(28 days)
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.
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.
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.
§ 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.