(131 days)
No reference devices were used in this submission.
No
The summary describes a standard medical image viewing and processing software with 2D and 3D visualization tools. There is no mention of AI, ML, deep learning, or any related concepts in the intended use, device description, or performance studies. The processing mentioned refers to standard image manipulation and display, not AI/ML-driven analysis.
No
The device is described as a diagnostic and review tool for medical images, not for providing therapy.
Yes
The intended use explicitly states that the device is intended for use as a diagnostic and review tool by trained healthcare professionals.
Yes
The device is explicitly described as a "software device" and "software device runs on the macOS X platform". While it requires suitable commercial standard hardware for installation and display, the device itself is the software component for image viewing and processing.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Definition of IVD: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The tests are performed outside the body (in vitro).
- Horos MD's Function: Horos MD is a software device for viewing, storing, communicating, processing, and displaying medical images acquired from imaging modalities like CT, MR, and ultrasound. It works with images generated by the body, not samples from the body.
- Intended Use: The intended use clearly states it's for viewing and reviewing images acquired from medical imaging systems. It's a diagnostic and review tool for trained healthcare professionals working with these images.
In summary, Horos MD is an imaging software device used for the interpretation and analysis of medical images, not for performing tests on biological samples.
N/A
Intended Use / Indications for Use
Horos MD™ is a software device intended for viewing images acquired from computed tomography (CT), computed radiography (CR), magnetic resonance (MR), ultrasound (US) and other DICOM compliant medical imaging systems when installed on suitable commercial standard hardware. Images and data can be stored, communicated, processed, and displayed within the system. It is intended for use as a diagnostic and review tool by trained healthcare professionals.
This device is not to be used for mammography.
It is the User's responsibility to operate the device in accordance with the software and hardware requirements listed in the instructions for use, in particular ensuring that monitor (display) quality, ambient light conditions, and image compression ratios are consistent with the clinical application.
Product codes
LLZ
Device Description
The Horos MD™ is an interactive image display and navigation software device for diagnosis of medical images. It provides both 2D and 3D image visualization tools for CT and MRI scans from different makes and models of image acquisition hardware. It does not produce any original medical images and does not contain controls for the direct operation of a diagnostic imaging system. Horos MD™ conforms to the DICOM standard to allow the sharing of medical images with other digital imaging systems such as PACS (Picture Archiving and Communication System).
The Horos MD™ software device runs on the macOS X platform, taking advantage of its optimized 3D graphic capabilities, which are provided by the METAL framework developed and maintained by Apple Inc.
The user interface of the software follows Apple's Human Interface Guidelines (HIG) in order to create a user interface that is intuitive and easy to use for users who are familiar with other Apple products. Typical users of this device are radiologists and clinicians who are familiar with 2D scan images.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
computed tomography (CT), computed radiography (CR), magnetic resonance (MR), ultrasound (US), and other DICOM compliant medical imaging systems.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained healthcare professionals such as radiologists, clinicians and other qualified physicians.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Data:
Software Verification and Validation Testing: All components of Horos MD™ software have been tested to ensure the system operates according to its intended use. Software verification testing was conducted, and documentation was provided as detailed in FDA's Guidance for Industry and FDA Staff: "Guidance for the content of Premarket Submissions for Software Contained in Medical Devices." Cybersecurity requirements, risk analysis, and mitigation were addressed in accordance with "Content of Premarket Submission for Management of Cybersecurity in Medical Devices (Oct 2014)."
Bench Performance Testing: No clinical testing was required. Non-clinical (bench) testing was sufficient to support the intended use.
The measurement accuracy for the distance (length) and area features was validated using Digital Reference Objects (n=75 test cases) compared against known values. These Digital Reference Objects were representative of the clinical range typically encountered in radiology practice (1-190 mm). Inter-operator error (reproducibility) and intra-operator error (repeatability) were assessed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Function Accuracy:
Distance (1-10mm): 99.68%
Distance (>10mm): 99.82%
Area (1-10mm): 99.19%
Area (>10mm): 99.66%
Angle (1-190mm): 100%
Point (1-190mm): 100%
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
iCat Solutions Ltd % Bhoomika Joyappa Senior Regulatory Consultant Medical Device Academy, Inc. 345 Lincoln Hill Rd Shrewsbury, Vermont 05738
January 3, 2024
Re: K232589
Trade/Device Name: Horos MD™M Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: December 13, 2023 Received: December 13, 2023
Dear Bhoomika Joyappa:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica Lamb
Jessica Lamb Assistant Director DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
Submission Number (if known)
Device Name
Horos MD TM
Indications for Use (Describe)
Horos MD™ is a software device intended for viewing images acquired from computed tomography (CT), computed radiography (CR), magnetic resonance (MR), ultrasound (US) and other DICOM compliant medical imaging systems when installed on suitable commercial standard hardware. Images and data can be stored, communicated, processed, and displayed within the system. It is intended for use as a diagnostic and review tool by trained healthcare professionals.
This device is not to be used for mammography.
It is the User's responsibility to operate the device in accordance with the software and hardware requirements listed in the instructions for use, in particular ensuring that monitor (display) quality, ambient light conditions, and image compression ratios are consistent with the clinical application.
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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3
| 510(k) Summary | ||
|---|---|---|
| Horos MD (HOROSMD) | Document: DOC-21 | Date: 2023/08/25 14:27:46 |
1. DESCRIPTION
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:
2. SUBMITTER
| Company Name | iCat Solutions Ltd |
|---|---|
| Address | 51-59 Rose Lane, NR1 1BY, Norwich, United Kingdom |
| tel | +44(0)7517456306 |
| Contact Person | Georgios Michalopoulos |
3. DATE PREPARED
2023/07/21
4. DEVICE
| Device Trade Name | Horos MD™ |
|---|---|
| Classification Name | Medical Image Management and Processing System |
| Regulation | 21 CFR 892.2050 |
| Regulatory Class | Class II |
| Device Panel | Radiology |
| Product Classification Code | LLZ |
4
| 510(k) Summary | ||
|---|---|---|
| Horos MD (HOROSMD) | Document: DOC-21 | Date: 2023/08/25 14:27:46 |
5. PREDICATE DEVICE
| Predicate Manufacturer | Pixmeo, Sarl |
|---|---|
| Predicate Trade Name | Osirix MD™ |
| Predicate 510(k) | K101342 |
No reference devices were used in this submission.
6. DEVICE DESCRIPTION
The Horos MD™ is an interactive image display and navigation software device for diagnosis of medical images. It provides both 2D and 3D image visualization tools for CT and MRI scans from different makes and models of image acquisition hardware. It does not produce any original medical images and does not contain controls for the direct operation of a diagnostic imaging system. Horos MD™ conforms to the DICOM standard to allow the sharing of medical images with other digital imaging systems such as PACS (Picture Archiving and Communication System).
The Horos MD™ software device runs on the macOS X platform, taking advantage of its optimized 3D graphic capabilities, which are provided by the METAL framework developed and maintained by Apple Inc.
The user interface of the software follows Apple's Human Interface Guidelines (HIG) in order to create a user interface that is intuitive and easy to use for users who are familiar with other Apple products. Typical users of this device are radiologists and clinicians who are familiar with 2D scan images.
7. INDICATIONS FOR USE
Horos MD™ is a software device intended for viewing images acquired tomography (CT), computed radiography (CR), magnetic resonance (MR), ultrasound (US) and other DICOM compliant medical imaging systems when institude commercial standard hardware. Images and data can be stored, communicated, processed, and displayed within the system. It is intended for use as a diagnostic and review tool by trained healthcare professionals. This device is not to be used for mammography.
5
| 510(k) Summary | ||
|---|---|---|
| Horos MD (HOROSMD) | Document: DOC-21 | Date: 2023/08/25 14:27:46 |
It is the User's responsibility to operate the device in accordance with the software requirements listed in the instructions for use, in particular ensuring that monitor (display) quality, ambient light conditions, and image compression ratios are consistent with the clinical application.
8. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The following characteristics were compared between the subject device and the predicate device in order to demonstrate substantial equivalence:
| Characteristics | Subject device
Horos MD™ | Primary Predicate
Osirix MD™ | Justification for
differences |
|------------------------|------------------------------------------------------------------------|-------------------------------------------------------------------|--------------------------------------------------------------|
| Submitter | iCat Solutions Ltd | Pixmeo, Sarl | - |
| 510(k) Number | K232589 | K101342 | - |
| Product classification | Class II | Class II | |
| Regulation Number | 21 CFR 892.2050 | 21 CFR 892.2050 | Same |
| Product code | LLZ | LLZ | Same |
| Type of use | Prescription (RX Only) | Prescription (RX Only) | Same |
| Class | II | II | |
| Regulations number | 21 CFR 892.2050 | 21 CFR 892.2050 | |
| Regulation Name^ | Medical Image Management and
Processing System | Picture archiving and
communications system | 21 CFR
892.2050 name has
been amended in
April 2021 |
| Classification Name | System, image processing, radiological | System, image processing,
radiological | Same |
| Product code | LLZ | LLZ | Same |
| Indications for Use | Horos MD™ is a software device
intended for viewing images acquired | OsiriX MD"M isa software device
intended for viewing of images | Same. |
Table 1: Comparison of Horos MD™ with Osirix MD™ (K101342).
6
| 510(k) Summary | ||
|---|---|---|
| Horos MD (HOROSMD) | Document: DOC-21 | Date: 2023/08/25 14:27:46 |
| | from computed tomography (CT),
computed radiography (CR), magnetic
resonance (MR), ultrasound (US) and
other DICOM compliant medical imaging
systems when installed on suitable
commercial standard hardware. Images
and data can be stored, communicated,
processed, and displayed within the
system.
It is intended for use as a diagnostic and
review tool by trained healthcare
professionals.
This device is not to be used for
mammography.
It is the User's responsibility to operate
the device in accordance with the
software and hardware requirements
listed in the instructions for use, in
particular ensuring that monitor (display)
quality, ambient light conditions, and
image compression ratios are consistent
with the clinical application. | acquired from CT, MR, CR, DR, US
and other DICOM compliant medical
imaging systems when installed on
suitable commercial standard
hardware.
Images and data can be captured,
stored, communicated, processed,
and displayed within the system and
or across computer networks at
distributed locations.
Lossy compressed mammographic
images and digitized film screen
images must not be reviewed for
primary diagnosis or image
interpretation. For primary diagnosis,
post process
DICOM "for presentation" images
must be used. Mammographic
images should only be viewed with a
monitor approved by FDA for viewing
mammographic images.
It is the User's responsibility to
ensure monitor quality, ambient light
conditions, and image compression
ratios are consistent with the clinical
application. | The subject device
is contraindicated
for Mammography.
Therefore, the
subject device
eliminates the risks
associated with the
analysis of
mammographic
images. |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Users | Trained healthcare professionals such as
radiologists, clinicians and other qualified
physicians | Trained healthcare professionals | Same |
| Mammography diagnostic use | No | Yes (Mammographic images should
only be viewed with a monitor
approved by FDA for viewing
mammographic images) | The subject device
is contraindicated
for Mammography.
Therefore, the |
7
| 510(k) Summary | |||
|---|---|---|---|
| Horos MD (HOROSMD) | Document: DOC-21 | Date: 2023/08/25 14:27:46 | |
| subject device | |||
| subject device | |||
| eliminates the risks | |||
| associated with the | |||
| diagnosis and | |||
| analysis of | |||
| mammographic | |||
| images. | |||
| Imaging modalities | • CT | ||
| • MR | |||
| • CR | |||
| • DR | |||
| • US | • CT | ||
| • MR | |||
| • CR | |||
| • DR | |||
| • US | Same | ||
| Communications | DICOM | DICOM | Same |
| Installation | Local computers | Local computers | Same |
| Operating system for | |||
| diagnostic viewing | MacOS (Mac) | MacOS (Mac) | Same |
| User authentication (unique | |||
| login) | Yes | Yes | Same |
| Access to DICOM studies | • Connect to existing onsite or | ||
| remote PACS | |||
| • Local computer/server | |||
| • USB drives / CD / DVD | • Connect to existing onsite or | ||
| remote PACS | |||
| • Local computer/server | |||
| • USB drives / CD / DVD | Same | ||
| Basic visualization tools | • Grayscale display | ||
| • Rotate | |||
| • Pan | |||
| • Zoom | |||
| • Magnification | |||
| • Fit to screen. | |||
| • Scroll | |||
| • Flip horizontal / vertical | |||
| • Axial / coronal / sagittal views | |||
| • Cross-hair | • Grayscale display | ||
| • Rotate | |||
| • Pan | |||
| • Zoom | |||
| • Magnification | |||
| • Fit to screen | |||
| • Scroll | |||
| • Flip horizontal / vertical | |||
| • Axial / coronal / sagittal views | |||
| • Cross-hair | Same |
8
| 510(k) Summary | |||||
|---|---|---|---|---|---|
| Horos MD (HOROSMD) | Document: DOC-21 | Date: 2023/08/25 14:27:46 | |||
| Adjustable windowing (WW/WL) HU (Hounsfield Unit) Slice indicator Reset | Adjustable windowing (WW/WL) HU (Hounsfield Unit) Slice indicator Reset | Adjustable windowing (WW/WL) HU (Hounsfield Unit) Slice indicator Reset | |||
| Advanced tools | Volume Rendering (3D) MPR | Volume Rendering (3D) MPR | Volume Rendering (3D) MPR SSD | The subject device | |
| does not include | |||||
| SSD. This limitation | |||||
| does not alter the | |||||
| device's intended | |||||
| use or indications | |||||
| for use, nor does it | |||||
| introduce any new | |||||
| safety risks. | |||||
| Therefore, there is | |||||
| no risk to the | |||||
| device's safety or | |||||
| performance. | |||||
| Measurements | Line Angle Area (circular, irregular shape, polygonal) Point Cobb Angle CTR | Line Angle Area (circular, irregular shape, polygonal) Point | Line Angle Area (circular, irregular shape, polygonal) Point | The subject device | |
| has additional | |||||
| measuring | |||||
| functions. Subject | |||||
| device features and | |||||
| functions are | |||||
| described in the | |||||
| user's manual and | |||||
| tested with intended | |||||
| users for clinical | |||||
| use. Additional | |||||
| measurement | |||||
| functions do not | |||||
| change the device's | |||||
| intended use or |
9
| 510(k) Summary | ||||
|---|---|---|---|---|
| Horos MD (HOROSMD) | Document: DOC-21 | Date: 2023/08/25 14:27:46 | ||
| Annotations | yes | yes | Same | |
| Anonymization function | yes | yes | Same | |
| Studies comparison | yes | yes | Same | |
| Share function | yes | yes | Same | |
| Export functions | Yes (JPEG, .dcm, .zip) | Yes (JPEG, PNG,.dcm, .zip) | The subject device exports files in JPEG, .dcm, and .zip formats but not in PNG format. This limitation does not alter the device's intended use or indications for use, nor does it introduce any new safety risks. Therefore, there is no risk to the device's safety or performance. | |
| Report generation | No | No | Same | |
| Device type/ form | Software device that operates on off-the-shelf hardware | Software device that operates on off-the-shelf hardware | Same | |
| 510(k) Summary | ||||
| Horos MD (HOROSMD) | Document: DOC-21 | Date: 2023/08/25 14:27:46 | ||
| DICOM standard for data | ||||
| exchange | NEMA PS3.1 2023b (2023) Digital | |||
| Imaging and Communications In | ||||
| Medicine (Dicom) Set | NEMA PS 3.1 - 3.20 (2016) Digital | |||
| Imaging and Communications In | ||||
| Medicine (Dicom) Set | Same | |||
| JPEG standard for image | ||||
| compression | IEC/ ISO 10918-1, Edition 1 (1994-02- | |||
| 15), Information Technology – Digital | ||||
| Compression and Coding of Continuous- | ||||
| Tone Still Images: Requirements And | ||||
| Guidelines [Including: Technical | ||||
| Corrigendum 1 (2005) | IEC/ ISO 10918-1, Edition 1 (1994- | |||
| 02-15), Information Technology - | ||||
| Digital Compression and Coding of | ||||
| Continuous-Tone Still Images: | ||||
| Requirements And Guidelines | ||||
| [Including: Technical Corrigendum 1 | ||||
| (2005) | Same |
10
9. EVALUATION OF SIMILARITIES AND DIFFERENCES
The main differences between the subject device and the primary predicate is in the system installation via the Apple AppStore versus installation from a .dmg binary file for the predicate device) and the support of mammography images (Horos MD™ must not be used for mammography diagnostic use)
Horos MD™ and the primary predicate device have the same technical characteristics, general function, intended use, and does not raise any new potential safety risks and is equivalent in performance. In terms of use and functions, both systems access, upload, and display DICOM images and metadata, and resources to trained healthcare professionals for study review and analysis.
10. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Non-Clinical Data
Software Verification and Validation Testing •
All of the different components of Horos MD™ software have been tested to ensure that the system as a whole provides all the capabilities necessary to operate according to its intended use. Software verification testing were conducted, and documentation was provided as detailed in FDA's Guidance for Industry and FDA Staff: "Guidance for the content of Premarket Submissions for Software Contained in Medical Devices."
11
| 510(k) Summary | ||
|---|---|---|
| Horos MD (HOROSMD) | Document: DOC-21 | Date: 2023/08/25 14:27:46 |
iCat Solutions Ltd has implemented security features for the device and data protection. Cybersecurity requirements, risk analysis, and mitigation was addressed in accordance Content of Premarket Submission for Management of Cybersecurity in Medical Devices (Oct 2014).
Bench Performance Testing .
No clinical testing was required to demonstrate safety or effectiveness for the subject device as the device's non-clinical (bench) testing was sufficient to support the intended use of the device.
The measurement accuracy for the distance (length), and area features was validated using Digital Reference Objects compared against the known values. The Digital Reference Objects (n=75 test cases) created were representative of the clinical range typically encountered in radiology practice (1-190 mm). Inter-operator error (reproducibility), and intra-operator error (repeatability) were assessed.
| Function | Accuracy |
|---|---|
| Distance (1-10mm) | 99.68% |
| Distance (>10mm) | 99.82% |
| Area (1-10mm) | 99.19% |
| Area (>10mm) | 99.66% |
| Angle (1-190mm) | 100% |
| Point (1-190mm) | 100% |
11. CONCLUSIONS
There is no difference between the subject device (Horos MD™ ) and the predicate device in terms of its intentions for use and fundamental scientific technology. Neithers in usage, safety, or effectiveness, thus no new questions regarding safety or effectiveness are raised. The non-clinical performance test data and validation demonstrate that the subject device performs comparably to and is as safe and effective as the predicate with the 21 CFR Part 807 and based on the information provided in this premarket notification, Horos MD™ is substantially equivalent to the predicate device.