3D-SHAPER
Device Facts
| Record ID | K220822 |
|---|---|
| Device Name | 3D-SHAPER |
| Applicant | 3D-Shaper Medical S.L |
| Product Code | KGI · Radiology |
| Decision Date | Dec 9, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1170 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device |
AI Performance
| Output | Algorithm | Acceptance | Observed | Dev DS | Dev Readers | Test DS | Test Readers |
|---|---|---|---|---|---|---|---|
| Bone mineral mass distribution and structural properties of the hip | — | — | Correlation coefficients (r) ≥ 0.9 for Integral vBMD, Trabecular vBMD, Cortical sBMD, CSA, CSMI, and Z; r ≥ 0.7 for Buckling Ratio. | — | — | Correlation study: 740 men and women aged 17 to 92 years old. | — |
Indications for Use
3D-SHAPER uses data from conventional Dual Energy X-Ray Absorptiometry (DXA) scans to measure the distribution of bone mineral mass at specific cross sections or regions of the hip and allows the physician to estimate structural properties of the hip, such as CSA, CSMI, Z, Buckling Ratio, cortical sBMD, trabecular vBMD and integral vBMD. 3D-SHAPER is indicated to be used by qualified medical professionals to assist healthcare professionals in the bone health evaluation & changes, and cannot fully substitute their clinical judgement.
Device Story
3D-SHAPER is a software application that reconstructs 3D hip models from 2D DXA scans. It processes DXA images to calculate bone mineral mass distribution and structural hip properties, including cortical surface bone mineral density (sBMD), trabecular/integral volumetric bone mineral density (vBMD), cross-sectional area (CSA), cross-sectional moment of inertia (CSMI), section modulus (Z), and buckling ratio (BR). Used by qualified medical professionals in clinical settings to assist in bone health evaluation and monitoring. The software provides numerical, graphical, 2D, and 3D visualizations to aid clinicians in assessing bone structural changes. It does not replace clinical judgment. The device supports DXA files from GE and Hologic scanners.
Clinical Evidence
No clinical testing performed. Evidence based on bench testing and correlation studies. Correlation study (n=740, 94% women, ages 17-92) compared 3D-SHAPER to predicate device, showing strong correlations (r≥0.9 for Integral vBMD, Trabecular vBMD, Cortical sBMD, CSA, CSMI, Z; r≥0.7 for Buckling Ratio). Bench testing against Quantitative Computed Tomography (QCT) showed strong correlations (r=0.91-0.96) for all parameters. Computing time < 2.5 minutes; convergence > 95%.
Technological Characteristics
Software-based 3D reconstruction from 2D DXA images. Operates on Windows. Connectivity: supports GE and Hologic DXA scanner files. Standards: ISO 14971 (risk management), IEC 62304 (software lifecycle), IEC 82304 (health software safety).
Indications for Use
Indicated for patients requiring bone health assessment. Not for pediatric patients or subjects with hip prostheses (total hip replacement, resurfacing, or osteosynthesis).
Regulatory Classification
Identification
A bone densitometer is a device intended for medical purposes to measure bone density and mineral content by x-ray or gamma ray transmission measurements through the bone and adjacent tissues. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Predicate Devices
- HIP STRUCTURAL ANALYSIS SOFTWARE OPTION FOR THE HOLOGIC QDR X-RAY BONE DENSITOMETERS (K061561)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 9, 2022
3D-Shaper Medical S.L % Ludovic Humbert CEO C/ Paris 179. 2-2 Barcelona, Barcelona 08036 SPAIN
Re: K220822
Trade/Device Name: 3D-SHAPER Regulation Number: 21 CFR 892.1170 Regulation Name: Bone densitometer Regulatory Class: Class II Product Code: KGI Dated: November 4, 2022 Received: November 4, 2022
Dear Ludovic Humbert:
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 medical devices and radiation-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,
2022.12.09
11:14:59
Lu Jiang
-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) K220822
Device Name 3D-SHAPER
### Indications for Use (Describe)
3D-SHAPER uses data from conventional Dual Energy X-Ray Absorptiometry (DXA) scans to measure the distribution of bone mineral mass at specific cross sections of the hip and allows the physician to estimate structural properties of the hip, such as CSA, CSMI, Z, Buckling Ratio, cortical sBMD, trabecular vBMD and integral vBMD.
3D-SHAPER is indicated to be used by qualified medical professionals to assist healthcare professionals in the bone health evaluation & changes, and cannot fully substitute their clinical judgement.
Type of Use (Select one or both, as applicable)
| <span style="font-size: 10px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|--------------------------------------------------------------------------------------|
| <span style="font-size: 10px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
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| 3D-SHAPER | Section 5 - 510(k) Summary | Doc Ref.: 05 |
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| 3D-SHAPER | 3D-SHAPER | Page 1 of 8 |
# 1 General Information
This 510(k) Summary of safety and effectiveness information is being submitted in accordance with the requirements detailed in 21 CFR 807.92.
The assigned 510(k) number is: K220822
| SUBMITTER NAME: | 3D-SHAPER MEDICAL S.L. |
|----------------------|---------------------------------------------------------------------------------------------------|
| SUBMITTER ADDRESS: | C/ Paris 179, 2º-2º |
| | 08036 Barcelona |
| | BARCELONA |
| | SPAIN |
| CONTACT: | Ludovic Humbert |
| TELEPHONE: | +34 93 328 3964 |
| E-MAIL: | ludovic.humbert@3d-shaper.com |
| DATE PREPARED: | March, 7, 2022 |
| DEVICE TRADE NAME: | 3D-SHAPER |
| COMMON NAME: | 3D Analysis software for Bone Densitometers |
| DEVICE CLASS: | Class II |
| REGULATION NUMBER | 892.1170 |
| REGULATION NAME | Bone Densitometer |
| PRODUCT CODE: | KGI |
| PREDICATE DEVICE(S): | HIP STRUCTURAL ANALYSIS SOFTWARE OPTION FOR THE HOLOGIC<br>QDR X-RAY BONE DENSITOMETERS (K061561) |
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| Image: 3D-SHAPER logo | Section 5 - 510(k) Summary | Doc Ref.: 05 |
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| 3D-SHAPER | 3D-SHAPER | Page 2 of 8 |
### Description of the device and its intended use ਜ
3D-SHAPER is a software reconstructing in 3D, the shape and bone mineral density from 2D DXA images. The software incorporates a DXA-based 3D reconstruction and measures the distribution of bone mineral mass at specific cross sections of the hip. It provides physicians with estimates of the structural properties of the hip, such as densities or geometrical parameters. The software is not suitable for use with paediatric patients or for subjects with hip prosthesis such as total hip replacement prosthesis, hip resurfacing prosthesis or an osteosynthesis system, since the software has not been tested against these conditions. 3D-SHAPER is indicated to be used by qualified medical professionals to assist healthcare professionals in the bone health evaluation & changes, and cannot fully substitute their clinical judgement.
The 3D-SHAPER® measurements include:
Cortical surface Bone Mineral Density (Cortical sBMD, mg/cm2)
Trabecular volumetric Bone Mineral Density (Trabecular vBMD, mg/cm³)
Integral volumetric Bone Mineral Density (Integral vBMD, mg/cm³), the integral compartment being the union of the cortical and trabecular compartments.
Hip structural measurements: Cross-Sectional Area (CSA, in cm²), Cross-Sectional Moment of Inertia (CSMI, in cm4), section modulus (Z, in cm3) and buckling Ratio (BR).
Cortical sBMD, trabecular VBMD and integral vBMD are calculated at the total femur. CSA, CSMI, Z and BR are calculated in cross-sections at the neck, intertrochanteric region and lower shaft.
### INTENDED USE:
As established in the Indications for Use Statement :
3D-SHAPER uses data from conventional Dual Energy X-Ray Absorptiometry (DXA) scans to measure the distribution of bone mineral mass at specific cross sections or regions of the hip and allows the physician to estimate structural properties of the hip, such as CSA, CSMI, Z, Buckling Ratio, cortical sBMD, trabecular vBMD and integral vBMD.
3D-SHAPER is indicated to be used by qualified medical professionals to assist healthcare professionals in the bone health evaluation & changes, and cannot fully substitute their clinical judgement.
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| 3D-SHAPER | Section 5 – 510(k) Summary | Doc Ref.: 05 |
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| | 3D-SHAPER | Page 3 of 8 |
## 2 Summary of Comparison with Predicate Device
Characteristics and features of the 3D-SHAPER software application have been compared to the features of the chosen, previously cleared, predicate device. The following predicate device was selected due to the similarities in application features, intended use and indications for use.
| 510(k)<br>Number | Product | Manufacturer |
|------------------|--------------------------------------------------------------------------------------------|---------------|
| K061561 | HIP STRUCTURAL ANALYSIS SOFTWARE<br>OPTION FOR THE HOLOGIC QDR X-RAY<br>BONE DENSITOMETERS | HOLOGIC, INC. |
Table 1. Information about Predicate Device
Comparison of the proposed device with the predicate device is summarized in the following table:
| Elements<br>of<br>Comparison | New Device | Predicate Device | Discussion |
|------------------------------|--------------------------------------|--------------------------------------------------------------------------------------------------------------------|------------|
| | 3D-SHAPER<br>(3D-SHAPER MEDICAL S.L) | Hip Structural Analysis (HSA)<br>Software Option for the Hologic<br>QDR X-Ray Bone Densitometers<br>(Hologic, Inc) | |
| Regulatory Data | | | |
| Regulatory Class | Class II | Class II | Identical |
| Classification<br>name | Bone Densitometer | Bone Densitometer | Identical |
| Regulation<br>Number | 21 CFR 892.1170 | 21 CFR 892.1170 | Identical |
| Product Code | KGI | KGI | Identical |
| FDA Clearance | - | 510(k) cleared: K061561 | - |
| Use | | | |
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| Image: 3D-SHAPER | Section 5 – 510(k) Summary | Doc Ref.: 05 |
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| 3D-SHAPER | 3D-SHAPER | Page 4 of 8 |
| Elements<br>of | New Device | Predicate Device | Discussion |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| Comparison | 3D-SHAPER<br>(3D-SHAPER MEDICAL S.L) | Hip Structural Analysis (HSA)<br>Software Option for the Hologic<br>QDR X-Ray Bone Densitometers<br>(Hologic, Inc) | |
| Indication for Use<br>/ Intended Use | 3D-SHAPER uses data from<br>conventional Dual Energy X-Ray<br>Absorptiometry (DXA) scans to<br>measure the distribution of<br>bone mineral mass at specific<br>cross sections or regions of the<br>hip and allows the physician to<br>estimate structural properties of<br>the hip, such as CSA, CSMI, Z,<br>Buckling Ratio, cortical sBMD,<br>trabecular vBMD and integral<br>vBMD.<br>3D-SHAPER is indicated to be<br>used by qualified medical<br>professionals to assist<br>healthcare professionals in the<br>bone health evaluation &<br>changes, and cannot fully<br>substitute their clinical<br>judgement. | The Hip Structure Analysis<br>(HSA®) for QDR X-ray Bone<br>Densitometers uses data from<br>conventional Dual Energy X-ray<br>Absorptiometry (DXA) scans to<br>measure the distribution of<br>bone mineral mass at specific<br>cross sections of the hip and<br>allows the physician to estimate<br>structural properties of the hip,<br>such as CSA, CSMI, Z and<br>Buckling Ratio. | Similar to<br>Predicate<br>device |
| Technical characteristics | | | |
| General<br>description | Is a software solution to<br>estimate bone mineral<br>distribution and structural<br>properties of the hip. | Is a software solution to<br>estimate bone mineral<br>distribution and structural<br>properties of the hip. | identical |
| Mode of action | Software Solution | Software Solution | Identical |
| Operating System | Windows | Windows | Identical |
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| Image: 3D-SHAPER logo | Section 5 – 510(k) Summary | Doc Ref.: 05 |
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| | 3D-SHAPER | Page 5 of 8 |
| Elements<br>of<br>Comparison | New Device | Predicate Device | Discussion |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| | 3D-SHAPER<br>(3D-SHAPER MEDICAL S.L) | Hip Structural Analysis (HSA)<br>Software Option for the Hologic<br>QDR X-Ray Bone Densitometers<br>(Hologic, Inc) | |
| Principles<br>of<br>operation | Analysis of DXA images | Analysis of DXA images | Identical |
| User Interface | Mouse, Keyboard | Mouse, Keyboard | Identical |
| Target Population | Patients needing a bone health<br>assessment. | Patients needing a bone health<br>assessment. | Identical |
| Anatomical sites | Hip | Hip | Identical |
| Conditions of use | It is intended for exclusive use<br>by professional users. | It is intended for exclusive use<br>by professional users. | Identical |
| | The software is intended to<br>assist healthcare professionals<br>in the bone health evaluation<br>and cannot fully substitute their<br>clinical judgement. | The software is intended to<br>assist healthcare professionals<br>in the bone health evaluation<br>and cannot fully substitute their<br>clinical judgement. | |
| Images supported | Dual<br>Energy<br>X-ray<br>Absorptiometry (DXA) scans<br>from Bone Densitometers | Dual<br>Energy<br>X-ray<br>Absorptiometry (DXA) scans<br>from Bone Densitometers | Identical |
| Image Features | | | |
| Image assessment | By visualization and analysis of<br>the images | By visualization and analysis of<br>the images | Identical |
| Image display and<br>manipulation | - 2D review<br><br>- Pan/zoom; magnify; maximize<br>and minimize; scroll through | - 2D review<br><br>- Adjust window level, contrast<br>and brightness. | Similar<br>to<br>predicate<br>device |
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| Image: 3D-SHAPER logo | Section 5 – 510(k) Summary | Doc Ref.: 05 |
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| 3D-SHAPER | 3D-SHAPER | Page 6 of 8 |
| Elements<br>of | New Device | Predicate Device | Discussion |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| Comparison | 3D-SHAPER<br>(3D-SHAPER MEDICAL S.L) | Hip Structural Analysis (HSA)<br>Software Option for the Hologic<br>QDR X-Ray Bone Densitometers<br>(Hologic, Inc) | |
| | slice stack; adjust window level,<br>contrast and brightness. | | |
| Result<br>visualization | - Numerical | - Numerical | Similar to<br>predicate<br>device |
| | - Graph | - Graph | |
| | - 2D view | - 2D view | |
| | - 3D view | | |
| Export capabilities | - Snapshots as PNG | - Numerical data as a database<br>file | Similar to<br>predicate<br>device |
| | - Numerical data as CSV file | - Study data as an internal file<br>format | |
| | - Study data as an internal file<br>format | - DXA scan as a proprietary file<br>format | |
| | - 3D-Shaper analysis as a<br>proprietary file format | - Report | |
| | - Report | | |
| Performing Bone Analysis | | | |
| | Measure the distribution of<br>bone mineral mass from a 3D<br>image of the hip and allow the<br>physician to estimate structural<br>properties of the hip, such as<br>CSA, CSMI, Z, Buckling Ratio,<br>volumetric bone mineral<br>densities and surface bone<br>mineral density. | Measure the distribution of<br>bone mineral mass from a 2D<br>image of the hip and allows the<br>physician to estimate structural<br>properties of the hip, such as<br>CSA, CSMI, Z and Buckling Ratio. | Similar to<br>predicate<br>device |
Table 2. Comparison of technological characteristics and features - proposed and Predicate device
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| Image: 3D-SHAPER logo<br>3D-SHAPER | Section 5 – 510(k) Summary | Doc Ref.: 05 |
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| | 3D-SHAPER | Page 7 of 8 |
3D-SHAPER software has the same indications for use and similar technological characteristics as the predicate device. Additionally, 3D-SHAPER and its predicate device are a software option to the Bone Densitometer equipment and as such, has the same Regulation Number & Product Code as the predicate device. Both devices proposed the same functionality in terms of Image display and manipulation, results visualization and export capabilities.
A correlation study has been performed to compare structural properties of the hip (such as CSA, CSMI, Z, Buckling Ratio) as well as volumetric bone mineral densities and surface bone mineral density obtained by 3D-SHAPER software and its predicate device. This study involved 740 men and women (94% women) aged 17 to 92 years old that were analysed using both 3D-SHAPER software and its predicate device. Very strong correlation coefficients (r≥0.9) were found between 3D-SHAPER and predicate device measurements for Integral vBMD, Trabecular vBMD, Cortical sBMD, CSA, CSMI and Z. Likewise, strong correlation coefficients (r≥0.7) were found between 3D-SHAPER and predicate device measurements for Buckling Ratio.
Based on this analysis, 3D-SHAPER Medical believes that the new device is considered substantially equivalent to the predicate device in terms of safety or effectiveness.
#### Design and Development of Device ന
Design and development included identification, evaluation and control of potential hazards as per standards ISO 14971 "Medical devices – Application of risk management to medical devices". The software development life-cycle included integration, verification testing and was successfully completed following standard IEC 62304 "Medical device software life-cycle processes" and IEC 82304 "Health software - Part 1: General requirements for product safety".
Additionally, 3D-SHAPER was designed, developed, tested, verified and validated according to documented procedures and specific protocols in line with the following FDA guidance documents:
- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices — May 11, 2005
- Guidance for Off-The-Shelf Software Use in Medical Devices September 27, 2019 .
- Guidance for Industry: Cybersecurity for Networked Medical Devices Containing Off-The-. Shelf (OTS) Software – January 14, 2005
- . General Principles of Software Validation; Final Guidance for Industry and FDA Staff – January 11, 2002.
- Guidance for Design Considerations and Pre-market Submission Recommendations for . Interoperable Medical Devices - September 6, 2017
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| Image: 3D-SHAPER | Section 5 – 510(k) Summary | Doc Ref.: 05 |
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| Image: 3D-SHAPER | 3D-SHAPER | Page 8 of 8 |
- . Guidance for Management of Cybersecurity in Medical Devices - October 18, 2018
#### Performance Bench Testing এ
The Performance Bench testing showed that 3D-SHAPER computing time was lower than two minutes and 30 seconds and software convergence superior to 95%. 3D-SHAPER provides accurate subjectspecific models of the femoral shape and measurements compared to Quantitative Computed Tomography (QCT). Very strong correlations (r) were found between 3D measurements obtained using 3D-SHAPER and QCT for integral vBMD (r=0.96), Cortical sBMD (r=0.95), Trabecular vBMD (r=0.93), CSA (r≥ 0.95), CSMI (r≥ 0.92) and Z (r≥ 0.91) while strong correlations were found for BR (r≥ 0.71). 3D-SHAPER provides precise 3D measurements that can be used to monitor bone changes over time. 3D-SHAPER supports DXA files obtained from GE and Hologic DXA Scanners.
### Clinical Testing ഥ
Safety and performance of the proposed software is based on the software development life-cycle and bench testing. Design & Verification did not require clinical testing.
#### Summary Conclusions റ
Device description, intended use and indications for use for 3D-SHAPER have been identified and established. Results obtained from all performance testing, show fulfilment of the device design specifications, where applicable in accordance with the reference standards.
Specific characteristics, intended use and indications for use of the different system components have been compared with corresponding predicate devices. Results of the comparison indicate the presence of minor differences that we believe do not affect safety and performance.
We therefore believe that all issues regarding safety and performance of the proposed device have been successfully addressed and that the similarity of the device with the established predicates strongly supports the determination of substantial equivalence.
