The BMDus Index is a clinical measure based on ultrasound variables of the forearm which is highly correlated with the value of BMD of the 1/3 radius as provided by DXA, with a standard error of the estimate of 0.041 grams/cm2.

BMDus Index is expressed in grams/cm² and as a T- and z-score, derived from comparison to a normative x-ray absorptiometry reference database.

BMD 15 Index has a precision comparable to that of x-ray absorptiometry, which makes it suitable for monitoring bone changes in postmenopausal women.

Device Description

The UltraScan 650 is an ultrasound device that is designed to non-invasively and quantitatively assess the amount of bone at the 1/3 location of the radius in the forearm of an individual.

The UltraScan 650, with a user-supplied laptop, is designed for the estimation of bone mineral density (BMD in g/cm²) of the radius at the 1/3 location. The UltraScan 650 outputs a BMD is Index an estimate of the BMD that would be measured by dual-energy X-ray absorptiometry (DXA) at the same anatomical location, that is, an estimate of BMDDXA, at the 1/3 radius. The UltraScan 650 also outputs the T-score in standard deviations (SD) and Z-score in SD as well. The precision of the measurement is 2.1%, when expressed as a coefficient of variation. The range of the output of the UltraScan 650, depends on the subjects that are measured. However, based on the normative (reference) data, we can calculate the range that will include 99.85% of all subjects.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the UltraScan 650, based on the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a formal, quantifiable list. However, based on the performance comparisons made to establish substantial equivalence, we can infer the key performance metrics and the reported results for the UltraScan 650. The primary goal is to correlate with DXA measurements and demonstrate comparable precision.

Acceptance Criteria (Inferred from comparison to references)	Reported Device Performance (UltraScan 650)
Correlation to BMD (DXA)	0.93 (against Hologic QDR 4500, K023398)
Precision	2.1% (expressed as a coefficient of variation)
Measurement Time	15 seconds
Ability to determine BMDus Index	Confirmed
Ability to assess appendicular fracture risk	Confirmed
Express BMDus Index as T- and z-score	Confirmed
Use of normative x-ray absorptiometry reference database	Yes (Hologic 1/3 radius adult white females and males, K023398 / K103265)
Electrical Safety (IEC 60601-1)	Compliant
EMC (IEC 60601-1-2)	Compliant
Acoustic Output	Max acoustic output, pulse intensity integrals, pulse total energy, pulse duration, pulse repetition rate, pulse average intensity, time average intensity, acoustic signal center frequency, beam total power all tested. Specific values not provided in this summary, but implied acceptable.

2. Sample Size Used for the Test Set and Data Provenance

The document provides limited detail on specific sample sizes for each clinical test. It mentions a "broader population" for patient population discussions and multiple "data sets."

Sample Size for Test Set: Not explicitly stated as a single number.
Data Provenance: The document generally refers to "Clinical Data" without specifying country of origin or whether it's retrospective or prospective. Given the FDA submission, it's likely the data were gathered for this submission. The reference database used is "Hologic 1/3 radius adult white females and males, K023398 / K103265," which suggests a US-centric or internationally recognized normative database.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The ground truth relies on DXA measurements, which are considered the "gold standard," but no details are given about the experts who performed or interpreted these DXA scans or established the ground truth.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If so, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

This device, the UltraScan 650, is a bone sonometer and not an AI-assisted diagnostic imaging interpretation tool for human readers. Therefore, an MRMC comparative effectiveness study involving human reader improvement with or without AI assistance is not applicable and was not performed. The device provides a direct measurement (BMDus Index) rather than assisting human interpretation of complex images.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the very nature of the UltraScan 650 is a standalone device. It's an "ultrasound device that is designed to non-invasively and quantitatively assess the amount of bone at the 1/3 location of the radius." It outputs a BMDus Index, T-score, and Z-score directly. There is no mention of a human-in-the-loop component for its primary function of generating these measurements.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The primary ground truth used for comparison and validation of the UltraScan 650 is Dual-energy X-ray Absorptiometry (DXA) measurements of BMD, specifically at the 1/3 radius. DXA is referred to as the "gold standard" for measuring BMD. The device's "BMD us Index" is described as an "estimate of the BMD that would be measured by DXA."

8. The Sample Size for the Training Set

The document does not explicitly state the sample size for a "training set." This type of device relies on a "normative x-ray absorptiometry reference database" (Hologic 1/3 radius adult white females and males, K023398 / K103265) for T- and z-score derivations. The "clinical data" mentioned are for "Estimation of BMD," "Reproducibility," "Fracture Risk," "Reference Data Base," and "Dominant vs Non-Dominant Arm," but specific sample sizes for these studies are not detailed.

9. How the Ground Truth for the Training Set Was Established

Since an explicit "training set" for an AI algorithm isn't detailed for this device, the concept of "ground truth for the training set" doesn't directly apply in the same way it would for AI-based image classification.

However, the device's T- and z-scores are "derived from comparison to a normative x-ray absorptiometry reference database." This means the ground truth for establishing these normative values would have been a large dataset of DXA measurements from a reference population (in this case, "Hologic 1/3 radius adult white females and males"). The establishment of this normative database itself would have involved numerous DXA scans performed according to established medical protocols to define normal bone density ranges across different age groups and genders.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the most prominent.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 5, 2017

CyberLogic, Inc. % Mr. Paul Dryden Consultant ProMedic, Inc. 24301 Woodsage Drive BONITA SPRINGS FL 34134

Re: K161919

Trade/Device Name: UltraScan 650 Regulation Number: 21 CFR 892.1180 Regulation Name: Bone Sonometer Regulatory Class: II Product Code: MUA Dated: March 29, 2017 Received: March 31, 2017

Dear Mr. Dryden:

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. O'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)

K161919

Device Name

UltraScan 650

Indications for Use (Describe)

UltraScan 650 can be used to determine BMDus Index in adult men and women and to assess appendicular fracture risk in postmenopausal women.

The BMD [] Index is a clinical measure based on ultrasound variables of the forearm which is highly correlated with the value of BMD of the 1/3 radius as provided by DXA, with a standard error of the estimate of 0.041 grams/cm2.

BMDus Index is expressed in grams/cm² and as a T- and z-score, derived from comparison to a normative x-ray absorptiometry reference database.

BMD 15 Index has a precision comparable to that of x-ray absorptiometry, which makes it suitable for monitoring bone changes in postmenopausal women.

Type of Use (Select one or both, as applicable)
XX Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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FORM FDA 3881 (8/14

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CyberLogic, Inc. 611 Broadway Suite 707 New York, NY 10012

Tel – 212-260-1351

Official Contact:	Jonathan J. Kaufman, President and CEO
Proprietary or Trade Name:	UltraScan ™ 650
Common/Usual Name:	Bone sonometer
Classification Name /Product Classification	Bone sonometerMUA, 21CFR 892.1180, Class II
Predicate Device:Reference Devices:	K103633 – GE Healthcare Achilles ultrasonometerK110646 – BeamMed – Omnisense 7000SK023398 – Hologic QDR Model 4500

Device Description:

The UltraScan 650 is an ultrasound device that is designed to non-invasively and quantitatively assess the amount of bone at the 1/3 location of the radius in the forearm of an individual.

Indications for Use:

UltraScan 650 can be used to determine BMDys Index in adult men and women and to assess appendicular fracture risk in postmenopausal women.

BMD IIs Index is expressed in grams/cm² and as a T- and z-score, derived from comparison to a normative x-ray absorptiometry reference database.

BMDgs Index has a precision comparable to that of x-ray absorptiometry, which makes it suitable for monitoring bone changes in postmenopausal women.

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510(k) Summary

Table 1 Substantial equivalence Comparison to Predicate
Attribute	PredicateGE – Achilles EXPIIK103633	Subject DeviceUltraScan 650
Indications for Use	Ultrasonometer measuresultrasound variables of the oscalcis to provide a clinicalmeasure called Stiffness Index.The Stiffness Index indicates riskof osteoporotic fracture inpostmenopausal womencomparable to bone mineraldensity (BMD) asmeasured by X-rayabsorptiometry at the spine or hip.Stiffness index results expressedas T--scores are used to assist thephysicians in the diagnosis ofosteoporosis in the same way asare T-scores obtained by x-rayabsorpiometry. Either the stiffnessindex T-score or x-rayabsorptiometry T-score can beutilized by a physician, inconjunction with other clinicalrisk factors, to provide acomprehensive skeletalassessment.The stiffness index has aprecision error in older womencomparable to that of x-rayabsorptiometry, which makes itsuitable for monitoring bonechanges.	UltraScan 650 can be used todetermine BMDUS Index in adultmen and women and to assessappendicular fracture risk inpostmenopausal women.The BMDUS Index is a clinicalmeasure based on ultrasoundvariables of the forearm which ishighly correlated with the valueof BMD of the 1/3 radius asprovided by DXA, with astandard error of the estimate of0.041 grams/cm2.BMDUS Index is expressed ingrams/cm2 and as a T- and z-score, derived from comparison toa normative x-ray absorptiometryreference database.BMDUS Index has a precisioncomparable to that of x-rayabsorptiometry, which makes itsuitable for monitoring bonechanges in postmenopausalwomen.
Environment of Use	Hospital, sub-acute care facilities,doctor's offices and clinics	Hospital, sub-acute care facilities,doctor's offices and clinics
Patient Population	Postmenopausal women	Assess appendicular fracture riskin postmenopausal women andfor determination of BMDUSIndex in adult men and women
Fundamental technology	Ultrasound	Ultrasound
Measurement mode	Transmission	Through-transmission
Measurement location	Heel	1/3 radius
Output results	T-scoreStiffness Index	T-scoreZ-scoreBMDUS Index
Attribute	PredicateGE - Achilles EXPIIK103633	Subject DeviceUltraScan 650
Measurement precision	Not stated	2.1%
Measurement time	< 1 minute	15 seconds
Correlation to BMDDXA	N/A	0.93
Use of normative reference x-rayabsorptiometry database	No	YesHologic 1/3 radius adult whitefemales and males, K023398 /K103265.
Accessories	N/A	Forearm length measuring device,elbow rest pad, and forearmpositioning device.
Materials in patient contact	N/A	Surface contact, Intact Skin,Limited duration of Use per ISO10993-1
Performance TestingSafety, EMC	IEC 60601-1 - SafetyIEC 60601-1-2 - EMC	IEC 60601-1 - SafetyIEC 60601-1-2 - EMCMaximum acoustic outputPulse intensity integralsPulse total energyPulse durationPulse repetition ratePulse average intensityTime average intensityAcoustic signal center frequencyBeam total power
Clinical		Comparative data to DXASimulation DataIn Vitro DataClinical Data - Estimation ofBMDClinical Data - ReproducibilityClinical Data - Fracture RiskClinical Data - Reference DataBaseClinical Data - Dominant vs Non-Dominant Arm

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510(k) Summary 29-Mar-17 Page 3 of 8

Discussion of Substantial Equivalence to Predicate

Table 1 above compares the key features of the UltraScan™ 650 with the identified predicate and it demonstrates that the proposed device can be found to be substantially equivalent. Table 2 compares the subject device to the reference devices, specifically for the anatomical location for taking measurements and the comparison of ultrasound to DXA for a BMDw Index value.

Indications for Use - The indications for use of measuring bone density. Discussion - Both device has similar indications for use but differ in the location that the measurement is taken, however there are reference devices which take bone density measurements at the 1/3 radius, K110646.

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Patient Population - The patient population is for assessing appendicular fracture risk in postmenopausal women and for determination of BMDus Index in adult men and women. Discussion - The subject device has included all individuals who may need BMD testing while the predicate is limited to postmenopausal women. We have included clinical data to support the broader population.

Environment of Use - The environment of use is hospitals, sub-acute care facilities, physician's offices, and clinics.

Discussion - There are no differences in the environment of use between the subject device and the predicate.

Technology - The technology is ultrasound via transmission utilizing multiple transducers. The subject device is placing the transducers at the 1/3 radius whereas the predicate places the transducers at the heel.

Discussion - While there is a difference in the location of the transducers between the subject device and the predicate, the reference device, K110646, BeamMed Omnisense 7000S is an ultrasound bone sonometer that is placed at the 1/3 radius. Therefore the difference between the subject device and predicate is addressed via the reference device which has similar indications for use and technology. The difference does not raise any new concerns related to substantial equivalence.

Performance - The correlation of the subject device to the gold standard DXA for measuring BMD is 0.93 vs. the reference, Hologic QDR 4500, K023398, 0.8. We did not compare performance to the predicate.

Discussion - We are making no claim of performance other than the subject device is substantially equivalent to the reference. Hologic ODR 4500. K023398. While the predicate discusses a Stiffness Index they have equated it to BMD. We believe given the higher correlation of the subject device we can present the data as BMDus Index as compared to BMDxx from a marketing perspective.

Materials – The materials which are in patient contact are for less than 1 minute and would be considered as incidental.

Discussion - The type and time of patient contact to the materials is very small and poses no safety risks.

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510(k) Summary 29-Mar-17 Page 5 of 8

Attribute	ReferenceBeamMed Omnisense 7000SK110646	ReferenceHologic QDR 4500K023398	Subject DeviceUltraScan 650
Indicationsfor Use	A non-invasive device that isdesigned for the quantitativemeasurement of the signalvelocity of ultrasound waves("Speed of Sound" or "SOS" inm/sec) propagating at multipleskeletal sites (i.e., the distal one-third of the radius , the proximalthird phalanx and the fifthmetatarsal). SOS provides anestimate of skeletal fragility.The output is also expressed as aT-score and a Z-score , and can beused in conjunction with otherclinical risk factors as an aid tothe physician in the diagnosis ofosteoporosis and other medicalconditions leading to reducedbone strength and, ultimately, inthe determination of fracture risk.Multiple skeletal site testingprovided clinicians withalternatives if one site is notaccessible and with additionalskeletal information (i.e., frombones with different combinationsof cortical and cancellous materialand from weight bearing and non-weight bearing sites) that assistsin diagnosing osteoporosis andrisk fracture.The SOS measured by MiniOmnihas a precision error low enoughin comparison with the expectedannual change in a patient'smeasurement to make it suitable	QDR X-Ray BoneDensitometers is indicated forthe estimation of bonemineral density (BMD) ,comparison of measuredvariables obtained from agiven QDR scan to a databaseof reference values, theestimation of fracture risk,vertebral deformityassessment, body compositionanalysis, and discrimination ofbone from prosthetics usingthe Hologic QDR X-Ray BoneDensitometers	UltraScan 650 can be usedto determine BMDUS Indexin adult men and womenand to assess appendicularfracture risk inpostmenopausal women.The BMDUS Index is aclinical measure based onultrasound variables of theforearm which is highlycorrelated with the value ofBMD of the 1/3 radius asprovided by DXA, with astandard error of theestimate of $0.041 grams/cm^2$ .BMDUS Index is expressedin $grams/cm^2$ and as a T-and z-score, derived fromcomparison to a normativex-ray absorptiometryreference database.BMDUS Index has aprecision comparable tothat of x-rayabsorptiometry, whichmakes it suitable formonitoring bone changes inpostmenopausal women.
Environmentof Use	for monitoring bone changeswhich occur in the early yearsfollowing menopause (i.e., agerange approx... 50-65 years).Hospital, sub-acute care facilities,doctor's offices and clinics	Hospital, sub-acute carefacilities, doctor's offices andclinics	Hospital, sub-acute carefacilities, doctor's officesand clinics
Attribute	ReferenceBeamMed Omnisense 7000SK110646	ReferenceHologic QDR 4500K023398	Subject DeviceUltraScan 650
PatientPopulation	Females 50-65 years old	Not specified	Assess appendicular fracturerisk in postmenopausal womenand for determination ofBMDUS Index in adult men andwomen
Fundamentaltechnology	Ultrasound	X-ray	Ultrasound
Measurementmode	Axial Transmission	X-ray	Through-transmission
Measurementlocation	Distal radius	1/3 radius	1/3 radius
Output results	T-scoreZ-scoreSOS	T-scoreZ-scoreBMDDXA	T-scoreZ-scoreBMDUS Index
Measurementprecision	Not stated	Not stated	2.1%
Measurementtime	< 1 minute	< 1 minute	15 seconds
Correlation toBMDDXA	N/A	0.8	0.93
Use ofnormativereference x-rayabsorptiometrydatabase	No	Yes	Yes
Accessories	N/A	N/A	Forearm length measuringdevice, elbow rest pad, andforearm positioning device.
Materials inpatient contact	N/A	N/A	Surface contact, Intact Skin,Limited duration of Use perISO 10993-1
PerformanceTesting
Safety, EMC	IEC 60601-1 - SafetyIEC 60601-1-2 - EMC	IEC 60601-1 - SafetyIEC 60601-1-2 - EMC	IEC 60601-1 - SafetyIEC 60601-1-2 – EMCMaximum acoustic outputPulse intensity integralsPulse total energyPulse durationPulse repetition ratePulse average intensityTime average intensityAcoustic signal centerfrequencyBeam total power
Clinical			Comparative data to DXASimulation Data, In Vitro DataClinical Data - Estimation ofBMD, Reproducibility, FractureRisk, Reference Data Base,Dominant vs Non-Dominant

Table 2 – Substantial equivalence Comparison to the References

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510(k) Summary 29-Mar-17

Page 6 of 8

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Discussion of Substantial Equivalence to Reference Devices

The UltraScan 650 is viewed as substantially equivalent to the predicate device because:

Indications for Use - The indications for use of measuring bone density. Discussion - All devices have similar indications for use and can be found substantially equivalent.

Patient Population - The patient population is for assessing appendicular fracture risk in postmenopausal women and for determination of BMDus in adult men and women. Discussion - The subject device has included all individuals who may need BMD testing while the references are limited to postmenopausal women. We have included clinical data to support the broader population.

Environment of Use - The environment of use is hospitals, sub-acute care facilities, physician's offices, and clinics.

Discussion - There are no differences in the environment of use between the subject device and the references.

Technology - The technology is ultrasound while one reference uses ultrasound the other uses Xray, all take the measurements at the 1/3 radius which includes the 1/3 radius. Discussion - While there is a difference in the technology for the K023398 DXA reference, we compared our clinical performance to this reference and found a significant correlation. The difference does not raise any new concerns related to substantial equivalence.

Performance - The correlation of the subject device to the gold standard DXA for measuring BMD is 0.93 vs. the reference, Hologic QDR 4500, K023398, 0.8.

Discussion - We are making no claim of performance other than the subject device is substantially equivalent to the reference, Hologic QDR 4500, K023398. While the predicate discusses a Stiffness Index they have equated it to BMD. We believe given the higher correlation of the subject device we can present the data as a BMD1Js Index as compared to BMD7xA from both a scientific and from a marketing perspective.

Non-Clinical Testing Summary -

We performed testing which evaluated:

AAMI/ANSI/ES60601-1:2005 for electrical safety ●
IEC 60601-1-2:2007 for EMC
Distance Validation:
Time Delay Correction: and ●
Quality Control
Acoustic output ●

Cinical Testing Summary -

The UltraScan 650 has been tested against several data sets to demonstrate the efficacy of the UltraScan 650. The data are:

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Simulation Data; ●
In Vitro Data; ●
Clinical Data - Estimation of BMD;
Clinical Data - Reproducibility;
Clinical Data Fracture Risk; ●
Clinical Data Reference Data Base; and ●
Clinical Data Dominant vs Non-Dominant Arm ●

Discussion of Differences –

The differences presented and discussed above are:

Patient population
. Comparison and correlation of the UltraScan 650 quantitatively estimates the bone mineral density (BMD) as measured by dual-energy x-ray absorptiometry (DXA), i.e., BMDnxA Index. We found the correlation to be 0.93 vs. the reference of 0.8.

These differences based upon the testing and risk assessment do not raise new concerns of safety and thus the subject device can be considered as substantially equivalent to the predicate.

Substantial Equivalence Conclusion -

Based upon the presented information the sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device and predicate have been found to be substantially equivalent and there are no new concerns raised.

Regulation Number and Section

§ 892.1180 Bone sonometer.

(a)
Identification. A bone sonometer is a device that transmits ultrasound energy into the human body to measure acoustic properties of bone that indicate overall bone health and fracture risk. The primary components of the device are a voltage generator, a transmitting transducer, a receiving transducer, and hardware and software for reception and processing of the received ultrasonic signal.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Bone Sonometers.” See § 892.1(e) for the availability of this guidance document.