The Osteoboost Belt is indicated to reduce the decline in bone strength and volumetric bone density, as assessed via CT (computed tomography) scans that were analyzed using the O.N. Diagnostics VirtuOst estimate of vertebral bone strength and density in postmenopausal women with osteopenia of the lumbar vertebrae or total hip as diagnosed via dual x-ray absorptiometry with a bone mineral density T-score between -1.0 and -2.49.

. The clinical effects have only been observed for the duration of the clinical study performed to support the indications for use (1 year).
Fracture risk was not evaluated in the clinical study to support the indications for use, so . it is not known how the treatment effects correlate with fracture risk.
. The clinical effects have been demonstrated only for those who used the device as indicated.

Device Description

The Osteoboost is a wearable belt with an incorporated motor that is designed to transmit lowamplitude, high-frequency (20-40 Hz) vibration to the spine and hips. Osteoboost consists of a vibration pack mounted to a belt made of nylon-covered neoprene. The device is intended to be worn on top of a thin layer of clothing and positioned such that the vibration pack sits tightly over the sacrum. The device includes a pressure sensor under the foam pad to ensure that the device has been fastened with adequate pressure to transmit the vibration correctly. In addition, the belt incorporates an accelerometer positioned at the iliac crest which measures the actual transmission of vibration to the skeleton.

AI/ML Overview

The Osteoboost Belt is a wearable vibration device designed to reduce the decline in bone strength and volumetric bone density in postmenopausal women with osteopenia. The acceptance criteria for this device are established through a combination of clinical and non-clinical performance testing, software verification, and safety assessments.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Osteoboost Belt are primarily derived from the "SPECIAL CONTROLS" section of the document, indicating the requirements for Class II devices. The reported device performance is extracted from the "SUMMARY OF NONCLINICAL/BENCH STUDIES" and "SUMMARY OF CLINICAL INFORMATION" sections.

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance/Study Findings
Clinical Performance	Reduction in loss of bone strength or bone mineral density. Evaluation of patient risks (pain, dizziness, blurred vision, muscle weakness, difficulty with balance, headache, nausea). Broad range of demographics for at-risk population (minimum 1 year).	Effectiveness: Statistical significance achieved for a 0.48% reduction in bone strength in the active group vs. a 2.84% reduction in the sham group (a difference of 2.36%). A 0.29% volumetric BMD loss in the active group vs. 1.97% loss in the sham group (a difference of 1.68%). This benefit was only observed for subjects who used the device per protocol (at least 3 weekly sessions of 24 minutes each). Duration: 1 year follow-up. Population: 126 postmenopausal women with osteopenia (T-score -1.0 to -2.49). Predominantly Caucasian (95%), with only 5% non-Caucasian subjects. Safety/Risks: No device-related Serious Adverse Events (SAEs). Increased incidence of non-serious adverse effects (back pain, dizziness, muscle weakness) in the active group, reversible upon cessation of use.
Non-clinical Performance	Verification and validation of critical performance characteristics (designed outputs, delivered outputs). Accuracy, reliability, and reproducibility of device output. Validation that vibration characteristics are within safe physiologic limits.	Constant Acceleration: Motor frequency remained consistent within approximately ±1% throughout the battery voltage cycle and use-life. Vibration Transmission: Met acceptance criteria; hip acceleration for walking and light chores was larger than when standing still. Accelerometer Accuracy: Measurements from motor and hip accelerometers compared to a calibrated reference accelerometer during varied PWM values met acceptance criteria. Safety of Strong Vibrations: Acceptance criteria for maximum allowable vibration exposure per ISO 2631-1 was met.
Biocompatibility	Patient-contacting components demonstrated to be biocompatible.	Not needed, as the device is intended to be worn on top of a thin layer of clothing and does not contact the patient directly. Biocompatibility risk assessment following FDA guidance document "Use of International Standard ISO 10993-1" was conducted.
Electrical & Thermal Safety, EMC	Performance data for electrical safety, basic safety, thermal safety, battery safety, and electromagnetic compatibility.	Battery Safety: Compliant with IEC 62133-2:2017. Alarms System: Compliant with IEC 60601-1-8. Electrical Safety/EMC: Compliant with IEC 60601-1:2012, IEC 60601-1-2:2014, and IEC 60601-1-11:2015. Confirmed normal operation in simulated electrosurgical environment, no unintentional radiated emissions, met performance requirements for radiated power/receiver sensitivity/frequency range/channel bandwidth/out-of-band power, immune to electrosurgical equipment. Electrical safety and usability assessed. Test results supported EMC and electrical safety in worst-case running mode.
Software	Software verification, validation, and hazard analysis.	Verification Testing: Unit, integration, and system level testing performed. All features pertaining to pressure sensing and modulating vibration speed passed acceptance criteria. Firmware Version: 3.0, C-programming. Hazard Analysis: Performed (implied by the statement "Risk controls were implemented based on the Use Failure Mode Effects Analysis" in the alarms test section).
Labeling	Appropriate patient warnings/precautions. Summary of clinical performance testing (outcomes, AEs). Information regarding limitations of clinical significance. Identification of population studied. Instructions on duration/frequency of use, when to discontinue. Instructions for device maintenance/disposal.	Labeling includes: device description, indications for use, instructions for use, warnings, summary of clinical studies, specific population warnings, precautions, charging/cleaning instructions, shelf life/disposal instructions, adverse events, side effects, risks. Meets 21 CFR 801.109 for prescription devices. Includes information on limitations of clinical significance and percentage benefit vs. sham. Specific warnings include: not for osteoporosis; not evaluated in non-Caucasian women, high-risk factors, or BMI > 35; contraindications for certain medical conditions (herniated disc, spinal fusion, joint replacement, active implant); requires thin clothing layer. Details on duration and frequency (at least 3 weekly sessions of 24 minutes each) are provided in the clinical study results and imply inclusion in labeling.

2. Sample Sizes and Data Provenance

Test Set Sample Size: For the pivotal clinical trial, the sample size was 126 subjects.
Data Provenance: The study was conducted at a single U.S. site. It was a prospective randomized, sham-controlled, triple-blinded clinical trial.

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly state the number of experts used to establish the ground truth for the test set or their specific qualifications (e.g., radiologist with 10 years of experience).

However, the ground truth for the primary effectiveness endpoint relied on:

CT scans analyzed using the O.N. Diagnostics VirtuOst estimate of vertebral bone strength and density. This implies that the VirtuOst software/methodology serves as the "expert system" or a validated analytical approach for deriving the ground truth metrics (bone strength and volumetric bone density) from CT data.
DEXA T-score for initial diagnosis of osteopenia, which would typically be assessed by qualified medical professionals.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method (e.g., 2+1, 3+1) for the test set. Given that the primary endpoint involves quantitative measurements from CT scans analyzed by a specific software (VirtuOst) and DEXA T-scores, it is less likely that a human reader adjudication process (like those used for image interpretation in qualitative studies) would be explicitly mentioned for these endpoints. The "ground truth" here is derived from the analysis of medical imaging data using a specified, presumably validated, method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no indication that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The clinical study was a randomized, sham-controlled trial comparing the device's effect on bone strength and density against a sham device, rather than a study comparing human readers with and without AI assistance for diagnosis or interpretation. The device itself delivers a physical therapy, not an AI-powered diagnostic output to a human reader.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

The device is a physical therapy device (wearable vibration belt), not a diagnostic algorithm. Therefore, no standalone (algorithm-only) performance was done in the context of diagnostic accuracy. The "performance" being evaluated is the physiological effect of the device on bone health in human subjects.

However, the software embedded in the device (firmware) controls its operation. Verification testing for this embedded software ensured that it functions as designed, including controlling the motor, collecting data from sensors, and monitoring device functionality. This can be considered a "standalone" evaluation of the internal control system's performance, but not in the sense of a standalone diagnostic algorithm.

7. Type of Ground Truth Used

The type of ground truth used for the clinical study was based on:

Quantitative Imaging Biomarkers: Measurements of vertebral bone strength and volumetric bone density, assessed via CT scans analyzed using the O.N. Diagnostics VirtuOst estimate.
Clinical Diagnosis: Diagnosis of osteopenia via Dual X-ray Absorptiometry (DXA) with a bone mineral density T-score between -1.0 and -2.49.
Adverse Events: Self-reported or clinically observed adverse events/side effects established the safety ground truth.

These are objective quantitative measurements from validated diagnostic methods, rather than expert consensus on subjective interpretations, pathology, or solely outcomes data (like fracture rates, which were explicitly stated as not evaluated as a primary endpoint).

8. Sample Size for the Training Set

The document does not provide information on a "training set" for an AI algorithm. The Osteoboost Belt is a medical device that delivers a physical vibration, not an AI-driven diagnostic or predictive model that would require a large training dataset. The software within the device is firmware for control and data collection, not a learning algorithm.

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

As there is no mention of an AI-based training set for a learning algorithm, the concept of establishing ground truth for a training set is not applicable to the information provided about the Osteoboost Belt. The software (firmware) verification focused on "that the system functions as designed," implying functional validation against predefined specifications, not learning from data.

Summary

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DE NOVO CLASSIFICATION REQUEST FOR OSTEOBOOST BELT

REGULATORY INFORMATION

FDA identifies this generic type of device as:

Wearable vibration device for orthopedic use. A wearable vibration device for orthopedic use is a wearable device that uses mechanical vibrations, targeted to specific regions of the skeleton, to reduce loss of bone strength or bone mineral density.

NEW REGULATION NUMBER: 21 CFR 888.5895

CLASSIFICATION: Class II

PRODUCT CODE: QZO

BACKGROUND

DEVICE NAME: Osteoboost Belt

SUBMISSION NUMBER: DEN230015

DATE DE NOVO RECEIVED: February 17, 2023

SPONSOR INFORMATION:

Bone Health Technologies, Inc. 370 Convention Way Redwood City, California 94107

INDICATIONS FOR USE

The Osteoboost Belt is indicated as follows:

. The clinical effects have only been observed for the duration of the clinical study performed to support the indications for use (1 year).
Fracture risk was not evaluated in the clinical study to support the indications for use, so . it is not known how the treatment effects correlate with fracture risk.

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. The clinical effects have been demonstrated only for those who used the device as indicated.

LIMITATIONS PER EXCERPTED LABELING FOR THE OSTEOBOOST BELT

. WARNINGS

· This device is not indicated for patients with osteoporosis.
The device has been evaluated in a clinical study with a high majority of O Caucasian women without high-risk factors for developing bone fragility, such as heavy smoking, type I diabetes, renal disease, or a history of fractures. The safety and effectiveness of the device has not been evaluated in a significant number of non-Caucasian women, in subjects with high-risk factors for developing bone fragility, or in subjects with a BMI > 35.
· Let your doctor know before use of the Osteoboost if you have any of the following conditions: 1) are allergic to neoprene, 2) are being treated for a herniated disc, 3) have had a spinal fusion procedure, 4) have a joint replacement implant in the ankle, knee, or hip, or 5) have an active implant (e.g. implanted neurostimulator) in the areas of the lumbar or thoracic spine, pelvis, or buttocks.
O Do not apply Osteoboost directly to the skin. Wear a thin layer of clothing between the device and the skin.

PRECAUTIONS .

O Only charge the Osteoboost with the supplied charger.
PLEASE REFER TO THE LABELING FOR A COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.

LIMITATIONS OF THE CLINICAL STUDY DATA

The clinical effects have only been observed for the duration of the clinical study . performed to support the indications for use (1 year).
. Fracture risk was not evaluated in the clinical study to support the indications for use, so it is not known how the treatment effects correlate with fracture risk.
. The clinical effects have been demonstrated only for those who used the device as indicated.
In the clinical study of the device, a very high majority of Caucasian patients were . evaluated (under-represented non-Caucasian population). Therefore, the effect of using the device in non-Caucasian population is not clearly demonstrated.
. The safety and effectiveness of the device has not been evaluated in patient populations with high-risk factors for developing bone fragility or fractures, such as heavy smoking,

DEVICE DESCRIPTION

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For a complete description of the device system components and subsystems, please refer to the accompanying labeling for additional details.

Image /page/2/Picture/2 description: The image shows a black wearable device with several numbered labels pointing to different parts. Label 1 points to the bottom edge of the device, while label 2 points to a gray module in the center. Labels 3, 4, and 5 point to the left side of the device, and labels 6, 7, 8, and 9 point to the right side.

Figure 1. Front view of the Osteoboost: (1) Nylon-covered neoprene belt, (2) vibration pack (housed of the back of the neoprene belt), (3) inner Velcro, (4) mylon straps, (5) clasp, (6) power button, (7) battery status light, (8) attention light, (9) hip accelerometer (located in the neoprene belf).

Belt

The Belt is comprised of several layers of neoprene, to which were added Velcro fasteners, nylon webbing loops, a zipper, and component pockets. Each layer of neoprene has a thin nylon fabric laminated on either side. The middle structural layer, which is 3 mm thick, supports most of the weight of the vibration pack and provides some rigidity. The outer layers of neoprene are 1 mm thick.

Image /page/2/Figure/6 description: The image shows a diagram of a product, labeled as "Size: Small (106 cm)". The diagram shows three separate pieces, one red, one tan, and one blue. The image also contains labels for the materials used, including "1.5mm LOOPTIK NEOPRENE", "1.5mm NEOPRENE", and "4mm NEOPRENE".

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Vibration Pack

The vibration pack uses a battery-powered rotating-mass motor controlled by pulse-width modulation (PWM) with duty cycle that can be tuned to change the rotation frequency and amplitude (over the motor frequency range of 20-40 Hz). The motor is attached to and oriented within the pack so to transmit vibration to the patient primarily in the sagittal plane (x- and zaxes, where the z-axis is parallel to the patient's height axis/long body axis).

Image /page/3/Picture/2 description: The image shows an exploded view of a device with various numbered components. Component 1 is a teal-colored, circular housing with screws. Component 3 is a green circuit board with electronic components, and component 6 is a cylindrical motor. The image also shows screws labeled 7, 8, 11, and 12, as well as plates labeled 9 and 10.

sploded view of vibration pack showing (clockwise from top): [1] Battery nack PCBA (4) PCBA scrows x 3 (5) Top half of housing (6) Motor (7) Motor using screws (7 in (otal) (9) Motor mount plate (10) Back plate (11) Belt attachmen

Software

The only software for the device is the firmware on the Osteoboost. There are no mobile medical apps or separate software associated with the subject device. The software controls the power level at which the motor operates along with data from all peripherals including the belt-fit force sensor, accelerometers, motor driver, and the batterv's fuel gauge and records this information to an onboard flash chip. It also monitors device functionality, such as battery temperature and motor current.

Accelerometers

The Osteoboost has two accelerometers. The main accelerometer, embedded within the neoprene belt, is used to quantify transmission of acceleration from the pack to the patient. A secondary accelerometer is located on the PCBA (Printed Circuit Board Assembly) proximal to the motor. where it is used to monitor motor activity directly. The accelerometers utilize MEMS (Micro-Electro-Mechanical Systems) technology. There are several sensors in Osteoboost which have a maximum range of ±16 g (although this range is set to ±4 g in practice to increase sensitivity) and is capable of high-resolution data rates up to 1.6 kHz.

Battery

The device is powered by a rechargeable lithium ion (Li-ion) 2000 mAh battery pack (RRC1120. RRC Power Solutions. Yorba Linda. California). The battery can last at least 3 treatment sessions before needing to be recharged. The battery is recharged using a supplied 5-V AC-DC power supply (wall wart) which plugs into a standard 120/240V outlet. The battery pack

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complies with all applicable safety standards including: UL2054. IEC62133, UN38.3, RoHS, REACH, and TIS 2217-2548.

SUMMARY OF NONCLINICAL/BENCH STUDIES

BIOCOMPATIBILITY/MATERIALS

The device is intended to be worn on top of a thin layer of clothing and the device does not contact the patient directly or indirectly. Based upon a biocompatibility risk assessment following the FDA guidance document "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", biocompatibility testing was not needed for this device.

SHELF LIFE/STERILITY

The subject device is a non-critical, non-sterile, single patient use device, that is for use in the home environment and is not expected to be used in a healthcare environment. Reprocessing instructions are included in the labeling. Any additional cleaning beyond what is currently stated in the instruction for use is not needed. There is no shelf life for this device.

Package performance testing was tested to ISTA-6-FEDEX-A, a specific test protocol created to perform the testing applicable to ISTA 3A (Recognition Number 5-126) but specifically formulated to cover the environmental conditions experience during FedEx air and ground shipping of packages weighing up to 150 lbs. One of each size of device (small, medium, and large) was packaged, shipped via FedEx, and tested according to ISTA-6-FEDEX-A.

ELECTROMAGNETIC CAPABILITY & ELECTROMAGNETIC SAFETY

Electromagnetic compatibility and electrical safety testing were performed in accordance with the following standards:

IEC 60601-1:2012 Medical electrical equipment Part 1: General requirements for . basic safety and essential performance;
IEC 60601-1-2:2014 Medical electrical equipment Part 1-2: General . requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances- Requirements and tests;
IEC 60601-1-11:2015 Medical electrical equipment Part 1-11: General . requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.

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The objectives of the series of tests to support electromagnetic compatibility and electrical safety, included the following:

The device should operate normally following exposure to a simulated . electrosurgical environment and shall not exhibit unintentional radiated emissions above recommended limits.
. The device should meet performance requirements related to radiated power. receiver sensitivity, frequency range, channel bandwidth and out-of-band power.
The testing should verify that the device does not exhibit unintentional radiated . emissions above recommended limits and is immune to electrosurgical equipment.
The testing should assess the electrical safety and usability of the subject device . components in the appropriate use setting.
. The testing should assess the safety, compatibility, radio frequency, and magnetic immunity.

The test results supported electromagnetic compatibility and electrical safety of the device use in its worst-case running mode.

SOFTWARE

Software Description

The Osteoboost device includes embedded firmware to control the operation of the device by the user. This medical device software is only active when the device has been turned on and deactivates when the device has been turned off. While the device is operating, the main routines of the software can be broken down into three categories:

. Motor Control
The motor power level is controlled by sending a Pulse-Width Modulated (PWM) signal from the processor to the motor driver.
Data collection .
During the calibration phase, the motor PWM is set to the default value, and acceleration amplitudes are recorded from the accelerometers located on the hip and on the back (near the motor).
. Device monitoring
The software continuously monitors the belt-fit force sensor to ensure adequate pressure is being applied to the patient. The software also continuously monitors the battery temperature and fuel gauge, the motor driver current limits and software watchdogs.

Verification testing

Software verification testing activities were performed for the software components to verify that the system functions as designed. Testing of the software components occurred at the unit, integration, and system level, as appropriate. Following completion of the verification procedures, all features pertaining to pressure sensing and modulating

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the vibration speed of the accelerometers to deliver the therapeutic treatment passed the testing acceptance criteria.

Revision Level History The current version of firmware component is as follows: Embedded firmware-Version 3.0 C-programming

PERFORMANCE TESTING - BENCH

· Battery Safety and characterization testing

The battery testing on the safety of the rearrangeable Lithium-Ion battery cell used in the Osteoboost Belt was conducted according to IEC 62133-2:2017, Secondary cells and batteries containing alkaline or other non-acid electrolytes -Safety requirements for portable sealed secondary cells, and for batteries made from them. for use in portable applications - Part 2: Lithium systems and was found to be in compliance with the standard.

. Alarms system testing

The alarm systems in the Osteoboost Belt followed IEC 60601-1-8 ("General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems") and was found to be compliant with the standard. Risk controls were implemented based on the Use Failure Mode Effects Analysis.

Bench verification testing for Constant Acceleration Throughout the Use-. Life of the Device

A verification test was performed to evaluate whether the device is capable of generating a constant acceleration throughout the use-life of the device, including both during each individual charge/discharge cycle of the battery, and across the use-life of the battery. To confirm the motor frequency does not vary over the lifetime of the device, the motor was run at a set input with a fully charged battery, the motor frequency was measured using a tachometer, and the motor continued to run over the range of voltages provided by the battery until it was fully depleted. The motor frequency variability was calculated over the life of the battery, and a percentage deviation from worst-case condition was provided. The acceptance criteria of the motor frequency remaining consistent throughout the battery voltage cycle and maintain within a range of approximately ±1% was met.

. Testing to evaluate the Range of Vibration Transmission to Targeted Anatomic Locations

A verification test was performed to evaluate whether the range of vibration transmission to targeted anatomic locations during different common activities was effective or not. The test monitored vibration levels experienced at the hip while performing activities described in the labeling for different body types. The

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acceptance criteria accounted for the hip acceleration for walking and performing light chores being larger than when the user is standing still. The device met the acceptance criteria.

Accuracy testing for accelerometers. .

A verification test was performed to evaluate whether the accelerometers support the effective use of the device in measuring and delivering appropriate vibrations. The testing consists of mounting the device and a paired hip accelerometer to a cantilevered plate with a calibrated reference accelerometer. The device motor is run at three different Pulse-Width Modulation (PWM) values to capture a range of vibration frequencies and amplitudes. A cantilevered plate was chosen to amplify the vibration measurements to reduce the effect of noise on the accelerometer measurements. Measurements from the Motor and Hip Accelerometers on the device were compared to measurements from the calibration reference accelerometer placed near the motor as acceptance criteria, which was met by the device.

Bench testing for safety assessment of strong vibrations .

A verification test was performed to evaluate the impact on the patient by the strong vibrations which are used for the proposed duration of treatment, specifically addressing the structures immediately surrounding the vibration box. Testing on the safety of the vibration to the hips and spine, with acceptance criteria, was compared against ISO 2631-1 (Ed. 2.0): 1997 + A1:2010, Mechanical vibration and shock - Evaluation of human exposure to whole-body vibration. While this standard is not directly applicable to the Osteoboost Belt because it does not create "whole-body vibration", the specific recommendations are used to set a general vibration safety standard for the design of the Osteoboost Belt along with literature articles supporting the use. In this test, acceptance criteria for the maximum allowable vibration exposure for safety. per ISO 2631-1. was met. Further, the results are also leveraged based on the clinical study and results.

SUMMARY OF CLINICAL INFORMATION

The sponsor conducted a randomized, sham controlled, "triple-blinded" (subject, Principal Investigator and Clinical Research Coordinator, as well as outcomes assessors), prospective, pivotal clinical trial consisting of 126 subjects at a single U.S. site. The study enrolled postmenopausal female subjects older than age 50 years diagnosed with low bone mass (osteopenia) defined by a DEXA T-score between -1.0 and -2.49. The majority of the subject population was Caucasian women (120/126; 95%), with only 6/126 (5%) non-Caucasian subjects.

Enrolled Population	Aged 52-82Osteopenia (DXA T-score between -1.0 and -2.49)Caucasian women (120/126; 95%), with only6/126 (5%) non-Caucasian subjects
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Excluded Population	Osteoporotic population High Fracture Risk Assessment(FRAX) score Type I Diabetes Heavy smoking Severe alcoholic history of severe renal disease orkidney failure treated for a herniated disc BMI > 35
	Had had a spinal fusion procedure Had an active implant (e.g., implantedneurostimulator) in the areas of thelumbar or thoracic spine, pelvis, orbuttocks Had had a major change in high-impact physical activity level(increase or decrease) in the past 3months Had undergone or was undergoingtransgender hormone therapy Had cancer and/or was being treatedfor cancer

The primary effectiveness endpoint was a comparison of the mean percentage change in vertebral bone strength between the active and sham treatment groups, as calculated at baseline and 12 months. The surrogate for lumbar vertebral bone strength was based on bone mineral density (BMD). BMD was measured by first lumbar vertebrae (L1) volumetric CT at baseline and at 12 months from which finite element analysis was used to estimate vertebral bone strength. The primary endpoints of BMD and Bone Strength are indirect measures of benefit (not demonstrated to correlate with fractures), and not the endpoints of fracture reduction. Safety was evaluated by adverse events. The sponsor provided 12 months of follow-up on all enrolled subjects.

The results showed that statistical significance, which corresponded to a 0.48% reduction in bone strength for patients who used the device versus an 2.84% reduction in bone strength for patients who used a sham, non-therapeutic version of the device, was only achieved for people who used the device for at least 3 weekly sessions of 24 minutes each (the number of patients who completed the study per protocol was 57.9% (73/126) of those randomized). There were no device-related Serious Adverse Events (SAEs). There were increased incidences of other adverse effects/side effects (e.g., back pain, dizziness, muscle weakness) in the active treatment group as

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compared to the sham group; however, these effects were reversible upon cessation of use of the device.

The clinical results indicate minimal risk to post-menopausal osteopenic women ( refer to labeling for detailed description of population) when the Osteoboost belt is used as indicated.

LABELING

The labeling includes the following: device description, indications for use, instructions for use, warnings, summary of clinical studies, clinical study population specific warnings, precautions, charging and cleaning instructions, shelf life and disposal instructions, adverse events, side effects and risks. The labeling meets the requirements of 21 CFR 801.109 for prescription devices. The labeling also includes information regarding the limitations of clinical significance of device output, as well as information about the percentage benefit when compared to sham device.

RISKS TO HEALTH

The table below identifies the risks to health that may be associated with use of a wearable vibration device for orthopedic use and the measures necessary to mitigate these risks.

Risks to Health	Mitigation Measures
Accelerated loss of bone strength andbone mineral density resulting fromapplication of inappropriate magnitudeand/or frequency of vibration	Clinical performance testing
	Non-clinical performance testing
	Human factors/usability evaluation
	Software verification, validation, and hazard analysis
	Electromagnetic compatibility testing
	Labeling
Adverse tissue reaction	Biocompatibility evaluation
Patient injury due to electrical,mechanical, or thermal hazards	Electrical safety testing
	Electromagnetic compatibility testing
	Mechanical and thermal safety testing
	Software verification, validation, and hazard analysis
	Labeling
Adverse effects on the patient such asregional pain, dizziness, difficulty withbalance, headache, nausea, blurredvision, muscle weakness	Clinical performance testing
	Labeling
User error leading to ineffectivereduction in loss of bone strength orbone mineral density	Clinical performance testing
	Human factors/usability evaluation
	Labeling

SPECIAL CONTROLS

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In combination with the general controls of the FD&C Act, the wearable vibration device for orthopedic use is subject to the following special controls:

(1) Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must evaluate the reduction in loss of bone strength or bone mineral density. Testing must evaluate patient risks, including regional pain, dizziness, blurred vision, muscle weakness, difficulty with balance, headache, nausea. The testing should include a broad range (demographics) for at-risk population studied for a minimum of 1 year.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following must be provided:
- (i) Verification and validation of critical performance characteristics of the device, including characterization of the designed outputs of the device as well as the outputs that are delivered to the patient;
- (ii) Non-clinical testing to demonstrate the accuracy, reliability, and reproducibility of device output;
- Validation that vibration characteristics are within safe physiologic limits; and (iii)
The patient-contacting components of the device must be demonstrated to be (3) biocompatible.
Performance data must be provided to demonstrate the electrical safety, basic safety, (4) thermal safety, battery safety, and electromagnetic compatibility of the device.
Software verification, validation, and hazard analysis must be performed. (5)
Labeling must include the following: (6)
- (i) Appropriate patient warnings and precautions associated with the use of the device:
- (ii) A summary of the clinical performance testing with the device, including clinical outcomes and observed adverse events:
- (iii) Information regarding limitations of the clinical significance of the clinical performance data:
- (iv) Identification of the population studied;
- Instructions on duration and frequency of use, and when to discontinue use of the (v) device: and
- Instructions for device maintenance, including appropriate cleaning of any (vi) reusable components and safe disposal of the device.

BENEFIT-RISK DETERMINATION

The probable risks of the device are based on data collected in a clinical study described above.

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There were no observed device-related SAEs. However, the adverse events associated with the use of the device were observed more frequently in the active treatment group than in the sham group. The most common adverse events were related to dizziness, lower or upper back pain, muscle weakness. leg or pelvic pain, tenderness or bruising at site of application and adverse skin reactions. However, it is noted that the observed adverse events/side effects/risks of the device were reversed with cessation of use of the device.

The probable benefits of the device are also based on data collected in a clinical study as described above.

The primary endpoints of reduction in the loss of BMD and Bone Strength are indirect measures of benefit and do not constitute direct endpoints of fracture reduction. The marginal statistical benefit observed between the active and sham groups (who used the device as indicated) show that the treatment group lost 0.48% of vertebral bone strength compared to a 2.84% loss in the sham group, while the treatment group lost 0.29% of their volumetric BMD compared to 1.97% in control subjects. Therefore, the difference of 2.36% in the decline of vertebral bone strength and the difference of 1.68% in the decline of volumetric BMD are considered as statistical benefit for this device. It should be noted that the endpoints used (vBMD and Bone Strength). while not direct assessments of fractures (i.e., the evidence supporting probable clinically relevant benefit is uncertain), are nonetheless important parameters that can impact fracture risk assessment.

Some additional factors that impact the device's benefit-risk profile are related to the population evaluated in the clinical study of the device. In the study of the device, a high majority of the evaluated patients were Caucasian, and non-Caucasian populations were underrepresented. Therefore, the clinical benefits of using the device in non-Caucasian populations have not been extensively demonstrated. Evaluated patients also lacked high risk factors for developing bone fragility such as heavy smoking, type I diabetes, history of fractures, or renal disease. Furthermore, subjects with a BMI >35 were not evaluated. The clinical benefit of the device (statistical benefit of 2.36% bone strength and 1.68% of BMD) is only observed for subjects who used the device per protocol.

This device is not indicated for patients with osteoporosis.

The device is a prescription use device with low risks (adverse events/side effects) that are reversible upon cessation of use of the device and demonstrated clinical benefit in slowing the age-related progressive loss of bone strength and bone mineral density in postmenopausal women with osteopenia.

Patient Perspectives

The low number of subjects completing the study per protocol, raises concerns towards the compliance of the device while using it. However, the low sample size was attributed to nondevice related reasons. Further, results from a patient preference survey were provided.

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Patient perspectives considered for the Osteoboost Belt during the review include information that captures relative acceptability of outcomes and favorable response in using the device.

Benefit/Risk Conclusion

In conclusion, given the available information above, for the following indication statement:

The Osteoboost Belt is indicated to reduce the decline in bone strength and volumetric bone density, as assessed via CT scans that were analyzed using the VirtuOst estimate of vertebral bone strength and density in postmenopausal women with osteopenia of the lumbar vertebrae or total hip as diagnosed via DXA with a BMD T-score between -1.0 and -2.49.

The clinical effects have only been observed for the duration of the clinical study . performed to support the indications for use (1 year).
Fracture risk was not evaluated in the clinical study to support the indications for . use, so it is not known how the treatment effects correlate with fracture risk.
. The clinical effects have been demonstrated only for those who used the device as indicated.

The probable benefits outweigh the probable risks for the Osteoboost Belt. The device provides benefits, and the risks can be mitigated by the use of general controls and the identified special controls.

CONCLUSION

The De Novo request for the Osteoboost Belt is granted and the device is classified as follows:

Product Code: QZO Device Type: Wearable vibration device for orthopedic use Regulation Number: 21 CFR 888.5895 Class: II

Regulation Number and Section

N/A