(205 days)
The Ortho Device is intended to generate tomosynthesis images of human anatomy for diagnostic purposes of the hand, elbow and foot in patients of all ages.
The imaging will provide the physician visualized information about anatomical structures to facilitate assessment in orthopedic cases such as:
• Fractures of bones in finger, metacarpus or wrist
• Fractures of foot, ankle or elbow joint
• Arthritis
The Ortho Device is a 3D tomographic X-ray device intended to be used to produce radiological images of a specific cross-sectional plane of the body. The device is comprised of a Flat Panel X-ray source combined with a digital detector within a mounting frame, a control unit and a workstation. It is intended to offer 3D imaging of orthopedic structures by using a panel of X-ray sources that construct a 3D tomosynthesis image with the associated reconstruction software from individual images; it is also possible to create synthetic 2D images of the desired anatomy.
The Ortho Device is a portable system that can be mounted on a stand for tabletop applications or on a trolley cart for added mobility with motorized vertical positioning. The C-Arm and Control Unit components are both designed to be carriable by a single person. To allow for the ideal positioning of the anatomy (hand and weight-bearing foot images) in the beam path and to achieve the desired plane of view, the Ortho Device C-Arm can be manually rotated by up to 90°. The central beam is aligned perpendicularly to the image receptor.
The "Ortho Device" was created to fill a diagnostic niche in orthopedic medicine for cost effective and portable imaging for patients and is used, amongst other applications, for 3D-radiographic diagnostic imaging of hand, elbow and foot in orthopedic and radiological practices as well as in emergency departments of hospitals. The Ortho Device results are detailed multi-slice 3D images of patients that allow radiologist interpretation of clinical image data and by this support medical professionals decisionmaking on human anatomy.
The Ortho Device system is designed to meet the requirements in accordance with relevant sections of 21CFR 1020.30-1020.31.
The provided text is a K221949 510(k) summary for the ADAPTIX 3D Orthopedic Imaging System ("Ortho Device"). It does not contain information about acceptance criteria, detailed study designs, or reader study results with explicit performance metrics. The document primarily focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and non-clinical testing.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts and their qualifications for ground truth establishment.
- Adjudication method for the test set.
- MRMC comparative effectiveness study results or effect sizes.
- Standalone performance details.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for the test set.
- Sample size for the training set.
- How ground truth for the training set was established.
However, based on the section "9. Non-Clinical Performance Data," I can extract the following relevant information regarding performance evaluation, albeit without specific quantitative acceptance criteria or detailed study methodologies:
The study that "proves the device meets the acceptance criteria" in this context refers to a series of non-clinical tests summarized in Section 9. While "acceptance criteria" for specific performance metrics are not explicitly stated with quantitative thresholds, the document implies that these criteria were met by stating "Passed" for each test.
1. A table of acceptance criteria and the reported device performance:
Since explicit quantitative acceptance criteria are not provided, the table below lists the performance aspects tested and the reported outcome.
| Performance Aspect Tested | Reported Device Performance/Outcome |
|---|---|
| In vitro Cytotoxicity (per ISO 10993-5) | Passed |
| Irritation and skin Sensitization (per ISO 10993-10) | Passed |
| Systemic toxicity (per ISO 10993-11) | Passed |
| Electrical safety (per IEC 60601-1) | Passed |
| Electromagnetic Disturbance (EMD) (per IEC 60601-1-2) | Passed |
| Radiation protection (per IEC 60601-1-3) | Passed |
| Medical Electrical Equipment Usability (per IEC 60601-1-6) | Passed |
| Safety and essential performance of X-ray tube assemblies (per IEC 60601-2-28 and IEC 60601-2-54) | Passed |
| Particular electrical testing performance req. for Radiation dose documentation (per IEC 61910-1) | Passed |
| Digital Imaging and Communications in Medicine (DICOM) (per NEMA PS 3.1) | Passed |
| Transportation Testing (per ASTM D4169) | Passed |
| Image quality (spatial and contrast resolution, homogeneity, linearity) | Passed |
| Ability of device to image all intended body parts (fingers, metacarpus/wrist, elbow, foot, ankle) | Evaluated and confirmed by radiologists |
| Ability of device to provide imaging data for assessment of bone fracture and arthritis | Evaluated and confirmed by radiologists |
| Software verification and validation (functional level, system compatibility, risk analysis per IEC 62304/FDA Guidance) | Completed for Moderate Level of Concern software |
| Risk Management (per EN ISO 14971) | All requirements met, risks reduced |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document mentions "sample clinical images" being evaluated by radiologists but does not specify the sample size, data provenance, or whether the study was retrospective or prospective for these clinical image evaluations. For other non-clinical tests (e.g., toxicity, electrical safety), the "sample size" would refer to the number of device units or components tested, which is not stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
The document states "Evaluation of sample clinical images by radiologists". It does not specify the number of radiologists, their qualifications, or their experience levels.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
The document does not describe any adjudication method used for the evaluation of clinical 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:
The document does not mention an MRMC comparative effectiveness study or any evaluation of human reader performance with or without AI assistance. The device is an imaging system, not explicitly described as having AI for interpretation in this summary.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The document describes the device as an "imaging system" that "results are detailed multi-slice 3D images of patients that allow radiologist interpretation of clinical image data and by this support medical professionals decision-making." This implies the device provides images for human interpretation, and there is no mention of an algorithm performing standalone diagnoses.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
For the evaluation of clinical images, "Evaluation of sample clinical images by radiologists to demonstrate that the device is able to image all intended body parts" and "to help clinician for the assessment of bone fracture and arthritis" implies that the ground truth for these evaluations was based on expert assessment/consensus (i.e., the radiologists' judgment). No pathology or outcomes data is mentioned as ground truth.
8. The sample size for the training set:
Not applicable/not provided. This document describes a medical imaging device, not a machine learning algorithm that requires a separate training set. The "software verification and validation testing" mentioned refers to the device's operational software, not an AI training process.
9. How the ground truth for the training set was established:
Not applicable/not provided, as there is no mention of a training set for an AI algorithm.
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January 26, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square are the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" in a smaller font below.
Pausch Medical GmbH % Oliver Eikenberg Lead Consultant Quality and Regulatory Affairs Emergo Global Consulting LLC 2500 Bee Cave Road Building 1. Suite 300 AUSTIN TX 78746
Re: K221949
Trade/Device Name: ADAPTIX 3D Orthopedic Imaging System ("Ortho Device") Regulation Number: 21 CFR 892.1740 Regulation Name: Tomographic x-ray system Regulatory Class: Class II Product Code: IZF , MQB Dated: December 22, 2022 Received: December 27, 2022
Dear Oliver Eikenberg:
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
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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 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 (OS) 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,
Lu Jiang
2023.01.26
17:03:19
-05'00'
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
Enclosure
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Indications for Use
510(k) Number (if known) K221949
Device Name
ADAPTIX 3D Orthopedic Imaging System ("Ortho Device")
Indications for Use (Describe)
The Ortho Device is intended to generate tomosynthesis images of human anatomy for diagnostic purposes of the hand, elbow and foot in patients of all ages.
The imaging will provide the physician visualized information about anatomical structures to facilitate assessment in orthopedic cases such as:
· Fractures of bones in finger, metacarpus or wrist
- · Fractures of foot, ankle or elbow joint
• Arthritis
| 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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510(k) Summary
ADAPTIX 3D Orthopedic Imaging System ("Ortho Device")
1. Submission Sponsor
Pausch Medical GmbH Graf - Zeppelin - Str. 1 91056 Erlangen, Bavaria, Germany Contact: Christian Stoian (CEO) Email: Christian.Stoian@mavig.com_ Phone: +49 (0)9131 / 99 92 - 0
2. Submission Correspondent
Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, TX 78746, US Email: LST.AUS.ProjectManagement@ul.com Office Phone: (512) 327-9997 Contact: Oliver Eikenberg, PhD Title: Senior Consultant, Quality & Regulatory Affairs, Emergo Group
3. Date Prepared
01/26/2023
4. Device Identification
| Trade/Proprietary Name: | ADAPTIX 3D Orthopedic Imaging System (“Ortho Device”) |
|---|---|
| Common/Usual Name: | Tomographic x-ray system |
| Regulation Number: | §892.1740 Tomographic x-ray system, §892.1680 Stationary x-ray sys |
| Product Code: | IZF Tomographic x-ray system, MQB solid state x-ray imager |
| Class: | Class II |
| Classification Panel: | Radiology |
5. Legally Marketed Predicate Device(s)
| Primary predicate device | |
|---|---|
| Device name: | DR 800 with Tomosynthesis |
| Regulation Number: | §892.1740 Tomographic x-ray system§892.1650 fluoroscopic, image-intensified x-ray system |
| Product Code: | IZF Tomographic x-ray system |
| Subsequent Product Code: | JAA fluoroscopic, image-intensified x-ray system |
| 510(k) number: | K183275 |
| Manufacturer: | Agfa N.V. |
Secondary predicate device
| Device name: | OrthoScan Mobile DI Mini C-Arm |
|---|---|
| Regulation Number: | §892.1650 fluoroscopic, image-intensified x-ray system |
| Product Code: | OXA mobile image-intensified fluoroscopic x-ray system |
| Subsequent Product Code: | JAA fluoroscopic, image-intensified x-ray system |
| 510(k) number: | K113708 |
| Manufacturer: | ORTHOSCAN, INC. |
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6. Indications for Use Statement
The Ortho Device is intended to generate tomosynthesis images of human anatomy for diagnostic purposes of the hand, elbow and foot in patients of all ages.
The imaging will provide the physician visualized information about anatomical structures to facilitate assessment in orthopedic cases such as:
- Fractures of bones in finger, metacarpus or wrist
- Fractures of foot, ankle or elbow joint
- Arthritis
7. Device Description
The Ortho Device is a 3D tomographic X-ray device intended to be used to produce radiological images of a specific cross-sectional plane of the body. The device is comprised of a Flat Panel X-ray source combined with a digital detector within a mounting frame, a control unit and a workstation. It is intended to offer 3D imaging of orthopedic structures by using a panel of X-ray sources that construct a 3D tomosynthesis image with the associated reconstruction software from individual images; it is also possible to create synthetic 2D images of the desired anatomy.
The Ortho Device is a portable system that can be mounted on a stand for tabletop applications or on a trolley cart for added mobility with motorized vertical positioning. The C-Arm and Control Unit components are both designed to be carriable by a single person. To allow for the ideal positioning of the anatomy (hand and weight-bearing foot images) in the beam path and to achieve the desired plane of view, the Ortho Device C-Arm can be manually rotated by up to 90°. The central beam is aligned perpendicularly to the image receptor.
The "Ortho Device" was created to fill a diagnostic niche in orthopedic medicine for cost effective and portable imaging for patients and is used, amongst other applications, for 3D-radiographic diagnostic imaging of hand, elbow and foot in orthopedic and radiological practices as well as in emergency departments of hospitals. The Ortho Device results are detailed multi-slice 3D images of patients that allow radiologist interpretation of clinical image data and by this support medical professionals decisionmaking on human anatomy.
The Ortho Device system is designed to meet the requirements in accordance with relevant sections of 21CFR 1020.30-1020.31.
8. Substantial Equivalence Discussion
The following table compares the Ortho Device to the predicate devices with respect to indications for use, principles of operation, technological characteristics, and performance, and forms the basis for the determination of substantial equivalence. The subject device does not raise any new questions of safety or effectiveness as compared to the predicate device.
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| Attribute | Primary Predicate DeviceDR 800 with Tomosynthesis | Secondary Predicate DeviceOrthoScanMobile DI Mini C-Arm | Subject DeviceOrtho Device | DEVICECOMPARISON |
|---|---|---|---|---|
| Manufacturer | Agfa N.V. | ORTHOSCAN, INC. | Pausch Medical GmbH | n/a |
| US PremarketNotification | K183275 | K113708 | K221949 | n/a |
| FDA ProductCode | IZF Tomographic X-ray system,JAA image-intensifiedfluoroscopic X-ray system | OXO Mobile Image-intensifiedfluoroscopic X-ray system,JAA image-intensifiedfluoroscopic X-ray system | IZF Tomographic X-raysystem,MQB solid state X-ray imager | Similar |
| Intended Use/ Indicationsfor Use | The DR 800 system is indicated forperforming dynamic imagingexaminations (fluoroscopy and/orrapid sequence) of the followinganatomies/procedures:•Positioning fluoroscopyprocedures•Gastro-intestinal examinations•Urogenital tract examinations•AngiographyIt is intended to replacefluoroscopic images obtainedthrough image intensifiertechnology. In addition, the systemis intended for project radiographyof all body parts.In addition, the system provides theAgfa Tomosynthesis option, whichis intended to acquire tomographicslices of human anatomy and to beused with Agfa DR X-Ray systems.Tomosynthesis is used tosynthesize tomographic slices froma single tomographic sweep.The DR 800 is not intended formammography applications. | The Orthoscan Mobile DI MiniC-Arm is designed to providethe physician with generalfluoroscopic visualization ofthe patient including, but notlimited to, surgical orthopedicprocedures and critical andemergency care procedures inhospital, emergency care,critical care or physician officeenvironment. | The Ortho Device is intendedto generate tomosynthesisimages of human anatomy fordiagnostic purposes of thehand, elbow and foot inpatients of all ages.The imaging will provide thephysician visualizedinformation about anatomicalstructures to facilitateassessment in orthopediccases such as:• Fractures of bones infinger, metacarpus orwrist• Fractures of foot, ankleor elbow joint• Arthritis | Similar |
| Device | Flat Panel detector | Flat Panel detector | Flat Panel detector (C-Arm) | Similar design |
| Components | X-ray GeneratorX-ray table with tube, housingand CollimatorMUSICA Acquisition Workstationwith Control Panel | X-ray GeneratorX-ray tube and housing | Board generating HighVoltage (C-Arm)Flat Panel Source (C-Arm)Emission Control Board (C-Arm)Acquisition Board (Control Unit)Workstation | and intended useto OrthoScan anddifferent to DR800 |
| Attribute | Primary Predicate Device | Secondary Predicate Device | Subject Device | DEVICECOMPARISON |
| DR 800 with Tomosynthesis | OrthoScan | Ortho Device | ||
| Mobile DI Mini C-Arm | ||||
| FlatPanelDetector | Thales Pixium RF4343 FLGadolinium Oxysulfide (GOS) orCesium lodide (Csl) ScintillatorField Sizes: 43 x 43 cm, 30 x 30cm, 20 x 20 cm, 15 x 15 cmResolution: 2840 x 2874Dynamic Range 16 bitPixel size 148 µm | CMOS detectorDetector size 15 x 12 cmField of View (full) 13.8 x 10.9cmResolution 2000 x 1500 Pixelpitch 75 µm | Flat Panel DetectorDetector dimensions: 15x11 cmResolution: 1488 x 1148ADC Conversion 14 bitPixel Pitch: 99 µm | Similar designand intended useto OrthoScan anddifferent to DR800 |
| X-rayGenerator(s) | kV range: 40 to 110 kVmA range: 1.5 to 50.8 mAChoice of three models:50, 65KW, 80 KW | kV range: 40 to 78 kVmA range: 0.040 to 0.160 mA | kV range: 60 kV (fixed)mA range: 0.01 to 0.05 mA | Different |
| Collimator | Ralco R 302 MLP/A | Fixed Aperture at fixed SID | Fixed Aperture at fixed SID | Similar toOrthoScan butdifferent to DR800 |
| Software | MUSICA DynamicMUSICA2MUSICA3/3+MUSICA DTS | Orthotouch | Adaptix Software Package(Acquisition &Reconstruction) | Different |
| SoftwareImageManipulationFunctions | Image acquisition control and display | Same | ||
| SoftwareImage fileformat | DICOM 3.0 File Output | Same | ||
| Type ofSoftwareApplication | Windows-based software application | Same | ||
| PanelInterface | Wired or wireless (optional) | Wired (Ethernet) | Similar | |
| Power Source | 230 V AC, 50/60 Hz (X-ray table) | AC: 100-230 V , 50-60 Hz | AC: 110 - 240 V, 50Hz/60Hz | Similar |
| Accessories | Ankle RestFoot RestHead Rest | Cart | Trolley (Cart)Foot RestPatient supporting arm rest | Similar |
| Protectiontype and levelagainstelectric shock | Class 1 | Same | ||
| ElectricalSafety,Electro-magneticCompatibilitystandards | IEC 60601-1IEC 60601-1-2IEC 60601-1-3IEC 60601-1-6IEC 60601-2-28IEC 60601-2-54 | Same |
Table 5A – Comparison of Characteristics between Subject Device and Predicate Devices
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9. Non-Clinical Performance Data
To demonstrate safety and effectiveness of Ortho Device and to show substantial equivalence to the predicate devices, Pausch Medical GmbH completed the following non-clinical tests. Results confirm that the design inputs and performance specifications for the device are met. The Ortho Device passed the testing in accordance with internal requirements, national standards, and international standards shown below, supporting its safety and effectiveness, and its substantial equivalence to the predicate devices.
- . In vitro Cytotoxicity testing per ISO 10993-5 – Passed
- . Irritation and skin Sensitization testing per ISO 10993-10 – Passed
- Systemic toxicity testing per ISO 10993-11 – Passed
- . Electrical safety testing per IEC 60601-1 – Passed
- Electromagnetic Disturbance (EMD) testing per IEC 60601-1-2 – Passed
- Radiation protection testing in diagnostic X-ray equipment per IEC 60601-1-3 – Passed
- . Medical Electrical Equipment Usability testing per IEC 60601-1-6 – Passed
- . Safety and essential performance testing of X-ray tube assemblies for medical diagnosis and X-ray equipment for radiography and radioscopy per IEC 60601-2-28 and IEC 60601-2-54 -Passed
- . Particular electrical testing performance requirements for Radiation dose documentation for X-ray equipment per IEC 61910-1 and Digital Imaging and Communications in Medicine (DICOM) per NEMA PS 3.1 - Passed
- Transportation Testing per ASTM D4169 demonstrates packaging integrity maintained
- . Testing for image quality - spatial and contrast resolution, homogeneity, and linearity etc. – Passed
- . Evaluation of sample clinical images by radiologists to demonstrate that the device is able to image all intended body parts (fingers, metacarpus/wrist, elbow, foot, ankle)
- . Evaluation of sample clinical images by radiologists to demonstrate that the device is able to provide imaging data to help clinician for the assessment of bone fracture and arthritis
- . Software verification and validation testing has been completed on a functional level for a Moderate Level of Concern software including system compatibility testing, risk analysis per IEC 62304/FDA Guidance
- . Risk Management per EN ISO 14971, all requirements were met and risks reduced as far as possible.
10. Statement of Substantial Equivalence
The Ortho Device has the same indications for use as the predicate devices OrthoScan Mobile DI Mini C-Arm and DR 800 with Tomosynthesis. Any minor differences in the technological characteristics of the subject device when compared to the predicate devices have been successfully evaluated through appropriate safety and performance testing which demonstrates that the subject device, when compared to the predicate devices, does not raise any new questions of safety and effectiveness. Therefore, the Ortho Device is substantially equivalent to the predicate devices.
§ 892.1740 Tomographic x-ray system.
(a)
Identification. A tomographic x-ray system is an x-ray device intended to be used to produce radiologic images of a specific cross-sectional plane of the body by blurring or eliminating detail from other planes. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.