(184 days)
The TherMassager is indicated for use in:
- Relief of minor muscle aches and pains
- Relief of muscle spasm
- Temporary improvement of local circulation (i.e., blood circulation)
- Temporary improvement in the appearance of cellulite
The TherMassager is a self-contained, 9.0 VIDC electrically powered therapeutic massager. The basic configuration is that of an ergonomically rounded hand-held box-like unit. Weight is approximately 4 pounds. The housing is made from medical grade plastic and contains a suction pump, a massage motor and skin rollers. The outside of the unit is affixed with a strap which may be secured over the operators hand to provide additional grip during treatment application. Three treatment rollers are supplied with each unit. The TherMassager unit has I spiral roller, 1 ribbed roller and 1 lobed (contoured) roller. The rollers are made from medical grade silicone elastomer meeting ISO 10993 biocompatibility standards.
The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner requested. This document is a 510(k) premarket notification for a therapeutic massager, the TherMassager.
Instead, the document details the device's substantial equivalence to a predicate device (UPC Therapeutic Massager, K990445) based on a comparison of device characteristics and intended use. The core of this submission is to demonstrate that the new device is as safe and effective as a legally marketed device, not to present novel performance data from a specific study against predefined acceptance criteria.
Therefore, I cannot provide the requested table, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, or ground truth information because this type of data is not present in the provided 510(k) summary.
The closest information available related to "acceptance criteria" is the comparison of device characteristics to the predicate device to establish substantial equivalence.
Here's a breakdown of what can be extracted or inferred based on the document's content, acknowledging the limitations for your specific request:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in a format of "acceptance criteria" versus "reported performance." Instead, the document presents a side-by-side comparison of features between the TherMassager and the predicate device (LPG). Substantial equivalence is the "acceptance criteria" here, meaning the device's characteristics and performance are similar enough to the predicate to be considered safe and effective for the same indications.
| Feature | TherMassager (Reported Device) | LPG (Predicate Device) | Substantially Equivalent? (SF?) |
|---|---|---|---|
| Indications for Use | Relief of minor muscle aches and pains | ||
| Relief of muscle spasm | |||
| Temporary improvement of local circulation | |||
| Temporary improvement in the appearance of cellulite | SAME | YES | |
| Power Requirements | AC/DC Adaptor | ||
| Input = 120 VDC - 60 Hz | |||
| Output = 9 VDC | 120 VAC -- 60 Hz | YES | |
| Weight: Massager | |||
| AC/DC Adapter | 1.8 Kg | ||
| .5 Kg | 2 Kg - Handpiece only | YES | |
| Leakage Current | ≤50 µamp |
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.