(182 days)
The VERABAND™ is a compact, lightweight, body-worn activity monitoring device designed to document physical movement associated with applications in physiological monitoring. The device is intended to monitor limb or body movements during daily living and sleep for a limited time interval (up to 30- days).
The VERABAND™ can be used to assess activity in any instance where quantifiable analysis of physical motion is desired. VERABAND™ is not intended for diagnostic purposes.
The VERABANDTM is a compact, wrist-worn battery-operated wearable device intended for collecting a patient's motion data for assessing patient activity. VERABANDTM is intended to acquire and store data while being worn during normal activities and/or during sleep. The device consists of a wearable band with compact housing for battery-powered on-board electronics with an accelerometer. The recorded activity data is timestamped and stored in non- volatile memory for later retrieval. Downloaded VERABANDTM data can be post-processed based on the timestamp and magnitude of acceleration for reporting.
Here's a breakdown of the acceptance criteria and study information for the Veraband™ device based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Accelerometer Accuracy and Precision | - Accelerometer shall meet full-range accuracy requirement. |
- Accelerometer shall meet static calibration point accuracy requirement.
- Accelerometer shall meet repeatability and reproducibility requirement. | Pass |
| Activation Trigger | - Device shall activate at the required light level. - Device shall not activate while in the packaging. | Pass |
| Device Donning/Doffing | Device shall be able to survive the required donning and doffing. | Pass |
| Device Band Separation and Elongation Forces | - Device shall meet force requirements for elongation. - Device shall meet force requirements for separation. | Pass |
| Battery Life for Duration of Use | Device shall meet the battery life requirements for Expected Device Life. | Pass |
| User Cleaning | Device shall maintain function after a required minimum number of cleanings. | Pass |
| Device Sampling Rate and Full-Scale Dynamic Range | Device shall have a sampling rate and full-scale dynamic range that meets the requirements. | Pass |
| Device Frequency Response | Device shall be within the requirement of the predicate's bandwidth. | Pass |
| VERABAND™ Intended Use | Device shall meet repeatability and reproducibility requirements for activity levels. | Pass |
| VERABAND™ Report Generation Comparison | Device output metrics shall meet the predicate comparison requirements. | Pass |
| Usability | Device shall meet the related usability requirement survey scores. | Pass |
| Packaging Testing | Device shall maintain function per requirements after shipping. | Pass |
| EMC | Device shall meet the related EMC requirements. | Pass |
| Electrical Basic Safety | Device shall meet the related electrical basic safety requirements. | Pass |
| Biocompatibility Testing | Device shall meet the related biocompatibility requirements. | Pass |
| Firmware Verification and Validation Testing | Device shall meet the related Firmware requirements. | Pass |
| Software Verification and Validation Testing | Device shall meet the related Software requirements. | Pass |
2. Sample Size and Data Provenance (for test set, if applicable)
The document primarily describes non-clinical engineering and performance testing. It does not explicitly state a "test set" in the context of clinical data. For the "VERABAND™ intended use" test, it states "Simulated users wearing the device perform activities at different intensities of motion and wear compliance times." While it implies subjects, no specific sample size is provided. The data is non-clinical/simulated.
3. Number of Experts for Ground Truth and Qualifications (for test set, if applicable)
Not applicable, as the provided data focuses on non-clinical and simulated testing for performance validation rather than expert-derived ground truth for a test set of patient data.
4. Adjudication Method (for test set, if applicable)
Not applicable. The reported tests are primarily objective engineering and performance validations against predefined criteria, not subjective human evaluations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document explicitly states: "The VERABAND™ did not require clinical studies to support substantial equivalence to the primary predicate device." Therefore, no MRMC study was conducted or reported.
6. Standalone (Algorithm Only) Performance Study
Yes, the majority of the reported testing falls under standalone performance. The "non-clinical testing summary" details various tests (e.g., accelerometer accuracy, battery life, sampling rate, frequency response, report generation comparison) that evaluate the device's technical functionality and performance in isolation or in comparison to a predicate device's output, without human-in-the-loop performance measurement.
7. Type of Ground Truth Used
For the non-clinical tests, the ground truth was based on:
- Established engineering specifications and requirements (e.g., full-range accuracy, required light level, expected device life, minimum number of cleanings, sampling rate, full-scale dynamic range, predicate's bandwidth, repeatability and reproducibility for activity levels, predicate comparison requirements for output metrics).
- Recognized consensus standards (e.g., IEC, ISO, ASTM).
- Simulated motions and user activities.
8. Sample Size for the Training Set
The document does not mention a "training set" in the context of machine learning or AI. The device is described as an activity monitoring device with an accelerometer to acquire and store data, which is then post-processed. It doesn't appear to be an AI/ML-driven diagnostic device that would typically involve a training set for model development.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a "training set" for an AI/ML model. The device's operation relies on sensor data acquisition and processing based on established algorithms and engineering principles, not on a trained machine learning model.
§ 882.5050 Biofeedback device.
(a)
Identification. A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to § 882.9.