(216 days)
The Nu Brilliance Light Pain Therapy system is an Over-The-Counter handheld device intended for the relaxation of muscles and relief of muscle spasms; temporary relief of minor muscle and joint aches, pains, and stiffness; temporary relief of minor pain and stiffness associated with arthritis; and to temporarily increase local blood circulation.
The NuBrilliance Light Pain Therapy device is a lightweight, light emitting diode (LED) device that emits light energy. The NuBrilliance Light Pain Therapy device is an Over-The-Counter (OTC), hand held, ergonomically designed pain relief device that uses the infrared lamp for therapeutic heating. The head consists of four (#4) visible diodes (red lights) in the 625 nm (±5%) spectrum, and (#56) fifty-six infrared diodes (purple lights) in the 940 nm (±5%) spectrum that are used in combination for therapeutic heating. It delivers infrared light to the skin resulting in a safe elevation of the skin temperature for therapeutic effects. The handle of the device contains the electronics of the device including a fan for cooling and an automatic shut-off safety feature. Treatment is controlled by the operator. There are no user settings or adjustments.
This document is an FDA 510(k) premarket notification for the NuBrilliance Light Pain Therapy device. As such, it primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device rather than presenting a detailed clinical study with specific acceptance criteria and performance data in the way one might expect for a novel device.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set details, type of ground truth) are not applicable because the submission explicitly states that no clinical performance data was required or submitted to establish substantial equivalence.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Not explicitly stated in terms of performance metrics, but implied by 510(k) process) | Reported Device Performance (as demonstrated by non-clinical testing and substantial equivalence) |
|---|---|---|
| Safety | Compliance with applicable safety standards, biocompatibility, electrical safety. | * Complies with applicable voluntary standards for biocompatibility. |
- Meets all requirements for overall design, biocompatibility, and electrical safety.
- Passed all testing to confirm output meets design inputs and specifications. |
| Effectiveness (via Substantial Equivalence) | Same intended use and similar technological characteristics as predicate device (K081570). | * Utilizes the same technological characteristics (LEDs emitting light energy). - Has the same intended use (relaxation of muscles, relief of muscle spasms, temporary relief of minor muscle/joint aches/pains/stiffness, temporary relief of minor pain/stiffness associated with arthritis, temporarily increase local blood circulation).
- Emits energy from LEDs with wavelengths of 625 nm and 940 nm (vs. 660 nm and 880 nm for predicate).
- Provides similar irradiance output to the treatment area.
- Desired therapeutic effects from both devices are generated by their emissions creating a local increased temperature.
- Differences do not raise new types of questions regarding safety and effectiveness. |
| Regulatory Compliance | Adherence to FDA regulations (e.g., general controls provisions). | FDA has determined the device is substantially equivalent, allowing marketing subject to general controls. |
2. Sample size used for the test set and the data provenance
- Not Applicable (N/A). The submission explicitly states: "There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with a proven safety and efficacy for the use of the device."
- Therefore, no specific clinical test set data from humans was generated for this 510(k) submission. Non-clinical (bench) testing was performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable (N/A). As no clinical test set data was required, no experts were needed to establish ground truth for a clinical comparison.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable (N/A). No clinical test set.
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 (N/A). This device is a light pain therapy system, not an AI-assisted diagnostic or imaging device used by human readers. No MRMC study was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable (N/A). This is a therapeutic device, not an algorithm, and its performance is assessed against its indicated use and comparison to a predicate device, not as a standalone algorithm.
7. The type of ground truth used
- For demonstrating substantial equivalence and safety: The "ground truth" essentially relies on the established safety and efficacy of the legally marketed predicate device (LED Technologies, LLC DPL™ Therapy System, K081570) and non-clinical testing of the NuBrilliance device itself against engineering specifications and industry standards.
- No clinical ground truth (e.g., pathology, outcomes data) was generated for this submission.
8. The sample size for the training set
- Not Applicable (N/A). This device did not involve machine learning or AI, and therefore no "training set" in that context was used.
9. How the ground truth for the training set was established
- Not Applicable (N/A). 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.