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510(k) Data Aggregation
(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: < 100 µA (FDA Guidance), Standard Limits | 0.1 µA | Predicate: 1.5 µA | Met (Compliant) |
| Patient Leakage Current - Single Fault Condition | Limit: < 500 µA (FDA Guidance), Standard Limits | 2 µA | Predicate: 40 µA | Met (Compliant) |
| Functional/Output Specs | Waveform | Biphasic | Identical | Met |
| Shape | Rectangular | Identical | Met | |
| Max Output Voltage | 60V@500Ω, 200V@2kΩ, 360V@10kΩ | Identical | Met | |
| Max Output Current | 120mA@500Ω, 100mA@2kΩ, 36mA@10kΩ | Identical | Met | |
| Pulse Width | 25 to 400 µs | Predicate: 20 to 400 µs | Almost Identical | |
| Frequency | 0.78, 1.56, 3.13, 6.25, 12.5 Hz | Identical | Met | |
| Net Charge @ 500 ohms | 0µC (biphasic, symmetrical) | Identical | Met | |
| Max Phase Charge | 24 µC @ 500Ω @12.5 Hz | Identical | Met | |
| Max Current Density | 1.1mA/cm² @ 500Ω | Identical | Met | |
| Max Power Density | 0.0044mW/cm² @500Ω | Identical | Met | |
| Software | Verification & Validation | Conducted according to FDA guidance | Predicate: Yes | Met (Compliant) |
| Biocompatibility | ISO 10993-1 | Performed according to FDA guidance | N/A (Standard Compliance) | Met |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable as the studies cited are primarily non-clinical electrical safety and performance testing, and engineering comparisons to a predicate device. There is no "test set" of patient data in the context of an AI/ML model for diagnostic performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. Ground truth for an AI/ML model is not relevant here. The "ground truth" for this device's performance is adherence to recognized industry standards for electrical safety and functional output.
4. Adjudication Method for the Test Set
Not applicable. There is no test set requiring adjudication in the context of this 510(k).
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a powered muscle stimulator, not an AI-assisted diagnostic tool. No human reader studies (MRMC) were conducted or are relevant for this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not feature a standalone algorithm or AI component in the sense of image analysis or diagnostic support. Performance is evaluated based on its physical and electrical characteristics.
7. The Type of Ground Truth Used
The "ground truth" for this submission is based on:
- Engineering specifications and measurements: Direct measurement of electrical outputs (voltage, current, pulse width, frequency, leakage current).
- Compliance with international and national standards: Adherence to IEC 60601 series for medical electrical equipment safety and essential performance, and FDA guidance for powered muscle stimulators.
- Substantial equivalence to a legally marketed predicate device: Demonstrating that differences do not raise new questions of safety or effectiveness.
8. The Sample Size for the Training Set
Not applicable. There is no AI/ML training set for this device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no AI/ML training set for this device.
In summary, the provided document details a 510(k) clearance for a medical device that operates on established electrical stimulation principles. The "acceptance criteria" and "studies" are focused on demonstrating that the new device is electrically safe, performs within expected parameters for its intended use, and is substantially equivalent to existing predicate devices, according to relevant industry standards and FDA guidance. This is distinct from the detailed performance evaluations required for AI/ML-driven diagnostic devices.
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