The Sunlight MiniOmni Ultrasound Bone Sonometer is a non-invasive device that is designed for the quantitative measurement of the signal velocity of ultrasound waves ("Speed of Sound" or "SOS" in m/sec) propagating at multiple skeletal sites (i.e., the distal one-third of the radius, the proximal third phalanx and the fifth metatarsal). SOS provides an estimate of skeletal fragility.

The output is also expressed as a T-score and a Z-score, and can be used in conjunction with other clinical risk factors as an aid to the physician in the diagnosis of osteoporosis and other medical conditions leading to reduced bone strength and, ultimately, in the determination of fracture risk.

Multiple skeletal site testing provided clinicians with alternatives if one site is not accessible and with additional skeletal information (i.e., from bones with different combinations of cortical and cancellous material and from weight bearing and non-weight bearing sites) that assists in diagnosing osteoporosis and risk fracture.

The SOS measured by MiniOmni has a precision error low enough in comparison with the expected annual change in a patient's measurement to make it suitable for monitoring bone changes which occur in the early years following menopause (i.e., age range approximately 50-65 years).

Device Description

The Sunlight MiniOmni Ultrasound Bone Sonometer is a noninvasive device that consists of:

Main unit, which contains an ultrasound transmission / reception printed circuit board (1) (ultrasound PCB) and mechanical and electric elements for connecting the ultrasound probes
(2) User interface and algorithmic calculation software provided in installation disc
(3) Hand-held probes (choice from 3 ultrasonic probe types already PMA-approved, plus one new probe)
Medical grade AC to DC power adaptor and cable (4)
(5) USB Connection cable
System quality verification (SQV) phantom; (6)
Spring-loaded positioning gauge; (7)
(8) Cushioned hand rest
(a) User Guide
Ultrasound gel (optional accessory)
Skin marker pencil (optional accessory)
Foot pedal (optional accessory) 12)
Sterile disinfection towelettes (optional accessory) (13)
Carrying case for easy mobility (optional accessory) (14)

The MiniOmni requires connection to a stand-alone computer and visual display unit provided by the user in order to operate as intended.

AI/ML Overview

The provided 510(k) summary for the BeamMed MiniOmni Bone Sonometer focuses on demonstrating substantial equivalence to a predicate device (Sunlight Omnisense 7000S Bone Sonometer) rather than presenting a standalone study with acceptance criteria and performance data for this new device.

The document explicitly states: "The performance of the MiniOmni is identical to that of the predicate device." Therefore, the "reported device performance" and "study that proves the device meets the acceptance criteria" are based on the predicate device's existing approvals.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Metric	Acceptance Criteria (Based on Predicate Device)	Reported Device Performance (MiniOmni)
Indications for Use	Quantitative measurement of signal velocity of ultrasound waves ("Speed of Sound" or "SOS" in m/sec) at distal one-third of the radius, proximal third phalanx, and fifth metatarsal. SOS provides an estimate of skeletal fragility. Output as T-score & Z-score, usable with clinical risk factors for osteoporosis diagnosis and fracture risk determination. Low precision error for monitoring bone changes post-menopause (age 50-65 years).	Same
Measurement Mode	Speed of Sound (SOS)	Same
Measurement Precision	0.40%-0.81% short term in-vivo precision (skeletal site dependent); 0.25%-0.50% instrumental accuracy (probe dependent)	Same
Measurement Time	Approximately 1 to 1½ minutes (3 to 5 measurement cycles of approx. 20 seconds each)	Same
Algorithms	As described in PMA P990035 (Predicate device's PMA)	Same
Calibration	Calibration free; Daily System Quality Verification (SQV) with Phantom is required	Same

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

The document does not provide information about a specific test set or sample size for a new study to prove the MiniOmni's performance. The basis for performance claims is the predicate device, the Sunlight Omnisense 7000S, which was approved under PMA P990035. Details regarding the original PMA study's sample size, data provenance, and study design are not included in this 510(k) summary.

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

This information is not available in the provided 510(k) summary, as it relies on the predicate device's prior approvals and does not describe a new ground truth establishment process for the MiniOmni.

4. Adjudication Method for the Test Set

This information is not available in the provided 510(k) summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI Improvement

This information is not available in the provided 510(k) summary. The device is a bone sonometer, which measures physical properties, and the submission primarily focuses on hardware and software equivalency, not on AI-driven interpretation or human-in-the-loop performance improvement.

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

The document states: "The performance of the MiniOmni is identical to that of the predicate device." The predicate device's algorithms were "As described in PMA P990035." It can be inferred that the algorithms for calculating SOS, T-scores, and Z-scores operate in a "standalone" fashion (algorithm only) after the user acquires the ultrasound data. However, a specific standalone performance study for the MiniOmni itself is not detailed. The MiniOmni operates with software on a user-provided computer, meaning the algorithm is separate from the physical measurement unit but still requires human interaction for data acquisition and input.

7. Type of Ground Truth Used

For bone sonometers like the MiniOmni, the "ground truth" for bone health assessment typically involves comparison with established reference standards or correlation with other bone density measurement techniques (e.g., DXA, which is considered a gold standard for bone mineral density). However, the provided document does not specify the type of ground truth used for the predicate device's original PMA, nor for any new evaluation of the MiniOmni. The device provides "an estimate of skeletal fragility" and calculates T-scores and Z-scores based on embedded reference databases, rather than directly measuring pathology or relying solely on outcomes data.

8. Sample Size for the Training Set

This information is not available in the provided 510(k) summary. The device utilizes "an embedded reference database" for T-score and Z-score calculations, which likely represents a "training set" in a broad sense, but its sample size and characteristics are not detailed.

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

This information is not available in the provided 510(k) summary. For the "embedded reference database," the ground truth would have been established through a clinical study or compilation of data from a large healthy population and age-matched populations. Details of this process are not included.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for BeamMed. The logo is in a serif font, with the words "BeamMed" in a larger font than the tagline. The tagline reads "Focused On Bone Health" and is located directly below the company name. The logo is black and white.

Device Name:

K110646

BeamMed MiniOmni Bone Sonometer

BeamMed Ltd. 8 Ha-Lapid Street OCT 1 2 2011 Petah Tikva 49170 lsrael

Appendix B

510(k) Summary in accordance with 21 CFR 807.92(c)

Type of 510(k) submission: Abbreviated Date of Submission: 24 February 2011 Manufacturer: BeamMed Ltd. 8 Halapid Street Petach Tikva ISRAEL 49170 FDA Establishment Registration Number: 3006701790 510(k) Owner: BeamMed Ltd. 8 Halapid Street Petach Tikva ISRAEL 49170 Trade Name: BeamMed Sunlight MiniOmni Bone Sonometer Common Name: Bone Sonometer Class: Class II Product Codes: MUA Classification Regulation: 892.1180 Predicate Device: Sunlight Omnisense 7000 Bone Sonometer Predicate Device Manufacturer: BeamMed Ltd. 8 Halapid Street Petach Tikva ISRAEL 49170

Device Description:

The Sunlight MiniOmni Ultrasound Bone Sonometer is a noninvasive device that consists of:

Main unit, which contains an ultrasound transmission / reception printed circuit board (1) (ultrasound PCB) and mechanical and electric elements for connecting the ultrasound probes
(2) User interface and algorithmic calculation software provided in installation disc
(3) Hand-held probes (choice from 3 ultrasonic probe types already PMA-approved, plus one new probe)
Medical grade AC to DC power adaptor and cable (4)
(5) USB Connection cable
System quality verification (SQV) phantom; (6)
Spring-loaded positioning gauge; (7)
(8) Cushioned hand rest
(a) User Guide

Page 1 of 7

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K110646

Image /page/1/Picture/1 description: The image shows the logo for BeamMed. The logo is in a stylized font, with the words "BeamMed" in large, bold letters. Below the company name is the tagline "Focused On Bone Health" in a smaller, less bold font. The logo is simple and professional, and it conveys the company's focus on bone health.

BeamMed Ltd. 8 Ha-Lapid Street Petah Tikva 49170 lsrael

Ultrasound gel (optional accessory)
Skin marker pencil (optional accessory)
Foot pedal (optional accessory) 12)
Sterile disinfection towelettes (optional accessory) (13)
Carrying case for easy mobility (optional accessory) (14)

The MiniOmni requires connection to a stand-alone computer and visual display unit provided by the user in order to operate as intended.

The MiniOmni has been developed from the Sunlight Omnisense 7000S device, which was originally approved for sale in the US by means of PMA P990035. In August 2008, FDA downclassified Bone Sonometers in Product Code MUA to Class II, special controls. This 510(k) submission identifies the Omnisense 7000S as the predicate device against which substantial equivalence is demonstrated.

The functionality of the MiniOmni is not significantly different from the Omnisense 7000S, although the Omnisense 7000s included an integral computer and visual display unit. The fundamental technology and operating principles are the Omnisense 7000S. The acoustic components (algorithm, analog card, and probes) of the MiniOmni are identical or functionally equivalent to those of the Omnisense 7000S.

Three ultrasound probes (codes CMB, CRB and CSB), the SQV phantom, spring-loaded positioning gauge, and cushion hand rest are identical to those included in the PMA-approved Omnisense 7000S system. A fourth, new CMC probe has a modified assembly process when compared with the standard CMB probe, in order to provide more stable operation in humid environments.

The MiniOmni has been designed to take advantage of electronic miniaturization and updated hardware components that have become available since design and development of the Omnisense 7000S. These modifications, however, have not changed the fundamental technology or operating principles used in the Omnisense 7000S.

The software of the MiniOmni includes certain minor modifications from the predicate Omnisense 7000S software in order to allow for proper hardware communication as a result of the electronic hardware updates mentioned previously. Additionally, several user convenience features have been added to the software. All of the software differences between the MiniOmni and the Omnisense 7000S were qualified through appropriate testing using standard test methods and approved protocols to demonstrate that each function was working properly in the integrated software.

the MiniOmni software is composed of three main subsystems according to the device's hardware architecture;

(1) The PC subsystem;
(2) The digital PCB Subsystem; and
(3) The PC-digital PCB Interface Subsystem.

Indications for Use:

The output is also expressed as a T-score and a Z-score, and can be used in conjunction with other clinical risk factors as an aid to the physician in the diagnosis of osteoporosis and other

Page 2 of 7

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Image /page/2/Picture/0 description: The image shows the logo for BeamMed. The logo consists of the word "BeamMed" in a stylized font, with the words "Focused On Bone Health" underneath in a smaller font. The logo is black and white.

K 110646

BeamMed Ltd. 8 Ha-Lapid Street Petah Tikva 49170 israel

medical conditions leading to reduced bone strength and, ultimately, in the determination of fracture risk.

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Image /page/3/Picture/0 description: The image shows the logo for BeamMed. The logo is in a serif font and is black. Below the logo is the tagline "Focused On Bone Health".

11/11/14/10

BeamMed Ltd. 8 Ha-Lapid Street Petah Tikva 49170 lsrael

Technological Characteristics:

The MiniOmni employs a hand-held probe designed to measure SOS values. The probe is connected by a cable to the MiniOmni Main Unit. During measurement, the probe is applied directly to the skin.

High frequency acoustic waves, at a center frequency of 1.25MHz, are produced by two transducers in the probe. The ultrasound waves are conducted along the patient's bone and detected by two different transducers in the same probe. The SOS of the bone is measured by the device.

The device software compares the SOS result with the SOS of a young healthy population, as well as an age-matched population, using an embedded reference database, and reports the comparison in the form of a T-score and a Z-score.

The user interfaces with the MiniOmni by means of items that are not supplied with the device, including PC (or laptop computer), keyboard, optional foot-pedal and printer. The operator uses these items mainly to inout patient into the PC and also for entering other administrative input required in order to operate the system.

Performance Data:

The performance of the MiniOmni is identical to that of the predicate device.

Comparison with predicate device:

The predicate device is the Sunlight 7000S Omnisense Bone Sonometer, which was the subject of PMA P990035, approved 20 January 2000.

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K110646

BeamMed Ltd. 8 Ha-Lapid Street
Petah Tikva 49170 lsrael

Item	Omnisense 7000S (predicate)	MiniOmni (subject device)
Indications for use	The Sunlight Omnisense 7000S Ultrasound BoneSonometer is a non-invasive device that isdesigned for the quantitative measurement of thesignal velocity of ultrasound waves ("Speed ofSound" or "SOS" in m/sec) propagating at multipleskeletal sites (i.e., the distal one-third of theradius, the proximal third phalanx and the fifthmetatarsal). SOS provides an estimate of skeletalfragility.The output is also expressed as a T-score and aZ-score, and can be used in conjunction withother clinical risk factors as an aid to thephysician in the diagnosis of osteoporosis andother medical conditions leading to reduced bonestrength and, ultimately, in the determination offracture risk.Multiple skeletal site testing provided clinicianswith alternatives if one site is not accessible andwith additional skeletal information (i.e., frombones with different combinations of cortical andcancellous material and from weight bearing andnon-weight bearing sites) that assists indiagnosing osteoporosis and risk fracture.The SOS measured by MiniOmni has a precisionerror low enough in comparison with the expectedannual change in a patient's measurement tomake it suitable for monitoring bone changeswhich occur in the early years followingmenopause (i.e., age range approximately 50-65years).	Same
MeasurementMode	Speed of Sound (SOS)	Same
MeasurementPrecision	0.40%-0.81% short term in- vivo precision (skeletalsite dependent) 0.25%-0.50% instrumentalaccuracy (probe dependent)	Same
Measurement Time	Approximately 1 to 1½ minutes (3 to 5measurement cycles of approximately 20 secondseach)	Same
Probe compatibility	Three proprietary multi-transducer probes; Centrefrequency = 1.25 MHz.	Four proprietary multi-transducer probes; Centrefrequency = 1.25 MHz.
Operating System	MS Windows 95	MS Windows XP, Windows 7
User Interface	Mouse and keyboard driven GUI (Windows 95) andfoot pedal	Mouse, keyboard and footpedal
Algorithms	As described in PMA 990035	Same
Calibration	Calibration free; Daily System Quality Verification(SQV) with Phantom is required	Same
System portability	Bench mounted	Portable
Screen size	SVGA 14" Monitor (CRT) or flat-panel (LCD)	Any size (software installed onuser's computer)
Printers	Standard PC printers (not supplied)Supported Printers: HP DeskJet 690 Series, 710Cand 815C; Epson 440; Lexmark 5700; and CannonBJC 4400 Series.	Any printer compatible withMS Windows XP / Windows 7and as specified in section4.6.2 of the User Guide

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Image /page/5/Picture/0 description: The image shows the logo for BeamMed. The logo is in a serif font, with the word "BeamMed" in large letters. Below the word "BeamMed" is the phrase "Focused On Bone Health" in smaller letters. The logo is black and white.

K110646

BeamMed Ltd. 8 Ha-Lapid Street Petah Tikva 49170 lsrael

Item	Omnisense 7000S (predicate)	MiniOmni (subject device)
Power	100-240 VAC (per specified order), 50Hz to 60 Hz	Same
Powerconsumption	Approximately 85 VA	Rated steady state inputconsumption: 3 W
Dimensions(w x h x d)	390 mm x 130 mm x 330 mm + Video Displaymonitor	140 mm x 223 mm x 140 mm
Weight	Approximately 7 kg	Approximately 1 kg
Electrical safety	Complies with IEC 60601-1:1988, includingAmendments 1 and 2	Complies with IEC 60601-1:1988 including Amendments 1and 2; IEC 60601-2-37: 2001including Amendments 1 and2; and IEC 60601-1: 2005
Electromagneticcompatibility	Complies with IEC 60601-1-2:1993	Complies with IEC 60601-1-2:2007
Power supply	Medical grade power supply	Same
OperatingEnvironment	Temperature: +10°C to +35 °CHumidity: 30% to 75%RH, non-condensingAtmospheric Pressure: 700 to 1060 Pc	Same
StorageEnvironment	Temperature: +0 °C to 50°CHumidity: 10% to 90% RH, non-condensing	Same
Backup Platform	Standard 3.5 inch drive (1.44 MB) Zip ™ drive (100MB)	Local PC/ USB device/network storage
Acoustic Module	Algorithm, analog card and probes	Same

On the basis of the above comparison, the only differences between the MiniOmni device and the Omnisense 7000 device are in the following areas:

1. The PMA-approved Omnisense 7000S device consisted of: a desktop personal computer Main Unit; a video display monitor; a keyboard; a set of earphones; ultrasound probes; SQV phantom; foot pedal; one spring- loaded positioning gauge; and a cushion hand support.
  The MiniOmni has eliminated the personal computer Main Unit, the video display monitor, a keyboard and the earphones. The MiniOmni has a separate main unit with a single 'Measure' button on top connected to the user's computer / laptop, as specified by the User Guide.
1. The PMA-approved Omnisense 7000S device analog and digital functions are performed by two separate PCBs connected to the PC motherboard through a PCI. The MiniOmni uses a single PCB containing both the analog and digital components connected to the PC via USB.
1. The PMA-approved Omnisense 7000S device uses three slots for connection of the different probes. The MiniOmni has one slot suitable for all probe types.

The above differences between the MiniOmni and the Omnisense 7000S do not have any effect on the safety and efficacy of the device.

Conclusion:

Based on the information contained within this submission, it is concluded that the BeamMed Sunlight MiniOmni Bone Sonometer is substantially equivalent to the identified predicate device already in interstate commerce within the USA.

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Image /page/6/Picture/0 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" arranged around the perimeter. Inside the circle is a stylized symbol featuring three curved lines that resemble a human figure.

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

OCT 1 2011

Ms. Rita Koremblum QA/RA Manager Beam-Med LTD 8 Halapid Str., P.O. Box 7520 Petach Tikva. 49170 ISRAEL

Re: K110646

Trade/Device Name: Sunlight MiniOmni Ultrasound Bone Sonometer Regulation Number: 21 CFR 892.1180 Regulation Name: Bone sonometer Regulatory Class: II Product Code: MUA Dated: September 11, 2011 Received: September 13, 2011

Dear Mr. Koremblum:

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 ffor the indications for usc 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.

If your device is classified (sec above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 1 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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/McdicalDevices/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Mary Patel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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K110646
P. 1 of 1

Indications for Use Statement

510(k) Number (if known): Not known

Device Name: Sunlight MiniOmni Ultrasound Bone Sonometer

Indications for Use: The Sunlight MiniOmni Ultrasound Bone Sonometer is a non-invasive device that is designed for the quantitative measurement of the signal velocity of ultrasound waves ("Speed of Sound" or "SOS" in m/sec) propagating at multiple skeletal siles (i.e., the distal one-third of the radius, the proximal third phalanx and the fifth metatarsal). SOS provides an estimate of skeletal fragility.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR -

Over-The-Counter Use (21 CFR 801 Subpart C)

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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K110646

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.