The SmartByte 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 of 27-35 kg/m² in conjunction with behavioral modification instruction.

Device Description

The Scientific Intake SmartByte device is an oral removable palatal space occupying device that includes a temperature recording sensor to monitor usage. The device includes a Palatal Mold Kit used by a healthcare professional to make the SmartByte device and an optional SmartByte Reader component that connects to a mobile application wirelessly via Bluetooth to allow usage data to be uploaded to assess frequency of device usage, i.e., adherence and patient reported weight management.

AI/ML Overview

The provided document is a 510(k) summary for the SmartByte Device, comparing it to a predicate device (Sensor Monitored Alimentary Restriction Therapy (SMART) Device). The core of the submission is to demonstrate substantial equivalence, primarily for a change in the software platform from a computer-based system to a wireless mobile application.

Based on the document, here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance:

The document does not present explicit "acceptance criteria" in the typical sense of quantitative performance metrics for a medical device's efficacy (e.g., sensitivity, specificity, accuracy for a diagnostic device). Instead, the acceptance criteria are focused on demonstrating that the modifications to the predicate device (specifically, the mobile app and Bluetooth connectivity) do not raise new questions of safety or effectiveness and that the new components function as intended.

The "reported device performance" is a demonstration of equivalence and functional verification rather than clinical outcomes.

Acceptance Criterion (Implicit)	Reported Device Performance
Functional Equivalence of Mobile App & Wireless Reader: The mobile app and wireless reader should perform the same functions as the predicate's PC portal and reader, specifically uploading usage data to assess adherence and patient-reported weight management.	Comparison Table (pages 4-5): States "Yes, Substantially Equivalent" for "Optional User Interface" (SmartByte App vs PC website portal) and "Optional Component" (SmartByte Reader vs SMART Reader). This implies the new interface and reader perform the equivalent function of data upload and display.
Software Integrity & Performance: The SmartByte and SmartByte mobile app software must be verified and validated as appropriate for release.	Verification and Validation Activities (page 5): "Software verification and validation was performed and results demonstrated that the SmartByte and SmartByte added mobile software application (SmartByte App) are appropriate for release."
Electrical Safety of Bluetooth Connection: The added Bluetooth connection must meet established safety standards.	Verification and Validation Activities (page 5): "In addition, the company completed testing per IEC 60950-1 for the added Bluetooth connection."
No New Safety or Effectiveness Questions Posed by Changes: The technological differences (mobile app, wireless reader) should not introduce new risks or alter the fundamental effectiveness.	Conclusion (page 5): "The conversion of the software platform to a mobile medical application with a wireless Reader does not raise new types of safety or effectiveness questions." This is a declarative statement based on the overall assessment and testing performed.
Biocompatibility: The device materials coming into contact with the body must be biocompatible. (This is for the physical oral device, not the software/reader).	Comparison Table (page 4): "The SmartByte device has been shown to be biocompatible per ISO 10993." (Same as predicate)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document does not specify a "test set" in the context of clinical data for efficacy or a specific dataset for algorithm performance. The testing described is primarily software verification and validation testing and electrical safety testing (IEC 60950-1). These types of tests typically involve controlled environments, specific test cases, and simulation rather than a "sample size" of patient data or data provenance from a real-world setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not applicable and not provided for this 510(k) submission. The device is not an AI/ML diagnostic tool requiring expert-established ground truth for image interpretation or similar tasks. The "ground truth" for the software and hardware components would be established by engineering specifications, functional requirements, and recognized safety standards, which are verified through the V&V activities.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable and not provided. Adjudication methods are typically used in clinical studies or studies involving human readers/interpreters to establish a reference standard for ambiguous cases. As this submission focuses on software and hardware functional equivalence and safety, such methods are not relevant.

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:

No, a MRMC comparative effectiveness study was not done. This device is an oral appliance for weight management with a data logging/display component; it is not an AI-assisted diagnostic tool that would typically involve human readers interpreting cases.

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

The device's data upload and display function via the app could be considered an "algorithm only" component in terms of its internal logic. However, the document describes "software verification and validation" (page 5) which confirms its standalone functionality. There is no specific mention of a separate "standalone performance study" in the context of AI algorithm performance metrics (e.g., AUC, sensitivity, specificity). The focus is on the software correctly performing its designed function of data handling and display.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The "ground truth" in this context is based on engineering specifications, functional requirements, and recognized industry standards (e.g., ISO 10993 for biocompatibility, IEC 60950-1 for electrical safety). For the software, the ground truth is that the software correctly processes, stores, and displays data according to its design, and that the wireless communication functions reliably and safely. These are verified through various engineering and software testing methods, not through clinical "outcomes data" or "expert consensus" on diagnostic interpretations.

8. The sample size for the training set:

This information is not applicable and not provided. The device is not an AI/ML model that undergoes a "training" phase with a dataset. The software is developed based on programming logic and then verified through testing.

9. How the ground truth for the training set was established:

This information is not applicable and not provided for the same reason as point 8.

Summary

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

May 18, 2017

Scientific Intake % Janice M. Hogan Regulatory Counsel Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, PA 19103

Re: K171165 Trade/Device Name: SmartByte Device Regulation Number: 21 CFR§ 876.5981 Regulation Name: Oral Removable Palatal Space Occupying Device for Weight Management and/or Weight Loss Regulatory Class: II Product Code: ONY Dated: April 20, 2017 Received: April 20, 2017

Dear Janice M. Hogan:

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.

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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 devicerelated 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.

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/ResourcesforYou/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,

Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known)

K171165

Device Name

SmartByte Device

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) SUMMARY Scientific Intake's SmartByte Device

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Scientific Intake 280 Merrimack Street Suite 503 Lawrence, MA 01843 E-mail: mgibelev@scientificintake.com Phone: 978 626 2637 Contact Person: Marc Gibeley, CEO

Date Prepared:	May 11, 2017
Name of Device:	SmartByte Device
Common or Usual Name:	Oral Removable Palatal Space Occupying Device for WeightManagement and/or Weight Loss (Product Code: ONY)
Predicate Device:	Sensor Monitored Alimentary Restriction Therapy (SMART) Device(DEN150033; Product Code ONY)

Intended Use / Indications for Use

Device Description

Comparison of Technological Characteristics

The purpose of this 510(k) is to modify the predicate SMART device by converting the existing computer-based software to a wireless mobile application. No changes have been made to the SmartByte Device oral component that is inserted and removed by the patient to achieve the intended use. A detailed comparison between the predicate SMART device and the subject SmartByte device is provided below:

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	Subject SmartByte Device	Predicate SMART Device(DEN150033)	SubstantiallyEquivalent (Yesor No)
Intended Use	Aid weight management inoverweight to obese individualsThe SmartByte device is intendedfor prescription use only	Aid weight management inoverweight to obese individualsThe SMART device is intended forprescription use only	Yes; Same
Indications forUse	For individuals with a body massindex (BMI) in the range of 27-35kg/m² in conjunction withbehavioral modification instruction	For individuals with a body massindex (BMI) in the range of 27-35kg/m² in conjunction withbehavioral modification instruction	Yes; Same
User Population	Individuals with a body mass index(BMI) in the range of 27-35 kg/m²	Individuals with a body mass index(BMI) in the range of 27-35 kg/m²	Yes; Same
TechnologicalCharacteristics	Removable palatal spaceoccupying device that includes atemperature recording sensor tomonitor usage	Removable palatal spaceoccupying device that includes atemperature recording sensor tomonitor usage	Yes; Same
Palatal Mold Kit	Used by a healthcare professionalto make the SmartByte device	Used by a healthcare professionalto make the SMART device	Yes; Same
OptionalComponent	A SmartByte Reader that allowsusage data to be uploaded toassess frequency of device usage,i.e., adherence and patientreported weight managementwirelessly	A SMART Reader that allowsusage data to be uploaded toassess frequency of device usage,i.e., adherence and patientreported weight management	Yes,SubstantiallyEquivalent
Use	To be worn during all eatingepisodes	To be worn during all eatingepisodes	Yes; Same
Biocompatibility	The SmartByte device has beenshown to be biocompatible perISO 10993	The SMART device has beenshown to be biocompatible perISO 10993	Yes; Same
Sterilization	Not sold sterile or sterilized byuser	Not sold sterile or sterilized byuser	Yes; Same
Shelf Life	Same labeled shelf life	Same labeled shelf life	Yes; Same
Optional UserInterface	SmartByte App interface with basicprogress information provided touser	PC website portal interface withbasic progress informationprovided to user	Yes,SubstantiallyEquivalent

Verification and Validation Activities

Software verification and validation was performed and results demonstrated that the SmartByte and SmartByte added mobile software application (SmartByte App) are appropriate for release. In addition, the company completed testing per IEC 60950-1 for the added Bluetooth connection.

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Conclusions

The subject SmartByte device is substantially equivalent to the predicate SMART device, with the same intended use and indications and minor technological differences. The conversion of the software platform to a mobile medical application with a wireless Reader does not raise new types of safety or effectiveness questions. The confirmatory software verification and validation testing, as well as testing to IEC 60950-1, further demonstrates that the device performs as intended and is substantially equivalent to the predicate device.

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.