(237 days)
EOSedge is intended for use in general radiographic exams and applications, excluding the evaluation of lung nodules and exams involving fluoroscopy, angiography, and mammography.
EOSedge allows the radiographic acquisition of either one or two orthogonal X-ray images, for diagnostic purposes, in one single scan of the whole body or a reduced area of investigation of a patient, in the upright or seated position. The Micro Dose feature is indicated for assessing global skeletal deformities in follow-up pediatric exams.
The EOSedge™ system is a digital radiography system comprised of an acquisition workstation, a gantry including an electrical cabinet housing the system power and communication controls, and an acquisition software to obtain diagnostic images. Two sets of detectors and X-ray tubes are positioned orthogonally to generate frontal and lateral images simultaneously by scanning the patient over the area of interest. If desired, the Micro Dose feature enables image acquisition for assessing global skeletal deformities in pediatric follow-up exams.
The diagnostic images are stored in a local database and are displayed on a high-resolution medical-quality non-diagnostic monitor. The diagnostic image can be transmitted through a DICOM compatible digital network for printing and archiving.
The provided text outlines the substantial equivalence of the EOSedge device to its predicate, rather than detailing a specific clinical study with AI assistance demonstrating performance against acceptance criteria for an AI/ML powered device. The document describes changes to an existing, cleared device (EOSedge, K202394), primarily the activation of a dual-energy detection mode within already integrated detectors.
Therefore, the information required to fully answer the question regarding acceptance criteria and a study proving a device meets these criteria for an AI/ML powered device is largely not present in the provided text. The document focuses on showing the modified EOSedge is substantially equivalent to the cleared EOSedge system, implying that the previous clearances and tests are sufficient.
However, based on the provided text, I can infer and extract some relevant (though limited) information regarding performance testing that aligns with aspects of an AI/ML device, particularly concerning image quality and software:
Acceptance Criteria and Reported Device Performance (Inferred from "Performance Data" and "Technological Characteristics" sections):
- No specific acceptance criteria for AI/ML performance metrics (e.g., sensitivity, specificity, AUC) are stated. The performance data section focuses on general device standards and image quality.
- The document does not detail specific "reported device performance" in terms of clinical accuracy or an AI model's output metrics. It states that the device "performs according to specifications and is as safe and effective as the predicate device."
Here's a table synthesizing the types of performance criteria and the general statement of performance, as can be extracted from the document:
| Acceptance Criteria Type | Reported Device Performance Statement |
|---|---|
| General Safety | Conforms to IEC 60601-1 (Medical electrical equipment - General requirements for basic safety and essential performance) |
| Image Quality | • Bench testing to confirm appropriate dosing and image quality. • IEC 62220-1-1 (Determination of the detective quantum efficiency) Conformance. • Pixel Depth: 17 bits (> 131,000 gray levels) • Pixel Size: 100 μm • Resolution: 3.7 lp/mm • Typical Dynamic Range: > 100 dB |
| Software Functionality | Software verification and validation testing conducted; performs according to specifications. |
Since the document is a 510(k) summary focused on demonstrating substantial equivalence of a modified X-ray system, it does not contain the detailed information typically found in a clinical study report for an AI/ML-powered diagnostic device.
Missing Information (for an AI/ML powered device, based on the provided text):
- Sample sizes used for the test set and data provenance: Not explicitly stated for any clinical performance evaluation of an AI component. The document mentions "bench testing."
- Number of experts used to establish ground truth & qualifications: Not applicable/not stated, as no clinical ground truth establishment for AI performance is described.
- Adjudication method for the test set: Not applicable/not stated.
- MRMC comparative effectiveness study: Not mentioned. The document is for an imaging system, not an AI assistance tool for human readers.
- Standalone (algorithm only) performance: Not mentioned, as it's a hardware system with software, not a pure AI algorithm.
- Type of ground truth used: Not applicable/not stated for an AI/ML performance evaluation. Only "bench testing" is mentioned.
- Sample size for the training set: Not applicable; no AI training set is mentioned.
- How ground truth for the training set was established: Not applicable; no AI training set is mentioned.
In conclusion, the provided text is a regulatory filing for an X-ray imaging system (EOSedge) demonstrating substantial equivalence to a predicate device, focusing on hardware and software modifications. It does not describe an AI/ML device, nor does it present clinical study data for AI performance against defined acceptance criteria. The "Performance Data" section primarily addresses compliance with general X-ray system standards (IEC 60601-1, IEC 62220-1-1) and software verification/validation, concluding that the modified device is as safe and effective as its predecessor.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and consists of the letters "FDA" stacked on top of the words "U.S. FOOD & DRUG ADMINISTRATION".
August 6, 2024
EOS imaging % Mathilde Masurel Design Quality and Regulatory Affairs Specialist 10 rue Mercoeur PARIS, 75011 FRANCE
Re: K233920
Trade/Device Name: EOSedge Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR Dated: March 29, 2024 Received: July 8, 2024
Dear Mathilde Masurel:
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 QS 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 mediation-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).
Sincerelv.
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological 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
510(k) Number (if known) K233920
Device Name EOSedge
Indications for Use (Describe)
EOSedge is intended for use in general radiographic exams and applications, excluding the evaluation of lung nodules and exams involving fluoroscopy, angiography, and mammography.
EOSedge allows the radiographic acquisition of either one or two orthogonal X-ray images, for diagnostic purposes, in one single scan of the whole body or a reduced area of investigation of a patient, in the upright or seated position. The Micro Dose feature is indicated for assessing global skeletal deformities in follow-up pediatric exams.
| 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/0 description: The image shows the logo for EOS imaging, an adtec company. The logo is in orange and consists of the letters "EOS" in a stylized font. Below the letters, the word "imaging" is written in a smaller, sans-serif font. Underneath "imaging" the text "AN adtec COMPANY" is written in a very small font.
510(k) Summary
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Image /page/4/Picture/0 description: The image shows the logo for EOS imaging, an adtec company. The logo is primarily orange. The letters 'EOS' are stacked on top of the word 'imaging', which is in a smaller font. Below 'imaging' is the text 'AN adtec COMPANY', also in a smaller font.
| 1 | SUBMITTER | |
|---|---|---|
| EOS imaging | ||
| 10 rue Mercoeur | ||
| Paris, France 75011 | ||
| Phone: +33 1 55 25 60 60 | ||
| Fax: +33 1 55 25 60 61 | ||
| Contact Person: | Mathilde Masurel | |
| Design Quality and Regulatory Affairs Specialist | ||
| EOS imaging | ||
| Contact Phone: +33 1 55 25 60 60 | ||
| Date Summary Prepared: | July 5, 2024 | |
| 2 | DEVICE | |
| Trade Name: | EOSedge | |
| Common or Usual Name: | Digital Radiography System | |
| Classification Name: | Stationary X-ray System | |
| (21 C.F.R. § 892.1680) | ||
| Regulatory Class: | Class II | |
| Product Code: | KPR | |
| 3 | PREDICATE DEVICE | |
| Trade Name: | EOSedge (K202394) | |
| Common or Usual Name: | Digital Radiography System | |
| Classification Name: | Stationary X-ray System | |
| (21 C.F.R. § 892.1680) | ||
| Regulatory Class: | Class II | |
| Product Code: | KPR |
DEVICE DESCRIPTION 4
The EOSedge™ system is a digital radiography system comprised of an acquisition workstation, a gantry including an electrical cabinet housing the system power and communication controls, and an acquisition software to obtain diagnostic images. Two sets of detectors and X-ray tubes are positioned orthogonally to generate frontal and lateral images simultaneously by scanning the patient over the area of interest. If desired, the Micro Dose feature enables image acquisition for assessing global skeletal deformities in pediatric follow-up exams.
The diagnostic images are stored in a local database and are displayed on a high-resolution medical-quality non-diagnostic monitor. The diagnostic image can be transmitted through a DICOM compatible digital network for printing and archiving.
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Image /page/5/Picture/0 description: The image shows the logo for EOS imaging, an atec company. The logo is in orange and features the letters "EOS" in a stylized font, with the "O" shaped like a diamond. Below "EOS" is the word "imaging" in a smaller font. Underneath "imaging" is the phrase "AN atec COMPANY" in an even smaller font.
INDICATIONS FOR USE 5
EOSedge is intended for use in general radiographic exams and applications, excluding the evaluation of lung nodules and exams involving fluoroscopy, and mammography. EOSedge allows the radiographic acquisition of either one or two orthogonal X-ray images, for diagnostic purposes, in one single scan of the whole body or a reduced area of investigation of a patient, in the upright or seated position.
The Micro Dose feature is indicated for assessing global skeletal deformities in follow-up pediatric exams.
TECHNOLOGICAL COMPARISON TO PREDICATES 6
Modified EOSedge has the same intended use, indications, principles of operation, and technological characteristics as the cleared predicate device. Modified EOSedge is an updated version of the cleared EOSedge System (K202394) with the main modifications being the activation of the dual energy detection mode for detectors, already previously integrated into the product. The activation of this mode, induced the following modifications:
- . Addition of dual energy acquisition protocols,
- New dual energy image process chain, and
- Detectors firmware modification to activate dual energy detection mode.
A substantial equivalence table summarizing similarities and differences between EOSedge and its predicate device is provided in Table 1 below.
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Image /page/6/Picture/0 description: The image shows the logo for EOS imaging. The logo is orange and consists of the letters "EOS" stacked on top of the word "imaging". Below the word "imaging" is the phrase "AN atec COMPANY" in a smaller font. The "O" in EOS is shaped like a diamond.
| EOS imaging's modified EOSedge system | EOS imaging's cleared EOSedge System(K202394) | SubstantiallyEquivalent? | |
|---|---|---|---|
| Intended Use | General X-ray imaging system | General X-ray imaging system | Yes - same |
| Indications for Use | EOSedge is intended for use in generalradiographic exams and applications,excluding the evaluation of lung nodules andexams involving fluoroscopy, angiography,and mammography. EOSedge allows theradiographic acquisition of either one or twoorthogonal X-ray images, for diagnosticpurposes, in one single scan, of the wholebody or a reduced area of investigation of apatient, in the upright or seated position.The Micro Dose feature is indicated forassessing global skeletal deformities infollow-up pediatric examinations. | EOSedge is intended for use in generalradiographic exams and applications,excluding the evaluation of lung nodules andexams involving fluoroscopy, angiography, andmammography. EOSedge allows theradiographic acquisition of either one or twoorthogonal X-ray images, for diagnosticpurposes, in one single scan, of the whole bodyor a reduced area of investigation of a patient,in the upright or seated position.The Micro Dose feature is indicated forassessing global skeletal deformities in follow-up pediatric examinations. | Yes - same |
| Contraindications | EOSedge is not designed to performfluoroscopy, angiography or mammographyexams.The Micro Dose feature is not designed formorphological analysis of bone structuresand lesions.The Micro Dose feature is not indicated:• for analysis of spine static in the presence offusion material or for analysis of the bone-implant interface• in the case of focal skeletal anomalies and/orother pediatric abnormalities | EOSedge is not designed to performfluoroscopy, angiography or mammographyexams.The Micro Dose feature is not designed formorphological analysis of bone structures andlesions.The Micro Dose feature is not indicated:• for analysis of spine static in the presence offusion material or for analysis of the bone-implant interface• in the case of focal skeletal anomalies and/orother pediatric abnormalities | Yes - same |
| EOS imaging's modified EOSedge system | EOS imaging's cleared EOSedge System (K202394) | Substantially Equivalent? | |
| • for use in patients with a Body Mass Index over 30 | • for use in patients with a Body Mass Index over 30 | ||
| User Population | Trained medical personnel | Trained medical personnel | Yes - same |
| TechnologicalCharacteristics | Digital radiography system in which two sets of detectors and X-ray tubes are positioned orthogonally to generate frontal and lateral images simultaneously by scanning the patient over the area of interest. The 2 orthogonal acquisition chains consist of HV generators, X-ray tubes, collimators and detectors, positioned on C-shaped arms translating along a vertical axis. | Digital radiography system in which two sets of detectors and X-ray tubes are positioned orthogonally to generate frontal and lateral images simultaneously by scanning the patient over the area of interest. The 2 orthogonal acquisition chains consist of HV generators, X-ray tubes, collimators and detectors, positioned on C-shaped arms translating along a vertical axis. | Yes - same |
| Dimensions(l x w x h) | 2.58 m x 2.58 m x 2.706 m(8.5 ft x 8.5 ft x 8.9 ft) | 2.58 m x 2.58 m x 2.706 m(8.5 ft x 8.5 ft x 8.9 ft) | Yes - same |
| Weight | 2 005 kg (4 420 lb) | 2 005 kg (4 420 lb) | Yes - same |
| Accessories | Laser safety barriersMotorized lifting platformPlatform consoleLaser positioning systemAccess and stabilization barsBar code reader | Laser safety barriersMotorized lifting platformPlatform consoleLaser positioning systemAccess and stabilization barsBar code reader | Yes - same |
| EOS imaging's modified EOSedge system | EOS imaging's cleared EOSedge System(K202394) | SubstantiallyEquivalent? | |
| PrinciplesofOperation | Tube preheatingSelection of the patient, the acquisitionplanes, and the anatomical area in single ordual energy, as well as patient positioningSelection of either AUTO (Automatic) modeor MANUAL (manual) modeSelection of patient morphotypeImage preview (Scout View)Image acquisition i.e., display of the exposurearea, configuration of the reference planes,and verification, validation of the acquisitionparameters and launch of the imageacquisitionImage review i.e., use of display tools and 2Dtools to add annotationsExport of the exam to DICOM server(s)(PACS and/or sterEOS). | Tube preheatingSelection of the patient, the acquisition planes,and the anatomical area in single energy, aswell as patient positioningSelection of either AUTO (Automatic) mode orMANUAL (manual) modeSelection of patient morphotypeImage preview (Scout View)Image acquisition i.e., display of the exposurearea, configuration of the reference planes,and verification, validation of the acquisitionparameters and launch of theimageacquisitionImage review i.e., use of display tools and 2Dtools to add annotationsExport of the exam to DICOM server(s) (PACSand/or sterEOS). | Yes - similar |
| Permanenttotalminimumfiltration(Al equivalent) | 1.7 mm Al at 75 kVAdditional filtrations:• 0.1 mm copper thickness (used for singleenergy images with or without Micro-Dose)• 0.3 mm copper thickness (used for dual-energy images without Micro-Dose)• 0.5 mm copper thickness (used for theScout View) | 1.7 mm Al at 75 kVAdditional filtrations:• 0.1 mm copper thickness (used for imageswith or without Micro-Dose)• 0.5 mm copper thickness (used for the ScoutView) | Yes - similar |
| Detectors | Direct conversion device - solid state detector | Direct conversion device - solid state detector | Yes – similar |
| EOS imaging's modified EOSedge system | EOS imaging's cleared EOSedge System (K202394) | Substantially Equivalent? | |
| with single and dual energy detection mode activated | with single energy detection mode activated | ||
| Pixel Depth | 17 bits (> 131 000 gray levels) | 17 bits (> 131 000 grey levels) | Yes - same |
| Pixel Size | 100 μm | 100 μm | Yes - same |
| Resolution | 3.7 lp/mm | 3.7 lp/mm | Yes - same |
| Typical Dynamic Range | > 100 dB | > 100 dB | Yes - same |
| Values of the kV parameters | 40 to 140 kV, bi-polar | 40 to 140 kV, bi-polar | Yes - same |
| Values of the mA parameters | 3 to 400 mA | 10 to 400 mA | Yes - similar |
| Software Specifications | Patient information management Image acquisitionDisplay imagesGeneration of dose reportSend exam to the PACS or USBMaintenance managementAccess management to the systemSystem acquisition configuration | Patient information management Image acquisitionDisplay imagesGeneration of dose reportSend exam to the PACS or USBMaintenance managementAccess management to the systemSystem acquisition configuration | Yes - same |
| Focal Spot | 0.6 x 1.3 at 120 kV – 100 mA | 0.6 x 1.3 at 120 kV – 100 mA | Yes - same |
| Linear Scanning Speed (cm/s) | From 4.1 to 32.5 | From 4.1 to 32.5 | Yes - same |
| EOS imaging's modified EOSedge system | EOS imaging's cleared EOSedge System(K202394) | SubstantiallyEquivalent? | |
| AverageAcquisition Time | 7 seconds for a spine and 13 seconds for anentire body | 7 seconds for a spine and 13 seconds for anentire body | Yes - same |
| Laser PositioningSystem | |||
| Maximumaverageradiantpower/wavelength | 0.136 mW / 520 nm (green)0.130 mW / 635 nm (red) | 0.136 mW / 520 nm (green)0.130 mW / 635 nm (red) | Yes - same |
| Class according toIEC 60825-1 | Class 1 | Class 1 | Yes - same |
Table 1: Comparison for Substantial Equivalence
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Image /page/7/Picture/0 description: The image shows the logo for EOS imaging. The logo is orange and consists of the letters "EOS" stacked on top of the word "imaging". Below "imaging" is the phrase "AN afdec COMPANY" in a smaller font. The logo is simple and modern.
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Image /page/8/Picture/0 description: The image shows the logo for EOS imaging. The logo is orange and consists of the letters "EOS" stacked on top of the word "imaging". Below "imaging" is the phrase "AN afdec COMPANY" in a smaller font. The logo is simple and modern.
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Image /page/9/Picture/0 description: The image shows the logo for EOS imaging. The logo is orange and consists of the letters "EOS" stacked on top of the word "imaging". Below "imaging" is the phrase "AN cdec COMPANY" in a smaller font. The "O" in "EOS" is shaped like a diamond.
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Image /page/10/Picture/0 description: The image shows the logo for EOS imaging. The logo is orange and consists of the letters "EOS" stacked on top of the word "imaging". Below "imaging" is the phrase "AN afdec COMPANY" in a smaller font. The logo is simple and modern.
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Image /page/11/Picture/0 description: The image contains the logo for EOS imaging. The logo consists of the letters "EOS" in a bold, sans-serif font, stacked above the word "imaging" in a smaller, lighter font. Below "imaging" is the text "AN cdec COMPANY" in a smaller font size. The color of the "EOS" letters is a light orange.
PERFORMANCE DATA 7
EOSedge is designed and has been certified to conform to IEC 60601-1 and collateral standards. Software verification and validation testing was also conducted. Additional performance and functional testing have confirmed the equivalent performance of EOSedge compared to the cleared predicate EOSedge System (K202394). This included bench testing to confirm appropriate dosing and image quality. Bench performance testing was conducted based on FDA's Guidance for the Submission of 510(k)'s for Solid-State X-ray Imaging Devices (September 1, 2016), to verify that EOSedge performs according to specifications and is as safe and effective as the predicate device.
All the testing standards used for bench testing of the EOSedge system related to the changes in this submission are listed in Table 2 below:
| Standards N°. | Standards Title | Date |
|---|---|---|
| IEC 62304 | Medical device software - Software life cycle processes | 2015 |
| IEC 62220-1-1 | Medical electrical equipment-Characteristics of digital X-rayimaging devices Part 1-1: Determination of the detectivequantum efficiency Detectors used in radiographic imaging | 2015 |
Table 2: Bench Testing Standard Used for the EOSedge System
8 CONCLUSION
Modified EOSedge has the same intended use, indications for use, technological characteristics, and similar principles of operation as its predicate device, the cleared EOSedge System (K202394). The minor differences in principles of operation and software specifications between EOSedge and its predicate device raise no new questions of safety or effectiveness. Performance data further demonstrates that modified EOSedge is as safe and effective as the cleared EOSedge System (K202394). Thus, the modified EOSedge is substantially equivalent.
§ 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.