(30 days)
The ActiGraph CentrePoint Insight Watch is a small worn activity monitor designed for document associated with applications in physiological monitoring. The device is intended to monitor the activity associated with movement during sleep. The Insight watch can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable.
The ActiGraph CentrePoint Insight Watch is a compact, battery-operated wearable activity recording device with physical characteristics similar to those of a small wristwatch. The watch is intended to acquire and store data from an onboard accelerometer while being worn during normal activities and/or during sleep. The data record is timestamped and stored in non-volatile memory for later retrieval. Downloaded data can be post-processed based on the timestamp and magnitude of acceleration along each axis.
The housing is constructed of a combination of opaque and clear copolyesters formulated specifically for medical devices (i.e., tested and determined biocompatible), and the core data collection sensor is a 3-axis microelectromechanical system (MEMS) accelerometer. A charging dock connected to a USB power source is used to charge the device battery and communicate with a PC or peripheral.
The ActiGraph CentrePoint Insight Watch is a wrist-worn activity monitor designed for physiological monitoring, particularly for tracking movement during sleep to analyze circadian rhythms and assess physical motion.
Here's a breakdown of the acceptance criteria and supporting studies:
- Table of acceptance criteria and the reported device performance:
| Characteristic | Acceptance Criteria (Predicate Device K080545) | Reported Device Performance (Subject Device K181077) |
|---|---|---|
| Indications for Use | Rx Only; A small worn activity monitor designed for documenting physical movement associated with applications in physiological monitoring. The device is intended to monitor the activity associated with movement during sleep. Can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable. | Same |
| Materials of Construction | Polycarbonate (housing); Nylon & Velcro® (wrist band) | Different: Combination Copolymer (housing); Silicon (wrist band), conforms to 10993-1 Fourth edition 2009-10-15 |
| Power Source | Lithium Ion Battery Rechargeable via USB | Same |
| Accelerometer Type | Microelectromechanical system (MEMS)-based integrated circuit | Same |
| Accelerometer Sampling Rate | 30 Hz, Analog method | Different: Digital method, 32 Hz – 256 Hz |
| Accelerometer Dynamic Range | +/- 5 g | +/- 8 g |
| Firmware | Embedded C | Embedded C (updated version) |
| Wireless Communications Interface | Polar® module | Different: Bluetooth® Low Energy; conforms to AAMI / ANSI / IEC 60601-1-2, Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests and IEC 60601-1-2, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances – Requirements And Tests. |
| Memory | 1024kB | 512 MB |
| Heart Rate | BPM | Same |
| Accelerometer Sensitivity | 4 milli-g per Least Significant Bit | Different: 2.4 milli-g per Least Significant Bit |
| Storage Temperature | -10 °C to 50 °C | Same |
| Operating Temperature | 0 °C to 40 °C | Different: -10°C to 55°C (discharging); 0°C to 45°C while charging |
| Water Resistance | IP21 (condensation) | Minimum IP57 (1m for 30 minutes) |
| Weight | 51 grams | 33 grams |
| Size | Width: 3.37 in (85.6 mm); Height: 1.5 in (38.1 mm); Thickness: 0.6 in (15.2 mm) | Width: 1.41 in (35.8 mm); Height: 1.97 in (50.1 mm); Thickness: 0.41 in (10.5 mm) |
| Recording Time @ 1 min. Epoch | 14 days | 30 days |
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The document states that "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence." Therefore, there is no clinical test set described in this submission. The "test set" in this context refers to devices used for non-clinical bench testing. The sample size for these non-clinical tests is not explicitly mentioned, nor is the provenance of data for these tests beyond being "bench testing." -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical test set for ground truth establishment is described. The acceptance is based on substantial equivalence to a predicate device through non-clinical bench testing.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no clinical test set requiring adjudication is described.
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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: Not applicable. This device is an activity monitor, not an AI-assisted diagnostic tool that would involve human readers or MRMC studies.
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If a standalone (i.e., algorithm only without human-in-the loop performance) was done: The document describes the device as a standalone activity monitor that records and stores data from an accelerometer. Non-clinical bench testing was performed to demonstrate its performance and reliability in this standalone function. The "study" mentioned is the series of non-clinical bench tests performed to support substantial equivalence.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the non-clinical tests, the "ground truth" would be established engineering specifications and recognized voluntary consensus standards. For example, accelerometer dynamic range, sampling rate, memory capacity, water resistance, weight, size, and recording time were compared against the predicate device's capabilities and against the device's own internal specifications validated through bench testing. The non-clinical bench tests included:
- Performance and reliability testing
- Comparative data analysis
- Basic safety and essential performance in accordance with AAMI ES60601
- Electromagnetic compatibility (EMC) in accordance with IEC 60601
- Biocompatibility and material standards confirms there is no harm to the patient wearing the device.
- System compatibility with ActiGraph software for data download and collection
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The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set for model development.
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How the ground truth for the training set was established: Not applicable, as there is no training set for an AI/ML model for this device.
§ 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.