(49 days)
The Ballancer® Platinum is a pneumatic massage system intended to provide gradient pressure in areas, which the inflatable garment is applied. The Ballancer® Platinum System is indicated for: Simulate kneading and stroking of the tissues by use of an inflatable garment. Temporary increase circulation in the areas which the garment is applied Temporary relief of minor muscle aches and pains
The Ballancer® Platinum is a pneumatic massage system intended to provide gradient pressure in areas, which the inflatable garment is applied.
The provided text is an FDA 510(k) clearance letter for a medical device called "Ballancer Platinum (1222)." This document does not describe the acceptance criteria or a study that proves the device meets the acceptance criteria. It is a regulatory clearance document, not a detailed study report.
Therefore, I cannot extract the requested information (acceptance criteria table, sample size, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, or training set details) from the provided text because it does not contain this information.
The document primarily focuses on the regulatory aspects of the device, such as:
- Device Name: Ballancer Platinum (1222)
- Regulation Number and Name: 21 CFR 890.5650, Powered Inflatable Tube Massager
- Regulatory Class: Class II
- Product Code: IRP
- Indications for Use: Simulating kneading and stroking, temporary increase circulation, temporary relief of minor muscle aches and pains.
- Type of Use: Over-The-Counter Use
- Regulatory Status: Substantially equivalent to legally marketed predicate devices.
§ 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).