(165 days)
The Micro C Medical Imaging System, M01 is a handheld and portable general purpose X-ray system that is indicated for use by qualified/trained clinicians on adult and pediatric patients for taking diagnostic static and serial radiographic exposures of extremities. The device is not intended to replace a radiographic system that has both variable tube current and voltages (kVp) in the range that may be required for full optimization of image quality and radiation exposure for different exam types.
The Micro C Medical Imaging System, M01 (subject device) is a handheld X-ray system designed to aid clinicians with point of care visualization through diagnostic X-rays of distal extremities. The device allows a clinician to select desired technique factors best suited for their patient anatomy. The Micro C Medical Imaging System, M01 consists of three major subsystems: The Emitter, Cassette, and Control Unit. The System is intended to interface an external Monitor (touchscreen or non-touchscreen display), keyboard and a mouse, and can provide a remote operator interface over the network to a laptop. The Micro C Medical Imaging System, M01 utilizes a computer vision positioning system to allow the emitter to be positioned above the patient anatomy and aligned to the cassette by the operator. The device is used in a clinical environment.
The provided document describes the Micro C Medical Imaging System, M01, and updates to its software to include AiLARA (Artificial Intelligence-based Algorithm for Radiography) modes. The primary focus of the document regarding acceptance criteria and performance relates to the validation of this new software feature.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria for the AiLARA algorithm's performance in terms of image quality or diagnostic accuracy using specific metrics like sensitivity, specificity, or AUC. Instead, the acceptance criteria seem to be qualitative and focused on the algorithm's learning trend, software requirement fulfillment, diagnostic relevance of images, and radiation dose limits.
| Acceptance Criteria Category | Description of Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| AiLARA Algorithm Verification | The model should learn the trend of the training dataset (truth). Mean Squared Error (MSE) and Mean Absolute Error (MAE) for both training and testing datasets should indicate no further benefit from additional training (epochs). | The model was able to learn the trend of the training dataset (truth). The mean squared error of the training and verification testing datasets were plotted, and the trend lines showed that the model had learned the general trend present in the data. Both training and testing Mean Squared Error and Mean Absolute Error showed that additional training (epochs) would have no added benefit. |
| Software Verification | The updated Micro C software should meet system-level software requirements, and software outputs should meet expected results. | Software outputs met the expected result in all cases, with no anomalies found. |
| Image Quality Validation | Images generated with AiLARA modes should be diagnostically and clinically relevant when reviewed by board-certified radiologists and an orthopedic surgeon. | All images were determined to be diagnostically and clinically relevant. |
| Radiation Dose Testing | AiLARA mode's radiation outputs should be below established Diagnostic Reference Levels (DRLs) and not statistically different from the predicate device's manual mode dose outputs for comparable techniques. | All AiLARA dose values were below the established Diagnostic Reference Levels (DRLs) and there was no statistical difference between AiLARA and Manual mode calculated entrance skin exposure doses. |
| Radiation Dose Testing on Small/Pediatric Anatomies | AiLARA's radiation outputs for small size extremity anatomies should be below DRLs and consistent across various emitter orientations and small anatomy thicknesses. | All AiLARA dose values were below the established Diagnostic Reference Levels (DRLs) for small size anatomies, and doses were similar among captures for each orientation within the same target thickness and SID category. |
| Usability Evaluation | All critical use tasks for the AiLARA modes should be completed with a passing result by 100% of participants. | All the identified critical use tasks were completed with a passing result by 100% of participants. The usability evaluation was performed in accordance with IEC 62366-1:2020 and FDA guidance. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: The AiLARA algorithm's full development dataset was split, with 20% of the data used as the testing set for algorithm verification.
- Data Provenance: The document does not specify the country of origin. The data used for algorithm verification was part of the "full development dataset" of AiLARA. For the "Image Quality Validation Study," the validation set was collected after the algorithm was frozen and transferred to the device, using phantoms at different emitter orientations and angles. The phantom types included ankle, elbow, hand, foot, knee, toe, and wrist. The study appears to be prospective in the sense that images were collected specifically for validation after the algorithm's finalization.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- For the Image Quality Validation Study, images were reviewed and rated by board certified radiologists and an orthopedic surgeon. The exact number of experts is not specified. Their qualifications are stated as "board certified" in their respective fields.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- The document does not describe a specific adjudication method (like 2+1 or 3+1) for establishing the ground truth or evaluating the test set images. It states that experts "reviewed and rated" the images.
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 comparative effectiveness study was done to evaluate human readers' improvement with AI assistance. The studies performed were primarily focused on the standalone performance and safety of the AiLARA algorithm and the updated device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, a standalone evaluation of the AiLARA algorithm was performed. The "AiLARA Algorithm Verification" specifically describes training the model and then sending the full testing set into the model to predict its performance on unseen data, which is a standalone assessment. The "Image Quality Validation Study" and "Radiation Dose Testing" also evaluate the device's output (images and dose) when using the AiLARA modes, which operate without human input on technique factors during image acquisition (the algorithm "determines and recommends a power setting and an exposure time for the X-ray without user input").
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the "AiLARA Algorithm Verification," the ground truth was referred to as the "truth" which the model was trained to learn the trend of. Given the context of determining optimal technique factors, this "truth" likely relates to ideal exposure parameters for specific anatomies and views.
- For the "Image Quality Validation Study," the ground truth for evaluating image quality was the assessment by board-certified radiologists and an orthopedic surgeon that images were "diagnostically and clinically relevant." This can be considered a form of expert consensus or subjective expert assessment of image utility.
8. The sample size for the training set
- 80% of AiLARA's full development dataset was used for the training set. The total size of the "full development dataset" is not specified.
9. How the ground truth for the training set was established
- The document states that the AiLARA model was trained to "learn the trend of the training dataset (truth)." It implies that the ground truth for the training set consisted of the correct or desired power settings and exposure times for various phantom anatomies and orientations. The specific methodology for establishing this "truth" (e.g., manual expert selection, physical measurements, reference images) for the training data is not detailed but is implicitly linked to generating "a clinically relevant image" while "reduc[ing] overexposures."
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February 4, 2022
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OXOS Medical, Inc. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k SAINT PAUL MN 55114
Re: K212654
Trade/Device Name: Micro C Medical Imaging System, M01 Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile X-Ray System Regulatory Class: Class II Product Code: IZL Dated: January 27, 2022 Received: January 28, 2022
Dear Prithul Bom:
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. 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 located 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.
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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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).
Sincerely,
Laurel Burk, Ph.D. Assistant Director Diagnostic X-Ray Systems Team Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K212654
Device Name Micro C Medical Imaging System, M01
Indications for Use (Describe)
The Micro C Medical Imaging System, M01 is a handheld and portable general purpose X-ray system that is indicated for use by qualified/trained clinicians on adult and pediatric patients for taking diagnostic static and serial radiographic exposures of extremities. The device is not intended to replace a radiographic system that has both variable tube current and voltages (kVp) in the range that may be required for full optimization of image quality and radiation exposure for different exam types.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CER 801 Subnart D) |
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Section 5 510(k) Summary
Image /page/3/Picture/2 description: The image shows a logo that reads "OXOS MEDICAL". The logo consists of four symbols: a circle with two gaps, an X, another circle with two gaps, and the letter S. The word "MEDICAL" is written in smaller letters below the symbols.
Section 5 510(k) Summary
In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the Micro C Medical Imaging System, M01 Traditional 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.
| Submitter: | OXOS Medical, Inc1230 Peachtree St NESuite #300Atlanta, GA 30309Tel: 1-855-SEE-XRAY |
|---|---|
| Submission Contact: | Mo KhosravanipourDirector of Program ManagementOXOS Medical, Inc.Email: Mo@oxos.comGrace Powers, MS, MBA, RACFounder/Principal ConsultantPowers Regulatory ConsultingEmail: grace@powersregulatory.com |
| Submission Date: | July 21, 2021 |
| Subject Device: | Trade Name: Micro C Medical Imaging System, M01Common Name: System, X-Ray, MobileRegulation: 21 CFR § 892.1720Regulatory Classification: 2Product Code: IZLClassification Panel: Radiology |
| Predicate Device: | Legally marketed device to which substantial equivalence is claimed:Micro C Medical Imaging System, M01 (K211473) |
Device Description:
The Micro C Medical Imaging System, M01 (subject device) is a handheld X-ray system designed to aid clinicians with point of care visualization through diagnostic X-rays of distal extremities. The device allows a clinician to select desired technique factors best suited for their patient anatomy. The Micro C Medical Imaging System, M01 consists of three major subsystems: The Emitter, Cassette, and Control Unit. The System is intended to interface an external Monitor (touchscreen or non-touchscreen display), keyboard and a mouse, and can provide a remote operator interface over the network to a laptop. The
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Section 5 510(k) Summary
Micro C Medical Imaging System, M01 utilizes a computer vision positioning system to allow the emitter to be positioned above the patient anatomy and aligned to the cassette by the operator. The device is used in a clinical environment. A description of the three major sub-systems is listed below.
- Emitter: This component contains the operator control panel, X-ray tube, and computer vision camera. The control panel allows the operator to control the major functions of the device, including the technique factors. This component is controlled and held in the operator's hand.
- Cassette: This component contains the X-ray detector that collects the X-ray energy and provides a digital representation to the control unit for eventual display. This component also contains status lights and IR lights to assist in X-ray field positioning. The patient anatomy of interest is placed on top of this module.
- Control Unit: This component contains the High Voltage generator, computing power, monitor and keyboard inputs, and other electronics required for the functioning of the device. This module is typically placed on a shelf, cart, counter, or other flat surface convenient to the operator and environment.
The system is intended to work in conjunction with a DICOM monitor, keyboard and a mouse and the mains power outlet.
The Micro C Medical Imaging System, M01 has custom validated software that includes a user interface that allows the operator to view and adjust captured radiographs and transfer radiographs to a PACS server or flash drive.
Image /page/4/Figure/8 description: The image shows a white box connected to a handheld device and a square base via cables. Two blue cables connect the box to the handheld device and the square base. Two gray cables also connect the box to the square base.
Figure 5-1: Subject Device - Micro C Medical Imaging System, M01
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Image /page/5/Figure/2 description: The image shows a computer setup with a monitor, keyboard, mouse, and a white device. The monitor is connected to the white device, and the keyboard and mouse are also connected to it. The white device has several ports on the back, including a power port, USB ports, and an Ethernet port. There are also two wall outlets visible in the image.
Intended Use:
The M01 System is a hand-held X-ray system designed to aid clinicians with point of care visualization through diagnostic X-rays of extremities.
Indications for Use:
The Micro C Medical Imaging System, M01 is a handheld and portable general purpose X-ray system that is indicated for use by qualified/trained clinicians on adult and pediatric patients for taking diagnostic static and serial radiographic exposures of extremities.
The device is not intended to replace a radiographic system that has both variable tube current and voltages (kVp) in the range that may be required for full optimization of image quality and radiation exposure for different exam types.
Technological Characteristics
The Micro C Medical Imaging System, M01 is identical to the predicate device cleared via K211473. The purpose of this submission is to update the software to include AiLARA modes as described below. The table below compares the subject and predicate device.
| Subject Device:Micro C Medical ImagingSystem, M01 | Predicate Device: MicroC Medical ImagingSystem, M01 (K211473) | Comparison | |
|---|---|---|---|
| Product Code | IZL (Mobile X-RaySystem) | IZL (Mobile X-RaySystem) | Identical |
| Regulation | 21 CFR 892.1720 | 21 CFR 892.1720 | Identical |
| ClassificationName | Mobile X-Ray System | Mobile X-Ray System | Identical |
| Classification | Class 2 | Class 2 | Identical |
| Indication forUse | The Micro C MedicalImaging System, M01 is ahandheld and portablegeneral purpose X-raysystem that is indicatedfor use by | The Micro C MedicalImaging System, M01 isa handheld andportable generalpurpose X-ray systemthat is indicated for use | Identical |
| Subject Device:Micro C Medical ImagingSystem, M01 | Predicate Device: MicroC Medical ImagingSystem, M01 (K211473) | Comparison | |
| qualified/trainedclinicians on adult andpediatric patients fortaking diagnostic staticand serial radiographicexposures of extremities.The device is notintended to replace aradiographic system thathas both variable tubecurrent and voltages(kVp) in the range thatmay be required for fulloptimization of imagequality and radiationexposure for differentexam types. | by qualified/trainedclinicians on adult andpediatric patients fortaking diagnostic staticand serial radiographicexposures ofextremities.The device is notintended to replace aradiographic systemthat has both variabletube current andvoltages (kVp) in therange that may berequired for fulloptimization of imagequality and radiationexposure for differentexam types. | ||
| Contraindications | Surgical applicationsPediatric patientsFluoroscopyFor cardiac and vascular applicationsMammographyDental applicationsContact with non-intact skin | Surgical applicationsPediatric patientsFluoroscopyFor cardiac and vascular applicationsMammographyDental applicationsContact with non-intact skin | Identical |
| Age of Device Use | Adults and Pediatric | Adults and Pediatric | Identical |
| Principle of Operation | General purpose diagnostic X-ray | General purpose diagnostic X-ray | Identical |
| Image type produced | Static, serial radiographicand photographic imagesfor convenience. | Static, serialradiographic andphotographic images forconvenience. | Identical |
| Detector | 6 x 6" digital detector | 6 x 6" digital detector | Identical |
| Collimator | The removable fixedcollimators (referred toas pucks) | The removable fixedcollimators (referred toas pucks) | Identical |
| Weight | Emitter: 2.86kg (6.3lbs) | Emitter: 2.86kg (6.3lbs) | Identical |
| Subject Device:Micro C Medical ImagingSystem, M01 | Predicate Device: MicroC Medical ImagingSystem, M01 (K211473) | Comparison | |
| Dimension/Size | Cassette: 6.5kg (14.3lbs)Control Unit: 8.6kg(19.0lbs)Emitter: 9.3"H x 3.5"W x8.3"L (excluding SSDCone)Cassette: 15.5"H x15.5"W x 2.8"LControl Unit: 16.4"H x12.9"W x 5.5"L | Cassette: 6.5kg (14.3lbs)Control Unit: 8.6kg(19.0lbs)Emitter: 9.3"H x 3.5"W x8.3"L (excluding SSDCone)Cassette: 15.5"H x15.5"W x 2.8"LControl Unit: 16.4"H x12.9"W x 5.5"L | Identical |
| TriggeringMechanism | Two stage triggering | Two stage triggering | Identical |
| MinimumSource toskin distance(SSD) | 20 cm SSD Cone ensuresminimum SSD of 20 cm | 20 cm SSD Cone ensuresminimum SSD of 20 cm | Identical |
| Source toDetectordistance | 20 - 45 cm | 20 - 45 cm | Identical |
| Light Field | Virtual light field onMonitor UI. No projectedlight field. | Virtual light field onMonitor UI. Noprojected light field. | Identical |
| EnergySource | 120 VAC / 60 Hz (norechargeable battery) | 120 VAC / 60 Hz (norechargeable battery) | Identical |
| ExposureTime | 33 ms - 99 ms | 33 ms, 66 ms, 99 ms | Similar- The overall range isidentical. Single AiLARAmode allows for ms valuesthroughout the range. SerialAiLARA mode has a fixedoutput of 33 ms. |
| mA | 1.0 mA fixed | 1.0 mA fixed | Identical |
| kVp | 40kVp-60kVp | 40kVp, 50kVp, and60kVp | Similar- The overall range isidentical. AiLARA allows forkVp values throughout therange. |
| ScintillatorResolution/Pixel size | Cesium lodide (CsI)99 μm | Cesium Iodide (Csl)99 μm | Identical |
| DQE @0Lp/mmMTF @ 1Lp/mm,RQA5 | 70%60% | 70%60% | Identical |
| Subject Device:Micro C Medical ImagingSystem, M01 | Predicate Device: MicroC Medical ImagingSystem, M01 (K211473) | Comparison | |
| IngressProtectionRating | IPOO | IPOO | Identical |
| ImageProcessing | User Interface can beused to drag, zoom,rotate and also adjustbrightness, contrast, andsharpness. | User Interface can beused to drag, zoom,rotate and also adjustbrightness, contrast,and sharpness. | Identical |
| ConnectivityOptions | WiFi, Ethernet, Four USB2.0 ports | WiFi, Ethernet, FourUSB 2.0 ports | Identical |
| DICOM | Yes- DICOM 3.0Compliant | Yes- DICOM 3.0Compliant | Identical |
| DevicePackageContents | • Cassette• Control Unit• Emitter• Collimation Pucks• SSD Cone• Cassette PowerCable• Cassette Data Cable• Control Unit PowerCable• Connector Covers• Instructions for Use• Case | • Cassette• Control Unit• Emitter• Collimation Pucks• SSD Cone• Cassette PowerCable• Cassette Data Cable• Control Unit PowerCable• Connector Covers• Instructions for Use• Case | Identical |
Table 5-2: Device Comparison
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AiLARA Software
The purpose of this Traditional 510(k) is to update the Micro C Medical Imaging System, M01 software to include two additional modes of use referred to as AiLARA is a static artificial intelligence (AI) based algorithm in the updated software. AiLARA adds two additional modes for the M01 device: Single AiLARA and Serial AiLARA. In these modes, the device determines and recommends a power setting and an exposure time for the X-ray without user input. This mode may help ensure that a clinically relevant image is taken and reduce overexposures and retaking of images.
The Micro C software, including the new AiLARA algorithm, has a Moderate level of concern per with Guidance for Industry and FDA Staff – Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (2005); software developmentation was provided in accordance with the guidance. There was no change to the Micro C software level of concern with the addition of the AiLARA algorithm. The software development lifecycle followed IEC 62304:2015, Medical device software – Software life cycle processes. Risk analysis to address the new algorithm was performed in accordance with ISO 14971:2019, Medical Devices – Application of Risk Management to Medical Devices.
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Section 5 510(k) Summary
Non-Clinical Performance Data
Testing specific to the Micro C software with AiLARA modes was performed and included with the 510(k) submission:
| Performance Test | Description |
|---|---|
| AiLARA AlgorithmVerification | AiLARA's full development dataset was split into a training set (80% ofthe data) and a testing set for algorithm verification (20% of the data)per Good Machine Learning Practices as outlined in FDA's ProposedRegulatory Framework for Modifications to Artificialintelligence/Machine Learning (AI/ML) Based Software as a MedicalDevice (SaMD)(2019). AiLARA's model was trained, and at the end ofevery epoch, the full testing set was sent into the model and waspredicted to show the model's performance on unseen data. The modelwas able to learn the trend of the training dataset (truth). The meansquared error of the training and verification testing datasets wereplotted, and the trend lines showed that the model had learned thegeneral trend present in the data. Both training and testing MeanSquared Error and Mean Absolute Error showed that additional training(epochs) would have no added benefit. |
| Software Verification | Software verification was performed to ensure the updated Micro Csoftware met system-level software requirements. Software outputsmet the expected result in all cases, with no anomalies found. |
| Image Quality ValidationStudy | An image quality study validation dataset was collected after theAiLARA algorithm was frozen, finalized, and transferred to the Micro Cdevice. This validation set was completely independent of the algorithmtraining and verification testing set. The emitter can move freely inspace (not attached to the detector), therefore the validation imageswere collected with independent inputs that the algorithm had notseen previously. The independent inputs were achieved by takingimages of phantoms at different emitter orientations and angles(geometries). The validation dataset included images taken from ankle,elbow, hand, foot, knee, toe, and wrist phantoms; each phantom wascaptured at multiple distinct SIDs that spanned the full device SID rangeof 20 cm to 45 cm. Additionally, each phantom view/SID combinationwas captured at multiple orientations. Once the validation images werecollected, the images were reviewed and rated by board certifiedradiologists and an orthopedic surgeon. All images were determined tobe diagnostically and clinically relevant. |
| Radiation Dose Testing | AiLARA technique and dose evaluation testing was performed toevaluate AiLARA mode's radiation outputs as compared to diagnosticreference levels from literature, to ensure an acceptable amount ofradiation was delivered. Additionally, AiLARA's dose outputs from theauto-selected techniques were compared to the predicate device'smanual mode dose outputs that result from the techniquesrecommended in the Instructions for Use. Results showed that allAiLARA dose values were below the established Diagnostic Reference |
| Radiation Dose Testing onSmall/Pediatric Anatomies | Levels (DRLs) and there was no statistical difference between AiLARA and Manual mode calculated entrance skin exposure doses.Testing was conducted to evaluate AiLARA's radiation outputs for small size extremity anatomies (representing low thicknesses seen for small patients, especially pediatrics) as compared to diagnostic reference levels from literature to ensure an acceptable amount of radiation was delivered. This study also included recording dose outputs at different Source to Image Distance (SID) and emitter orientation configurations to ensure doses are consistently acceptable at various emitter orientations and small anatomy thicknesses. Results showed that all AiLARA dose values were below the established Diagnostic Reference Levels (DRLs) for small size anatomies, and doses were similar among captures for each orientation within the same target thickness and SID category. |
| Usability Evaluation | A usability evaluation was performed for the addition of the AiLARA modes for single radiography and serial radiography (DDR) imaging to ensure the Micro C Medical Imaging System, M01 has acceptable use-related risks and effectiveness during use. The study included 15 participants who were licensed to perform x-ray procedures and had previous experience operating x-ray devices. All the identified critical use tasks were completed with a passing result by 100% of participants. The usability evaluation was performed in accordance with IEC 62366-1:2020, Medical devices - Part 1: Application of usability engineering to medical devices and Guidance for Industry and FDA Staff – Applying Human Factors and Usability Engineering to Medical Devices (2016) |
Table 5-3: Non-Clinical Performance Data
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In addition, the following specific FDA guidance documents were utilized in the device development to ensure the safety of this device for both the operators and patients:
- Guidance for Medical X-ray Imaging Devices Conformance with IEC Standards (2019) ●
- Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices (2016)
- Radiation Safety Considerations for X-ray Equipment Designed for Hand-held Use (2008)
- Pediatric Information for X-ray Imaging Device Premarket Notifications (2017)
Clinical Performance Data
Non-clinical data generated using imaging phantoms representative of the intended patient populations was sufficient to support the updates to the Micro C device software; no clinical studies were performed. The determination of substantial equivalence is not based on an assessment of clinical performance data.
Conclusion
The Micro C Medical Imaging System, M01 is identical in physical design to the legally marketed predicate device. The updated software is acceptable as demonstrated by the performance data and does not raise different questions of safety and effectiveness.
§ 892.1720 Mobile x-ray system.
(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.