(119 days)
The RecoveryAir PRO is an air compression therapy device intended to provide graduated pressure to compression garments. The RecoveryAir PRO is indicated for the temporary relief of minor muscle aches and pains, and for temporary increase in circulation to the treated areas in good health. The RecoveryAir PRO simulates kneading and stroking of tissues by using an inflatable garment.
The RecoveryAir PRO is an air compression therapy device intended to provide graduated pressure to compression garments. The Console (Pressure control unit) supplies air at a regulated pressure to a compression garment worn over the area to be treated. The console contains a compressor which generates the air pressure, valves which control the outlet air, user control panel and firmware which controls the pressure and treatment cycle. The pressure control unit is powered by external DC Power Adapter, plugged into a wall electrical outlet or by a recharqeable battery which can operate the device for more than four hours. The battery is located inside the Console and can be charged while the device operates from a wall electrical outlet. The Prong Plug is used as a dummy hose plug for sealing the second air outlet to prevent air escape when the other outlet is connected to the pressure garment. The Medical grade DC Power Adapter, which is supplied with the device, is powered from the wall electrical outlet (100-240 VAC, 50-60 Hz) and supplies 12 VDC 3A to the Console. The DC power adaptor is also used for charging the Battery. The Battery Pack is located inside the Console's enclosure is used as backup power. When Battery is fully charged it can power the Console for more than four (4) hours. The Battery may be charged during normal operation of the console. The Battery charging time is up to 8 hours. Smart-phone application uses low power Bluetooth wireless to communicate with the Console. The application enables modifying, storage and display of the device's treatment parameters, and start/stop treatment via Bluetooth communication, similar to reference device (K190493).
The provided text describes a 510(k) premarket notification for the RecoveryAir PRO device. This type of submission is a declaration of substantial equivalence to a predicate device, rather than a demonstration of meeting specific performance acceptance criteria through the kind of clinical study typically associated with AI/software as a medical device (SaMD) clearances.
Therefore, the document does not contain the information requested regarding acceptance criteria related to AI performance, sample sizes for test sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance.
The "Performance Data" section (Page 12) refers to standard medical device testing for electrical safety, EMC, biocompatibility, and software verification/validation, which are engineering and quality control tests, not clinical performance studies for an AI/SaMD.
Here's a breakdown of why the requested information is absent:
- Acceptance Criteria for AI Performance: The device (RecoveryAir PRO) is a physical, air compression therapy device. It's regulated as a powered inflatable tube massager (21 CFR 890.5650). While it has a smartphone application with Bluetooth communication (Pages 4, 11), this appears to be for user control and display of parameters, not for an AI algorithm performing a diagnostic or prognostic function. Therefore, there are no AI-specific performance acceptance criteria in this submission.
- Study Design (Test Set, Ground Truth, Experts, MRMC, Standalone): Because the device is not an AI/SaMD performing a medical image analysis or similar task, no such studies (clinical or even retrospective data analysis focused on AI performance) were conducted or reported. The 510(k) relies on demonstrating substantial equivalence to a predicate device based on similar indications for use, technological characteristics, and safety/EMC/biocompatibility testing, not on clinical performance derived from AI output.
- Training Set Information: Similarly, since there's no disclosed AI model for a medical function that would require a "training set" of patient data, this information is not applicable and not present.
In summary, the provided document is a 510(k) for a physical medical device. It does not provide information about AI acceptance criteria or studies proving AI performance because the device, as described, does not appear to incorporate an AI component that performs a medical function requiring such validation.
§ 890.5650 Powered inflatable tube massager.
(a)
Identification. A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.(b)
Classification. Class II (performance standards).