(244 days)
The Air Compression Therapy Recovery System (model: MF-AWI.LED.A-801, MF-AWI.LED.B-801, MF-AWI.OLED.A-601, MF-AWI.LED.A-601, MF-AWI.LED.B-601, MF-AWI.OLED.A-401, MF-AWI.LED.A-401, MF-A WI.LED.B-401) is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas. The Air Compression Therapy Recovery System simulates kneading of tissues by using an inflatable garment. This device is Over-The-Counter (OTC). It is intended for use by healthy adults who are over 21 years old.
The Air Compression Therapy Recovery System (model: MF-AWI.LED.A-801, MF-AWI.LED.B-801, MF-AWI.OLED.A-601, MF-AWI.LED.A-601, MF-AWI.LED.B-601, MF-AWI.OLED.A-401, MF-AWI.LED.A-401, MF-AWI.LED.B-401) is a portable inflatable tube massage system which simulates kneading and stroking of leg, arm and hip by the use of inflatable air compression techniques. The device can be used to temporarily increase blood circulation and temporarily relieve minor muscle aches and pains. This device is Over-The-Counter (OTC). It is intended for use by healthy adults who are over 21 years old.
The device utilizes the pneumatically controlled chambers actuated by an electronically controlled air pump and air valve. The pump, air valve and other components are protectively housed within the ABS plastic enclosure of the control unit.
The device consists of a control unit, two RecoveryLeg (air boot with attached hose connector), two RecoveryArm (air arm sleeve with attached hose connector) and one RecoveryPants (air pants with two attached hoses and hose connectors). The RecoveryLeg, RecoveryArm and RecoveryPants work under the action of sensor and microprocessor. Software controls the timing and pressure reflected by the sensor, cycling airflow into and out of the boots, sleeves or pants to compress body.
The device is categorized to have long-term skin contact of greater than 30 days.
Environment of use of the device: Clinics, hospital, athlete training, and home environments.
The provided text is a 510(k) summary for the "Air Compression Therapy Recovery System." It outlines the device's characteristics and its comparison to predicate devices to establish substantial equivalence. However, this document does not contain the specific information required to describe acceptance criteria and a study proving a device meets these criteria in the context of an AI/ML medical device performance evaluation.
The document describes a physical medical device (a massager) and focuses on its electrical safety, EMC, biocompatibility, and software verification as part of non-clinical performance testing. It explicitly states: "Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively."
Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI/ML device from this specific document. The questions you posed, such as "Sample sized used for the test set," "Number of experts used," "Adjudication method," "MRMC comparative effectiveness study," "Standalone performance," and "Type of ground truth," are typically relevant for evaluating the performance of AI/ML algorithms in diagnostic or prognostic applications, which is not the subject of this 510(k) submission.
§ 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).