(94 days)
The LightStim for Pain LED Belt is an Over-The-Counter device intended to emit energy in the visible and near infrared spectrum 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 for Pain LED Belt is a portable device that has between one and four separate LED pods, each of which has 52 LEDs and are attached to a elastic belt that stretches to encircle different sizes from as small as an ankle to as large as the torso, and attaches to itself with Velcro. Each pod has an LED array of 630nm, 865nm, and 940nm. The device is powered by a separate AC to DC 12-volt power supply and has an on/off switch, with a timer that shuts the device off automatically after 30 minutes of operation. Recommended treatment time is 5 to 30 minutes.
Here's an analysis of the provided text regarding the LightStim for Pain LED Belt, focusing on the acceptance criteria and the study performed:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" with quantitative benchmarks for efficacy. Instead, it describes performance testing related to safety and usability. The closest to performance efficacy is the temperature testing, but without pre-defined acceptance criteria, it's hard to classify it as such for clinical effectiveness.
| Performance Metric | Acceptance Criteria (Implicit/Explicit) | Reported Device Performance |
|---|---|---|
| Safety | ||
| Electrical Safety | Compliance with 60601-1 and 60601-1-2 standards | Device tested according to 60601-1 and 60601-1-2. (Implicitly, it passed these standards, as it was cleared.) |
| Thermal Performance (Therapeutic Intent) | Elevation of tissue temperature to a level that provides "topical heating for the purpose of elevating tissue temperature". No specific target temperature or range for therapeutic effect is stated as an acceptance criterion. | Warmed skin to 40°C or more within 5 minutes on all 3 individuals. Fluctuated between 40.0°C and 41.8°C during the entire 30-minute test. |
| Usability | Ability of users to correctly self-select and understand/use the device based on the instruction manual. No specific percentage or pass/fail threshold is explicitly stated as an acceptance criterion. | 100% of participants correctly self-selected. 97% (32 of 33) correctly answered all 19 questions and demonstrated understanding/use. |
2. Sample Size Used for the Test Set and Data Provenance
- Temperature Testing:
- Sample Size: 3 individuals
- Data Provenance: Not specified, but likely prospective (performed for this submission). No country of origin is mentioned.
- Usability Study:
- Sample Size: 33 male and female participants
- Data Provenance: Not specified, but likely prospective (performed for this submission). No country of origin is mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Temperature Testing: Ground truth is objective temperature measurement. No human expert interpretation is mentioned for establishing the truth of the temperature readings themselves.
- Usability Study: The "ground truth" for the usability study would be the correct answers to the instruction manual questions and correct demonstration of device use. This wasn't established by external experts adjudicating subjective data, but rather by comparing participant responses/actions against the intended use and instruction manual.
4. Adjudication Method for the Test Set
- Temperature Testing: No adjudication method mentioned as the data would be objective sensor readings.
- Usability Study: No adjudication method mentioned. The evaluation seems to have been based on direct observation and participant responses to questions.
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, an MRMC comparative effectiveness study was not done.
- This device, an LED belt for pain relief, is not an AI-powered diagnostic or interpretive device that would typically involve human "readers" or be subject to AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, a standalone (algorithm only) study was not done. This device does not feature an AI algorithm.
7. The Type of Ground Truth Used
- Temperature Testing: Objective physical measurement (temperature readings).
- Usability Study: Compliance with the instruction manual and proper device operation (based on pre-defined correct actions/answers).
8. The Sample Size for the Training Set
- There is no mention of a "training set" as this device does not utilize machine learning or AI algorithms requiring such a set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as no training set was used.
§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.