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510(k) Data Aggregation
(52 days)
LUMIWAVE 1X4 INFRARED THERAPY DEVICE
BioCare system's infrared therapy products emit energy in the infrared spectrum for the purposes of elevating tissue temperature; for temporary relief / reduction of minor muscular pain, minor muscular back pain and minor joint pain and stiffness. Additionally, these products are intended to provide a temporary increase in local blood circulation and provide temporary relief of muscle spasms and minor sub-acute or chronic pain associated with arthritis, sprains or strains.
The LumiWave 1X4 Infrared Therapy Device is an over-the-counter, infrared-therapy device, designed to emit energy at infrared frequencies to provide topical heating. The LumiWave 1X4 Infrared Therapy Device provides infrared therapy through the use of an efficient and easy to use set of 4 small pods that delivers infrared light for the purpose of elevating tissue temperature to treat living tissue in the body. Infrared light is delivered to the tissue through 49 Gallium Aluminum Arsenide (GaAlAs) Light Emitting Diodes (LEDs) (per pod) distributed under the each pod cover of the LumiWave 1X4 Infrared Therapy Device. The LEDs used in the LumiWave 1X4 Infrared Therapy Device have average wavelengths of between 880 nm and 893 nm depending on temperature.
The provided text is a 510(k) summary for the LumiWave 1X4 Infrared Therapy Device, which is an infrared therapy device. It does not contain information about acceptance criteria or a study proving the device meets those criteria, as one would expect for a novel device undergoing a rigorous performance study.
Instead, this 510(k) summary is focused on demonstrating substantial equivalence to a previously cleared predicate device (BioCare System's PremIR 818, K042532). The performance data cited is primarily technical specifications of the device itself, rather than clinical performance data against specific acceptance criteria.
Therefore, many of the requested fields cannot be answered from the provided text.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
The document does not specify general "acceptance criteria" for clinical performance. Instead, it details technical specifications and compares them to the predicate device to establish substantial equivalence.
| Characteristic | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (LumiWave 1X4) |
|---|---|---|
| Indications for Use | Equivalent to Predicate Device (PremIR 818) | Same as Predicate Device |
| Wavelength (Central) | Similar to Predicate Device | HIGH Mode: 900 nm; LOW Mode: 899 nm |
| Wavelength (Mean) | Similar to Predicate Device | HIGH Mode: 893 nm; LOW Mode: 890 nm |
| Wavelength (Min) | Similar to Predicate Device | HIGH Mode: 824 nm; LOW Mode: 822 nm |
| Wavelength (Max) | Similar to Predicate Device | HIGH Mode: 941 nm; LOW Mode: 934 nm |
| Delivered Energy | Similar to Predicate Device | 12 – 56 mW/cm² |
| Thermal Control | Skin temperature regulation | Between 40-43°C (HIGH Mode) and 38-41°C (LOW Mode) |
| Electromagnetic Compatibility | Compliant with EN 60601-1-2 | Complies with EN 60601-1-2 |
| General Electrical Safety | Compliant with EN 60601-1 | Complies with EN 60601-1 |
2. Sample size used for the test set and the data provenance
- Sample size: Not applicable. No clinical test set data is provided in this 510(k) summary for performance evaluation against acceptance criteria. The document focuses on technical specifications.
- Data provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No clinical test set data is provided.
4. Adjudication method for the test set
- Not applicable. No clinical test set data is provided.
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 an infrared therapy device, not an AI-based diagnostic tool. No MRMC study was conducted or reported here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is an infrared therapy device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No clinical performance study is detailed with a "ground truth" for patient outcomes. The ground truth for this submission is substantial equivalence to the predicate device based on technical and safety specifications.
8. The sample size for the training set
- Not applicable. The device is a physical infrared therapy device, not an algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable.
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