(109 days)
The intended use of the Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702 is to provide muscle relaxation therapy by delivering heat and soothing massage. Additionally, the product provides topical radiant infrared heat for:
-Temporary relief of minor muscle and joint pain stiffness
-Temporary relief of minor joint pain associated with arthritis
-Temporary increase in local circulation where applied
- Relaxation of muscles
The Air Cell Massager (only CGM MB-1701) is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in blood circulation to the treated areas. The Air Cell Massager stimulates kneading of tissues by using an inflatable garment.
The Ceragem Automatic Thermal Massager with Air Cell Massager is an updated version of the predicate device with an addition of a leg massaging feature. This feature utilizes an "air compression transfer," and its principle is as follows: Air Cell Massager consists of an air pump, air pressure sensor, and sleeves working together as one unit. The air pump is connected to the dedicated sleeves via a series of hoses; each sleeve has 4 compression chambers. The compression massage direction is from foot to thigh. By inflating the air chambers sequentially and then deflating as one cycle, the pressure can be adjusted to avoid any discomfort to the patient. The sleeve works under the action of sensor and microprocessor. Software controls the timing and pressure cognized to the sensor, cycling airflow into and out of sleeves to compress body.
The provided text is related to a 510(k) premarket notification for a medical device (Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702). It discusses the device's indications for use, description, and a comparison to predicate and reference devices to demonstrate substantial equivalence.
However, the document does not contain information about acceptance criteria, a specific study proving the device meets those criteria, sample sizes for test or training sets, data provenance, expert ground truth establishment, adjudication methods, or MRMC studies. The document specifically states "The subject device has undergone safety and performance tests, and the results conformed with the test requests," and lists several non-clinical tests (Skin Temperature Study, Usability Study, EMC and electrical safety testing, software validation, and Biocompatibility studies). These are general tests demonstrating safety and compatibility, not a study designed to evaluate performance against specific clinical acceptance criteria as typically seen for AI/ML devices.
Therefore, I cannot provide the requested information from the given text. The text does not detail a study proving the device meets specific performance acceptance criteria for clinical efficacy or accuracy in the way the prompt implies (e.g., for an AI/ML algorithm). The listed tests primarily focus on electrical safety, EMC, biocompatibility, software functionality, and user manual usability, which are safety and basic functional performance aspects, not clinical performance against acceptance criteria.
§ 890.5880 Multi-function physical therapy table.
(a)
Identification. A multi-function physical therapy table is a device intended for medical purposes that consists of a motorized table equipped to provide patients with heat, traction, and muscle relaxation therapy.(b)
Classification. Class II (performance standards).