(260 days)
Not Found
No
The description focuses on calculating a score based on image texture and integrating it with a known risk assessment tool (FRAX). There is no mention of AI/ML techniques like training, testing, or specific algorithms typically associated with these technologies. The performance studies describe clinical validation against existing data and cohorts, not the performance of an AI/ML model.
No
The software aids in diagnosis and risk assessment, and helps monitor treatment effects, but it explicitly states that it does not treat disease or recommend treatment regimens.
Yes
The intended use explicitly states that 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."
Yes
The device is explicitly described as "software provided for use as a complement to both DXA analysis and clinical examination." It processes existing DXA image files and clinical data to calculate scores and fracture risk, without including any hardware components.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- TBS iNsight's function: TBS iNsight analyzes images (DXA scans) of the spine. It does not analyze biological samples taken from the patient.
- Intended Use: The intended use describes the software as a complement to DXA analysis and clinical examination, aiding in the diagnosis of osteoporosis and assessment of fracture risk based on image texture and clinical factors. This is distinct from analyzing biological markers in a sample.
Therefore, while TBS iNsight is a medical device used in diagnosis and risk assessment, it falls under the category of image analysis software rather than 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 diagnose disease, or recommend treatment regimens. Only the health care professional can make these judgments.
Product codes
KGI
Device Description
TBS iNsight is a software provided for use as a complement to to both DXA analysis and clinical examination. It computes the AP spine DXA examination file and calculates the 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.
It provides as an option an assessment of 10-year fracture risk, based on the WHO's FRAX® Tool, after adjustment for the TBS.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DXA
Anatomical Site
antero-posterior spine
Indicated Patient Age Range
Between 40 and 90 years old
Intended User / Care Setting
physician, health care professional
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)
The performance of TBS iNsight was evaluated via clinical studies covering the following:
- Clinical Aspects FRAX adjusted for TBS: TBS is an independent clinical risk factor for fracture and can be used in association with WHO's FRAX® to adjust and improve the FRAX® probability of hip fracture and of major osteoporotic fracture in postmenopausal women and in men. This was demonstrated using 3 published studies and a report provided by the Frax group to Medimaps.
- Clinical Aspects TBS iNstats: TBS iNsight provides a breakdown of the patients DXA exams based on their BMD and TBS values. The fracture risk in each cell has been evaluated based on a cohort of 29,000 Canadian women. Two studies have been used to demonstrate that the TBS categories of fracture risk computed from the Canadian study are applicable to the US population and another study to demonstrate that the TBS values of the population included in the Canadian study are similar to the normal TBS values of the US population.
- Normative data: A US clinical study including Non-Hispanic white US women and men. Non-Hispanic black US women and men and Mexican women and men, aged 20 to 85 years has been conducted. The data provided from the Nhanes IV database, which is the reference database for the US. TBS values obtained for all lumbar vertebral combinations (L1, L2, L3, L4) decreased significantly with age. These decreases seen in lumbar spine TBS reflect the age-related microarchitecture changes at spine.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol often associated with healthcare and medicine.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 29, 2016
Medimaps Group SA % Mr. Christophe Lelong Chief Technical Officer 18, Chemin des Aulx CH-1228 Plan les Ouates SWITZERLAND
Re: K152299
Trade/Device Name: TBS iNsight Regulation Number: 21 CFR 892.1170 Regulation Name: Bone Densitometer Regulatory Class: II Product Code: KGI Dated: March 22, 2016 Received: March 25, 2016
Dear Mr. Lelong:
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. 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D.'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K152299
Device Name TBS iNsight
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)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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Image /page/3/Picture/2 description: The image shows the logo for "medimaps". The logo consists of the word "medimaps" in a sans-serif font, with the letters in black. To the right of the word is a graphic of several squares arranged in a diagonal pattern. The squares are colored in teal and black.
510(K) SUMMARY
This summary of the 510(k) Premarket Notification for the TBS iNsight software is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is : K152299
| Owner: | Medimaps group
Chemin des aulx, 18
1294 Plan les Ouates
Switzerland |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Telephone:
Fax: | + (41) 22 884 86 44
- (41) 22 794 66 65 |
| Contact Person: | Christophe Lelong
Chief Technology Officer
e-mail: clelong@medimapsgroup.com |
| Date Prepared: | April 25, 2016 |
| Device Names: | |
| Trade/Proprietary Name: | TBS iNsight |
| Common or Usual Name: | TBS iNisght® software, and its calibration phantom, for analysis
of bone microarchitecture and osteoporosis management. |
| Device Class | Class II |
| Classification Name:
Product Code: | 21 CFR 892.1170 - Bone Densitometer
KGI |
4
Image /page/4/Picture/0 description: The image contains the logo for Medimaps. The logo consists of the word "medimaps" in a sans-serif font, with the "m" in lowercase. To the right of the word is a graphic element composed of nine small squares arranged in a 3x3 grid. The squares are in two colors: teal and black, with the teal squares forming a diagonal line from the upper left to the lower right of the grid.
DEVICE DESCRIPTION
TBS iNsight is a software provided for use as a complement to to both DXA analysis and clinical examination. It computes the AP spine DXA examination file and calculates the 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.
It provides as an option an assessment of 10-year fracture risk, based on the WHO's FRAX® Tool, after adjustment for the TBS.
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.
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 agematched 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 vears 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.
5
Image /page/5/Picture/0 description: The image shows the logo for Medimaps. The logo consists of the word "medimaps" in a sans-serif font, with the "m" in lowercase and the rest of the letters in lowercase. To the right of the word is a small graphic consisting of nine squares arranged in a 3x3 grid. The squares are colored in a teal and black pattern.
PREDICATE DEVICES
The TBS iNsight software is considered substantially equivalent to FDA cleared predicate devices with regards to both indications for use and technological characteristics. In that both TBS iNsight and its predicate devices provide an assessment of the risk for fracture of patients based on DXA scans.
This predicate devices are Med-Imaps TBS iNsight, cleared under K121716, and GE Lunar FRAX™ 10-year Fracture Risk software option, cleared under K082317.
SUBSTANTIAL EQUIVALENCE
The following table provides a more detailed substantial equivalence discussion :
| Subject Device | Predicate Device 1 | Predicate Device 2 | |
|---|---|---|---|
| Product Name | TBS iNsight | TBS iNsight | GE Lunar FRAX™ 10-year Fracture |
| Risk software option | |||
| Classification | Class II | Identical | Identical |
| Product Code | KGI | Identical | Identical |
| Classification | |||
| Name | Bone Densitometer | Identical | Identical |
| Classification Rule | 21 CFR 892.1170 | Identical | Identical |
| 510(k) | K152299 | K121716 | K082317 |
| Intended 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 | The Med-Imaps TBS iNsight is a
software provided for use as a
complement to a DXA analysis. 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 and fracture risk.
This data 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 | The FRAX™ 10-Year Fracture Risk
software option is an accessory to
currently marketed GE Lunar bone
densitometer devices, which are
intended to estimate the bone mineral
density and body composition (lean and
fat tissue mass) of patients when
medically indicated by their physicians.
This software option is intended to
provide an assessment of 10-year
fracture risk. The option 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
patient's age, sex, country, ethnicity,
height, weight, femur neck BMD T-
score, and the presence or absence of
several risk factors and is computed
using the FRAX™ Fracture Risk
Assessment Tool endorsed by the
World Health Organization (WHO). The
tool has been validated for men and
post-menopausal women between 40
and 90 years old. The output is
provided in a separate screen display
and report that can be viewed or
printed or exported to an optional
physician report generator tool.
The results can be used by a physician
in conjunction with other clinical risk
factors as an aid in the diagnosis of |
| | Subject Device | Predicate Device 1 | Predicate Device 2 |
| Product Name | TBS iNsight | TBS iNsight | GE Lunar FRAX™ 10-year Fracture
Risk software option |
| | osteoporosis and other medical
conditions leading to altered trabecular
bone microarchitecture, and ultimately
in the assessment of fracture risk. | | osteoporosis and medical conditions
leading to reduced bone density, 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. | The TBS score can assist the health
care professional in assessment of
fracture risk and 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. | 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. | |
| Software Level of
concern | Moderate | Identical | Identical |
| Technique | Dual Energy X-ray Absorptiometry
(DXA) | Identical | Identical |
| Input Data | Raw DXA images and patients data | Identical | Identical |
| Measurements
provided | •Lumbar Spine TBS
•TBS T-score and Z-score
•TBS Category of fracture risk: high,
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 or %
probability of a major osteoporotic
fracture (clinical spine, forearm, hip
or shoulder fracture) in the next 10
years | •Lumbar Spine TBS
•Indication of fracture risk based on
the patient's TBS | •Lumbar Spine BMD
•Femur BMD
•BMD T-score and Z-score
•WHO Category of bone loss:
normal, osteopenia (low bone
mass), or osteoporotic
•WHO FRAX™ Estimate of 10-Year
Fracture Risk based on BMD and
clinical risk factors: Indication of %
probability of a hip fracture in the
next 10 years or % probability of a
major osteoporotic fracture (clinical
spine, forearm, hip or shoulder
fracture) in the next 10 years. |
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Image /page/6/Picture/0 description: The image contains the word "medimaps" in bold, black font. To the right of the word is a small, square logo. The logo is made up of nine smaller squares, arranged in a 3x3 grid. The squares are colored in black and teal.
Based on the comparison given above and the discussion of the intended use, technological characteristics, input data and measurements provided by the subject and predicate devices, the subject device is substantially equivalent to the cited predicate devices.
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Image /page/7/Picture/0 description: The image contains the logo for Medimaps. The logo features the word "medimaps" in a sans-serif font, with "medimaps" in lowercase letters. To the right of the wordmark is a stylized graphic composed of small squares arranged in a grid-like pattern. The squares are in two colors: teal and black.
CONFORMITY TO RECOGNISED STANDARDS
TBS iNsight has been developed in accordance with the following product standards & FDA Guidance :
-
- IEC 62304:2006, Medical Device Software: Software Life Cycle Processes
- II. ISO 14971:2007, Medical Devices: Application of Risk Management to Medical Devices
- III. General Principles of Software Validation: Final Guidance for Industry and FDA Staff (2002)
- Guidance for Off-the-Shelf Software Use in Medical Devices (1999) IV.
- V. Guidance for Industry - Cybersecurity for Networked Medical Devices Containing Off-the Shelf (OTS) Software (2005)
PERFORMANCE BENCH TESTING
No new bench testing since K121716.
CLINICAL TESTING
The performance of TBS iNsight was evaluated via clinical studies covering the following :
- Clinical Aspects FRAX adjusted for TBS ● TBS is an independent clinical risk factor for fracture and can be used in association with WHO's FRAX® to adjust and improve the FRAX® probability of hip fracture and of major osteoporotic fracture in postmenopausal women and in men. This was demonstrated using 3 published studies and a report provided by the Frax group to Medimaps.
- Clinical Aspects TBS iNstats ●
TBS iNsight provides a breakdown of the patients DXA exams based on their BMD and TBS values. The fracture risk is each cell has been evaluated based on a cohort of 29,000 Canadian women. Two studies have been used to demonstrate that the TBS categories of fracture risk computed from the Canadian study are applicable to the US population and another study to demonstrate that the TBS values of the population included in the Canadian study are similar to the normal TBS values of the US population.
- Normative data ●
A US clinical study including Non-Hispanic white US women and men. Non-Hispanic black US women and men and Mexican women and men, aged 20 to 85 years has been conducted. The data provided from the Nhanes IV database, which is the reference database for the US. TBS values obtained for all lumbar vertebral combinations (L1, L2, L3, L4) decreased significantly with age. These decreases seen in lumbar spine TBS reflect the age-related microarchitecture changes at spine.
Based on this clinical studies, no new questions arise regarding the safety and effectiveness of this device, which can be considered substantially equivalent to the predicate devices.
CONCLUSION
Medimaps group has demonstrated through the testings that the safety and effectiveness of TBS iNsight is not compromised and that they met all acceptance criteria, demonstrating that it can be considered substantially equivalent to the predicate devices.