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510(k) Data Aggregation
(224 days)
LightStim Professional LED Bed
The LightStim Professional LED Bed is an over-the-counter device intended to emit energy in the visible and IR spectrum intended to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local blood circulation, and the temporary relaxation of muscles.
The LightStim Professional LED Bed is a device that is similar in design to the bottom half of a tanning bed. It is approximately 6.5 feet in length and 3 feet wide. It has 18,240 LEDs. There is an on/off switch that turns off after 30 minutes of use, and an AC to DC power supply.
This document is a 510(k) premarket notification for the LightStim Professional LED Bed. It focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than a de novo clinical study with specific acceptance criteria and detailed performance metrics as one might find for a novel, higher-risk device.
Therefore, the requested information, particularly regarding specific acceptance criteria, a standalone study demonstrating performance against those criteria, sample sizes for test and training sets, and expert-adjudicated ground truth, is not present in this document in the typical format for a clinical effectiveness study. The focus here is on demonstrating the new device performs similarly to existing, legally marketed devices.
However, based on the provided text, I can infer and extract some relevant points:
1. Table of Acceptance Criteria and Reported Device Performance
Strict "acceptance criteria" for a clinical outcome are not explicitly stated in this document as it's a substantial equivalence submission. Instead, the performance is demonstrated by showing similar characteristics and results to predicate devices, particularly regarding temperature elevation which is linked to the intended use for pain relief and circulation.
| Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance (LightStim Professional LED Bed) |
|---|---|
| Output in milliwatts: 60mW cm$^2$ (matching predicates) | 60mW cm$^2$ (Matches predicates, procured from same manufacturer with exact same specifications) |
| Treatment Time: 5-30 minutes (matching predicates) | 5-30 minutes (Matches predicates) |
| Wavelengths (nm): 630nm, 660nm, 855nm, 940nm (matching predicates) | 630nm, 660nm, 855nm, 940nm (Matches predicates) |
| Skin Temperature Elevation: Within FDA guidelines for ILY category (implied by predicate success) | Fluctuation between 40-41.3 degrees Celsius during 30-minute test. ("almost identical to the readings of the predicate devices") |
2. Sample size used for the test set and the data provenance
The document mentions "The LightStim Professional LED Bed device was tested using the same skin temperature testing as all of the predicate devices. The participants skin temperature was measured..." This implies a test set was used, but the sample size is not specified. The data provenance is implied to be prospective for this specific device's temperature testing, conducted by the manufacturer (LED Intellectual Properties, LLC). Country of origin is not explicitly stated but the manufacturer is based in Irvine, California, USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of information is not applicable here. The "ground truth" for the temperature study is the direct measurement of skin temperature. It does not involve expert adjudication or interpretation as a diagnostic or prognostic AI algorithm would.
4. Adjudication method for the test set
Not applicable. The measurement is direct physical measurement (temperature), not subjective interpretation requiring adjudication.
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
No, a MRMC comparative effectiveness study was not done. This device is not an AI diagnostic or assistive tool, but a therapeutic energy emission device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A "standalone" performance test in the context of an algorithm was not done because this is not an algorithm. However, performance testing of the device itself (e.g., temperature output, electrical safety) was conducted. The temperature testing described ("participants skin temperature was measured...") represents a form of standalone performance measurement for the device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the skin temperature testing was direct physical measurement of skin temperature using a "Mastercool, Infrared Laser Thermometer". For the substantial equivalence claim, the "ground truth" for characteristics like output, wavelengths, treatment time, and safety/performance standards is comparison to the specifications and clearances of the predicate devices.
8. The sample size for the training set
Not applicable. This device is hardware and does not involve AI or machine learning algorithms that require a "training set."
9. How the ground truth for the training set was established
Not applicable. See point 8.
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