(112 days)
Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. (Not for mammography)
This is a complete stationary diagnostic x-ray system employing a digital x-ray panel coupled with image acquisition software. The acquisition software is installed on a Windows compatible workstation. The high frequency generator is available in four different power ratings. All components are either 510(k) exempt or previously cleared. The only difference between the two models is the configuration of the tube stand. Galaxy has a straight arm and the Galaxy+ Plus is in a U-Arm configuration. Generators are available in 40-50-65-or 80 kW (High Frequency) models.
The provided text describes a 510(k) summary for the Galaxy and Galaxy+ Plus Digital Diagnostic X-Ray System. It does not contain information about specific acceptance criteria or a detailed study proving the device meets them in the way typically found for AI/algorithm-driven devices.
The document focuses on demonstrating substantial equivalence to a predicate device (Sedecal X-Plus LP Plus Digital Diagnostic X-Ray Systems, K090238) rather than meeting pre-defined performance acceptance criteria for an AI algorithm. The core of the submission is to show that the new device has "essentially the same technological characteristics" and similar clinical indications for use as the predicate.
Here's an analysis based on the information provided, highlighting what is present and what is not:
Acceptance Criteria and Device Performance:
The document doesn't explicitly state "acceptance criteria" in terms of specific performance metrics (e.g., sensitivity, specificity, AUC) for an AI component, nor does it report such metrics for the device. Instead, the "acceptance criteria" for this 510(k) submission appear to be implicitly about demonstrating that the new device is as safe and effective as the predicate device.
Table of Acceptance Criteria and Reported Device Performance:
| Criterion Category (Implicit) | Description / Device Performance (from text) |
|---|---|
| Indications for Use Equivalence | Identical indications for use as the predicate device: "Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. (Not for mammography)" |
| Technological Characteristics Equivalence | "Essentially the same technological characteristics" as the predicate—differences are in manufacturer for digital panels, x-ray generator, and tube stands, but with "functionally identical capabilities." Key technological comparison points include: - Digital Receptor Panel: Atlaim ATAL 8 and ATAL 8C (Cleared in K113812), compared to Canon panels in predicate. - Panel Communication: Tethered Ethernet, one panel (Same as predicate). - Panel Resolution: Pixel size 139 x 139 μm, Image matrix size 3072 x 3072 pixels, Approx. 9.4 million pixels (Predicate: 160 x 160 μm, 2208 x 2688 pixels, Approx. 5.9 million pixels). The new device has higher resolution. - DICOM: Yes (Same software as cleared in K112527) (Same as predicate). - Tube Stand: One model is a straight arm, the other is similar to U-Arm (Predicate: U-Arm). - Generator: CPI, 40-50-65-or 80 kW (High Frequency) (Predicate: Sedecal 65 kW, optional 80 kW). |
| Electrical Safety & EMC | "The unit has undergone electrical safety and electromagnetic compatibility testing... The unit meets IEC safety and EMC standards." (Implicitly, this is an acceptance criterion). |
| Software Validation & Risk Analysis | "software validation and risk analysis" were performed. (Implicitly, this is an acceptance criterion). |
| Clinical Image Quality | "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." (This is the primary "performance" metric related to clinical utility). |
Detailed Study Information:
The document describes non-clinical and clinical tests, but these are general descriptions rather than a detailed study protocol for an AI/algorithm.
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified. The clinical tests mention "Clinical images were obtained," but no quantity is given.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified, but referred to as "professional radiologist" (plural).
- Qualifications of Experts: "professional radiologist." No years of experience or specific subspecialty mentioned.
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Adjudication method for the test set:
- Not specified. The text simply states images "were evaluated by professional radiologists and found to be of good diagnostic quality." No mention of consensus, voting, or specific adjudication rules.
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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 MRMC study was performed or described. This submission is for a conventional digital X-ray system, not an AI-driven diagnostic aid. The "clinical tests" assessed the diagnostic quality of the images produced by the system itself, not the performance of human readers with or without AI assistance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No standalone algorithm performance study was done. This device is a diagnostic imaging system, not an algorithm. The "performance" being evaluated is the image quality produced by the system for human interpretation.
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The type of ground truth used:
- The "ground truth" for the clinical images appears to be the expert opinion/consensus of professional radiologists regarding the "good diagnostic quality" of the images generated by the device. It's not pathology, outcomes data, or a pre-defined objective reference standard for specific病灶 detection, but rather an assessment of general image utility.
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The sample size for the training set:
- Not applicable. This device is a digital X-ray system, and the submission does not mention any machine learning or AI components that would require a "training set."
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How the ground truth for the training set was established:
- Not applicable, as no training set for an AI algorithm is mentioned or implied.
Summary of the Device and Submission Context:
This 510(k) pertains to a new digital X-ray system. The "study" described is a testing and evaluation process for a medical device's physical and functional characteristics, not a clinical trial or performance study for an AI algorithm. The device produces images, and the "clinical tests" verified that these images are of "good diagnostic quality" as assessed by radiologists, aligning with the performance expected from similar legally marketed predicate devices. The core argument for clearance is substantial equivalence based on comparable indications for use, technological characteristics (with the new device having higher resolution panels), and meeting relevant safety and EMC standards.
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510(k) Summary K132294
- Submitter: RADIOLOGY SOLUTIONS LLC 1912 Golfcrest Dr Commerce Twp, MI 48382 Tel. 866.681.6681 Date Prepared: October 10, 2013 Contact: Scott Milgrom, President
NOV 1 2 2013
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- Identification of the Device: Galaxy and Galaxy+ Plus Digital Diagnostic X-Ray System. Classification Name: Stationary x-ray system ; Common/Usual Name: Stationary x-ray system Regulation Numbers: 21 CFR 892.1680, Product Codes: MQB and KPR
- Predicate Device: The Galaxy systems are substantially equivalent to The Sedecal X-Plus LP Plus 3. Digital Diagnostic X-Ray Systems, K090238.
- A description of the device: This is a complete stationary diagnostic x-ray system employing a digital 4. x-ray panel coupled with image acquisition software. The acquisition software is installed on a Windows compatible workstation. The high frequency generator is available in four different power ratings. All components are either 510(k) exempt or previously cleared. The only difference between the two models is the configuration of the tube stand. Galaxy has a straight arm and the Galaxy+ Plus is in a U-Arm configuration. Generators are available in 40-50-65-or 80 kW (High Frequency) models.
- ട. Indications for Use: Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. (Not for mammography)
- The Galaxy and Galaxy Plus have essentially the same technological characteristics (i.e., design, ર. material, chemical composition, energy source) as the predicate device Sedecal. See the comparison table below. There are really only a few main differences: The digital panels, x-ray generator, and tube stands are from different manufacturers but with functionally identical capabilities.
| Characteristic | Predicate Device | Galaxy and Galaxy+ Plus |
|---|---|---|
| The Sedecal X-Plus LP Plus Digital DiagnosticX-Ray Systems, K090238. | ||
| Indications | Intended for use by a qualified/trained doctor ortechnician on both adult and pediatric subjectsfor taking diagnostic radiographic exposures ofthe skull, spinal column, chest, abdomen,extremities, and other body parts. Applicationscan be performed with the patient sitting,standing, or lying in the prone or supine position. | Intended for use by a qualified/trained doctoror technician on both adult and pediatricsubjects for taking diagnostic radiographicexposures of the skull, spinal column, chest,abdomen, extremities, and other body parts.Applications can be performed with the patientsitting, standing, or lying in the prone or supineposition. (Not for mammography) |
| Digital ReceptorPanel | CANON panels, multiple models: 50C, 50G, 40C& 40G (Various clearances) | Atlaim ATAL 8 AND ATAL 8C (Cleared inK113812) to be known as "IRIS" AND "IRIS C" |
| Characteristic | Predicate DeviceThe Sedecal X-Plus LP Plus Digital DiagnosticX-Ray Systems, K090238. | Galaxy and Galaxy+ Plus |
| PanelCommunication | Tethered Ethernet, one panel | Same |
| PanelResolution | Pixel size160 × 160 μmImage matrix size2208 × 2688 pixelsNumber of pixels Approx. 5.9 million pixels | Pixel size 139 x 139 μmImage matrix size 3072 x 3072 pixelsNumber of pixels Approx. 9.4 million pixels |
| DICOM | Yes | Yes (Same software as cleared in K112527) tobe known as "Nexxus" |
| Tube Stand | U-Arm | One model is a straight arm, the other is similarto a U-Arm. See below |
| Generator | Sedecal 65 kW, optional 80 kW (High frequency) | CPI, 40-50-65-or 80 kW (High Frequency) |
| Safety | UL Listings and IEC Standards IEC 60601-1 andIEC 60601-1-2, US Performance Standards | UL/CSA Listings and IEC Standards IEC 60601-1and IEC 60601-1-2, US Performance Standards |
| Photo | Image: Sedecal X-Plus LP Plus Digital Diagnostic X-Ray Systems | Image: GalaxyImage: Galaxy+ Plus |
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- Description of non-clinical tests. The unit has undergone electrical safety and electromagnetic compatibility testing, as well as software validation and risk analysis. The unit meets IEC safety and EMC standards. The technical characteristics of the new system have been measured and included in the bench testing information performed by a radiology physicist.
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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.
- ਰੇ. Conclusions drawn: The nonclinical and clinical tests that demonstrate 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows a circular seal with text around the perimeter and a symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The symbol in the center appears to be a stylized representation of a person or figure, possibly with flowing lines or ribbons.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002
November 12, 2013
Radiology Solutions LLC % Daniel Kamm, P.E. Principal Engineer Kamm & Associates 8870 Ravello Court NAPLES FL 34114
Re: K132294
Trade/Device Name: Galaxy and Galaxy+ Plus Digital Radiography Systems Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR and MQB Dated: August 12, 2013 Received: August 15, 2013
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 for ass sured in the energenent date of the enactment date of the Medical Device Amendments, or to connities that have been reclassified in accordance with the provisions of the Federal Food, Drug, ue necs that have occh roulabilities in assire approval of a premarket approval application (PMA). and Cosinctic Act (Act) that to norice, subject to the general controls provisions of the Act. The 1 ou may, dierelove, manov of the Act include requirements for annual registration, listing of general controls provisions of ractice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability additeration. Thease note: CDTCP acce not evaluate mast be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (bee 2001). Existing major regulations affecting your device can be may be subject to additional controls. "Encling any and 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 Please be advised hat I DA 3 issualled of a complies with other requirements of the Act ulat I DA has made a decorminations administered by other Federal agencies. You must of any I edefal statutes and regarantents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical CFK Fart 807), labeling (21 CFR 803); montal en anufacturing practice requirements as set
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Page 2 - Mr. Kamm
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree 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.fda.gov/MedicalDevices/Safety/ReportalProblem/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 Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Smh 7)
l'or
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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Indications for Use
510(k) Number (if known): K132294
Device Name: Galaxy and Galaxy+ Plus
Indications for Use:
Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. (Not for mammography)
Prescription Use X
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Smh
(Division Sign-Off)
Division of Radiological Health
Office of In Vitro Diagnostics and Radiological Health
K132294 510(k)
Page 1 of 1
§ 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.