(55 days)
The LILY device is indicated for muscle conditioning to stimulate healty muscles.
The device is not intended to be used in conjunction with therapy or treatment of medical disease or medical conditions of any kind.
The device is intended to be operated by a trained professional who is present to monitor treatment.
The DEKA LILY device consists of a main unit that generates electrical pulses and delivers rectangular biphasic waveforms via electrodes incorporated in an EMS applicator connected to the main unit.
The delivery of the electrical energy is controlled by a footswitch.
The DEKA LIL Y is provided with an applicator to perform EMS (Electrical Muscle Stimulation).
The applicator is provided with two different tips: Large and Medium, used to treat areas having different sizes, which include 3 stainless-steel equidistant electrodes.
The Applicator is directly applied on the area to be treated and moved by the operator across the skin.
The overall weight is approximately 62 kg and the sizes 47cm x 56cm x 106cm (L x W x H).
Electrical requirements: 115V, 50/60Hz, 2300VA.
Here's a breakdown of the acceptance criteria and study information for the DEKA LILY device, based on the provided FDA 510(k) summary:
Important Note: The provided document is a 510(k) summary for a Powered Muscle Stimulator (DEKA LILY). For this type of device, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are primarily focused on safety and electrical performance to demonstrate substantial equivalence to a predicate device, rather than diagnostic accuracy or clinical efficacy studies that would typically involve AI/ML models. Therefore, many of the questions related to AI/ML model evaluation (e.g., ground truth, expert adjudication, MRMC studies) are not applicable in this context.
1. Table of Acceptance Criteria and Reported Device Performance
For the DEKA LILY, acceptance criteria are generally defined by compliance with recognized electrical safety and performance standards for muscle stimulators, and a comparison to a legally marketed predicate device.
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance (DEKA LILY) | Comparison to Predicate (Legend Pro DMA) | Comment on Acceptance |
|---|---|---|---|---|
| Electrical Safety | ANSI AAMI ES60601-1 | Compliant | N/A (Standard Compliance) | Met |
| IEC 60601-1-2 (EMC) | Compliant | N/A (Standard Compliance) | Met | |
| IEC 60601-2-10 | Compliant | N/A (Standard Compliance) | Met | |
| Patient Leakage Current - Normal Condition | Limit: |
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).