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510(k) Data Aggregation
(336 days)
TEXAS APPLIED BIOMEDICAL SERVICES, INC.
The Lumix 3 100W Plus and Lumix 3 250W Ultra IR Laser Systems are intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and / or the temporary relaxation of muscle.
Lumix 3 100W Plus and Lumix 3 250W Ultra IR Laser Systems are laser therapy devices for applications suitable to be used in an ambulatory setting and under the care of a licensed healthcare provider. In particular the device works by providing infrared energy to elevate tissue temperature.
The Lumix 3 series laser therapy heat lamp heat devices deliver visible and invisible laser light at the wavelength of 910 nm (pulsed infrared), 808nm (continuous and interrupted infrared) and 650nm (continuous red visible). The pulsed laser sources used are of diodic type for pulsed working mode; the continuous laser sources used are of diodic type for continuous and frequenced working mode.
The laser light beam produced by the diode is carried to the focusing lens optic fibers with very low attenuation and high mechanical strength. The laser light, produced by the different sources, is emitted in a single bright beam, which at the optical unit output has a diameter equal to at 20mm. The flexible arm can be oriented by the user at will to heat-treat the required tissue area.
The optical unit contains a focusing lens with a high transmission coefficient used to focus the light beam carried by the optical fibers on the tissue to be treated. In order to identify precisely the tissue area to be irradiated, it is important to have a guide light available (650nm red) with a beam collimated with the laser light beam. The guide light allows one to visualize the target site clearly. The red quide light has no therapeutic value.
Here's a breakdown of the acceptance criteria and the study details for the Lumix 3 Plus and Lumix 3 Ultra IR Laser Systems, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Achieve therapeutic heat temperature range of 40 - 45 degrees Centigrade. | The Lumix 3 100W Plus and Lumix 3 250W Ultra IR Laser Systems demonstrated that they meet the generally accepted topical temperature range for therapeutic heat of 40 - 45 degrees Centigrade. |
| Increase in topical heating of tissue level by at least 5 degrees Centigrade. | An increase in topical heating of the tissue level by at least 5° Centigrade was reached within one (1) minute. |
| Maintain therapeutic temperature range for at least ten (10) minutes. | The therapeutic temperature range (40-45°C) was maintained for at least ten (10) minutes. |
| Compliance with EN 60601-1:2007 (Medical Electrical Equipment, Part 1, General Safety) | Bench Testing: Electrical safety and functional performance testing demonstrated compliance with this standard. |
| Compliance with EN 60601-1-2:2007 (Medical Electrical Equipment, EMC) | Bench Testing: Electrical safety and functional performance testing demonstrated compliance with this standard. |
| Compliance with EN 60601-2-22 (Medical Electrical Equipment, Safety of diagnostic and therapeutic laser equipment) | Bench Testing: Electrical safety and functional performance testing demonstrated compliance with this standard. |
| Compliance with EN 60601-1-4:1996 (Programmable electrical medical systems) | Bench Testing: Electrical safety and functional performance testing demonstrated compliance with this standard. |
| Compliance with ISO 13485:2003 (Medical Device Quality Management System) | Bench Testing: Electrical safety and functional performance testing demonstrated compliance with this standard. |
| Compliance with Council Directive 93/42/EEC (EC Declaration of Conformity) | Bench Testing: Electrical safety and functional performance testing demonstrated compliance with this standard. |
| Substantial Equivalence to Predicate Device (ICL 60 Series) | The Lumix 3 100W Plus and Lumix 3 250W Ultra Systems have the same intended uses, and technical, functional and performance characteristics as the predicate devices (ICL 60, Model 100 and Model 250, K042256). The new device does not raise different questions regarding its safety and effectiveness compared to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 8 subjects.
- Data Provenance: The text does not explicitly state the country of origin, but the context of an FDA submission (USA Laser Biotech, Inc. based in Richmond, VA) suggests the study was likely conducted in the United States or at a minimum, for the purpose of U.S. regulatory approval. The study appears to be prospective as it involved measurements on subjects using the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of experts or an "established ground truth" in the traditional sense for this type of device (e.g., diagnostic imaging). The study focuses on direct physical measurements related to temperature, which are objective and do not require expert interpretation as "ground truth."
4. Adjudication Method for the Test Set
Not applicable. As noted above, the study involved direct physical measurements (temperature) which do not require adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No. An MRMC comparative effectiveness study was not done. This type of study is typically relevant for diagnostic devices where human readers interpret medical images or data, and the AI's impact on their performance is being evaluated. The Lumix 3 systems are therapeutic devices that provide topical heating.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, in a way. The device's performance was evaluated based on its ability to produce and maintain therapeutic temperatures. This is a standalone performance evaluation of the device's physical output, independent of human interaction beyond operating the device. The "clinical testing" referenced for temperature measurements represents this standalone assessment of the device's therapeutic effect (i.e., heating).
7. The type of ground truth used
The "ground truth" for the non-clinical and clinical testing was the direct measurement of physical parameters, specifically:
- Therapeutic temperature range: 40 - 45 degrees Centigrade, accepted by the FDA as a therapeutic heat temperature range.
- Temperature increase: At least 5 degrees Centigrade.
- Duration of maintained temperature: At least 10 minutes.
- Pre-exposed topical skin temperature (ranged from 36 to 39 degrees Centigrade) served as a baseline for the temperature increase.
8. The sample size for the training set
Not applicable. The provided document describes a premarket notification (510(k)) and does not mention any artificial intelligence or machine learning component that would require a separate "training set" for an algorithm. The device's operation is based on fixed physical parameters (laser wavelengths, power, pulse rates).
9. How the ground truth for the training set was established
Not applicable, as there is no training set mentioned for an algorithm.
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