The SMART Device is intended to aid in weight management in overweight to obese individuals. The device is indicated for individuals with a body mass index (BMI) in the range 27-35 kg/m2 in conjunction with behavioral modification instruction.

Device Description

The SMART Device is an oral removable palatal space occupying device that includes an embedded temperature recording sensor. The device is intended to be worn only during meals. to limit bite size and slow the intake of food, thereby reducing the amount of food that is consumed. The SMART Device is available using wire clasps and using a wraparound method (the wraparound technique is an added alternative to accommodate different oral anatomies) where the wires are coated with acrylic and wrapped around teeth in a symmetrical manner to secure the fit of the device (see Figure 1, below). The device is then removed after each meal or snack and the patient or healthcare professional has the option to use the temperature recording sensor embedded in the device to monitor device usage. This component of the SMART Device automatically records adherence, eliminating manual record-keeping by the user. The sensor is operated by a 3 volt lithium coin battery and measures ambient temperature at 5 minute intervals, storing the time and temperature data. The battery and the sensor are both double-encased and hermetically sealed in the acrylic. The SMART Device is provided with the Palatal Mold Kit and SMART Reader components. The Palatal Mold Kit is used to fabricate the SMART Device to match the patient's oral anatomy. The device is made from a mold of the upper oral cavity of the patient taken by a trained healthcare provider using the Palatal Mold Kit. The SMART Reader (See Figure 2, below) is an optional component that connects the sensor to a computer. Usage data are uploaded using infrared data transfer and a record of use can be produced. The user is provided instructions to download software for communicating between a personal computer and the SMART Reader and for displaying the time of day that the SMART Device was used. This software allows information from the embedded sensor to be uploaded to a secure, password protected Patient Portal website. Use of the Patient Portal allows the patient or healthcare provider to assess frequency of device usage.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Sensor Monitored Alimentary Restriction Therapy (SMART) Device, based on the provided text:

Acceptance Criteria and Reported Device Performance

Test/Endpoint	Acceptance Criteria	Reported Device Performance	Met Criteria?
Non-Clinical Performance
Force Measurement	Exerted force b(4)	Passed	Yes
Durability Measurement	No abrasions, tears, separation, or indications of wear for simulated use of 1.2 years (438 days)	Passed	Yes
Battery Life	Battery use life ≥ 1.2 years (438 days)	Passed	Yes
Clinical Performance (Pivotal Study - Primary Endpoint)
%TBWL (ITT Population)	40% of the device group would achieve 5% total body weight loss (%TBWL) as compared to 10% or less of the control group	20.6% (21 of 102) lost more than 5% TBWL (p=0.0059) compared to 5.6% (4 of 71) in control.	No
Clinical Performance (Confirmatory Study - Co-Primary Endpoints)
%TBWL (PP Population) - Co-primary 1	At least 40% of the subjects would be observed to have at least 5% weight loss (%TBWL)	30% (12 of 40) had at least 5% TBWL. (95% CI: [17%, 47%])	No
Mean %TBWL (PP Population) - Co-primary 2	Mean %TBWL would be at least 4%	Mean %TBWL was 2.9% [95% CI: 1.8%, 4.1%]	No
Clinical Performance (Pivotal Study - Safety)
Device-related Adverse Events	Incidence of adverse events (goal of less than 10%)	4.9% (5 of 102) device-related AEs. (95% CI: [1.6%, 11.1%])	Ambiguous*
Clinical Performance (Confirmatory Study - Safety)
Device-related Adverse Events	Not explicitly stated as a numerical acceptance criterion, but low incidence of non-serious events is implied.	2 (out of 24 total AEs in 12 subjects) were possibly device-related.	Yes
Clinical Performance (Confirmatory Study - Secondary Endpoint)
Clinical fit of the device	Implicit: Good clinical fit	100% (20 of 20) subjects assessed for fit by dental professionals were determined to have good clinical fit.	Yes
Clinical Performance (Consumer Preference Study)
Subject Acceptance/Satisfaction	High acceptance and satisfaction	Subjects reported comfortable use within 1-3 days; acceptance and satisfaction high.	Yes

*Note on Safety Criteria for Pivotal Study: While the observed rate (4.9%) was less than 10%, the 95% confidence interval [1.6%, 11.1%] extended above 10%, meaning it couldn't be definitively claimed that the true rate was less than 10%. However, the events were non-serious and resolved, supporting a favorable safety profile overall.

Study Details

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

Pivotal Study:

Test Set Sample Size (ITT Population): 173 subjects (102 device group, 71 control group)
Test Set Sample Size (PP Population): 108 subjects (41 device group, 67 control group)
Data Provenance: Prospective, randomized, controlled, open-label study conducted at five US centers.

Confirmatory Study:

Test Set Sample Size (ITT Population): 76 subjects
Test Set Sample Size (PP Population): 40 subjects
Data Provenance: Prospective, single-arm, multicenter study conducted at 4 US investigational centers.

Consumer Preference Study:

Test Set Sample Size: 24 subjects
Data Provenance: A separate consumer and provider acceptance study; presumed prospective.

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

Pivotal & Confirmatory Studies: The ground truth for weight loss was established through direct measurement of body weight by study personnel at study site assessments. No expert consensus on image interpretation or similar cognitive tasks was required for the primary and secondary endpoints related to weight.
Confirmatory Study (SMART Fit Acceptability Sub Study): "Dental professionals assessed clinical fit of the device in 20 subjects." Their specific qualifications (e.g., years of experience) are not provided, but they are identified as "dental professionals."

4. Adjudication Method for the Test Set

Pivotal & Confirmatory Studies: Not applicable for the primary endpoints, which involved objective measurements (weight, device usage via sensor data). Adverse events would typically be adjudicated by the study investigators and reported to the sponsor, but a specific multi-expert adjudication method (e.g., 2+1) is not explicitly described.

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

No MRMC study was done. This device does not involve human readers interpreting images or data to make a diagnosis or assessment where AI assistance would directly improve their performance on a cognitive task. This is a physical medical device for weight management, and clinical outcomes were measured directly.

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

Yes, in part. The device's sensor automatically records adherence, providing data independently of human input for that specific function. However, the overall device effectiveness for weight management is and was evaluated in human subjects in conjunction with behavioural modification, making it a human-in-the-loop system for its intended use. The clinical studies measured the device's standalone effect on patients (when used as intended by patients), rather than an algorithm's standalone performance on a dataset.

7. Type of Ground Truth Used

Pivotal & Confirmatory Studies: Objective Clinical Measurements (e.g., measured body weight at baseline and follow-up for %TBWL, sensor data for device usage/adherence) and Adverse Event Reporting by investigators.
Confirmatory Study (Fit Sub Study): Expert Assessment by dental professionals for clinical fit.
Consumer Preference Study: Patient Self-Report for acceptance and satisfaction, and Objective Clinical Measurements (measured body weight) for weight loss.

8. Sample Size for the Training Set

Not Applicable. The SMART Device is a physical medical device, not an AI/ML algorithm that requires a "training set" in the computational sense. The "training" that occurred was the device's development and iterative testing.

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

Not Applicable. As above, there is no "training set" in the context of an AI/ML algorithm. The "ground truth" for the device's design and functionality would have been established through engineering specifications, previous research on palatal devices, and pre-clinical bench testing.

Summary

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DE NOVO CLASSIFICATION REQUEST FOR

Sensor Monitored Alimentary Restriction Therapy (SMART) Device

REGULATORY INFORMATION

FDA identifies this generic type of device as:

Oral removable palatal space occupying device for weight management and/or weight loss. An oral removable palatal space occupying device for weight management and/or weight loss is a prescription device that is worn during meals to limit bite size, thereby reducing the amount of food that is consumed. The device may contain recording sensors for monitoring patient use. This classification does not include devices that are intended to treat any dental diseases or conditions.

NEW REGULATION NUMBER: 21 CFR 876.5981

CLASSIFICATION: Class II

PRODUCT CODE: ONY

BACKGROUND

DEVICE NAME: Sensor Monitored Alimentary Restriction Therapy (SMART) Device

SUBMISSION NUMBER: DEN150033

DATE OF DE NOVO: July 31, 2015

CONTACT: Scientific Intake 1835 Market Street, 29th Floor2859 Paces Ferry Road Atlanta, GA 30339

REQUESTER'S RECOMMENDED CLASSIFICATION: Class II

INDICATIONS FOR USE

LIMITATIONS

The sale, distribution, and use of the device are restricted to prescription use in accordance with 21 CFR §801.109.

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Healthcare professional use of the device requires completion of a training program for determining a patient's oral health status, making a palatal mold, and assessing potential issues with the device that may require service by the manufacturer.

In the clinical study of the device, patients were required to use the SMART Device along with a weight management program of nutrition, diet, and exercise instruction provided on DVD.

PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.

DEVICE DESCRIPTION

Figure 1. SMART Device

Image /page/1/Picture/6 description: The image shows two different views of a dental appliance. The appliance is made of a clear, pinkish plastic material and has a blue circular sticker with the word "smart" printed on it. In one view, the appliance is shown on its own, while in the other view, it is placed on a dental model with teeth.

*wire clasp version (left) and wraparound version (right)

The device is then removed after each meal or snack and the patient or healthcare professional has the option to use the temperature recording sensor embedded in the device to monitor device usage. This component of the SMART Device automatically records adherence, eliminating manual record-keeping by the user. The sensor is operated by a 3 volt lithium coin battery and measures ambient temperature at 5 minute intervals, storing the time and temperature data. The battery and the sensor are both double-encased and hermetically sealed in the acrylic.

The SMART Device is provided with the Palatal Mold Kit and SMART Reader components. The Palatal Mold Kit is used to fabricate the SMART Device to match the patient's oral anatomy. The device is made from a mold of the upper oral cavity of the patient taken by a trained healthcare provider using the Palatal Mold Kit.

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The SMART Reader (See Figure 2, below) is an optional component that connects the sensor to a computer. Usage data are uploaded using infrared data transfer and a record of use can be produced. The user is provided instructions to download software for communicating between a personal computer and the SMART Reader and for displaying the time of day that the SMART Device was used. This software allows information from the embedded sensor to be uploaded to a secure, password protected Patient Portal website. Use of the Patient Portal allows the patient or healthcare provider to assess frequency of device usage.

Figure 2. SMART Reader

Image /page/2/Picture/2 description: The image shows a white, electronic device with a rounded bottom and a cord coming out of the top. The device has a recessed area at the top, which appears to be a scanner. Below the scanner is a blue button with the word "smart" on it, and below that is the phrase "COMPLIANCE READER". The device is sitting on a dark blue surface.

SUMMARY OF NONCLINICAL/BENCH STUDIES

Non-clinical/bench studies conducted on the SMART Device to demonstrate a reasonable assurance of safety and effectiveness of the device are summarized below.

BIOCOMPATIBILITY/MATERIALS

Based on the nature of contact and duration of exposure, the SMART Device is considered a surface device, mucosal membrane contacting for a limited duration. In accordance with ISO10993-1. Biological evaluation of medical devices, the following tests were performed on the SMART Device:

· Cytotoxicity
· Sensitization
· Irritation

The results supported the biocompatibility of the SMART Device.

Based on the nature of contact and duration of exposure, the Palatal Mold Kit is considered a surface device, mucosal membrane contacting for a limited duration. Previous clearance (K082560) of the Palatal Mold Kit materials and biocompatibility testing certification from the manufacturer support the biocompatibility of the Palatal Mold Kit.

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SHELF LIFE/STERILITY

The SMART Device is provided non-sterile. The expected use life of the SMART Device is 1.2 years, based on the clinical and non-clinical testing.

ELECTROMAGNETIC COMPATIBILITY AND ELECTRICAL SAFETY

Electromagnetic Compatibility (EMC):

The SMART Device was evaluated for conformance to IEC 60601-1-2 (2014), and was found to comply with all applicable requirements of this EMC testing standard.

Electrical Safety:

The SMART device was evaluated for conformance to ANSI/AAMI ES60601-1 (2012) (general requirements) and IEC 60601-1-11 (2010) (electrical systems used in a home healthcare environment). Review of the results concluded that the device complies with all of the electrical safety requirements specified in this standard.

SOFTWARE

The SMART Device software functions to communicate with the SMART Reader and to collect data from the sensor and send information to a Patient Portal website.

The software/firmware was reviewed according to the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005. Details of the software review are described below:

. The graphing component of the software in the Online Portal uses Microsoft Excel.
. The software provides graphing tools and a macro-programming language. The device uses Microsoft Excel, by Microsoft Corporation, Version 2003 (11.6355.6360 SP1), release date 2003.
All of the elements of software documentation corresponding to the risk level of ● the software ("Minor" Level of Concern as outlined in FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices) was provided and is adequate. The following software documentation, specified in the FDA document Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," was provided and is adequate.

PERFORMANCE TESTING - BENCH

Non-clinical performance tests were conducted to demonstrate mechanical integrity and functionality of the SMART Device. Table 1 below summarizes each of these bench tests, which included appropriate acceptance criteria for the intended use of the device.

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Test	Purpose	Acceptance Criteria	Results
ForceMeasurement	Testing was performed todetermine the amount ofcompression force placed onthe premolars and molars	Exerted force b(4)	Passed
DurabilityMeasurement	Testing was performed todetermine durability ofsimulated use	No abrasions, tears,separation, or indicationsof wear for simulated useof 1.2 years (438 days)	Passed
Battery Life	Testing was performed todetermine the use life of thebattery	Battery use life ≥ 1.2years (438 days)	Passed

Table 1. Summary of Non-clinical Performance Testing

SUMMARY OF CLINICAL INFORMATION

Clinical data from a pivotal and confirmatory study were leveraged to evaluate the safety and effectiveness of the SMART Device.

Pivotal Study:

The pivotal study was a randomized (1:1:5), controlled, prospective, open-label study to evaluate the safety and effectiveness of the device in an overweight to obese population (BMI of 26-36 kg/m²), along with a weight management program of nutrition, diet, and exercise instruction provided on a DVD. Subjects who met the inclusion and exclusion criteria and successfully completed a 4 week weight-stabilization period were weighed and randomized to one of the two groups. The device group received the SMART Device, plus nutrition, diet and exercise education via a DVD. The control group received the same nutrition, diet and exercise education via a DVD. Study site assessments occurred every two weeks through 16 weeks at which time the subjects were weighed, assessed for any adverse events, and watched the educational DVD. One-hundred seventy-three (173) subjects completed the screening and weight stabilization periods and were randomized into device (n=102) and control (n=71) groups at five US centers. This population constituted the intent-to-treat (ITT) population. The ITT population included all enrolled subjects with any missing data filled-in using the last observation carried forward (LOCF) approach. The per protocol (PP) population (n= 41 device, n=67 control) included the subjects who were adherent to study protocol, with attendance of at least 4 of 7 visits for both groups, and, for the device group, use of the device at least 33% of the time. The primary effectiveness endpoint was that 40% of the device group would achieve 5% total body weight loss (%TBWL) as compared to 10% or less of the control group, as measured at the end of the 4 month study period. Secondary endpoints included an evaluation of the incidence of adverse events (goal of less than 10%) and differences in the SF-36 (Quality of Life 36 Question 'Sort Form') scores between the treatment and control group.

Pivotal study results demonstrated, in the ITT population, that 20.6% (21 of 102) lost more than 5% TBWL as the end of the 16 week study as compared to 5.6% (4 of 71) of the control group that lost more than 5% TBWL. Therefore the pivotal study did not meet the primary effectiveness endpoint. The PP population demonstrated that 48.8% (20 of 41) lost more than 5%

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TBWL as the end of the 16 week study as compared to 4.5% (3 of 67) of the control group that lost more than 5% TBWL.

The ITT population demonstrated 1.65% TBWL at 16 weeks as compared to the control group that demonstrated 0.36% TBWL. The PP population demonstrated 4.39% TBWL as compared to the control group that demonstrated 0.29% TBWL at 16 weeks. In regard to excess weight loss (EWL), at 16 weeks, the ITT population demonstrated 14.55% EWL as compared to the control group that demonstrated 3.95% EWL. The PP population demonstrated 38.14% EWL as compared to the control group that demonstrated 2.31% EWL. There were no clinical significant changes in the SF-36 scores between the treatment and control groups.

The pivotal study demonstrated that there were 6 device-related adverse events in 5 subjects. The observed device-related AE rate of 4.9% (5 of 102) is less than the pre-defined goal of 10%. However, the 95% confidence interval for this rate was [1.6%, 11.1%], so it cannot be claimed that the true device-related AE rate is less than 10%. These events were classified as non-serious and were resolved quickly without need for further medical intervention (transient choking on food (n=2), gag reflex on insertion (n=1), mouth soreness (n=1) and gum irritation (n=2)). No serious adverse events (SAEs) were associated with use of the SMART Device.

Due to failure to meet the pre-specified primary endpoints, high dropout rates (only 41 subjects were included in the PP population), and non-compliance (35 of 102 of the treatment group were excluded) of device usage in the pivotal study, the sponsor conducted an additional clinical study, the confirmatory SMART Practices Study, to provide additional supportive safety and effectiveness data.

Confirmatory Study:

The confirmatory SMART Practices Study was a prospective, single-arm, multicenter study that evaluated the safety and weight loss effectiveness of the SMART Device in addition to a DVD weight loss education program for overweight and obese individuals with BMI between 27 and 35 kg/m². A total of 146 subjects were consented at 4 US investigational centers. Seventy-six (76) subjects were enrolled in the Intent-to-Treat (ITT) population, and 67 subjects completed the last study visit (study period was 16 weeks). Subject assessments occurred every two weeks at which time the subjects were weighed, assessed for any adverse events, and watched an educational DVD. During the biweekly visits, adherence data were taken from the SMART sensor and uploaded to a computer using the Client Software. Enrollment included a 5-day consecutive run-in period where subjects self-evaluated the fit of the device, a healthcare provider examined and confirmed the fit, and subjects were instructed to use the device during every eating episode, including meals, snacks, and sugar-sweetened beverages.

The study included two pre-specified co-primary endpoints. The first co-primary endpoint evaluated whether at least 40% of the subjects would be observed to have at least 5% weight loss (%TBWL), while the second co-primary endpoint evaluated whether the observed mean %TBWL would be at least 4%. These primary endpoints assessed weight loss at week 16 relative to baseline and were analyzed in the Per Protocol (PP) population. The PP population included

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subjects who used the device for at least 33% of all meals and at least 7 times per week for at least 14 of the 16 study weeks, and completed the final study visit.

Secondary endpoints included: mean %Excess Weight Loss (%EWL), mean absolute weight loss (AWL), proportion of subjects achieving greater than 4%TBWL proportion of subjects achieving greater than 12% EWL, relationship between SMART Device usage and weight loss, and scores on an objective clinical evaluation of the fit of the device (SMART Fit Acceptability Sub Study: dental professionals assessed clinical fit of the device in 20 subjects).

The confirmatory study results demonstrated that 30% (12 of 40) of the subjects in the PP population had at least 5% TBWL, thus this co-primary endpoint was not met. The 95% CI for this success rate was [17%, 47%]. In regard to the second co-primary endpoint, the mean %TBWL observed in the PP population was 2.9% [95% CI: 1.8%. 4.1%] and the co-primary endpoint was not met. Although not a pre-specified primary endpoint analysis, the ITT population demonstrated that 20.9% (15 of 76) had at least 5% TBWL and mean TBWL was 2.2%.

In regard to secondary endpoint results, the mean %EWL in the PP and ITT populations was 18.76% and 13.66%, respectively. Mean AWL was 2.35 kg and 1.70 kg in the PP and ITT population, respectively. Forty (40) percent (16 of 40) of the PP and 28.9% (22 of 76) of the ITT population had at least 4% TBWL at week 16. In addition, 60% (24 of 40) of the PP and 47.4% (36 of 76) of the ITT population achieved at least 12% EWL at week 16. Weight loss was associated to some degree with the level of device use, however, higher use did not necessarily lead to greater weight loss success. One hundred percent (20 of 20) of subjects assessed for fit by dental professionals were determined to have good clinical fit.

In regard to safety, the confirmatory study demonstrated that there were twenty-four (24) adverse events reported for 12 subjects in the study (15.8%). Of those 24 events in 2 subjects were considered as being possibly related to the device. The three events were a hard palate abrasion and two tongue lacerations that were all considered moderate in severity and resolved without medical intervention. All subjects that had possibly device-related adverse events completed the study.

Consumer Preference Study:

In a separate consumer and provider acceptance study, 24 subjects who had a BMI of at least 26.5 kg/m² were initially weighed and fitted for a device. The primary goal of this testing was to measure subject acceptance and satisfaction with the device, and satisfaction with weight loss, over 30 days. A secondary goal was to assess provider experiences. Subjects reported comfortable use within 1-3 days of exposure to the device and acceptance and satisfaction were high. While all 24 subjects lost weight at the 30 day weigh-in. 19 of the 24 (79%) lost more than 4 pounds with a mean weight loss of 5.9 pounds and an average of 75% usage during eating periods. Providers were satisfied with the ease of the mold fitting, minimal office time needed, device quality, and motivation of subjects.

LABELING

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The labeling includes a Device User Guide, Physician's Instructional Guide, Palatal Mold-Making Instructions, and package labels for the SMART Device. The labeling provided satisfies the requirements of 21 CFR § 801.109 Prescription devices. The Device User Guide and Physician's Instructional Guide address some of the hazards and risks of the device for the intended use and incorporate safety statements to mitigate these risks. The labeling includes:

. Safety instructions intended to minimize the risks of improper insertion, removal and use of the SMART Device.
Contraindications and warnings to ensure usage of the device for the intended patient . population.
A detailed summary of the clinical testing including device effectiveness and device related . adverse events
. Palatal Mold making instructions for the physician.

RISKS TO HEALTH

The table below identifies the risks to health that may be associated with use of Oral removable palatal space occupying device for weight management and the measures necessary to mitigate these risks.

RISK MITIGATION:

Identified Risk	Mitigation Method
Tooth Movement, Irritation and Soreness of Mouth or Gums,Improper mold making User error Damage to material (soft edge separation)	Non-clinical Performance TestingLabelingTraining
Choking or Gag Reflex	Clinical Performance TestingLabeling
Adverse Tissue Reaction	Biocompatibility Evaluation
Incorrect data interpretationHardware Malfunction (sensor malfunction)	Non-clinical Performance TestingLabelingTraining
Electrical Shock and Electrical Interference With Other Devices	Non-clinical Performance Testing
Weight Gain	Clinical Performance TestingLabeling

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SPECIAL CONTROLS:

In combination with the general controls of the FD&C Act, the Oral removable palatal space occupying device for weight management is subject to the following special controls:

1. The patient-contacting components of the device must be demonstrated to be biocompatible for its intended use.
1. Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions for use, as follows:
- a) Mechanical testing must demonstrate that the device performs as intended for the labeled use life and does not create forces that result in movement of teeth and damage to teeth.
- b) Electrical safety and electromagnetic compatibility testing must demonstrate that the device performs as intended.
- c) Software verification and validation must demonstrate that the device performs as intended.
- d) Battery testing must demonstrate that the device battery performs as intended.
1. Clinical performance testing must demonstrate the device performs as intended and must include an evaluation for choking.
1. Device labeling must address the following:
- a) Patient labeling must state:
  - the clinical benefit of weight management and/or weight loss as assessed by 1. using percent total body weight loss;
  - ii. treatment must be offered in combination with a behavioral modification program:
  - iii. instructions on how to use the device as intended; and
  - iv. the use life of the device.
- b) Phvsician labeling must state:
  - the clinical benefit of weight management and/or weight loss as assessed by i. using percent total body weight loss;
  - ii. treatment must be offered in combination with a behavioral modification program;
  - iii. instruction on how to use the device as intended; and

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iv. the use life of the device.
1. Training must be provided to health professionals that include procedures for determining a patient's oral health status, instructions for making the palatal mold, and assessment of issues with the device that may require service by the manufacturer.

BENEFIT/RISK DETERMINATION

The risks of the device are based on data collected in clinical studies described above. The pivotal study demonstrated that there were 6 device-related adverse events (transient choking on food (n=2), gag reflex on insertion (n=1), mouth soreness (n=1) and gum irritation (n=2)) in 5 subjects that were non-serious and resolved quickly without need for further medical intervention. No serious adverse events (SAEs) were associated with use of the SMART Device in the pivotal study. In the confirmatory study, there were twenty-four (24) adverse events reported for 12 subjects in the study (15.8%). Of those 24 events in 2 subjects were considered as being possibly related to the device (hard palate abrasion (n=1) and tongue lacerations (n=2) that were all considered moderate in severity and resolved without medical intervention. Therefore, the device has a very low-risk and favorable safety profile, with the only device related adverse events being transient in nature and resolving without medical intervention.

The probable benefits of the device are also based on data collected in clinical studies as described above. The pivotal study demonstrated that the ITT population lost 1.65% TBWL at 16 weeks as compared to the control group that lost 0.36% TBWL. The pivotal study did not meet the primary efficacy hypothesis (a statistically significant difference in weight loss between SMART Device users and control subjects at the end of four months of treatment) as only 20.6% (21 of 102) lost more than 5% TBWL as the end of the 16 week study as compared to 5.6% (4 of 71) of the control group that lost more than 5% TBWL (p= 0.0059). The PP population demonstrated 4.39% TBWL as compared to the control group that demonstrated 0.29% TBWL at 16 weeks (the second co-primary endpoint that mean %TBWL would be at least 4% in PP population was met). In the confirmatory study, the ITT population lost 2.2% TBWL. The confirmatory study did not meet the co-primary study endpoints (Endpoint 1) at least 40% of the subjects would be observed to have at least 5% TBWL and 2) the observed mean %TBWL would be at least 4%) as only 30% (12 of 40) of the subjects in the PP population had at least 5% TBWL and the %TBWL observed in the PP population was 2.9%.

The effectiveness results from the pivotal and confirmatory studies for the SMART Device demonstrated minimal weight loss of 1.65 to 2.2% at 16 weeks in patients who used the device when compared to baseline. This level of effectiveness is not clinically significant as it is less than 5% TBWL. Hence the device is not appropriate for an indication of weight loss. However, the results do demonstrate that patients who used the device were able to maintain weight at 16 weeks when compared to baseline. Therefore, the SMART Device (based on the pivotal and confirmatory studies) has demonstrated effectiveness when used as a weight management tool.

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In conjunction with the indication that specifies that the device is effective for weight management, the probable benefits of a small amount of weight loss outweigh the few risks of the device.

An additional factor to be considered in determining probable risks and benefits for the SMART device include robustness of the analysis of the study results and degree of the effectiveness. As stated above, due to failure to meet the pre-specified primary endpoints, high dropout rates, and non-compliance of device usage in the pivotal study, the Sponsor conducted the confirmatory SMART Practices Study. The results of the pivotal study were repeatable as the confirmatory study demonstrated a similar TBWL in the treatment group (1.65 vs 2.2 %TBWL, respectively). As stated above, the low risks of the device are outweighed by the devices effectiveness as a weight management device.

Patient Perspectives

Patient perspectives considered for the SMART Device included the evaluation of a consumer preference study that assessed acceptance and satisfaction with use of device and weight loss achieved. over 30 days in 24 patients. Subjects reported comfortable use within 1-3 days of exposure to the device and acceptance and satisfaction was high. While all 24 subjects lost weight at the 30 day weigh-in, 19 of the 24 (79%) lost more than 4 pounds with a mean weight loss of 5.9 pounds and an average of 75% usage during eating periods.

Benefit/Risk Conclusion

In conclusion, given the available information above, the data support the device to be used as an aid for weight management in overweight to obese individuals with a body mass index (BMI) in the range of 27-35 kg/m² in conjunction with behavioral modification instruction, and the probable benefits outweigh the probable risks for the SMART Device. The device provides benefit as a weight management device and the risks can be mitigated by the use of general and the identified special controls.

CONCLUSION

The de novo for the SMART Device is granted and the device is classified under the following:

Product Code: ONY Device Type: Oral removable palatal space occupying device for weight management and/or weight loss Class: II

Regulation: 21 CFR 876.5981

Regulation Number and Section

§ 876.5981 Oral removable palatal space occupying device for weight management and/or weight loss.

(a)
Identification. An oral removable palatal space occupying device for weight management and/or weight loss is a prescription device that is worn during meals to limit bite size, thereby reducing the amount of food that is consumed. The device may contain recording sensors for monitoring patient use. This classification does not include devices that are intended to treat any dental diseases or conditions(b)
Classification. Class II (special controls). The special controls for this device are:(1) The patient-contacting components of the device must be demonstrated to be biocompatible for its intended use.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions for use, as follows:
(i) Mechanical testing must demonstrate that the device performs as intended for the labeled use life and does not create forces that result in movement of teeth and damage to teeth.
(ii) Electrical safety and electromagnetic compatibility testing must demonstrate that the device performs as intended.
(iii) Software verification and validation must demonstrate that the device performs as intended.
(iv) Battery testing must demonstrate that the device battery performs as intended.
(3) Clinical performance testing must demonstrate the device performs as intended and must include an evaluation for choking.
(4) Device labeling must address the following:
(i) Patient labeling must state:
(A) The clinical benefit of weight management and/or weight loss as assessed by using percent total body weight loss;
(B) Treatment must be offered in combination with a behavioral modification program;
(C) Instructions on how to use the device as intended; and
(D) The use life of the device.
(ii) Physician labeling must state:
(A) The clinical benefit of weight management and/or weight loss as assessed by using percent total body weight loss;
(B) Treatment must be offered in combination with a behavioral modification program;
(C) Instructions on how to use the device as intended; and
(D) The use life of the device.
(5) Training must be provided to health professionals that includes procedures for determining a patient's oral health status, instructions for making the palatal mold, and assessment of issues with the device that may require service by the manufacturer.