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.

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 TBS score can assist the health care professional in monitoring the effect of treatments on patients across time.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the TBS iNsight device, based on the provided text:

Acceptance Criteria and Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in the format requested. However, it describes that the device's performance was evaluated through clinical studies against the predicate devices and known clinical associations. The core acceptance criteria appear to be substantial equivalence to the predicate devices and the demonstration that TBS is a valid clinical risk factor for fracture and can improve FRAX probability estimates.

Implied Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria (Implied)	Reported Device Performance
Clinical Efficacy (TBS)	TBS is an independent clinical risk factor for fracture.	"TBS is an independent clinical risk factor for fracture" was "demonstrated using 3 published studies and a report provided by the Frax group to Medimaps."
Clinical Efficacy (FRAX Adjustment)	TBS 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.	"demonstrated using 3 published studies and a report provided by the Frax group to Medimaps."
Applicability of TBS Categories to US Population	The fracture risk associated with TBS categories (derived from a Canadian cohort) is applicable to the US population.	"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." Additionally, another study demonstrated 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 for US Population	Establishment of normative TBS data for different demographics within the US.	A US clinical study was conducted "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." The data was referenced against the NHANES IV database. The study confirmed that "TBS values obtained for all lumbar vertebral combinations (L1, L2, L3, L4) decreased significantly with age."
Substantial Equivalence	Device is substantially equivalent to predicate devices in intended use, technological characteristics, input data, and measurements.	The filing states: "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." (Predicate devices: Med-Imaps TBS iNsight (K121716) and GE Lunar FRAX™ 10-year Fracture Risk software option (K082317)).
Software Standards & Risk Management	Conformance to recognized standards for medical device software, risk management, and cybersecurity.	Adherence to IEC 62304, ISO 14971, and FDA guidances for software validation, Off-the-Shelf software, and cybersecurity.

Study Details:

Sample Size Used for the Test Set and Data Provenance:
- Clinical Aspects FRAX adjusted for TBS: "3 published studies and a report provided by the Frax group to Medimaps." The specific sample sizes for these studies are not provided in this document. The provenance of these studies is implied to be international given the reference to WHO's FRAX® and the Frax group. The nature (retrospective/prospective) of these studies is not specified.
- Clinical Aspects TBS iNstats:
  - Canadian cohort: "29,000 Canadian women" (retrospective, likely).
  - Studies for US applicability: "Two studies" but their sample sizes are not provided. The provenance is implied to be US for the applicability demonstration.
- 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." The data was "provided from the Nhanes IV database." The specific sample size for this US clinical study is not provided within this summary. NHANES IV data is retrospective/cross-sectional.
Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
The document does not specify the number or qualifications of experts used to establish ground truth for the clinical studies mentioned. It refers to "published studies" and the "Frax group," implying established methodologies and expert involvement, but direct details are missing.
Adjudication Method for the Test Set:
The document does not specify any adjudication methods (e.g., 2+1, 3+1) used for the clinical studies or for establishing ground truth.
Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it provide an effect size for human readers improving with AI vs. without AI assistance. The device is described as a "complement" to DXA analysis and clinical examination, implying assistance but not a direct comparison of human performance with and without the tool.
Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
The document does not explicitly state if a standalone algorithm performance study was done. The focus is on its role as a "complement" to clinical examination and DXA analysis, and its ability to adjust FRAX scores, which inherently involve human interpretation and clinical data.
Type of Ground Truth Used:
The ground truth implicitly used in the clinical studies relates to:
- Fracture events: The studies evaluated the device's ability to predict fracture risk, so actual fracture outcomes (e.g., hip fracture, major osteoporotic fracture) served as ground truth.
- Bone microarchitecture: TBS is described as "related to bone microarchitecture," suggesting that underlying microarchitectural properties (likely measured through other means in the mentioned "published studies") were part of the ground truth for validating the TBS score itself.
- Normative population data: For the normative data study, the "Nhanes IV database" served as the reference for US population TBS values.
Sample Size for the Training Set:
The document does not disclose the sample size used for training the TBS iNsight algorithm. It details evaluation studies, not algorithm development or training specifics.
How the Ground Truth for the Training Set Was Established:
The document does not provide information on how the ground truth for the training set was established, as it does not discuss the training phase of the algorithm.

Summary

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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.

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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

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Indications for Use

510(k) Number (if known) K152299

Device Name TBS iNsight

Indications for Use (Describe)

The TBS score can assist the health care professional in monitoring the effect of treatments on patients across time.

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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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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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 groupChemin des aulx, 181294 Plan les OuatesSwitzerland
Telephone:Fax:	+ (41) 22 884 86 44+ (41) 22 794 66 65
Contact Person:	Christophe LelongChief Technology Officere-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 analysisof bone microarchitecture and osteoporosis management.
Device Class	Class II
Classification Name:Product Code:	21 CFR 892.1170 - Bone DensitometerKGI

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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

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 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 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 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.

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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 FractureRisk software option
Classification	Class II	Identical	Identical
Product Code	KGI	Identical	Identical
ClassificationName	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 foruse as a complement to both DXAanalysis and clinical examination. Itcomputes the antero-posterior spineDXA examination file and calculates ascore (Trabecular Bone Score - TBS)that is compared to those of the age-matched controls. The TBS is derivedfrom the texture of the DXA image andhas been shown to be related to bonemicroarchitecture.TBS iNsight provides as an option anassessment of 10-year fracture risk. Itprovides an estimate of 10-yearprobability of hip fracture and 10-yearprobability of a major osteoporoticfracture (clinical spine, forearm, hip orshoulder fracture). This estimate isbased on the WHO's FRAX® FractureRisk Assessment Tool, after adjustmentfor the TBS. The tool has beenvalidated for Caucasian and Asian menand post-menopausal women between40 and 90 years old.TBS provides information independentof BMD value; it is used as acomplement to the data obtained fromthe DXA analysis and the clinicalexamination (questioning by theclinician about patient history, bioassayof bone resorption markers...).The results can be used by a physicianin conjunction with other clinical riskfactors as an aid in the diagnosis of	The Med-Imaps TBS iNsight is asoftware provided for use as acomplement to a DXA analysis. Itcomputes the antero-posterior spineDXA examination file and calculates ascore (Trabecular Bone Score - TBS)that is compared to those of the age-matched controls. The TBS is derivedfrom the texture of the DXA image andhas been shown to be related to bonemicroarchitecture and fracture risk.This data provides informationindependent of BMD value; it is used asa complement to the data obtainedfrom the DXA analysis and the clinicalexamination (questioning by theclinician about patient history, bioassayof bone resorption markers...).The results can be used by a physicianin conjunction with other clinical riskfactors as an aid in the diagnosis of	The FRAX™ 10-Year Fracture Risksoftware option is an accessory tocurrently marketed GE Lunar bonedensitometer devices, which areintended to estimate the bone mineraldensity and body composition (lean andfat tissue mass) of patients whenmedically indicated by their physicians.This software option is intended toprovide an assessment of 10-yearfracture risk. The option provides anestimate of 10-year probability of hipfracture and 10-year probability of amajor osteoporotic fracture (clinicalspine, forearm, hip or shoulderfracture). This estimate is based on thepatient's age, sex, country, ethnicity,height, weight, femur neck BMD T-score, and the presence or absence ofseveral risk factors and is computedusing the FRAX™ Fracture RiskAssessment Tool endorsed by theWorld Health Organization (WHO). Thetool has been validated for men andpost-menopausal women between 40and 90 years old. The output isprovided in a separate screen displayand report that can be viewed orprinted or exported to an optionalphysician report generator tool.The results can be used by a physicianin conjunction with other clinical riskfactors 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 FractureRisk software option
	osteoporosis and other medicalconditions leading to altered trabecularbone microarchitecture, and ultimatelyin the assessment of fracture risk.		osteoporosis and medical conditionsleading to reduced bone density, andultimately in the assessment of fracturerisk.
	The TBS score can assist the healthcare professional in monitoring theeffect of treatments on patients acrosstime.	The TBS score can assist the healthcare professional in assessment offracture risk and in monitoring the effectof treatments on patients across time.
	Overall fracture risk will depend onmany additional factors that should beconsidered before making diagnostic ortherapeutic recommendations. Thesoftware does not diagnose disease, orrecommend treatment regimens. Onlythe health care professional can makethese judgments.	Overall fracture risk will depend onmany additional factors that should beconsidered before making diagnostic ortherapeutic recommendations. Thesoftware does not diagnose disease, orrecommend treatment regimens. Onlythe health care professional can makethese judgments.
Software Level ofconcern	Moderate	Identical	Identical
Technique	Dual Energy X-ray Absorptiometry(DXA)	Identical	Identical
Input Data	Raw DXA images and patients data	Identical	Identical
Measurementsprovided	•Lumbar Spine TBS•TBS T-score and Z-score•TBS Category of fracture risk: high,medium, or low•FRAX® Adjusted for TBS Estimateof 10-Year Fracture Risk based onclinical risk factors, BMD and TBS:Indication of % probability of a hipfracture in the next 10 years or %probability of a major osteoporoticfracture (clinical spine, forearm, hipor shoulder fracture) in the next 10years	•Lumbar Spine TBS•Indication of fracture risk based onthe patient's TBS	•Lumbar Spine BMD•Femur BMD•BMD T-score and Z-score•WHO Category of bone loss:normal, osteopenia (low bonemass), or osteoporotic•WHO FRAX™ Estimate of 10-YearFracture Risk based on BMD andclinical risk factors: Indication of %probability of a hip fracture in thenext 10 years or % probability of amajor osteoporotic fracture (clinicalspine, forearm, hip or shoulderfracture) 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 :

1. 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.

Regulation Number and Section

§ 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.