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510(k) Data Aggregation
(255 days)
Omm Imports d/b/a Zero Gravity
The Elevare Plus is an Over-the-Counter (OTC) device intended for the use in treating wrinkles on the face.
The Elevare Plus is an over-the-counter, battery powered, hand-held light emitting diode (LED) device that emits light energy in the red and I/R spectrum for the treatment of wrinkles on the face. The system components include the handheld unit containing the LED array, 2 Li-ion rechargeable batteries, power adapter, charging cord, charging cradle and travel case.
The unit is applied directly to the skin to ensure consistent administration of light during each treatment. The device does not contain any user serviceable components. The device is sold as Over the Counter (OTC).
The provided text does not contain information about acceptance criteria or a study that proves the device meets the acceptance criteria in the way typically found for AI/ML medical devices. The document is a 510(k) summary for a light-based device (Elevare Plus) intended for wrinkle reduction, and its focus is on demonstrating substantial equivalence to predicate devices based on safety and performance testing, rather than a clinical study with detailed performance metrics against a defined acceptance criterion.
However, I can extract the relevant information from the document that pertains to how the device's performance was evaluated and compared, even if it doesn't align perfectly with the structure requested for AI/ML device studies.
Here's an interpretation based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in terms of clinical efficacy endpoints or statistical thresholds for AI/ML performance. Instead, it demonstrates performance through technical specifications and comparison to predicate devices. The "acceptance criteria" are implied to be meeting technical specifications and demonstrating "substantial equivalence" to other legally marketed devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Conformity to Electrical Safety Standards | IEC/EN 60601-1:2005 Edition 3/(R)2012 And A1:2012 (Medical Electrical Equipment) Met. |
| Conformity to EMC Standards | IEC 60601-1-2 Edition 4: 2014 (Electromagnetic Disturbances) Met. |
| Conformity to Biocompatibility Standards | ISO 10993-1:2009/(R) 2013, ISO 10993-5:2009/(R) 2014, ISO 10993-10 Third Edition 2010-08-01 (Biological Evaluation) Met. |
| Conformity to Photobiological Safety Standards | IEC 62471 First Edition 2006-07 (Photobiological Safety) Met. |
| Conformity to Home Healthcare Environment Standards | IEC 60601-1-11 Edition 2.0 2015-01 (Home Healthcare Environment) Met. |
| Software Validation | Software was tested and validated in accordance with FDA's "Guidance for the content of Premarket Submissions for Software Contained in Medical Devices." |
| Skin Temperature (within 41+/- 2 ºC and not above 43 ºC) | Two devices tested; temperatures recorded every 1 minute for up to 30 minutes. Test results concluded the device was within specification of 41+/- 2 ºC and did not elevate skin temperature above 43ºC under nominal use conditions (continuous movement). |
| Wavelength/Power Output (meets specifications) | Tested for Radiant Flux (Output energy, W) and Output energy Spectral distribution (W/nm) to ensure product meets specifications. (Specific values not provided in this summary, but confirmed to be within specification.) |
| Substantial Equivalence to Predicate Devices (overall technical characteristics and safety/efficacy) | Evaluation testing compared the Elevare Plus to several FDA cleared devices with the same indications for use. Conclusion: "the Elevare Plus device is substantially equivalent to other legally marketed devices" based on: same indications, treatment time, regime; similar infrared wavelength to reference devices; differences in number of LEDs/treatment surface/power output don't affect safety/efficacy. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: For "Skin Temperature Testing", two devices were tested. For "Predicate Comparison Testing," "several FDA cleared devices" were evaluated against the Elevare Plus device. No other specific sample sizes for testing are mentioned.
- Data Provenance: The testing appears to be prospective bench testing and performance testing conducted by the manufacturer specifically for this submission. The origin of the data (country) is not explicitly stated but is implied to be part of the manufacturer's testing efforts.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is generally not applicable to a submission for a physical device like the Elevare Plus, which relies on technical performance and safety testing rather than interpretation of data by human experts for ground truth. The "ground truth" here is defined by physical measurements against established engineering and safety standards.
4. Adjudication Method for the Test Set
Not applicable. The testing described involves objective measurements against established standards, not interpretation or adjudication by multiple human readers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. An MRMC study is relevant for assessing the diagnostic performance of an AI system, often comparing AI-assisted vs. unassisted human performance. This document describes the safety and engineering performance of a physical light therapy device, not an AI/ML diagnostic algorithm.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This refers to AI/ML algorithm performance. The Elevare Plus is a physical device, not an AI/ML algorithm, so this concept is not applicable.
7. The Type of Ground Truth Used
The ground truth used for the performance evaluation described in this summary consisted of:
- International consensus standards for electrical safety, EMC, biocompatibility, photobiological safety, and home healthcare environments.
- Manufacturer's internal specifications for software validation, skin temperature limits (41+/- 2 ºC, not above 43ºC), and wavelength/power output.
- Technical characteristics and documented performance of legally marketed predicate and reference devices (as detailed in their 510(k) summaries) for comparison purposes to establish substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. The Elevare Plus is a physical light therapy device, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device submission.
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