(77 days)
These are stationary x-ray systems intended for obtaining radiographic images of various portions of the human body in a clinical environment. The devices are not intended for mammography
This is a complete stationary diagnostic x-ray system employing digital x-ray panels coupled with image acquisition software. The key features are: Ceiling Tube Suspension, Motorized Movements, Auto-Positioning, Tube Mounted 10" Touch Screen, Elevating 6 Way Table Patient Load: 5501bs, Single User Interface, High Frequency Generator. This ergonomic design incorporates automatic motorized positioning, creating an efficient workflow increasing the patient throughput. Precision offers automatic stitching enhancing the workflow further. Tube, vertical wall stand and table have extended range of motion for easy patient positioning. The acquisition software is installed on a Windows compatible workstation. The high frequency generator is available in different power ratings. All components are either 510(k) exempt or previously cleared. Generators are available in 50, 65, 80 kW (High Frequency) models.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Arcoma AB 0180 Intuition & 0072 Precision Stationary Digital X-Ray Systems (K140683):
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly list quantitative acceptance criteria for the device's performance. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Arcoma Intuition, K073632) through functional comparisons, non-clinical tests, and a qualitative clinical evaluation.
The "acceptance criteria" can be inferred from the overall claim of substantial equivalence and the scope of the testing performed, primarily that the modified device is "as safe, as effective, and performs as well as or better than the legally marketed device."
| Acceptance Criteria (Inferred from Substantial Equivalence and Testing) | Reported Device Performance (Summary) |
|---|---|
| Non-Clinical Performance: - Individual and system performance. - Electrical safety and electromagnetic compatibility. - Software integration validation. - Risk analysis. - Compliance with IEC safety and EMC standards. | Met. "The modified unit has undergone individual and system performance tests, electrical safety and electromagnetic compatibility testing, as well as software integration validation and risk analysis. The unit meets IEC safety and EMC standards." Functionally identical capabilities to predicate device despite panel, generator, and tube stand modifications. Specifically, new Canon digital panels (K103591, K102012) each have their own 510(k) clearances, implying their individual performance meets regulatory standards. |
| Clinical Performance: - Diagnostic quality of images. | Met. "Clinical images were obtained in accordance with the FDA Guidance Document on Solid State Imaging Devices. They were evaluated by professional radiologist and found to be of good diagnostic quality." |
| Overall Equivalence: - As safe and effective as predicate. - Performs as well as or better than predicate. | Met. "The nonclinical and clinical tests that the device is as safe, as effective, and performs as well as or better than the legally marketed device identified in paragraph 3." Technological characteristics are "essentially the same" as the predicate, with modifications to digital panels, x-ray generator, and tube stands that retain "functionally identical capabilities." New panels offer higher resolution and wired/wireless options, suggesting potential improvements without detrimental impact. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a numerical sample size for the clinical images used in the clinical study. It states only that "Clinical images were obtained."
- Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: The document states that clinical images "were evaluated by professional radiologist" (singular, though likely implying multiple, it does not specify the number).
- Qualifications of Experts: The experts are described only as "professional radiologist." No further details on their experience level (e.g., "10 years of experience") are provided.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the clinical image evaluation. It simply states that the images "were evaluated by professional radiologist and found to be of good diagnostic quality."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study described is a qualitative evaluation of image quality by radiologists, comparing the modified device's performance to an implicit standard of "good diagnostic quality" rather than a direct comparison against the predicate by multiple readers on multiple cases. Therefore, no effect size of human readers improving with AI vs. without AI assistance is applicable or reported, as this device is a traditional x-ray system, not an AI-powered diagnostic tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone (algorithm only) performance study was not done. This device is a digital X-ray system, and its primary output is human-interpretable images, not an automated diagnostic algorithm.
7. The Type of Ground Truth Used
The ground truth for the clinical images seems to be based on expert consensus (or individual expert opinion) regarding "good diagnostic quality." The text does not mention pathology, outcomes data, or other objective ground truth measures for evaluating the images.
8. The Sample Size for the Training Set
This information is not applicable and not provided in the document. This device is a traditional digital X-ray system, not an AI or machine learning algorithm that requires a training set. The "software integration validation" mentioned refers to the system's operational software, not an AI model.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for an AI/ML algorithm described.
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Page 1 of 2
JUN 0 3 2014
510(k) Summary, Device Modification, K14 0 68 3
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- Submitter: Arcoma AB Annavagen 1 SE-352 46 Vaxjo Sweden Phone: +46 470 70 69 00 Contact/Prepared by: Mikael Larsson, CEO. Date prepared: 17 February 2014
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- Identification of the Device: 0180 Intuition & 0072 Precision Stationary Digital X-Ray Systems Classification Name: Stationary x-ray system Common/Usual Name: Stationary digital x-ray system Regulation Number: 21 CFR 892.1680 Product Codes: KPR and MQB
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- Predicate Device: Arcoma Intuition, K073632
- Modification Summary: (1) Newer versions of Canon digital panels will be supplied. (2) A 4. different brand of high frequency generator will be supplied. (3) The overhead tube crane has been motorized. (4) The wall stand now has motorized vertical movement.
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- A description of the device: This is a complete stationary diagnostic x-ray system employing digital x-ray panels coupled with image acquisition software. The key features are:
- Ceiling Tube Suspension a.
- Motorized Movements, Auto-Positioning ﻗ
- c. Tube Mounted 10" Touch Screen
- Elevating 6 Way Table Patient Load: 5501bs ರ.
- Single User Interface e.
- High Frequency Generator 。
This ergonomic design incorporates automatic motorized positioning, creating an efficient workflow increasing the patient throughput. Precision offers automatic stitching enhancing the workflow further. Tube, vertical wall stand and table have extended range of motion for easy patient positioning. The acquisition software is installed on a Windows compatible workstation. The high frequency generator is available in different power ratings. All components are either 510(k) exempt or previously cleared. Generators are available in 50, 65, 80 kW (High Frequency) models.
-
- These are stationary x-ray systems intended for obtaining radiographic Indications for use: images of various portions of the human body in a clinical environment. They are not intended for mammography.
-
- The 0180 Intuition & 0072 Precision Stationary Digital X-Ray Systems have essentially the same technological characteristics (i.e., design, material, chemical composition, energy source) as the predicate device Arcoma Intuition, K073632. See the comparison table below. There are really only a few main differences: The digital panels, x-ray generator, and tube stands have been modified but have functionally identical capabilities. The proposed new digital x-ray panels each have their own 510(k) clearances.
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K140683
Page 2 of 2
| Characteristic | Arcoma Intuition, K073632 | 0180 Intuition 0072 Precision |
|---|---|---|
| Indications | The 0170 Intuition is a stationary x-raysystem intended for obtainingradiographic images of various portionsof the human body in a clinicalenvironment. The 0170 Intuition is notintended for mammography | The 0180 Intuition and 0072 Precision arestationary digital x-ray systems intendedfor obtaining radiographic images ofvarious portions of the human body in aclinical environment. They are notintended for mammography |
| Digital ReceptorPanel | Canon 40C/G K031633 andand Canon 50G K031447 | Canon 401C K103591and Canon 70C wireless K102012 |
| Panel Resolution | Canon 40C/GImaging area 43 x 43 cmPixel Pitch 160 $\mu m$Image matrix size 2,688 x 2,688 pixelsCanon 50GImaging area 35 x 43 cm.Pixel Pitch 160 $\mu m$Image matrix size 2,208 x 2,688 pixels | Canon 70CImaging area 35 X 43 cmPixel Pitch: 125 $\mu m$Image matrix size: 2,800 x 3,408 PixelsCanon 401CEffective imaging area: 41.5 × 42.6 cmPixel pitch: 125 $\mu m$Image matrix size: 3320 × 3408 pixels |
| Panel Connection | Wired | Wired or Wireless (WiFi) |
| DICOM | Yes | Yes |
| Tube Stand | Ceiling Mount | Same |
| Collimator | Siemens or Ralco | Siemens |
| Generator | EMD EPS 50, 65, 80 kW (High Frequency) | CPI, CMP 200 50, 65, 80 kW (HighFrequency) |
| Safety | UL Listings and IEC Standards IEC60601-1 and IEC 60601-1-2, USPerformance Standards | UL/CSA Listings and IEC Standards IEC60601-1 and IEC 60601-1-2, USPerformance Standards |
| Photo | Image: Arcoma Intuition, K073632 | Image: 0180 Intuition 0072 Precision |
- Description of non-clinical tests. The modified unit has undergone individual and system 8. performance tests, electrical safety and electromagnetic compatibility testing, as well as software integration validation and risk analysis. The unit meets IEC safety and EMC standards.
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- Description of clinical tests. Clinical images were obtained in accordance with the FDA Guidance Document on Solid State Imaging Devices. They were evaluated by professional radiologist and found to be of good diagnostic quality.
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- Conclusions drawn: The nonclinical and clinical tests that the device is as safe, as effective, and performs as well as or better than the legally marketed device identified in paragraph 3, above.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three wing-like shapes extending from its body.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Asenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 3. 2014
Arcoma AB % Daniel Kamm, P.E. Kamm & Associates 8870 Ravello Court NAPLES FL 34114
Re: K140683
Trade/Device Name: 0180 Intuition and 0072 Precision Stationary Digital X-Ray Systems Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: April 29, 2014 Received: May 05, 2014
Dear Mr. Kamm:
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 (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. 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 docs 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.
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Kamm
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fdg.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
for
Janine M Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510{k) Number (if known) K140683
Device Name
0180 Intuition and 0072 Precision Digital Radiography Systems
Indications for Use (Describe)
These are stationary x-ray systems intended for obtaining radiographic images of various portions of the human body in a clinical environment. The devices are not intended for mammography
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (1/14)
PSL" Publiching Seri nees 1 2011 443-4740 H
Page 17 of 3587
§ 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.