(105 days)
Not Found
No
The description focuses on image processing techniques (variogram, fractal-like approach) and statistical adjustments based on device and scan mode, not AI/ML algorithms. There is no mention of training or test sets for model development.
No
The device is a diagnostic tool that calculates a score to assess bone health and fracture risk; it does not provide any therapeutic function.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The results can be used by a physician in conjunction with other clinical risk factors as an aid in the diagnosis of osteoporosis and other medical conditions leading to altered trabecular bone microarchitecture, and ultimately in the assessment of fracture risk." This indicates its role in aiding diagnosis.
Yes
The device is described as a "software application" that processes images acquired from a separate hardware device (DXA system). It does not include any hardware components itself.
Based on the provided information, TBS iNsight is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- TBS iNsight's Function: TBS iNsight analyzes images acquired from a DXA system (Dual Energy X-ray Absorptiometry). It processes these images to calculate a score related to bone texture and microarchitecture. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it's a "software provided for use as a complement to both DXA analysis and clinical examination." It aids in the diagnosis and assessment of fracture risk based on image analysis and clinical factors, not through the analysis of in vitro samples.
Therefore, while TBS iNsight is a medical device used in the diagnostic process, it falls under the category of image processing software or a medical image analysis device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
TBS iNsight is a software provided for use as a complement to both DXA analysis and clinical examination. It computes the antero-posterior spine DXA examination file and calculates a score (Trabecular Bone Score - TBS) that is compared to those of the age matched controls. The TBS is derived from the texture of the DXA image and has been shown to be related to bone microarchitecture.
TBS iNsight provides as an option an assessment of 10-year fracture risk. It provides an estimate of 10-year probability of hip fracture and 10-year probability of a major osteoporotic fracture (clinical spine, forearm, hip or shoulder fracture). This estimate is based on the WHO's FRAX® Fracture Risk Assessment Tool, after adjustment for the TBS. The tool has been validated for Caucasian and Asian men and post-menopausal women between 40 and 90 years old.
TBS provides information independent of BMD value: it is used as a complement to the data obtained from the DXA analysis and the clinical examination (questioning by the clinician about patient history, bioassay of bone resorption markers...).
The results can be used by a physician in conjunction with other clinical risk factors as an aid in the diagnosis of osteoporosis and other medical conditions leading to altered trabecular bone microarchitecture, and ultimately in the assessment of fracture risk.
The TBS score can assist the health care professional in monitoring the effect of treatments on patients across time. Overall fracture risk will depend on many additional factors that should be considered before making diagnostic or therapeutic recommendations. The software does not disease or recommend treatment regimens. Only the health care professional can make these judgments.
Product codes
KGI
Device Description
TBS iNsight is a software application provided for use as a complement to bone mineral density (BMD) acquired from dual energy X-ray absorptiometry (DXA) and other clinical risk factors for osteoporosis and fragility fracture. It calculates a score (Trabecular Bone Score - TBS) derived from the texture of the DXA image of the anterior-posterior (AP) lumbar spine and has been shown to be related to bone microarchitecture. The method analyzes X-ray based images acquired by DXA imaging systems and produces the TBS based on the computation of an Adapted Experimental Variogram (modified fractallike approach). This variogram is used to measure the degree of spatial variation between pairs of data points in a spatial dimension of a region of a digital image.
The absolute TBS values for the same equivalent tissue thickness vary slightly between GE and Hologic systems. Additionally, within each system, variability in TBS values can be observed across different scan modes. To address these differences, corrections are applied that are both device-specific and mode-specific. For instance, TBS is corrected differently for GE and Hologic systems to account for inherent differences in tissue thickness assessment. Furthermore, corrections are also tailored separately for each scan mode within the same system, ensuring that TBS measurements remain consistent and reliable regardless of the scan mode used. These device-specific and mode-specific corrections are necessitated by differences in the dynamic range of tissue thickness measurements between GE and Hologic devices. The variations arise due to differences in the methodologies used to assess tissue thickness. To harmonize these discrepancies and ensure measurement accuracy, correction fits derived from ex-vivo data are applied individually to each device and scan mode. This approach ensures the accuracy and consistency of TBS measurements across all configurations.
The device is intended to be used for bone health assessment in medical facilities employing one or more DXA system(s) to which the subject device is connected. These facilities are usually hospitals, clinics, healthcare centers, radiology practices and medical imaging centers. The software is designed to be used by qualified clinical professionals (including physicians, radiologists and DXA technicians) and the physicians are solely responsible for making all final patient management decisions.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Dual Energy X-ray Absorptiometry (DXA)
Anatomical Site
Antero-posterior spine / Lumbar Spine
Indicated Patient Age Range
The intended patient population for TBS iNsight comprises both men and women, with its purpose for the assessment of bone health and fracture risk. Currently, TBS has not been validated for individuals younger than 20 years of age.
The intended patient population for FRAX-adjusted by TBS are Caucasian and Asian men and women between 40 and 90 years old, for 10-year fracture risk assessment.
Intended User / Care Setting
Qualified clinical professionals (including physicians, radiologists and DXA technicians).
Medical facilities employing one or more DXA system(s) to which the subject device is connected. These facilities are usually hospitals, clinics, healthcare centers, radiology practices and medical imaging centers.
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
Standalone Performance Testing Summary:
The primary advancement in TBS version 4.0 is the replacement of BMI-based adjustments with direct measurement of tissue thickness from DXA scan images. A series of validation studies confirm the performance, accuracy, and reproducibility of TBS version 4.0 compared to the predicate device.
Software Verification and Validation demonstrate specified requirements are met and the software functions as intended. Cybersecurity controls and processes have been implemented to ensure the software and related systems are cybersecurity documentation and testing demonstrates the software, and related systems are in alignment with the recommendations in the "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions" guidance as well as the requirements of Section 524B of the FD&C Act.
Clinical Association:
Study 1: Evaluated the correlation between TBS values and bone microarchitecture parameters using 30 human cadaver lumbar vertebrae. Micro-computed tomography (microCT) measurements were compared to TBS values, revealing strong and statistically significant correlations with parameters such as trabecular number and separation. The study concluded that TBS version 4.0 maintained or exceeded the correlations established with the predicate, ensuring its validity in reflecting bone microarchitecture.
Study 2: Examined the agreement between TBS version 4.0 and the predicate software using 15 human cadaver vertebrae. Measurements were performed on multiple DXA systems, and the analysis showed excellent agreement, with correlation coefficients exceeding 0.99. Bland-Altman statistics confirmed negligible differences between versions, supporting the consistency and reliability of TBS version 4.0 across different DXA platforms.
Analytical Reproducibility:
Ex vivo study: Measurements from dried human lumbar vertebrae demonstrated that TBS version 4.0 provides precision and least significant change (LSC) values that are comparable to or slightly improved over those of the predicate. These results were consistent across various DXA systems.
In vivo testing: Involved 132 participants scanned on four different DXA systems. The analysis included repositioning between scans to assess precision and reproducibility under clinical conditions. Results showed that TBS version 4.0 met or exceeded precision standards established by the International Society for Clinical Densitometry (ISCD), with LSC values within acceptable thresholds. This level of precision helps to support the utility of TBS version 4.0 to assist physicians in monitoring bone health over time.
Performance and Utility:
Direct measurements of tissue thickness were validated in-vivo, establishing a valid tissue thickness range of 7-30 cm, aligning with physiological parameters relevant to TBS calculations.
Population-specific reference curves for age, sex, and ethnicity were generated, demonstrating the applicability of TBS version 4.0 across diverse demographic groups, including multi-ethnic populations in the United States. Comparisons with the predicate software confirmed statistical equivalence.
For fracture risk assessment, data from over 17,000 individuals across 14 international cohorts were analyzed to compare the performance of TBS-adjusted FRAX and BMD T-scores using the updated software. TBS version 4.0 demonstrated similar TBS-adjusted FRAX and BMD T-scores for major osteoporotic and hip fractures than the predicate.
Additionally, data from a large cohort of postmenopausal women with osteoporosis demonstrated the effectiveness of TBS version 4.0 for accurately outputting TBS-adjusted FRAX and BMD T-scores for major osteoporotic and hip fractures over time in order to assist physicians with treatment monitoring, with substantial equivalence to the predicate.
Key Metrics
Correlation coefficients exceeding 0.99 (between TBS version 4.0 and predicate software).
Valid tissue thickness range of 7-30 cm.
Precision and least significant change (LSC) values comparable to or slightly improved over the predicate, and meeting or exceeding ISCD standards.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1170 Bone densitometer.
(a)
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.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 17, 2025
Medimaps Group SA % Giorgio Zoia Quality and Regulatory VP, Medimaps SA Group Chemin du Champ-des-Filles 36 Plan-les-Ouates, 1228 SWITZERLAND
Re: K243218
Trade/Device Name: TBS iNsight (V4) Regulation Number: 21 CFR 892.1170 Regulation Name: Bone Densitometer Regulatory Class: Class II Product Code: KGI Dated: December 20, 2024 Received: December 20, 2024
Dear Giorgio Zoia:
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.
1
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).
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 QS 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-regulatory
2
assistance/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
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
3
Indications for Use
510(k) Number (if known) K243218
Device Name TBS iNsight (v4)
Indications for Use (Describe)
TBS iNsight is a software provided for use as a complement to both DXA analysis and clinical examination. It computes the antero-posterior spine DXA examination file and calculates a score (Trabecular Bone Score - TBS) that is compared to those of the age matched controls. The TBS is derived from the texture of the DXA image and has been shown to be related to bone microarchitecture.
TBS iNsight provides as an option an assessment of 10-year fracture risk. It provides an estimate of 10-year probability of hip fracture and 10-year probability of a major osteoporotic fracture (clinical spine, forearm, hip or shoulder fracture). This estimate is based on the WHO's FRAX® Fracture Risk Assessment Tool, after adjustment for the TBS. The tool has been validated for Caucasian and Asian men and post-menopausal women between 40 and 90 years old.
TBS provides information independent of BMD value: it is used as a complement to the data obtained from the DXA analysis and the clinical examination (questioning by the clinician about patient history, bioassay of bone resorption markers...).
The results can be used by a physician in conjunction with other clinical risk factors as an aid in the diagnosis of osteoporosis and other medical conditions leading to altered trabecular bone microarchitecture, and ultimately in the assessment of fracture risk.
The TBS score can assist the health care professional in monitoring the effect of treatments on patients across time. Overall fracture risk will depend on many additional factors that should be considered before making diagnostic or therapeutic recommendations. The software does not disease or recommend treatment regimens. Only the health care professional can make these judgments.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | 区 |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
510(K) SUMMARY
| Date: | January 16, 2025 |
|---|---|
| ------- | ------------------ |
510(k) Number: K243218
1) Applicant Information
| 510(k) Owner: | Medimaps Group SA |
|---|---|
| Chemin du Champ-des-Filles 36 Plan-les- | |
| Ouates | |
| 1228 Switzerland | |
| Contact Person: | Giorgio Zoia, PhD |
| Quality and Regulatory VP | |
| Phone 41 22 515 01 14 | |
| Email regulatory@medimapsgroup.com |
-
- Device Identification
| Trade Name: | TBS iNsight (V4) |
|---|---|
| Common Name: | Bone densitometer |
| Regulation Number : | 892.1170 |
| Regulation Name: | Bone densitometer |
| Regulatory Class: | II |
KGI
3) Predicate Device
Product Code:
| Trade Name: | TBS iNsight |
|---|---|
| 510 (k) Number: | K152299 |
| Common Name: | Bone densitometer |
| Regulation Number : | 892.1170 |
| Regulation Name: | Bone densitometer |
| Regulatory Class: | ============================================================================================================================================================================== |
| Product Code: | KGI |
5
Device Description Summary
TBS iNsight is a software application provided for use as a complement to bone mineral density (BMD) acquired from dual energy X-ray absorptiometry (DXA) and other clinical risk factors for osteoporosis and fragility fracture. It calculates a score (Trabecular Bone Score - TBS) derived from the texture of the DXA image of the anterior-posterior (AP) lumbar spine and has been shown to be related to bone microarchitecture. The method analyzes X-ray based images acquired by DXA imaging systems and produces the TBS based on the computation of an Adapted Experimental Variogram (modified fractallike approach). This variogram is used to measure the degree of spatial variation between pairs of data points in a spatial dimension of a region of a digital image.
The absolute TBS values for the same equivalent tissue thickness vary slightly between GE and Hologic systems. Additionally, within each system, variability in TBS values can be observed across different scan modes. To address these differences, corrections are applied that are both device-specific and mode-specific. For instance, TBS is corrected differently for GE and Hologic systems to account for inherent differences in tissue thickness assessment. Furthermore, corrections are also tailored separately for each scan mode within the same system, ensuring that TBS measurements remain consistent and reliable regardless of the scan mode used. These device-specific and mode-specific corrections are necessitated by differences in the dynamic range of tissue thickness measurements between GE and Hologic devices. The variations arise due to differences in the methodologies used to assess tissue thickness. To harmonize these discrepancies and ensure measurement accuracy, correction fits derived from ex-vivo data are applied individually to each device and scan mode. This approach ensures the accuracy and consistency of TBS measurements across all configurations.
The device is intended to be used for bone health assessment in medical facilities employing one or more DXA system(s) to which the subject device is connected. These facilities are usually hospitals, clinics, healthcare centers, radiology practices and medical imaging centers. The software is designed to be used by qualified clinical professionals (including physicians, radiologists and DXA technicians) and the physicians are solely responsible for making all final patient management decisions.
Intended Use
TBS iNsight is indicated as an adjunct to BMD and other clinical factors, for the assessment of bone health and the management of primary and secondary osteoporosis. Primary osteoporosis can occur in both sexes with aging, and in females due to the menopause and associated estrogen deficiency. Secondary osteoporosis occurs as a result of an underlying disease or condition, which alters bone metabolism leading to a net loss of bone and degradation of bone quality, for example, diabetes, hyperparathyroidism, chronic kidney disease and rheumatological conditions.
Indication for Use
TBS iNsight is a software provided for use as a complement to both DXA analysis and clinical examination. It computes the antero-posterior spine DXA examination file and calculates a score (Trabecular Bone Score - TBS) that is compared to those of the age matched controls. The TBS is derived from the texture of the DXA image and has been shown to be related to bone microarchitecture.
TBS iNsight provides as an option an assessment of 10-year fracture risk. It provides an estimate of 10year probability of hip fracture and 10-year probability of a major osteoporotic fracture (clinical spine, forearm, hip or shoulder fracture). This estimate is based on the WHO's FRAX® Fracture Risk
6
Assessment Tool, after adjustment for the TBS. The tool has been validated for Caucasian and Asian men and post-menopausal women between 40 and 90 years old.
TBS provides information independent of BMD value; it is used as a complement to the data obtained from the DXA analysis and the clinical examination (questioning by the clinician about patient history, bioassay of bone resorption markers...).
The results can be used by a physician in conjunction with other clinical risk factors as an aid in the diagnosis of osteoporosis and other medical conditions leading to altered trabecular bone microarchitecture, and ultimately in the assessment of fracture risk.
The TBS score can assist the health care professional in monitoring the effect of treatments on patients across time.
Overall fracture risk will depend on many additional factors that should be considered before making diagnostic or therapeutic recommendations. The software does not diagnose disease or recommend treatment regimens. Only the health care professional can make these judgments.
Technological Comparison
The subject device, TBS iNsight V4, has been designed to maintain identical core functionalities as its predicate, specifically in the computation of Trabecular Bone Score (TBS) from DXA (Dual-energy X-ray Absorptiometry) image texture and the provision of complementary DXA analysis. TBS iNsight V4 and the predicate compute TBS from DXA image textures and provide complementary DXA analysis, ensuring continuity in the primary operational utility of the technology.
Differences:
-
Algorithm for Tissue Thickness: Unlike the predicate device which uses BMI to estimate tissue thickness in its TBS computation algorithm, the subject device directly measures tissue thickness (TT) using the DXA system. This direct measurement potentially increases the accuracy of TBS calculations.
-
System Architecture: The system architecture of the subject device represents an evolution from the standalone software model used in the predicate. The subject device includes a two-component system comprising a TBS Agent (client) installed on each DXA device and a centralized server that manages results and facilitates DICOM communication with PACS. This advancement supports enhanced scalability and integration within clinical settings.
-
Data Security: TBS iNsight V4 introduces robust encryption protocols by incorporating encryption or role-based access control, aligning the new device with current best practices in data security.
Table 1. Substantial equivalence of TBS iNsight v4 to predicate device
| Elements of
Comparison | Subject device | Predicate Device | Comparison
to predicate
device |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| Device Name | TBS iNsight | TBS iNsight | Unchanged |
| Software Version | 4 | 3 | Updated |
| Manufacturer | Medimaps | Medimaps | Unchanged |
| 510(k) # | K243218 | K152299 | N/A |
| Class | Class II | Class II | Unchanged |
| Elements of
Comparison | Subject device | Predicate Device | Comparison
to predicate
device |
| Classification Rule /
Name | 21 CFR 892.1170 Bone Densitometer | 21 CFR 892.1170 Bone Densitometer | Unchanged |
| Product Code | KGI | KGI | Unchanged |
| Level of Concern | Basic Documentation | Moderate | Unchanged |
| Intended Use | TBS is indicated as an aid, in conjunction with other
clinical factors, for the diagnosis of primary and
secondary osteoporosis. Primary osteoporosis can occur
in both sexes with ageing, and in women due to the
menopause and associated estrogen deficiency.
Secondary osteoporosis occurs as a result of an
underlying disease or condition, which alters bone
metabolism leading to a net loss of bone and degradation
of bone quality, for example, diabetes,
hyperparathyroidism, chronic kidney disease and
rheumatological conditions. | TBS is indicated as an aid, in conjunction with other
clinical factors, for the diagnosis of primary and
secondary osteoporosis. Primary osteoporosis can occur
in both sexes with ageing, and in women due to the
menopause and associated estrogen deficiency.
Secondary osteoporosis occurs as a result of an
underlying disease or condition, which alters bone
metabolism leading to a net loss of bone and degradation
of bone quality, for example, diabetes,
hyperparathyroidism, chronic kidney disease and
rheumatological conditions. | Unchanged |
| Indications for Use | TBS iNsight is a software provided for use as a
complement to both DXA analysis and clinical
examination. It computes the antero-posterior spine DXA
examination file and calculates a score (Trabecular Bone
Score - TBS) that is compared to those of the age
matched controls. The TBS is derived from the texture of
the DXA image and has been shown to be related to bone
microarchitecture.
TBS iNsight provides as an option an assessment of 10-
year fracture risk. It provides an estimate of 10-year
probability of hip fracture and 10-year probability of a
major osteoporotic fracture (clinical spine, forearm, hip
or shoulder fracture). This estimate is based on the
WHO'S FRAX® Fracture Risk Assessment Tool, after
adjustment for the TBS. The tool has been validated for
Caucasian and Asian men and post-menopausal women
between 40 and 90 years old.
TBS provides information independent of BMD value; it is
used as a complement to the data obtained from the DXA
analysis and the clinical examination (questioning by the
clinician about patient history, bioassay of bone
resorption markers...).
The results can be used by a physician in conjunction with
other clinical risk factors as an aid in the diagnosis of
osteoporosis and other medical conditions leading to
altered trabecular bone microarchitecture, and ultimately
in the assessment of fracture risk.
The TBS score can assist the health care professional in
monitoring the effect of treatments on patients across
time.
Overall fracture risk will depend on many additional
factors that should be considered before making
diagnostic or therapeutic recommendations. The
software does not diagnose disease or recommend
treatment regimens. Only the health care professional
can make these judgments. | TBS iNsight is a software provided for use as a
complement to both DXA analysis and clinical
examination. It computes the antero-posterior spine DXA
examination file and calculates a score (Trabecular Bone
Score - TBS) that is compared to those of the age
matched controls. The TBS is derived from the texture of
the DXA image and has been shown to be related to bone
microarchitecture.
TBS iNsight provides as an option an assessment of 10-
year fracture risk. It provides an estimate of 10-year
probability of hip fracture and 10-year probability of a
major osteoporotic fracture (clinical spine, forearm, hip
or shoulder fracture). This estimate is based on the
WHO'S FRAX® Fracture Risk Assessment Tool, after
adjustment for the TBS. The tool has been validated for
Caucasian and Asian men and post-menopausal women
between 40 and 90 years old.
TBS provides information independent of BMD value; it is
used as a complement to the data obtained from the DXA
analysis and the clinical examination (questioning by the
clinician about patient history, bioassay of bone
resorption markers...).
The results can be used by a physician in conjunction with
other clinical risk factors as an aid in the diagnosis of
osteoporosis and other medical conditions leading to
altered trabecular bone microarchitecture, and ultimately
in the assessment of fracture risk.
The TBS score can assist the health care professional in
monitoring the effect of treatments on patients across
time.
Overall fracture risk will depend on many additional
factors that should be considered before making
diagnostic or therapeutic recommendations. The
software does not diagnose disease or recommend
treatment regimens. Only the health care professional
can make these judgements. | Unchanged |
| Technological Characteristics | | | |
| Mode of operation | Dual Energy X-ray Absorptiometry | Dual Energy X-ray Absorptiometry | Unchanged |
| Input data | Raw DXA images and patient data | Raw DXA images and patient data | Unchanged |
| Measurements
provided | Lumbar Spine TBS | Lumbar Spine TBS | Unchanged |
| Elements of
Comparison | Subject device | Predicate Device | Comparison
to predicate
device |
| | TBS T-Score and Z-score
TBS Category of fracture risk: normal, medium,
or low
FRAX® Adjusted for TBS Estimate of 10-Year
Fracture Risk based on clinical risk factors, BMD
and TBS; indication of % probability of a hip
fracture in the next 10 years and % probabilityof a major osteoporotic fracture (clinical spine,
forearm, hip or shoulder fracture) in the next 10
years. | TBS T-Score and Z-score
TBS Category of fracture risk: normal, medium,
or low
FRAX® Adjusted for TBS Estimate of 10-Year
Fracture Risk based on clinical risk factors, BMD
and TBS; indication of % probability of a hip
fracture in the next 10 years and % probability
of a major osteoporotic fracture (clinical spine,
forearm, hip or shoulder fracture) in the next 10
years. | |
| Target population | The intended patient population for TBS iNsight
comprises both men and women, with its purpose for the
assessment of bone health and fracture risk. Currently,
TBS has not been validated for individuals younger than
20 years of age.
The intended patient population for FRAX-adjusted by
TBS are Caucasian and Asian men and women between
40 and 90 years old, for 10-year fracture risk assessment. | The intended patient population for TBS iNsight
comprises both men and women, with its purpose for the
assessment of bone health and fracture risk. Currently,
TBS has not been validated for individuals younger than
20 years of age.
The intended patient population for FRAX-adjusted by
TBS are Caucasian and Asian men and women between
40 and 90 years old, for 10-year fracture risk assessment. | Unchanged |
| Users | DXA technologists, Physicians, Radiologists | DXA technologists, Physicians, Radiologists | Unchanged |
| DXA manufacturer
supported | GE HC, Hologic | GE HC, Hologic | Unchanged |
| Segmentation | Automatic ROI segmentation, possibly corrected
manually | Automatic ROI segmentation, possibly corrected
manually | Unchanged |
| Functionality | Computes TBS from DXA image texture.
Outputs complement DXA analysis. | Computes TBS from DXA image texture.
Outputs complement DXA analysis. | Unchanged |
| -Algorithm for Tissue
Thickness | Directly uses tissue thickness (TT) measured by the DXA,
in the TBS computation algorithm. | Uses BMI to estimate tissue thickness (TT) in the TBS
computation algorithm. | Updated |
| -System Architecture | -Two components: TBS Agent (client) installed on each
DXA and a centralized server that manages results and
DICOM communication with PACS. | Standalone software installed on the DXA system,
capable of communicating with PACS. | Updated |
| Data security | Implements encryption for data at rest and in transit, as
well as role-based access control to enhance
cybersecurity. | No encryption or role-based access control. | Updated |
Substantial Equivalence
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Performance Testing Summary & Conclusions
Standalone Performance Testing Summary
The primary advancement in TBS version 4.0 is the replacement of BMI-based adjustments with direct measurement of tissue thickness from DXA scan images. A series of validation studies confirm the performance, accuracy, and reproducibility of TBS version 4.0 compared to the predicate device.
Software Verification and Validation demonstrate specified requirements are met and the software functions as intended. Cybersecurity controls and processes have been implemented to ensure the software and related systems are cybersecurity documentation and testing demonstrates the software, and related systems are in alignment with the recommendations in the "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions" guidance as well as the requirements of Section 524B of the FD&C Act.
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Clinical Association
Two pivotal studies validated the ability of TBS version 4.0 to accurately reflect bone microarchitecture. The first study evaluated the correlation between TBS values and bone microarchitecture parameters using 30 human cadaver lumbar vertebrae. Micro-computed tomography (microCT) measurements were compared to TBS values, revealing strong and statistically significant correlations with parameters such as trabecular number and separation. The results demonstrated that TBS version 4.0 maintained or exceeded the correlations established with the predicate, ensuring its validity in reflecting bone microarchitecture.
The second study examined the agreement between TBS version 4.0 and the predicate software using 15 human cadaver vertebrae. Measurements were performed on multiple DXA systems, and the analysis showed excellent agreement, with correlation coefficients exceeding 0.99. Bland-Altman statistics confirmed negligible differences between versions, supporting the consistency and reliability of TBS version 4.0 across different DXA platforms.
Analytical Reproducibility
The reproducibility of TBS measurements with version 4.0 was evaluated in both ex vivo and in vivo settings. In the ex vivo study, measurements from dried human lumbar vertebrae demonstrated that TBS version 4.0 provides precision and least significant change (LSC) values that are comparable to or slightly improved over those of the predicate. These results were consistent across various DXA systems.
In vivo testing involved 132 participants scanned on four different DXA systems. The analysis included repositioning between scans to assess precision and reproducibility under clinical conditions. Results showed that TBS version 4.0 met or exceeded precision standards established by the International Society for Clinical Densitometry (ISCD), with LSC values within acceptable thresholds. This level of precision helps to support the utility of TBS version 4.0 to assist physicians in monitoring bone health over time.
Performance and Utility
The performance and utility of TBS version 4.0 were evaluated across diverse scenarios, including fracture risk assessment, population-specific reference curves, and monitoring treatment responses. A key advancement of the software is the transition from BMI-based adjustments to direct measurements of tissue thickness. This was validated in-vivo, establishing a valid tissue thickness range of 7-30 cm, which aligns with the physiological parameters relevant to TBS calculations.
The generation of population-specific reference curves for age, sex, and ethnicity demonstrated the applicability of TBS version 4.0 across diverse demographic groups, including multi-ethnic populations in the United States. Comparisons with the predicate software confirmed statistical equivalence, reinforcing the reliability of the subject device in representing bone health across different populations.
For fracture risk assessment, data from over 17,000 individuals across 14 international cohorts were analyzed to compare the performance of TBS-adjusted FRAX and BMD T-scores using the updated software. TBS version 4.0 demonstrated similar TBS-adjusted FRAX and BMD T-scores for major osteoporotic and hip fractures than the predicate.
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Additionally, data from a large cohort of postmenopausal women with osteoporosis, demonstrated the effectiveness of TBS version 4.0 for accurately outputting TBS-adjusted FRAX and BMD T-scores for major osteoporotic and hip fractures over time in order to assist physicians with treatment monitoring, with substantial equivalence to the predicate.
Conclusion
TBS version 4.0 demonstrates substantially equivalent performance in the assessment of bone quality and TBS-adjusted FRAX and BMD T-scores. Standalone validation studies confirm the performance, reliability, and utility of the updated software across diverse populations and DXA systems