Yes | Yes | Same |
| Proposed Device | Predicate Device | SE Note | |
| DICOM Print | Yes | Yes | Same |
| Measurementtools | Advanced tools are added:Cobb angle, Cardiothoracicratio, Acetabular depth ratio,Sharp angle | Basic tools available:Angle and Ruler | Different |
[Table. Comparison of Proposed Device to Predicate Device]
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Image /page/7/Picture/0 description: The image shows the LG Electronics logo. The logo consists of a red circle with a stylized white "L" and "." inside. To the right of the circle is the text "LG Electronics" in a gray, sans-serif font. The logo is simple and modern.
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Image /page/8/Picture/0 description: The image shows the LG Electronics logo. The logo consists of a red circle with the letters "L" and "G" inside, followed by the words "LG Electronics" in gray. The logo is simple and modern, and it is easily recognizable.
The proposed device is an updated version of the predicate device, with improvements and changes made to the operations software, image processing algorithm, and measurement tools. More specifically, as shown in the above comparison table, the following items of the proposed device are different from the predicate device: Software version, Processor,
Operation software, Image processing algorithm, and Advanced measurement tools. Software version, Processor and operation software have been updated from the predicate device, and the software has been validated accordingly. In terms of image processing algorithm, the proposed device has undergone a performance testing to assess the new WDV algorithm.
The newly added advanced measurement tools have been validated and verified by the software validation.
Based on those reviews, it has been determined that these changes do not have any negative impact on the safe and effective use of the product.
8. Non-Clinical Test Summary [21 CFR 807.92(b)(1)]
The following data were provided in support of the substantial equivalence determination:
1) Software Validation
The ASHK100G belongs to a Basic Documentation Level. The software was designed and
developed according to a software development process and was verified and validated.
Software information is provided in accordance with FDA guidance:
- · The content of premarket submissions for Device Software Functions (June 14, 2023)
2) Cybersecurity
Cybersecurity documents are provided in accordance with the below FDA guidance:
- · Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (September 27, 2023)
- Postmarket Management of Cybersecurity in Medical Devices (December 28, 2016)
- Performance Test
- Performance for WDV (Wide Dynamic View) ●
- Compatibility with Generator Test
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Image /page/9/Picture/0 description: The image shows the LG Electronics logo. The logo consists of a red circle with a stylized "L" and "G" inside, followed by the text "LG Electronics" in gray. The logo is simple and modern, and it is easily recognizable.
● Compatibility with LG DXD
The performance test report for the addition of the Wide Dynamic View (WDV) algorithm, as well as the compatibility tests with LG DXD (Digital X-ray Detector) and generators, have been submitted as part of the nonclinical tests.
The performance test results indicate that the WDV algorithm enhances the performance of the proposed medical device by normalizing tissue through the creation of a regional map based on image location and distribution characteristics. This leads to more natural and consistent images compared to those that rely solely on residual and image brightness signal composition. Despite the inclusion of algorithms with a high operation quantity, the optimization process has minimized the increase in image processing time.
In conclusion, the addition of the WDV feature has not had any negative impact on the performance and safety of the proposed device.
The compatibility tests with LG DXDs and generators also confirm that the proposed device can interface and control the Console workstation and DXDs in real-time without any functional bugs. Additionally, safety trials have been conducted to ensure that values cannot be set beyond the limitations.
9. Clinical Test Summarv [21 CFR 807.92(b)(2)]
No clinical studies were considered necessary and performed.
The main improvement in the proposed device, as compared to the predicate, is the addition of the WDV algorithm to the existing imaging processing. It is important to note that this update does not require clinical testing. Instead, the performance test for the WDV algorithm includes clinical opinions on the images processed with WDV. Therefore, a separate clinical study is not applicable in this case.
10. Conclusion [21 CFR 807.92(b)(3)]
Based on the information provided in this premarket notification and in accordance with the Federal Food, Drug, and Cosmetic Act, 21 CFR Part 807, LG Electronics Inc. has determined that there are no significant differences between the proposed device and the predicate device that would negatively impact its use. The proposed device has been shown to be as safe and effective as the predicate version previously cleared in K212137. It shares the same intended
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Image /page/10/Picture/0 description: The image shows the LG Electronics logo. The logo consists of a red circle with a stylized "L" and "G" inside, followed by the text "LG Electronics" in gray. The logo is simple and modern, and it is easily recognizable.
use and similar technological characteristics, with any differences supported by performance testing. Therefore, the technological variances between the proposed device and its predicate device do not raise any new concerns regarding safety or effectiveness, and the proposed device can be considered substantially equivalent to the predicate device.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).