Bindex measures apparent cortical bone thickness at the proximal tibia and can be used in conjunction with other clinical risk factors or patient characteristics as an aid to the physician in the diagnosis and other medical conditions leading to reduced bone strength and in the determination of fracture risk.

Device Description

The Bindex Bl-2 system consists of handheld ultrasound transducer and software. Bindex Bl-2 is connected to the USB port of a computer and controlled with computer software. Bindex Bl-2 is used for measurement of cortical bone thickness and it provides Density Index (DI), a parameter which estimates bensity at the hip as measured with DXA. For measurements, gel is applied on skin and ultrasound transducer is manually placed on the measurement location. Standardized measurement location is at proximal tibia (1/3 length of tibia). Transducer is manually oriented perpendicularly to the cortical bone to achieve accepted measurement. Measurement is repeated five times at each measurement location. Finally, transducer is disinfected by wiping gel off with isopropyl alcohol moistened cloth.

AI/ML Overview

The provided document is a 510(k) summary for the Bindex BI-2 device, which measures apparent cortical bone thickness. The device received substantial equivalence based on its similarity to a predicate device (Bindex BI-100). The document focuses on demonstrating substantial equivalence rather than presenting an exhaustive de novo clinical study with specific acceptance criteria and detailed device performance metrics against a clinical ground truth.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance for clinical accuracy in the traditional sense of a de novo study. Instead, it relies on demonstrating that the Bindex BI-2 (subject device) is substantially equivalent to the Bindex BI-100 (predicate device), for which previous clinical and pre-clinical data supports its safe and effective use.

The "acceptance criteria" here are implicitly related to the predicate device's established performance and the subject device's ability to demonstrate equivalence in technical and functional aspects. The performance data presented are primarily related to engineering and safety testing, not direct clinical diagnostic performance metrics (like sensitivity, specificity, accuracy against a gold standard for bone strength or fracture risk).

Acceptance Criteria (Implied for Equivalence)	Reported Device Performance (Bindex BI-2)
Functional Equivalence: Same Indications for Use as predicate (Bindex BI-100).	Identical Indications for Use: "Bindex measures apparent cortical bone thickness at the proximal tibia and can be used in conjunction with other clinical risk factors or patient characteristics as an aid to the physician in the diagnosis and other medical conditions leading to reduced bone strength and in the determination of fracture risk."
Technical Equivalence: Same measurement mode, probe compatibility, and core measurement principle as predicate.	Same measurement mode (Apparent Cortical Thickness (Ct.Th.)), same transducer (centre frequency = 3.0 MHz (nominal)), same fundamental ultrasound technology and measurement principle.
Biocompatibility: Meet ISO 10993 standards for skin contact (<24 hours).	Evaluation conducted per FDA Blue Book Memo #G95-1 and ISO 10993-1. Testing recommended includes Cytotoxicity, Sensitization, Irritation. Conclusion: "very low risk" due to short skin contact on healthy skin. Safety of materials discussed in Biocompatibility report (Section 13).
Electrical Safety & EMC: Comply with IEC 60601-1, IEC 60601-2-37, and IEC 60601-1-2 standards.	System complies with IEC 60601-1, IEC 60601-2-37 (safety), and IEC 60601-1-2 (EMC).
Software V&V: Satisfy FDA guidance for software in medical devices (moderate concern).	Software verification and validation conducted; documentation provided per FDA guidance. Software classified as "moderate" level of concern.
Mechanical & Acoustic Testing: Demonstrate robustness and acoustic output equivalence (drop test, ball pressure test, moulding stress relief).	Acoustic output equivalence to predicate shown in test documentation. Drop test (1m), Ball pressure test (5mm, 20N, 75°C), Moulding stress relief (70°C, 7 hours) conducted.
Clinical Equivalence: Safe and effective use supported by existing clinical/pre-clinical data of the predicate device (Bindex BI-100).	"The same clinical and pre-clinical data supports the safe and effective use of Bindex Bl-100, to which substantial equivalence is shown." "The safety and effectiveness of Bindex Bl-2 device has been discussed in clinical evaluation document Section 16."

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

The document does not describe a separate "test set" in the context of a de novo clinical study with human subjects for the Bindex BI-2. Its performance demonstration relies on showing equivalence to the predicate device.

Clinical Studies: The document states, "The same clinical and pre-clinical data supports the safe and effective use of Bindex Bl-100, to which substantial equivalence is shown." This implies that the clinical data for the predicate device (Bindex BI-100) serves as the basis for clinical effectiveness.
Engineering Tests (Biocompatibility, Electrical, EMC, Mechanical, Acoustic): These tests were conducted on the Bindex BI-2 itself, but sample sizes for these specific engineering tests are not provided (e.g., number of devices dropped, number of units tested for EMC). The provenance is implied to be internal testing by Bone Index Finland, Ltd.

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

Not applicable for this submission. The submission is a 510(k) for substantial equivalence to a predicate device, not a de novo clinical study establishing new clinical ground truth for a novel device. The document references "other clinical risk factors or patient characteristics" as aids to diagnosis for the physician, suggesting the device provides data to be used in conjunction with a physician's expert judgment, rather than replacing it or having its output directly adjudicated by a panel.

4. Adjudication Method for the Test Set

Not applicable. No new clinical test set requiring adjudication is described for the Bindex BI-2 device in this submission.

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

Not applicable. The Bindex BI-2 is described as a medical device (bone sonometer) that measures "apparent cortical bone thickness" and provides a "Density Index (DI)." It is not an AI-based diagnostic image interpretation system with a "human-in-the-loop" component in the way that an MRMC study would typically evaluate. The device provides quantitative measurements to aid a physician, not AI-assisted readings of complex medical images.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

The Bindex BI-2 operates as a standalone measurement device. It directly measures cortical bone thickness using ultrasound. The output (thickness, Density Index) is a quantitative measurement, not an "algorithm-only" interpretation in the sense of a machine learning model. The device itself is the "standalone" entity that performs the measurement. However, its output is intended to be used by a physician "in conjunction with other clinical risk factors or patient characteristics."

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the Bindex BI-2 itself, the ground truth for its technical performance (e.g., accuracy of thickness measurement) is not explicitly detailed in this summary. Instead, the submission relies on the established "safe and effective use" of the predicate device (Bindex BI-100). The predicate device's indications for use mention "diagnosis of osteoporosis" and "determination of fracture risk," implying that its effectiveness was likely demonstrated against clinical endpoints such as bone mineral density (often measured by DXA, as suggested by the BI-2 providing a parameter estimating density at the hip as measured with DXA), or potentially fracture outcomes data, for which ultrasound measurements serve as a surrogate.

The Bindex BI-2's output (Density Index) "estimates density at the hip as measured with DXA," suggesting DXA as a clinical ground truth for the predicate's or implied target value.

8. The Sample Size for the Training Set

Not applicable for a training set in the context of machine learning. The device is a measurement instrument, not an AI model that requires a training set. If "training set" refers to the data used to develop the algorithms for the predicate device, that information is not provided in this summary.

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

Not applicable, as there is no mention of an algorithm training set in the context of machine learning.

Summary

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

January 9, 2017

Bone Index Finland, Ltd. % Janne Karjalainen Chief Technology Officer (CTO) Microkatu 1 Kuopio 70211 FINLAND

Re: K161971 Trade/Device Name: Bindex BI-2 Regulation Number: 21 CFR 892.1180 Regulation Name: Bone sonometer Regulatory Class: II Product Code: MUA Dated: July 12, 2016 Received: December 15, 2016

Dear Janne Karjalainen:

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) K161971

Device Name Bindex BI-2

Indications for Use (Describe)

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

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510(k) Summary

SUBMITTER l.

Bone Index Finland, Ltd. Microkatu 1 Kuopio, Finland 70211 Phone: +358 45 896 2650 Contact Person: Janne Karjalainen Date Prepared: 2 Dec, 2016

II. DEVICE

Name of Device: Bindex BI-2 Common or Usual Name: Bone sonometer Classification Name: Bone sonometer (21 CFR 892.1180) Regulatory Class: II Product Code: MUA

III. PREDICATE DEVICE

Bindex BI-100 bone sonometer, K152020.

This predicate has not been subject to a design-related recall.

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IV. DEVICE DESCRIPTION

The associated accessories include:

Measurement stick
Ultrasound gel (optional)

V. INDICATIONS FOR USE

Indications for use discussion

The Indications for Use statement for the Bindex Bl-2 is identical to the predicate device; thus raises no additional questions on safety and effectiveness.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE VI. DEVICE

The predicate and subject devices are based similar ultrasound technology and are based on the same measurement principle. The main differences between the devices are structural in terms mechanics and electronics. Importantly, the transducer (responsible for conversion of electrical energy to kinetic mechanical energy), is the same for both devices.

The predicate and subject devices are compared in table 1.

Table 1. Device comparison table.

#	Item	Bindex BI-100 (Predicate)	Bindex BI-2 (subject)
1	Indications for use	Bindex measures apparent cortical bone thickness at the proximal tibia	Same

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		and can be used in conjunction withother clinical risk factors or patientcharacteristics as an aid to thephysician in the diagnosis ofosteoporosis and other medicalconditions leading to reduced bonestrength and in the determinationof fracture risk.
2	Measurement mode	Apparent Cortical Thickness(Ct.Th.).	Same
3	Probe compatibility	One transducer, centre frequency =3.0 MHz (nominal)	Same
4	Electrical safety	IEC 60601-2-37:2001 includingAmendments 1 and 2; and IEC60601-1:2005	Same
5	Electromagneticcompatibility	Complies with IEC 60601-1-2:2007	Same
6	Power supply	PC USB port powered.	Same
7	OperatingEnvironment	Temperature: +10°C to +40°CHumidity: 5% to 85% RH, non-condensingAtmospheric Pressure: 600 to 1060Pc	Same
8	Storage Environment	Temperature: +10°C to +40°CHumidity: 5% to 85% RH, non-condensing	Same
9	Calibration	Calibration before each use.	Same

VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility testing

The biocompatibility evaluation for the Bindex Bl-2 device was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,"May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices –Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing along the ISO 10993-1 would recommend the following tests:

Cytotoxicity
Sensitization
Irritation

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The Bindex Bl-2 is in skin contact for duration of less than 24 hours. Since the use of Bindex involves very short skin contact (typically less than 10 minutes) on a healthy skin and therefore poses a very low risk. Safety of the manufacturing and used materials has been further discussed in Biocompatibility report (Section 13).

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the measurement system, consisting of the Bindex Bl-2 and a laptop computer (on battery use or connected to power supply with isolation transformer). The system complies with the IEC 60601-1, and IEC 60601-2-37 standards for safety and the IEC 60601-1-2 standard for EMC.

Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."

The software for this device was considered as a "moderate" level of concern.

Mechanical and acoustic testing

The acoustic output and mechanical properties have been tested along the principles presented in harmonized standards IEC 62359 and IEC 60601-1:

. Acoustic Testing has been conducted on the predicate device and test documentation in this submission shows equivalence of the devices on behalf of acoustic output.
Drop test (hand piece dropped from 1m on hard surface).
. Ball pressure test (pressed with steel ball 5mm in diameter with force of 20N one hour at a temperature of 75±2°C)
Moulding stress relief (device placed in circulating air oven at 70 °C for 7 hours and let cool down)

Clinical Studies

The same clinical and pre-clinical data supports the safe and effective use of Bindex Bl-100, to which substantial equivalence is shown.

The safety and effectiveness of Bindex Bl-2 device has been discussed in clinical evaluation document Section 16.

CONCLUSIONS VIII.

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The related safety standards are the same for the predicate and subject device. The same clinical evidence applies to both devices. In the present submission, the performance testing comparing the two models shows that the subject device is substantially equivalent to the predicate device and does not raise additional questions on safety or effectiveness.

Date: 12/02/2016

mm / dd / year

signature

Janne Karjalainen, CTO, Bone Index Finland Ltd.

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.